HEALTH PRODUCTS (THERAPEUTIC PRODUCTS) REGULATIONS 2016

ARRANGEMENT OF REGULATIONS Regulation PART 1 PRELIMINARY 1. Citation and commencement 2. Definitions 3. Scope of Regulations PART 2 MANUFACTURE AND IMPORT OF THERAPEUTIC PRODUCTS Division 1 — Manufacture 4. Requirements for issue of manufacturer’s licence Division 2 — Import 5. Requirements for issue of importer’s licence 6. Import of therapeutic products containing psychotropic substances PART 3 SUPPLY OF THERAPEUTIC PRODUCTS 7. Requirements for purposes of section 17 Division 1 — Requirements for wholesale supply of therapeutic products 8. Export of therapeutic products containing psychotropic substances 9. Export of codeine cough preparations Regulation 10. Wholesale of therapeutic products containing Second Schedule ingredients Division 2 — Requirements for retail supply of registered therapeutic products 11. Supply by retail sale of prescription-only medicine 12. Supply by administration of prescription-only medicine 13. Supply by retail sale of pharmacy-only medicine 14. Restrictions on supply by retail sale of codeine cough preparations 15. Supply of general sale list medicine by retail sale vending machine Division 3 — Other requirements for supply of therapeutic products 16. Records of supply of prescribed therapeutic products 17. Supply by dispensing therapeutic products Division 4 — Requirements for wholesaler’s licence 18. Requirements for issue of wholesaler’s licence PART 4 PRESENTATION OF THERAPEUTIC PRODUCTS 19. Trade descriptions 20. Information to be provided with therapeutic products 21. Corrective measures in relation to contravening trade descriptions or failure to provide prescribed information PART 5 REGISTRATION OF THERAPEUTIC PRODUCTS 22. Requirements for registration 23. Whether therapeutic product subject to patent 24. Cancellation of registration of therapeutic product subject to patent dispute 24A. Prescribed time for cancellation of registration of therapeutic product for non‑payment of retention fee 25. Offences for making false patent declaration 26. Protection of confidential supporting information relating to innovative therapeutic product applications Regulation 27. Circumstances where protection under regulation 26 does not apply 28. Disclosure of information on applications for registration 29. Registration exclusivity PART 6 DUTIES AND OBLIGATIONS OF MANUFACTURERS, IMPORTERS, ETC., OF THERAPEUTIC PRODUCTS Division 1 — General duties 30. Duty to comply with enforcement requirements 31. Duty to maintain records of manufacture 32. Duty to maintain records of receipt and supply 33. Duty to maintain records of defects and adverse effects 34. Duty to report defects and adverse effects 35. Duty to notify Authority concerning recall Division 2 — Duties specific to licensees 36. Duty of licensed manufacturer 37. Duty of licensed importer 38. Duty of licensed wholesaler 39. Responsible person 40. Offence for contravention of duties 41. Changes affecting licence Division 3 — Duties specific to registrants 42. Changes concerning registered therapeutic product 43. Information on validity of data submitted to or considered by Authority 44. Submission of benefit-risk evaluation reports 45. Duty to carry out risk management plan PART 7 EXCEPTIONS — MANUFACTURE, IMPORT AND WHOLESALE OF THERAPEUTIC PRODUCTS WITHOUT LICENCE Division 1 — Specified healthcare service licensees Regulation 46. Compounding of therapeutic products at approved permanent premises, etc., of specified healthcare service licensees without manufacturer’s licence 47. Transfer of therapeutic products by specified healthcare service licensees without wholesaler’s licence Division 2 — Licensed retail pharmacies 48. Compounding of therapeutic products at licensed retail pharmacies without manufacturer’s licence 49. Wholesale supply by holders of pharmacy licences without wholesaler’s licence Division 3 — Named patients 50. Re-labelling of therapeutic products without manufacturer’s licence 51. Import of therapeutic products for patients’ use without importer’s licence Division 4 — Personal imports 52. Import of therapeutic products for personal use without importer’s licence Division 5 — Wholesale of therapeutic products for export 53. Wholesale of therapeutic products imported solely for export without wholesaler’s licence Division 6 — Other exceptions 54. Import of health products by licensed manufacturer without importer’s licence 55. Wholesale of self-manufactured therapeutic products without wholesaler’s licence 56. Wholesale of therapeutic products to ships or aircraft without wholesaler’s licence 57. Therapeutic products for research or non‑clinical purposes PART 8 EXCEPTIONS — SUPPLY OF THERAPEUTIC PRODUCTS WITHOUT REGISTRATION Regulation 58. Prescribed exceptions 59. Supply of therapeutic products compounded under contractual agreement with licensed manufacturer 60. Previously registered therapeutic products PART 8A EXCEPTION — EMERGENCY THERAPEUTIC PRODUCTS 60A. Manufacture, import and supply of emergency therapeutic product PART 9 MISCELLANEOUS 61. Certification of therapeutic products intended for export 62. Certificate of manufacturing standard of therapeutic products 63. Certificate of distribution standard of therapeutic products 64. Other certificates or documents 65. Product quality surveillances 66. Non-compliant therapeutic products 67. Confidential information 68. [Deleted] The Schedules In exercise of the powers conferred by sections 71 and 72 of the

PART 1 PRELIMINARY Citation and commencement

1. These Regulations are the Health Products (Therapeutic Products) Regulations 2016 and come into operation on 1 November 2016. Definitions

2.—(1) In these Regulations, unless the context otherwise requires —

“acute hospital service”, “ambulatory surgical centre service”, “assisted reproduction service”, “blood banking service”, “community hospital service”, “contingency care service”, “nuclear medicine service”, “nursing home service”, “outpatient dental service”, “outpatient medical service”, “outpatient renal dialysis service” and “radiological service” have the meanings given by paragraph 2 of the First Schedule to the Healthcare Services Act 2020; [S 811/2023 wef 18/12/2023] “administer”, in relation to a substance or article, means to give or apply it to a human being, whether — (a) orally; (b) by injection or by introduction into the body in any other way; or (c) by external application, whether by direct contact with the body or not; “appropriate non-proprietary name”, in relation to an active ingredient of a therapeutic product, means — (a) the name or synonym of the active ingredient described in the relevant monograph appearing in the latest edition of any specified publication; (b) where the active ingredient is not described in a monograph in any specified publication, its international non-proprietary name; or (c) where paragraph (a) or (b) is not applicable, the accepted scientific name or other name descriptive of the true nature of the active ingredient; “appropriate quantitative particulars”, in relation to a therapeutic product, means — (a) the quantity of each active ingredient, identified by its appropriate non-proprietary name, in each dosage unit of the therapeutic product and expressed in terms of weight, volume, capacity or units of activity; or (b) where there is no dosage unit of the therapeutic product, the quantity of each active ingredient, identified by its appropriate non-proprietary name, in the container of the therapeutic product and expressed in terms of weight, volume, capacity or units of activity or percentage by weight or volume of the total quantity; “approved conveyance”, “approved permanent premises” and “permanent premises” have the meanings given by section 2(1) of the Healthcare Services Act 2020; [S 436/2023 wef 26/06/2023] “Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg; “business name”, in relation to a healthcare service licensee, means the name under which the healthcare service licensee is authorised by a licence under the Healthcare Services Act 2020 to carry on the business of providing a licensable healthcare service; [S 436/2023 wef 26/06/2023] “codeine cough preparation” means a therapeutic product that — (a) is in liquid or solid form; (b) contains codeine or its salts; and (c) is intended for the treatment of coughs; [S 732/2021 wef 01/10/2021] “collaborative prescribing practitioner” has the meaning given by regulation 2 of the Healthcare Services (Collaborative Prescribing Service) Regulations 2023 (G.N. No. S 398/2023); [S 436/2023 wef 26/06/2023] “compound”, in relation to a therapeutic product, means to formulate, mix, assemble, package or label the therapeutic product, with the intention of dispensing or administering the therapeutic product to a patient in accordance with the written instructions of a qualified practitioner; “container”, in relation to a therapeutic product, means an article or packaging immediately covering the therapeutic product, including any bottle, ampoule, blister pack, sachet, dial dispenser pack, strip pack, syringe, tube, vessel, vial, wrapper or other similar article, but does not include — (a) an article for ingestion; or (b) an outer package or other packaging in which the container is further enclosed; “dispense”, in relation to a therapeutic product, means to prepare and supply the therapeutic product to a patient, where the preparation and supply is made by — (a) a qualified practitioner or collaborative prescribing practitioner, or a person acting under the supervision of a qualified practitioner or collaborative prescribing practitioner; or [S 119/2018 wef 01/03/2018] (b) a qualified pharmacist or a person acting under the supervision of a qualified pharmacist; “expiry date”, for a therapeutic product, means the date after which, or the month and year after the end of which, the therapeutic product should not be used; “general sale list medicine” means a therapeutic product registered under the classification of “general sale list medicine” in the Register of Health Products; [Deleted by S 436/2023 wef 26/06/2023] [Deleted by S 436/2023 wef 26/06/2023] “healthcare service licensee” means a person who holds a licence under the Healthcare Services Act 2020 to provide a licensable healthcare service; [S 436/2023 wef 26/06/2023] “importer’s licence” means an importer’s licence authorising the holder of the licence to import a therapeutic product under section 13 of the Act; “international non-proprietary name”, for an active ingredient, means a name which has been selected by the World Health Organization as a recommended international non- proprietary name for the active ingredient; [Deleted by S 436/2023 wef 26/06/2023] “licensable healthcare service” has the meaning given by section 3(1) of the Healthcare Services Act 2020; [S 436/2023 wef 26/06/2023] “licensed importer” means the holder of an importer’s licence; “licensed manufacturer” means the holder of a manufacturer’s licence; “licensed retail pharmacy” means premises specified in a pharmacy licence; “licensed wholesaler” means the holder of a wholesaler’s licence; “licensee”, in relation to a therapeutic product, means a licensed manufacturer, licensed importer or licensed wholesaler; “manufacturer’s licence” means a manufacturer’s licence authorising the holder of the licence to manufacture a therapeutic product under section 12 of the Act; [Deleted by S 436/2023 wef 26/06/2023] “non-clinical purpose” means any purpose not involving any application of a therapeutic product on, or use of a therapeutic product by, humans; [Deleted by S 811/2023 wef 18/12/2023] [Deleted by S 811/2023 wef 18/12/2023] “outpatient dental service licensee” means a healthcare service licensee who is authorised to provide an outpatient dental service; [S 436/2023 wef 26/06/2023] “outpatient medical service licensee” means a healthcare service licensee who is authorised to provide an outpatient medical service; [S 436/2023 wef 26/06/2023] “outpatient renal dialysis service licensee” means a healthcare service licensee who is authorised to provide an outpatient renal dialysis service; [S 436/2023 wef 26/06/2023] “personnel”, in relation to a healthcare service licensee providing a licensable healthcare service, means any individual employed or engaged by the healthcare service licensee to assist the licensee in providing a licensable healthcare service; [S 811/2023 wef 18/12/2023] “Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products” means the text of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products as set out on the Authority’s website from time to time; “pharmacy licence” means a licence issued under the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016); “pharmacy-only medicine” means a therapeutic product registered under the classification of “pharmacy‑only medicine” in the Register of Health Products; “prescription-only medicine” means a therapeutic product registered under the classification of “prescription‑only medicine” in the Register of Health Products; [Deleted by S 436/2023 wef 26/06/2023] “proprietary name” means a word or words used in connection with the sale or supply of a therapeutic product for the purpose of indicating that it is the product of a particular person who manufactures, selects the name of, certifies or deals with the therapeutic product, or offers it for sale or supply; “psychotropic substance” means a substance specified in the First Schedule; “qualified pharmacist” means a person who — (a) is registered as a pharmacist under the Pharmacists Registration Act 2007; [S 436/2023 wef 31/12/2021] (b) holds a valid practising certificate granted under section 23 of that Act; and (c) is in active practice as defined in regulation 2 of the Pharmacists Registration (Practising Certificates) Regulations 2008 (G.N. No. S 438/2008); “qualified practitioner” means — (a) a registered medical practitioner under the Medical Registration Act 1997; or [S 436/2023 wef 31/12/2021] (b) a registered dentist under the Dental Registration Act 1999 whose name appears in the first division of the Register of Dentists maintained and kept under

section 13(1)(a) of that Act;

[S 436/2023 wef 31/12/2021] “relevant fee” means a fee specified in the Eighth Schedule to the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022); [S 458/2022 wef 01/07/2022] “remote service kiosk” has the meaning given by regulation 2(1) of the Healthcare Services (Outpatient Medical Service) Regulations 2023 (G.N. No. S 410/2023); [S 436/2023 wef 26/06/2023] “repacking”, in relation to the compounding of a therapeutic product, means removing the therapeutic product from the container in which it is originally supplied by its manufacturer and — (a) placing it in a different container; or (b) changing the outer packaging or other packaging in which the container is further enclosed; “specified healthcare service licensee” means a healthcare service licensee who is authorised to provide any of the following licensable healthcare services: (a) an acute hospital service; (b) an ambulatory surgical centre service; (c) an assisted reproduction service; (d) a blood banking service; (e) a community hospital service; (f) a contingency care service; (g) a nuclear medicine service; (ga) a nursing home service; [S 811/2023 wef 18/12/2023] (h) an outpatient dental service; (i) an outpatient medical service; (j) an outpatient renal dialysis service; (k) a radiological service; [S 436/2023 wef 26/06/2023] “specified publication” means any of the following: (a) the British Pharmacopoeia; (b) the European Pharmacopoeia; (c) the United States Pharmacopoeia and the National Formulary; “supply by retail sale” means sale by retail and includes exposure or display as an invitation to treat; “temporary premises” means any premises other than permanent premises; [S 436/2023 wef 26/06/2023] “therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act; “trade description” means any description, statement or indication which, directly or indirectly and by any means given, relates to any of the following matters in respect of a therapeutic product: (a) the quantity, liquid volume or weight of the therapeutic product; (b) the method of manufacture, production, or processing, of the therapeutic product; (c) the characteristics or composition of the therapeutic product; (d) the fitness for purpose (including expiry date), dosage strength, or intended purpose, of the therapeutic product; (e) any physical characteristics or presentation of the therapeutic product not referred to in paragraphs (a) to (d); (f) the testing of the therapeutic product by any person and the results of the test; (g) the approval of the therapeutic product by any person or its conformity with a product description approved by any person; (h) the place or date of manufacture, production, or processing, of the therapeutic product; (i) the name of the person who manufactured, produced or processed the therapeutic product; “wholesaler’s licence” means a wholesaler’s licence authorising the holder of the licence to supply a therapeutic product by wholesale under section 14 of the Act.

(2) Scope of Regulations

For the purposes of these Regulations, a prescription is valid only if the prescription — (a) is written and signed by a qualified practitioner or collaborative prescribing practitioner; and [S 119/2018 wef 01/03/2018] (b) contains all of the following particulars: (i) the date of the prescription; (ii) the name and address of the qualified practitioner or collaborative prescribing practitioner giving the prescription; [S 119/2018 wef 01/03/2018] (iii) the name, identity card or other identification document number, and contact details, of the patient to whom the prescription relates; (iv) the name and total amount of the prescribed therapeutic product to be supplied to, and the dose to be taken by, the patient; (v) where the qualified practitioner or collaborative prescribing practitioner giving the prescription intends for the prescription to be repeated, an indication of the number of times, and the time period between which, the prescribed therapeutic product may be supplied; [S 119/2018 wef 01/03/2018] (vi) where the prescription is given by a dentist, a declaration by the dentist that the prescription is “for dental treatment only”.

3. These Regulations do not apply to any therapeutic product that is clinical research material as defined in regulation 2(1) of the Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016 (G.N. No. S 332/2016).

PART 2

MANUFACTURE AND IMPORT OF THERAPEUTIC PRODUCTS

Division 1 — Manufacture Requirements for issue of manufacturer’s licence

4. For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue, to an applicant, of a manufacturer’s licence for a therapeutic product are that —

(a) the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities as are necessary for carrying out the stages of the manufacture of the therapeutic product to be authorised by the licence; (b) the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the applicant’s ownership, possession or control; (c) the applicant is able to conduct all manufacturing operations in such a way as to ensure that the therapeutic product is of the correct identity and conforms with the applicable standards of strength, quality and purity for that therapeutic product; and (d) the applicant is able to comply with the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co‑operation Scheme Guide to Good Manufacturing Practice for Medicinal Products in relation to the manufacture of the therapeutic product.

Division 2 — Import Requirements for issue of importer’s licence

5.—(1) For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue, to an applicant, of an importer’s licence for a therapeutic product are that —

(a) the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the applicant’s ownership, possession or control; (b) the therapeutic product — (i) is imported on behalf of a specified healthcare service licensee pursuant to a valid prescription given by a qualified practitioner (who is a personnel of the specified healthcare service licensee) for the use of the qualified practitioner’s patient; [S 811/2023 wef 18/12/2023] (ii) is intended to be supplied solely for the purpose of scientific education or research and development, or for a non-clinical purpose; (iii) is imported solely for the purpose of export; (iv) is intended to be supplied for use on a ship, and the therapeutic product is one that is required to be carried on board the ship under the Merchant Shipping (Medical Stores) Regulations (Rg 3), the Merchant Shipping (Maritime Labour Convention) (Medicines and Medical Equipment) Regulations 2014 (G.N. No. S 181/2014) or any other written law, for the treatment of persons on board that ship; [S 436/2023 wef 31/12/2021] (v) is intended to be supplied for use on an aircraft, and the therapeutic product forms part of the medical supplies required under the Air Navigation Order (O 2) or any other written law, for the treatment of persons on board the aircraft; [S 436/2023 wef 31/12/2021] (vi) is authorised for import by the registrant of the therapeutic product; or (vii) is in all respects the same as a registered therapeutic product, the registrant of which has not authorised the applicant to import that registered therapeutic product; and (c) the applicant is able to comply with the requirements in the Authority’s Guidance Notes on Good Distribution Practice for importers set out on the Authority’s website if the therapeutic product is imported in accordance with sub‑paragraph (b)(i), (vi) and (vii).

(2)

In addition to the requirements in paragraph (1), an applicant who intends to import a therapeutic product under paragraph (1)(b)(vii) must obtain the Authority’s prior approval for each consignment of such therapeutic product to be imported.

(3) Import of therapeutic products containing psychotropic substances

An application for the Authority’s approval under paragraph (1) must be made in the form and manner specified on the Authority’s website.

6.—(1) Any person who intends to import a therapeutic product that contains a psychotropic substance must obtain the Authority’s

prior approval for each consignment of such therapeutic product to be imported.

(2)

The amount of each consignment of a therapeutic product to be imported under paragraph (1) must not exceed the quantity approved by the Authority.

(3)

An application for the Authority’s approval under paragraph (1) must be made in the form and manner specified on the Authority’s website.

(4)

This regulation applies in addition to the requirements in section 13 of the Act.

PART 3 Requirements for purposes of section 17

SUPPLY OF THERAPEUTIC PRODUCTS

7. Divisions 1 to 3 of this Part prescribe the requirements for the supply of therapeutic products, whether registered or not, to give effect to section 17(1) of the Act.

Division 1 — Requirements for wholesale supply of therapeutic products Export of therapeutic products containing psychotropic substances

8.—(1) Any person who intends to export a therapeutic product that contains a psychotropic substance must obtain the Authority’s prior approval for each consignment of such therapeutic product to be exported.

(2)

An application for the Authority’s approval under paragraph (1) must be made in the form and manner specified on the Authority’s website.

(3) Export of codeine cough preparations

This regulation applies in addition to the requirements in section 14 of the Act.

9.—(1) Any person who intends to export a codeine cough preparation must obtain the Authority’s prior approval for each consignment of such codeine cough preparation to be exported.

[S 732/2021 wef 01/10/2021]

(2)

An application for the Authority’s approval under paragraph (1) must be made in the form and manner specified on the Authority’s website.

(3) Wholesale of therapeutic products containing Second Schedule ingredients

This regulation applies in addition to the requirements in section 14 of the Act.

10.—(1) This regulation applies to a therapeutic product that —

(a) is a preparation containing an active ingredient specified in Part 1 of the Second Schedule; (b) is within any class of therapeutic products specified in Part 2 of that Schedule; or (c) is a preparation containing an active ingredient specified in Part 3 of that Schedule.

(2)

A person who supplies by wholesale to another (called the recipient) any therapeutic product in paragraph (1) must — (a) before the supply, be satisfied that the recipient carries on the trade, business or profession stated in the order and that such trade, business or profession is one in which the therapeutic product is used; (b) at the time of the supply, ensure that there is an order in writing, signed by the recipient, stating the recipient’s name and address, trade, business or profession, and the name and total quantity of the therapeutic product supplied; and (c) after the supply, insert in the appropriate entry in the record of supply prescribed by regulation 32(2)(b) a reference number by which the order can be identified.

(3)

Paragraph (2) does not apply to the supply by wholesale of a therapeutic product under regulation 47 or 59.

Division 2 — Requirements for retail supply of registered therapeutic products Supply by retail sale of prescription-only medicine

11. A person must not supply by retail sale any prescription-only medicine unless — Supply by administration of prescription-only medicine

(a) the supply is made at or from a licensed retail pharmacy in accordance with regulation 3(1) and (2) of the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016); (b) the supply is made by a healthcare service licensee to a patient of the healthcare service licensee, and is in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner who is a personnel of the healthcare service licensee; [S 811/2023 wef 18/12/2023] (c) the following requirements are satisfied: (i) the person is a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner; (ii) the supply is made to a patient under the care of the qualified practitioner or collaborative prescribing practitioner; or [S 119/2018 wef 01/03/2018] (d) the person is specified in the first column of the Third Schedule, the prescription‑only medicine is of the type specified in the corresponding paragraph in the second column of that Schedule, and the supply is in accordance with the conditions specified in the corresponding paragraph in the third column of that Schedule.

12. A person must not administer a prescription-only medicine unless — Supply by retail sale of pharmacy-only medicine

(a) the person is a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner; or [S 119/2018 wef 01/03/2018] (b) the person is specified in the first column of the Third Schedule, the prescription-only medicine is specified in the corresponding paragraph in the second column of that Schedule, and the administration of the prescription-only medicine is in accordance with the conditions specified in the third column of that Schedule.

13.—(1) A person must not supply by retail sale any pharmacy- only medicine unless —

(a) the supply is made at or from a licensed retail pharmacy in accordance with regulation 3(1) of the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016); (b) the supply is made by a healthcare service licensee to a patient of the healthcare service licensee, and is in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner who is a personnel of the healthcare service licensee; or [S 811/2023 wef 18/12/2023] (c) the following requirements are satisfied: (i) the person is a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner; (ii) the supply is made to a patient under the care of the qualified practitioner or collaborative prescribing practitioner. [S 119/2018 wef 01/03/2018]

(2)

A person who supplies by retail sale any pharmacy-only medicine must keep, at the premises where or from which the medicine is supplied, a record of every such supply, and the record must contain all of the following particulars in relation to each supply: (a) the date of the supply; (b) the name, identity card or other identification document number, and contact details, of the person to whom the pharmacy-only medicine is supplied; (c) the name, strength and total amount of pharmacy-only medicine to be supplied; (d) the dosage, and the frequency and purpose of the treatment for which the supply is made.

(3)

The record required under paragraph (2) must be made on the day on which the pharmacy-only medicine is supplied or, if that is not reasonably practicable, within 24 hours after that day, and must be kept for a period of at least 2 years after the date of the supply.

(4)

A supplier of a pharmacy-only medicine by retail sale must make available for inspection by the Authority at all reasonable times any record made under paragraph (2).

(5) Restrictions on supply by retail sale of codeine cough preparations

This regulation does not apply to the supply of any pharmacy- only medicine by administration to, or application in, any person in the course of any diagnosis, treatment or test.

14.—(1) A qualified practitioner or qualified pharmacist who supplies by retail sale any codeine cough preparation must not supply more than the following to any individual within a period of 7

days: (a) where codeine cough preparations are supplied to the individual in liquid form only — an aggregate amount of 240 ml of codeine cough preparations; (b) where codeine cough preparations are supplied to the individual in solid form only or in both liquid and solid forms — an aggregate amount of 355 mg of codeine (calculated as codeine base) contained in the codeine cough preparations supplied.

(2)

A qualified practitioner or qualified pharmacist who supplies by retail sale any codeine cough preparation must, on each occasion of the supply of the codeine cough preparation to an individual, provide professional counselling on the use of the codeine cough preparation.

(3) Supply of general sale list medicine by retail sale vending machine

A qualified practitioner who supplies by retail sale any codeine cough preparation must, on each occasion of the supply of the codeine cough preparation to an individual, in addition to complying with regulation 16, record the purpose of the treatment for which the codeine cough preparation was supplied. [S 732/2021 wef 01/10/2021]

15. A person may supply by retail sale any general sale list medicine by means of an automatic vending machine, if all of the following requirements are satisfied:

(a) the person’s name and contact information is prominently displayed on the automatic vending machine; (b) the automatic vending machine is sufficiently equipped and secure to ensure appropriate storage conditions for the medicine; (c) the medicine is labelled and packaged in accordance with the conditions attached by the Authority to the registration of the medicine under the Act; (d) the package size of the medicine is the same as the package size specified for the registration of the medicine, and the total amount of the medicine in each package does not exceed a total dosage of 3 months per individual.

Division 3 — Other requirements for supply of therapeutic products Records of supply of prescribed therapeutic products

16.—(1) A supplier must, in respect of the supply by retail sale of any therapeutic product prescribed by a qualified practitioner or collaborative prescribing practitioner, keep at the premises where or from which the therapeutic product is supplied a record, complying with paragraphs (2) and (3), of every such supply.

[S 119/2018 wef 01/03/2018]

(2)

The record required under paragraph (1) must contain all of the following particulars: (a) the date of supply; (b) the name, identity card or other identification document number, and contact details, of the person to whom the therapeutic product is supplied; (c) the name of the therapeutic product, being either the proprietary name or the appropriate non-proprietary name, and the total amount supplied; (d) if the therapeutic product is supplied by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, or at or from a licensed retail pharmacy, the name and address of the qualified practitioner or collaborative prescribing practitioner who signed the prescription. [S 119/2018 wef 01/03/2018]

(3)

The record in paragraph (1) must be made on the day on which the therapeutic product is supplied or, if that is not reasonably practicable, within 24 hours after that day, and must be kept for a period of at least 2 years after the date of the supply.

(4)

A supplier must make available for inspection by the Authority at all reasonable times any record made under paragraph (1).

(5) Supply by dispensing therapeutic products

This regulation does not apply to the supply of any therapeutic product by wholesale.

17.—(1) A relevant person may dispense a therapeutic product only if the package or container of the therapeutic product is labelled with all of the following information in English:

(a) the name of the person to whom the therapeutic product is to be administered; (b) where the product is supplied or dispensed — (i) at a licensed retail pharmacy — the name, address and any identification number or logo of the licensed retail pharmacy; [S 811/2023 wef 18/12/2023] (ii) at any approved permanent premises by a healthcare service licensee under a business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; (iii) at any temporary premises or approved conveyance by a healthcare service licensee under a business name — (A) if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or (B) in any other case — the business name, address and any identification number or logo of the healthcare service licensee; or (iv) by a healthcare service licensee using a remote service kiosk or by delivery under a business name — (A) if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or (B) in any other case — the business name, address and any identification number or logo of the healthcare service licensee; [S 436/2023 wef 26/06/2023] (c) the date that the therapeutic product is dispensed; (d) the directions for use of the therapeutic product; (e) the name of the therapeutic product, being either the proprietary name or the appropriate non-proprietary name; (f) where the appropriate non-proprietary name is included on the label, the appropriate quantitative particulars of any active ingredient of the therapeutic product.

(2)

A prescription-only medicine may be dispensed only in accordance with the following requirements: (a) where the qualified practitioner or collaborative prescribing practitioner giving the prescription does not specify that the prescription is to be repeated, the relevant person dispensing the prescription-only medicine must — (i) when dispensing, mark the prescription in a manner so as to permanently attach the person’s name and address and the dispensing date to the prescription; and (ii) retain the prescription for a period of at least 2 years after dispensing; or [S 119/2018 wef 01/03/2018] (b) where the qualified practitioner or collaborative prescribing practitioner giving the prescription specifies that the prescription is to be repeated, the relevant person dispensing the prescription-only medicine — (i) must not dispense more than the total number of times specified on the prescription; (ii) when dispensing, must mark the prescription in such a manner as to permanently attach the person’s name and address and the dispensing date to the prescription; and (iii) must retain the prescription for a period of at least 2 years after dispensing for the last time. [S 119/2018 wef 01/03/2018]

(3)

In this regulation, “relevant person” means — (a) a qualified practitioner or collaborative prescribing practitioner, or a person acting under the supervision of a qualified practitioner or collaborative prescribing practitioner; or [S 119/2018 wef 01/03/2018] (b) a qualified pharmacist or a person acting under the supervision of a qualified pharmacist.

Division 4 — Requirements for wholesaler’s licence Requirements for issue of wholesaler’s licence

18. For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue, to an applicant, of a wholesaler’s licence for a therapeutic product are that —

(a) the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling, storage and distribution of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the applicant’s ownership, possession or control; and (b) the applicant is able to comply with the Authority’s Guidance Notes on Good Distribution Practice for wholesalers set out on the Authority’s website.

PART 4 Trade descriptions

PRESENTATION OF THERAPEUTIC PRODUCTS

19.—(1) For the purposes of section 18(1) of the Act, the presentation of a therapeutic product must comply with all of the following requirements:

(a) a trade description which is false or misleading must not be applied to the therapeutic product; (b) a trade description which explicitly or implicitly suggests that the supply or use of the therapeutic product is promoted or endorsed by the Authority, the Ministry of Health or the Health Promotion Board must not be applied to the therapeutic product.

(2)

For the purposes of paragraph (1)(a), a trade description is false or misleading if — (a) it contains any false statement or information concerning the therapeutic product; or (b) it is likely to create an erroneous impression regarding the formulation, composition, quality, safety, efficacy or uses of the therapeutic product.

(3)

For the purposes of paragraph (1), a person applies a trade description to a therapeutic product if the person — (a) affixes or annexes the trade description to, or in any manner marks it on or incorporates it in — (i) the therapeutic product; or (ii) any thing in or on the therapeutic product or with which the therapeutic product is supplied; (b) places the therapeutic product in, on or with any thing which the trade description has been affixed or annexed to, marked on or incorporated in; or (c) makes any oral or written statement of the trade description, or uses the trade description in any other manner, which is likely to be understood as referring to the therapeutic product.

(4) Information to be provided with therapeutic products

A person supplying a therapeutic product is taken to have applied a trade description to the therapeutic product if — (a) the therapeutic product is supplied pursuant to a request in which the trade description is used; and (b) it is reasonable in the circumstances to infer that any therapeutic product so supplied will correspond to that trade description.

20.—(1) In addition to regulation 19, a therapeutic product must, for the purposes of section 18(1) of the Act, be accompanied by all of the following information, where applicable, when it is supplied:

(a) the name of the therapeutic product, being the proprietary name and the appropriate non-proprietary name; (b) the appropriate quantitative particulars of any active ingredient of the therapeutic product; (c) an appropriate control number, such as a serial number, batch number or lot number; (d) the expiry date of the therapeutic product; (e) where the therapeutic product is registered, the registration number assigned to the registered therapeutic product by the Authority.

(2)

Where a therapeutic product contains any substance specified in the first column of the Fourth Schedule, the therapeutic product must be labelled with a statement declaring the presence of that substance, and that substance may be described by a corresponding term specified in the second column of that Schedule.

(3)

Where a therapeutic product contains any substance specified in the first column of the Fifth Schedule, the therapeutic product must be labelled with the caution set out in the second column of that Schedule.

(4)

Where a therapeutic product is contained in a container, which is in the form of a bubble, blister or other sealed unit and is part of a continuous series comprising a sheet or strip of like containers, paragraph (2) or (3), as the case may be, is taken to have been complied with if the statement mentioned in paragraph (2) or the caution mentioned in paragraph (3) is printed or displayed or otherwise marked in a prominent position at frequent intervals on the sheet or strip of the container.

(5) Corrective measures in relation to contravening trade descriptions or failure to provide prescribed information

All information accompanying the therapeutic product mentioned in paragraph (1), including the statement mentioned in paragraph (2) and the caution mentioned in paragraph (3) — (a) must be provided in English; and (b) must be legible and indelible.

21.—(1) Where any manufacturer, importer, supplier or registrant of a therapeutic product has applied a trade description in contravention of regulation 19, the Authority may order that manufacturer, importer, supplier or registrant, as the case may be, to do all or any of the following:

(a) to stop disseminating, publishing or using the trade description with immediate effect; (b) to stop applying the trade description to the therapeutic product, or to stop supplying the therapeutic product applied with the trade description, with immediate effect; (c) to take such measures as may be reasonable and necessary in the circumstances to discontinue or remove any trade description that may already have been applied, disseminated, published or used; (d) to apply, disseminate or publish a corrective trade description in such manner and containing such information as the Authority may require.

(2)

Where any manufacturer, importer, supplier or registrant of a therapeutic product fails to provide any information required by regulation 20 to accompany the supply of the therapeutic product, the Authority may order that manufacturer, importer, supplier or registrant, as the case may be, to take such corrective measures as the Authority may require, including — (a) to stop supplying the therapeutic product with immediate effect; or (b) to take such measures as may be reasonable and necessary in the circumstances to ensure that the therapeutic product is only supplied with the required information.

(3)

A person to whom an order under paragraph (1) or (2) is directed must comply with the order at the person’s own cost and within the time specified in the order or, if no time is specified in the order, within a reasonable time after the date of the order.

(4)

A person who fails to comply with paragraph (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

(5)

Without prejudice to paragraph (4), the Authority may take such steps as the Authority thinks reasonable and necessary to implement the requirements of an order directed to any person under paragraph (1) or (2), and recover any costs and expenses reasonably incurred by the Authority in so doing from the person.

PART 5 Requirements for registration

REGISTRATION OF THERAPEUTIC PRODUCTS

22. For the purposes of section 30(2)(a)(iii) of the Act, the Authority may, after carrying out an evaluation under section 33 of the Act, register a therapeutic product, if the Authority is satisfied — Whether therapeutic product subject to patent

(a) that the overall intended benefits to a user of the therapeutic product outweigh the overall risks associated with the use of the therapeutic product; and (b) based on the formulation, manufacturing process controls, specifications and shelf life of the therapeutic product, and the stability of the therapeutic product under the recommended storage conditions, that the therapeutic product is suitable for its intended purpose and that any risk associated with its use is minimised.

23.—(1) In dealing with an application for the registration of a therapeutic product, the Authority must consider whether a patent under the Patents Act 1994 is in force in respect of the therapeutic product and, if so —

(a) whether the applicant for the registration of the therapeutic product is the proprietor of the patent; or (b) if the applicant is not the proprietor of the patent, whether — (i) the proprietor has consented to or has acquiesced in the grant of the registration of the therapeutic product to the applicant; or (ii) the patent is invalid or will not be infringed by the doing of the act for which the registration of the therapeutic product is sought. [S 436/2023 wef 31/12/2021]

(2)

Unless the Authority otherwise determines, the applicant must, at the time of the application and at such other time before the determination of the application as the Authority may require, make and furnish to the Authority a declaration in the form specified on the Authority’s website, stating — (a) whether a patent under the Patents Act 1994 is in force in respect of the therapeutic product; and [S 436/2023 wef 31/12/2021] (b) whether the applicant is the proprietor of the patent.

(3)

If the applicant is not the proprietor of the patent in respect of the therapeutic product and there is such a patent in force, the applicant must further state in the declaration mentioned in paragraph (2) — (a) the name and address of the proprietor of the patent; (b) whether — (i) the proprietor has consented to or has acquiesced in the grant of the registration of the therapeutic product by the applicant; or (ii) in the opinion of the applicant and to the best of the applicant’s belief, the patent is invalid or will not be infringed by the doing of the act for which the registration of the therapeutic product is sought; and (c) such other information as the Authority may require in any particular case.

(4)

For the purposes of paragraph (1), the Authority may rely upon, and need not be concerned to inquire into the truth of, any statement made in the declaration furnished under paragraph (2).

(5)

Where the applicant is not the proprietor of a patent under the Patents Act 1994 that is in force in respect of the therapeutic product, the Authority may require the applicant to serve, in accordance with section 67 of the Act, on the proprietor of the patent, a notice in the form specified on the Authority’s website, and within such time as the Authority may determine, if — (a) the applicant has declared that, in the applicant’s opinion and to the best of the applicant’s belief, the patent is invalid or will not be infringed by the doing of the act for which the registration is sought; or (b) the Authority considers it appropriate in any particular case for the applicant to do so. [S 436/2023 wef 31/12/2021]

(6)

The applicant must furnish to the Authority such evidence of the service of the notice mentioned in paragraph (5) as the Authority may require.

(7)

The Authority need not determine the application until the applicant has complied with paragraph (2) and, where applicable, paragraphs (5) and (6), to the reasonable satisfaction of the Authority.

(8)

If the Authority is satisfied that the notice mentioned in paragraph (5) has been served on the proprietor of the patent, the Authority may register the therapeutic product if the proprietor does not, before the 45th day after the date that notice is served on the proprietor — (a) apply to — (i) a court for an order restraining the act for which the registration of the therapeutic product is sought; or (ii) a court or the Registrar of Patents or a Deputy Registrar of Patents holding office under the Patents Act 1994, for a declaration that the patent is valid or will be infringed by the doing of the act for which the registration of the therapeutic product is sought; and [S 436/2023 wef 31/12/2021] (b) give written notice to the Authority stating that such application in sub‑paragraph (a) has been made, accompanied by evidence of the application.

(9)

The Authority may register the therapeutic product without further notice to the proprietor of the patent, if no order or declaration mentioned in paragraph (8)(a) has been made at the end of 30 months after the date of the application for the order or declaration.

(10) Cancellation of registration of therapeutic product subject to patent dispute

If, before the end of the period mentioned in paragraph (9), the proprietor of the patent submits to the Authority a copy of the order or declaration mentioned in paragraph (8)(a), the Authority may refuse to register the therapeutic product.

24.—(1) Without prejudice to the generality of section 37(1) of the Act, the Authority may, upon an application by any interested person, cancel the registration of a therapeutic product, if the Authority is

satisfied — (a) that — (i) a court or the Registrar of Patents or a Deputy Registrar of Patents holding office under the Patents Act 1994 has determined that the doing of an act authorised by the registration infringes a patent under the Patents Act 1994; or [S 436/2023 wef 31/12/2021] (ii) a court has determined that the declaration made under regulation 23(2) contains a statement that is false or misleading in a material particular or omits to disclose any matter that is material to the application; and (b) that the determination mentioned in sub‑paragraph (a)(i) or (ii) is final.

(2) Prescribed time for cancellation of registration of therapeutic product for non‑payment of retention fee 24A. For the purposes of section 37(2) of the Act, the prescribed time is 60 days after the anniversary of the date of the registration of the therapeutic product. Offences for making false patent declaration

For the purposes of paragraph (1)(b), a determination is final if it is not subject to further appeal. [S 458/2022 wef 01/07/2022]

25. A person who, when making a declaration under regulation 23(2) — Protection of confidential supporting information relating to innovative therapeutic product applications

(a) makes any statement or furnishes any document which the person knows or has reason to believe is false in a material particular; or (b) by the intentional suppression of any material fact, furnishes information which is misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

26.—(1) Without prejudice to section 66 of the Act, where the Authority receives an innovative therapeutic product application with confidential supporting information, the Authority, during the protected period in relation to such confidential supporting information —

(a) must take reasonable steps to ensure that the confidential supporting information is kept confidential to the Authority; and (b) must not use that confidential supporting information for the purpose of determining whether to grant any other application to register a therapeutic product.

(2) Circumstances where protection under regulation 26 does not apply

In this regulation and regulation 27, unless the context otherwise requires — “confidential information” includes — (a) trade secrets; and (b) information that has commercial value that would be, or would be likely to be, diminished by disclosure; “confidential supporting information” means confidential information given — (a) in, or in relation to, an innovative therapeutic product application; and (b) about the therapeutic product that is the subject of that application; “innovative therapeutic product application” means an application to register a therapeutic product that refers to a substance — (a) that is an ingredient in the manufacture or preparation of the therapeutic product to which the application relates; and (b) that has not, before that application is received by the Authority, been referred to as an ingredient in the manufacture or preparation of any other therapeutic product in any other application to register that therapeutic product under the Act; “protected period”, in relation to confidential supporting information relating to an innovative therapeutic product application received by the Authority, means a period of 5 years after the date that application is received by the Authority.

27.—(1) Despite regulation 26, the Authority may, during the protected period in relation to confidential supporting information —

(a) disclose that confidential supporting information, or use that confidential supporting information for the purpose of determining whether to grant any other application to register a therapeutic product — (i) with the consent of the applicant who made the application to which the confidential supporting information relates; or (ii) if that disclosure or use is, in the opinion of the Authority, necessary to protect the health or safety of members of the public; (b) disclose that confidential supporting information to a Government department or statutory body for the purpose of facilitating or assisting such Government department or statutory body in carrying out its duties if, in the opinion of the Authority, the Government department or statutory body, as the case may be, will take reasonable steps to ensure the confidential supporting information is kept confidential; or (c) disclose that confidential supporting information to, if so requested by, any one or more of the following: (i) the World Health Organization; (ii) the Food and Agriculture Organization of the United Nations; (iii) any regulatory agency of a country that is a party to the Agreement establishing the World Trade Organization adopted at Marrakesh on 15 April 1994; (iv) any Advisory Committee established under section 10 of the Act.

(2) Disclosure of information on applications for registration

The power to grant consent under paragraph (1)(a)(i) may be exercised by a person (P) other than the applicant mentioned in that paragraph if — (a) that applicant — (i) has notified the Authority in writing that P may grant that consent; and (ii) has not notified the Authority in writing that P’s authority to grant that consent has been withdrawn; or (b) that applicant’s rights in respect of the relevant confidential supporting information have been transferred to P and the applicant or P has notified the Authority in writing of the transfer.

28. For the purposes of section 66(2)(d) of the Act, the Authority may from time to time disclose, for the information of the public and in the manner determined by the Authority, such particulars of applications for the registration of therapeutic products which it receives as it may determine, provided that the particulars to be disclosed under this regulation exclude — Registration exclusivity

(a) any trade secret; and (b) any information that has commercial value that would be, or would be likely to be, diminished by the disclosure.

29. Where —

(a) information relating to the safety or efficacy of a therapeutic product has been provided to the Authority by an applicant in support of the application for the registration of that therapeutic product; and (b) the Authority has registered that therapeutic product (called the earlier registration), the Authority may not, for a period of 5 years after the date of the earlier registration, register, on the application of any other person, a similar therapeutic product on the basis of the earlier registration, unless the registrant of the earlier registration has consented to the registration on that basis.

PART 6

DUTIES AND OBLIGATIONS OF MANUFACTURERS, IMPORTERS, ETC., OF THERAPEUTIC PRODUCTS

Division 1 — General duties Duty to comply with enforcement requirements

30.—(1) An enforcement officer may conduct routine inspections of —

(a) any premises that are used for the manufacture, supply or storage of therapeutic products; and (b) any conveyance that is being used for the transport of therapeutic products.

(2) Duty to maintain records of manufacture

An enforcement officer conducting a routine inspection under paragraph (1) may — (a) require any person having possession or control of any therapeutic product that is found during the inspection to furnish, without charge, a sample of such therapeutic product for the Authority’s examination; and (b) take or cause to be taken any photograph of — (i) the premises or conveyance mentioned in paragraph (1); or (ii) any property or material found on the premises or in the conveyance.

31.—(1) A manufacturer of a therapeutic product, other than a healthcare service licensee, must maintain records of —

(a) such information relating to the therapeutic product and its manufacture or assembly as the Authority may specify on the Authority’s website or, if the manufacturer is the holder of a manufacturer’s licence, in the manufacturer’s licence; and (b) the manufacture of each batch of the therapeutic product and of the tests carried out on each of such batch, in the manner specified on the Authority’s website or in the relevant licence issued by the Authority (if applicable). [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023]

(2)

The manufacturer must maintain for any therapeutic product the records mentioned in paragraph (1) for the longer of the following periods: (a) one year after the expiry date of the therapeutic product; (b) 5 years after the date of manufacture of the therapeutic product.

(3)

A manufacturer of a therapeutic product who fails to comply with paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

(4) Duty to maintain records of receipt and supply

A person who, in compliance or purported compliance with paragraph (1), furnishes the Authority or an enforcement officer with any record which the person knows is false or misleading shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

32.—(1) Paragraphs (2) and (3) apply to a person (P) who is —

(a) a licensee or registrant of a therapeutic product; or (b) the supplier of a therapeutic product in accordance with regulation 47, 49, 51, 58(1)(b), (c) or (d) or 60A(3) or (4). [S 969/2020 wef 01/12/2020] [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023]

(2)

P must — (a) if P is not the manufacturer of the therapeutic product, maintain a record of every receipt by P of the therapeutic product; (b) maintain a record of every supply by P of the therapeutic product; and (c) produce for inspection by the Authority or an enforcement officer the record of every receipt or supply as and when required by the Authority or enforcement officer.

(3)

P must ensure that every record mentioned in paragraph (2) — (a) contains, in relation to each receipt by P of the therapeutic product, all of the following information: (i) the proprietary name or appropriate non‑proprietary name of the therapeutic product, if the therapeutic product is supplied by a manufacturer, importer or wholesaler, as the case may be; (ii) the date on which the therapeutic product is received; (iii) the name and address of the person from whom the therapeutic product is received; (iv) the quantity of the therapeutic product received; (v) the identification number (including the control number, lot number, batch number or serial number) of the therapeutic product received; (b) contains, in relation to each supply by P of the therapeutic product, all of the following information: (i) the proprietary name or appropriate non‑proprietary name of the therapeutic product; (ii) the date on which the therapeutic product is supplied; (iii) the name and address of the person to whom the therapeutic product is supplied; (iv) the quantity of the therapeutic product supplied; (v) the identification number (including the control number, lot number, batch number or serial number) of the therapeutic product supplied; and (c) is retained for at least 2 years after the date on which the therapeutic product is so supplied to another person.

(4)

A person who fails to comply with paragraph (2) or (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

(5) Duty to maintain records of defects and adverse effects

A person who, in compliance or purported compliance with paragraph (2) or (3), furnishes the Authority or an enforcement officer with any record which the person knows is false or misleading shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

33.—(1) Every manufacturer, importer or registrant of a therapeutic product must —

(a) maintain a record of every event or other occurrence that reveals any defect in the therapeutic product or that concerns any adverse effect arising from the use of the therapeutic product; and (b) produce such record for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer.

(2)

A person mentioned in paragraph (1) must ensure that every record mentioned in that paragraph — (a) contains all of the following information: (i) the proprietary name or appropriate non‑proprietary name of the therapeutic product which is defective or of which an adverse effect has arisen from its use; (ii) the date on which the person first became aware of the event or occurrence; (iii) the identification number or mark (including the control number, lot number, batch number or serial number) of the therapeutic product; (iv) the nature of the defect or adverse effect; (v) any other information that the Authority may specify in writing; and (b) is retained for at least 2 years after the expiry date of the therapeutic product.

(3)

A person who fails to comply with paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

(4) Duty to report defects and adverse effects

A person who, in compliance or purported compliance with paragraph (1) or (2), furnishes the Authority or an enforcement officer with any record which the person knows is false or misleading shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

34.—(1) For the purposes of section 42(1)(a) of the Act, every manufacturer, importer, supplier or registrant of a therapeutic product

must, upon becoming aware of any defect in the therapeutic product, report the defect to the Authority — (a) if the defect represents a serious threat to persons or public health, within 48 hours; or (b) in all other cases, within 15 days, after the manufacturer, importer, supplier or registrant, as the case may be, first receives notice of the defect.

(2)

For the purposes of section 42(1)(b) of the Act, every manufacturer, importer, supplier or registrant of a therapeutic product must, upon becoming aware of any serious adverse reaction arising from the use of the therapeutic product, report the serious adverse reaction to the Authority immediately, but in any case no later than 15 days after the manufacturer, importer, supplier or registrant first becomes aware of the serious adverse reaction.

(3) Duty to notify Authority concerning recall

In this regulation, “serious adverse reaction” means an adverse effect that is unintended and occurs in association with the use or administration of a therapeutic product at doses normally used in humans for prophylaxis, diagnosis or therapy of a disease or for the restoration, correction or modification of a physiological function, and that — (a) may result in a person’s death; (b) may threaten a person’s life; (c) results in a person being hospitalised or prolongs a person’s existing stay in hospital; (d) results in a person’s persistent or significant disability or incapacity; (e) results in a congenital anomaly or birth defect; or (f) is judged to be medically important even though the effect might not be immediately life-threatening or result in death or hospitalisation, but may jeopardise the person’s health or may require intervention to prevent the person’s death or one of the other outcomes mentioned in sub‑paragraphs (c), (d) and (e).

35.—(1) For the purposes of section 44(1) of the Act, every manufacturer, importer, supplier or registrant of a therapeutic product who intends to recall a therapeutic product must immediately, but in any case no later than 24 hours before the start of the intended recall, notify the Authority of, and the reasons for, the intended recall.

(2)

The notice in paragraph (1) must be made in such form and manner as the Authority may require.

(3)

Where the Authority has been notified of the intended recall of a therapeutic product under paragraph (1), the Authority may by written notice require the manufacturer, importer, supplier or registrant of the therapeutic product to do either or both of the following: (a) investigate the matter occasioning the recall of the therapeutic product and provide a report of the findings of the investigation; (b) take such other measures as the Authority thinks necessary.

(4)

A person to whom a notice in paragraph (3) is given must comply with the notice at the person’s own cost and within the time specified in the notice or, if no time is specified in the notice, within a reasonable time after the date of the notice.

(5)

A person who fails to comply with paragraph (4) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

Division 2 — Duties specific to licensees Duty of licensed manufacturer

36. Without prejudice to any other provision in this Part, a holder of a manufacturer’s licence for a therapeutic product — Duty of licensed importer

(a) must ensure, and maintain objective evidence to establish, that the manufacture of the therapeutic product complies with the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products; (b) must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities as are necessary for carrying out, in accordance with the holder’s licence, such stages of the manufacture of the therapeutic product as are undertaken by the holder; (c) must not carry out any stages of manufacture of the therapeutic product in any premises not specified in the holder’s licence; (d) must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the holder’s ownership, possession or control; (e) must only use the premises specified in the holder’s licence, or such other premises as may be approved from time to time by the Authority, for handling or storing the therapeutic product; (f) must carry out, or arrange for a testing laboratory as specified in the licence to carry out, tests on the strength, quality and purity of the therapeutic product to ensure that the standards of the therapeutic product comply with any applicable standard set by the Authority for the therapeutic product; (g) must conduct all manufacturing operations in such a way as to ensure that the therapeutic product is of the correct identity and conforms with the applicable standards of strength, quality and purity; and (h) must ensure that any tests for determining conformity with the applicable standards and specifications applying to the therapeutic product are, unless otherwise provided in the licence, applied to samples taken after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the Authority.

37. Without prejudice to any other provision in this Part, a holder of an importer’s licence for a therapeutic product — Duty of licensed wholesaler

(a) must ensure, and maintain objective evidence to establish, that the handling and storage of the therapeutic product complies with any standard set out by the Authority on the Authority’s website for the therapeutic product; (b) must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the holder’s ownership, possession or control; and (c) must not use, for any purpose mentioned in paragraph (b), any premises other than the premises specified in the holder’s licence, or such other premises as may be approved from time to time by the Authority.

38. Without prejudice to any other provision in this Part, a holder of a wholesaler’s licence for a therapeutic product — Responsible person

(a) must ensure, and maintain objective evidence to establish, that the handling, storage and distribution of the therapeutic product complies with any standard set out by the Authority on the Authority’s website for the therapeutic product; (b) may only supply the therapeutic product by wholesale to a person who may lawfully supply such therapeutic products in accordance with the Act; (c) must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling, storage and distribution of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the holder’s ownership, possession or control; and (d) must not use, for any purpose mentioned in paragraph (c), any premises other than the premises specified in the holder’s licence, or such other premises as may be approved from time to time by the Authority.

39.—(1) A licensee must appoint one or more persons as a responsible person to be named as such in the licence.

(2)

The licensee must ensure that — (a) the responsible person has adequate knowledge of the activities to be carried out and of the procedures to be performed under the licence; (b) the responsible person has relevant working experience relating to those activities and procedures; (c) in the case of a manufacturer’s licence, the responsible person named in the licence has practical experience in production supervision or in testing and checking to ensure the quality of therapeutic products or related health products; (d) in the case of an importer’s licence or wholesaler’s licence for the import or supply of any therapeutic product that is not registered at the request of a qualified practitioner for the use of the qualified practitioner’s patient, the responsible person named in the licence is a qualified pharmacist or such other person as the Authority may approve; (e) in the case of an importer’s licence or a wholesaler’s licence for the import or supply by wholesale of prescription-only medicine or pharmacy-only medicine, the responsible person named in the licence is a qualified pharmacist or such other person as the Authority may approve; and (f) at any time, there is at least one responsible person who is contactable by the Authority by way of a mobile telephone number or an email address.

(3)

The licensee must ensure that the responsible person discharges the duties imposed on such a person by the terms of the licence.

(4) Offence for contravention of duties

The licensee must ensure that no person, other than the person or persons named as the responsible person in the licence, may act as the responsible person.

40. A licensee who fails to comply with regulation 36, 37, 38 or 39 shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both. Changes affecting licence

41.—(1) Every licensee must notify the Authority of —

(a) any change or proposed change to any particulars furnished by the licensee to the Authority in relation to the application for the licensee’s licence; and (b) any change or proposed change that significantly affects the activities of the licensee that are authorised by that licence.

(2)

A notice under paragraph (1) must — (a) be made in such form and manner as the Authority may require; (b) be submitted within such time as the Authority may specify in the conditions of the licence; (c) be accompanied by such particulars, information, documents and samples as the Authority may require; (d) be accompanied by the relevant fee; and [S 458/2022 wef 01/07/2022] (e) if required by the Authority, be accompanied by a statutory declaration by the licensee verifying any information contained in or relating to the notice.

(3)

A licensee must not, without the prior approval of the Authority, make any change that significantly affects the activities of the licensee that are authorised by the licensee’s licence.

(4)

An application for the Authority’s approval under paragraph (3) must be made in the form and manner specified on the Authority’s website.

(5)

For the purposes of paragraphs (1) and (3), a change that significantly affects the activities of a licensee that are authorised by the licensee’s licence includes a change of one or more of the following: (a) the premises where the licensee operates; (b) the facilities and equipment used by the licensee; (c) the operations and processes carried out by the licensee; (d) the responsible person mentioned in regulation 39.

(6)

A licensee who fails to comply with paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

(7)

A licensee who — (a) in compliance or purported compliance with paragraph (1), furnishes the Authority with any notice under paragraph (1) which the licensee knows is false or misleading; or (b) fails to comply with paragraph (3), shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

Division 3 — Duties specific to registrants Changes concerning registered therapeutic product

42.—(1) A registrant of a registered therapeutic product must, unless the change is of a type specified on the Authority’s website to be one for which the Authority’s approval is not required, obtain prior approval from the Authority before effecting —

(a) any change to any particulars provided in relation to the registration of the therapeutic product; or (b) any change that may affect the quality, safety or efficacy of the therapeutic product.

(2)

An application for the Authority’s approval under paragraph (1) must — (a) be made in such form and manner as the Authority may require; (b) be submitted within such time as the Authority may specify in the conditions of the registration of the therapeutic product; (c) be accompanied by such particulars, information, documents and samples as the Authority may require; (d) be accompanied by the relevant fee; and [S 458/2022 wef 01/07/2022] (e) if required by the Authority, be accompanied by a statutory declaration by the registrant verifying any information contained in or relating to the application.

(3)

Where the Authority’s approval is required under paragraph (1), the registrant of the therapeutic product must ensure that no supply is made of the therapeutic product that is subject to the proposed change until after the Authority has given its approval for the change.

(4)

A registrant of a therapeutic product who fails to comply with paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

(5) Information on validity of data submitted to or considered by Authority

A registrant of a therapeutic product who — (a) in compliance or purported compliance with paragraph (1), furnishes the Authority with any information under paragraph (1) which the registrant knows is false or misleading; or (b) fails to comply with paragraph (3), shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

43.—(1) A registrant of a therapeutic product must, within 15 days after receiving any information that adversely affects the validity of any data furnished by the registrant to the Authority relating to the quality, safety or efficacy of any therapeutic product to which the registrant’s registration relates, inform the Authority of such information.

(2)

A registrant of a therapeutic product who fails to comply with paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

(3) Submission of benefit-risk evaluation reports

A registrant of a therapeutic product who, in compliance or purported compliance with paragraph (1), furnishes the Authority with any information which the registrant knows is false or misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

44.—(1) The Authority may require any registrant of a therapeutic product to submit, within the timelines specified by the Authority, a benefit-risk evaluation report relating to the therapeutic product.

(2)

Where the Authority has not specified any timelines within which a benefit-risk evaluation report is required to be submitted, a registrant of a therapeutic product who is required by the Authority to submit such a report must submit the report — (a) for an initial period of 2 years, at intervals of 6 months commencing from either the date of registration of the therapeutic product, or its international birth date; and (b) annually, for the next 3 years.

(3)

A person who fails to provide a benefit-risk evaluation report — (a) as required by the Authority under paragraph (1); or (b) within the timelines stipulated under paragraph (2), shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

(4) Duty to carry out risk management plan

In paragraph (2)(a), “international birth date”, for a therapeutic product, means the date of the first marketing approval granted to any person for the sale of the therapeutic product in any country in the world.

45.—(1) The Authority may, for the purposes of minimising risks relating to unsafe and inefficacious use of therapeutic products, direct a registrant of a therapeutic product to implement a risk management plan which includes, but is not limited to, the following:

(a) producing and distributing educational material; (b) producing and distributing safety information; (c) performing clinical studies of the therapeutic product; (d) implementing active surveillance programmes of the therapeutic product; (e) implementing programmes to restrict the supply of the therapeutic product.

(2)

A registrant of a registered therapeutic product who fails to comply with a direction of the Authority under paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

PART 7

EXCEPTIONS — MANUFACTURE, IMPORT AND WHOLESALE OF THERAPEUTIC PRODUCTS WITHOUT LICENCE

Division 1 — Specified healthcare service licensees Compounding of therapeutic products at approved permanent premises, etc., of specified healthcare service licensees without manufacturer’s licence

[S 811/2023 wef 18/12/2023] [S 436/2023 wef 26/06/2023]

46.—(1) A specified healthcare service licensee may compound a therapeutic product without holding a manufacturer’s licence, if —

(a) the therapeutic product is compounded from an active ingredient or another therapeutic product; (b) the final form or packaging of the compounded therapeutic product is not available or marketed for commercial supply in Singapore; (c) the compounding is carried out — (i) [Deleted by S 811/2023 wef 18/12/2023] (ii) where the therapeutic product is compounded by a specified healthcare service licensee — (A) at any approved permanent premises, temporary premises or approved conveyance of the specified healthcare service licensee or, in the case of a sterile therapeutic product, at a practice setting within the approved permanent premises, temporary premises or approved conveyance where standards established for the operation of clean rooms and the preparation of sterile products are in place and properly documented; and (B) by or under the supervision of a qualified practitioner or a qualified pharmacist who is a personnel of the specified healthcare service licensee; and [S 436/2023 wef 26/06/2023] (d) an appropriate expiry date, either in accordance with standards set out in any specified publication or supported by a stability study, accompanies the compounded therapeutic product. [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023]

(2)

In addition to the requirements in paragraph (1), the therapeutic product must be compounded in accordance with the written instructions of a qualified practitioner, if — (a) the therapeutic product is for the use of any patient under the care of the qualified practitioner; and (b) the therapeutic product contains an active ingredient specified in Part 1 of the Second Schedule or is within any class of therapeutic products specified in Part 2 of that Schedule.

(3)

Paragraph (2) does not apply if the compounding consists only of repacking for the purpose of dispensing the therapeutic product.

(4)

It does not matter whether the patient mentioned in paragraph (2) is or is not a patient — (a) [Deleted by S 811/2023 wef 18/12/2023] (b) at the approved permanent premises, temporary premises or approved conveyance of the specified healthcare service licensee at which the compounding is carried out. [S 436/2023 wef 26/06/2023]

(5)

A therapeutic product compounded under paragraph (1) by a specified healthcare service licensee who is authorised to provide an outpatient dental service, outpatient medical service or outpatient renal dialysis service at any approved permanent premises, temporary premises or approved conveyance, must not be supplied to any of the following unless the approval of the Authority has been obtained for the supply: (a) [Deleted by S 811/2023 wef 18/12/2023] (b) any approved permanent premises of the specified healthcare service licensee (other than the approved permanent premises at which the therapeutic product was compounded); (c) any approved permanent premises of another specified healthcare service licensee. [S 436/2023 wef 26/06/2023]

(6)

An application for the Authority’s approval under paragraph (5) must be made in the form and manner specified on the Authority’s website.

(7)

For the purposes of section 45 of the Act, a specified healthcare service licensee who compounds a therapeutic product under paragraph (1) must ensure that the therapeutic product is compounded in accordance with the requirements in paragraph (1)(c) and (d), and, if applicable, paragraph (2). [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023]

(8)

A person who fails to comply with paragraph (7) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

(9) Transfer of therapeutic products by specified healthcare service licensees without wholesaler’s licence

For the purposes of section 41 of the Act, the Authority may require a specified healthcare service licensee who compounds a therapeutic product under paragraph (1) to furnish records of any stability study mentioned in paragraph (1)(d). [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] [S 811/2023 wef 18/12/2023]

47.—(1) [Deleted by S 811/2023 wef 18/12/2023]

(2)

A specified healthcare service licensee (other than an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis licensee) (called in this paragraph A) may, in the case of a therapeutic product compounded by A under regulation 46(1) at any approved permanent premises, temporary premises or approved conveyance, transfer A’s stock of the therapeutic product at the approved permanent premises, temporary premises or approved conveyance (as the case may be) to any of the following without holding a wholesaler’s licence: (a) [Deleted by S 811/2023 wef 18/12/2023] (b) another approved permanent premises, temporary premises or approved conveyance of A; (c) any approved permanent premises, temporary premises or approved conveyance of another specified healthcare service licensee.

(3)

A specified healthcare service licensee who is an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee (called in this paragraph B) may, in the case of a therapeutic product compounded by B under regulation 46(1) at any approved permanent premises, temporary premises or approved conveyance, transfer B’s stock of the therapeutic product at the approved permanent premises, temporary premises or approved conveyance (as the case may be) to any of the following without holding a wholesaler’s licence, if the approval of the Authority has been obtained under regulation 46(5) for the transfer: (a) [Deleted by S 811/2023 wef 18/12/2023] (b) any approved permanent premises of B; (c) any approved permanent premises of another specified healthcare service licensee.

(4)

A specified healthcare service licensee (called in this paragraph C) may, in the case of a therapeutic product that is imported by C under regulation 51 or imported by a licensed importer under regulation 58(1)(f), transfer C’s stock of the therapeutic product to another specified healthcare service licensee without holding a wholesaler’s licence. [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] [S 811/2023 wef 18/12/2023]

Division 2 — Licensed retail pharmacies Compounding of therapeutic products at licensed retail pharmacies without manufacturer’s licence

48.—(1) The holder of a pharmacy licence relating to a licensed retail pharmacy may compound a therapeutic product without holding a manufacturer’s licence, if —

(a) the therapeutic product is compounded from an active ingredient or another therapeutic product; (b) the final form or packaging of the compounded therapeutic product is not available or marketed for commercial supply in Singapore; (c) the compounding is carried out — (i) at the licensed retail pharmacy; (ii) by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist; (iii) for the purposes and under the conditions described in paragraph (2), (3) or (4), whichever is applicable; and (iv) in the case of a sterile therapeutic product, at premises where standards established for the operation of clean rooms and the preparation of sterile products are in place and properly documented; and (d) an appropriate expiry date, either in accordance with standards set out in any specified publication or supported by a stability study, accompanies the compounded therapeutic product.

(2)

If the therapeutic product is to be compounded for the use of any patient under the care of a qualified practitioner and it contains an active ingredient specified in Part 1 of the Second Schedule or is within any class of therapeutic products specified in Part 2 of that Schedule, it must be compounded in accordance with — (a) a valid prescription given by the qualified practitioner; or (b) the written instructions of the qualified practitioner, if the qualified practitioner is a personnel of a specified healthcare service licensee. [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023]

(3)

Paragraph (2) does not apply if the compounding consists only of repacking for the purpose of dispensing the therapeutic product.

(4)

If the therapeutic product is to be compounded for the purpose of supplying for use on a ship, the therapeutic product must — (a) be required to be carried on board the ship under the Merchant Shipping (Medical Stores) Regulations (Rg 3), the Merchant Shipping (Maritime Labour Convention) (Medicines and Medical Equipment) Regulations 2014 (G.N. No. 181/2014) or any other written law, for the treatment of persons on board that ship; and [S 436/2023 wef 31/12/2021] (b) be compounded in accordance with such terms and conditions as the Authority may specify in the holder’s pharmacy licence.

(5)

If the therapeutic product is to be compounded for the purpose of supplying for use on an aircraft, the therapeutic product must — (a) form part of the medical supplies required under the Air Navigation Order (O 2) or any other written law, for the treatment of persons on board the aircraft; and [S 436/2023 wef 31/12/2021] (b) be compounded in accordance with such terms and conditions as the Authority may specify in the holder’s pharmacy licence.

(6)

For the purposes of section 45 of the Act, any holder of a retail pharmacy licence who compounds a therapeutic product under paragraph (1) must ensure that the therapeutic product is compounded in accordance with the requirements in paragraph (1)(c) and (d), and, if applicable, paragraph (2), (4) or (5).

(7)

A person who fails to comply with paragraph (6) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

(8) Wholesale supply by holders of pharmacy licences without wholesaler’s licence

For the purposes of section 41 of the Act, the Authority may require the holder of a retail pharmacy licence who compounds a therapeutic product under paragraph (1) to furnish records of any stability study mentioned in paragraph (1)(d).

49. The holder of a pharmacy licence may supply a therapeutic product by wholesale without holding a wholesaler’s licence, if the supply —

(a) is to a healthcare service licensee; [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] (b) is for use on a ship or an aircraft in accordance with the requirements in regulation 5(1)(b)(iv) or (v), respectively; (c) is for the purpose of scientific education or research and development, or for a non‑clinical purpose; (d) is to a Government department or statutory board for the provision of public services; (e) is between licensed retail pharmacy outlets under the same management chain; or (f) consists of the supply of registered therapeutic products to companies outside Singapore for the purpose of any business or trade carried out by those companies.

Division 3 — Named patients Re-labelling of therapeutic products without manufacturer’s licence

50. Without prejudice to regulation 20, a person who imports, or supplies by wholesale, any therapeutic product that is not registered, at the request of a qualified practitioner for the use of the qualified practitioner’s patient, may attach a different label to the therapeutic product without holding a manufacturer’s licence. Import of therapeutic products for patients’ use without importer’s licence

51.—(1) Subject to paragraph (3), a specified healthcare service licensee may, without holding an importer’s licence, import a therapeutic product that is not registered, if the therapeutic product —

(a) is required by, and on the written instructions of, a qualified practitioner who is a personnel of the specified healthcare service licensee; and [S 811/2023 wef 18/12/2023] (b) is for the use of the qualified practitioner’s patient. [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023]

(2)

Subject to paragraph (3), the holder of a pharmacy licence may import, without holding an importer’s licence, a therapeutic product that is not registered, if the therapeutic product is intended for the use by a patient of a qualified practitioner pursuant to a valid prescription given by the qualified practitioner.

(3)

The Authority’s prior approval must be obtained for each consignment of a therapeutic product that is imported under paragraph (1) or (2), and the amount imported must not exceed — (a) a total dosage of 3 months per patient as recommended by the manufacturer of the therapeutic product; or (b) such other quantity as approved by the Authority.

(4)

An application for the Authority’s approval under paragraph (3) must be made in the form and manner specified on the Authority’s website.

Division 4 — Personal imports Import of therapeutic products for personal use without importer’s licence

52.—(1) Subject to paragraph (2), a person may, without holding an importer’s licence, import for that person’s personal use or for the use of any member of that person’s family a therapeutic product not containing —

(a) any psychotropic substance; or (b) an amount greater than the amount specified in the second column of the Seventh Schedule of any substance specified in the first column of that Schedule.

(2)

The amount of the therapeutic product imported under paragraph (1) must not exceed a total dosage of 3 months per individual as recommended by — (a) the manufacturer of the therapeutic product; or (b) a foreign doctor or dentist by way of a written recommendation, or a qualified practitioner by way of a valid prescription.

Division 5 — Wholesale of therapeutic products for export Wholesale of therapeutic products imported solely for export without wholesaler’s licence

53. Without prejudice to any other provision in these Regulations, a person who holds a valid importer’s licence may supply by wholesale, without a wholesaler’s licence, a therapeutic product that is imported solely for the purpose of export, if the supply is in accordance with such terms and conditions as the Authority may specify in the importer’s licence.

Division 6 — Other exceptions Import of health products by licensed manufacturer without importer’s licence

54. The holder of a manufacturer’s licence may import any health product without holding an importer’s licence, if the health product is Wholesale of self-manufactured therapeutic products without wholesaler’s licence

required for the purpose of carrying out the manufacture of a therapeutic product in accordance with the conditions of the manufacturer’s licence.

55. The holder of a manufacturer’s licence may supply by wholesale any therapeutic product manufactured by the holder under the manufacturer’s licence without holding a wholesaler’s licence, if the holder is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the distribution of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the holder’s ownership, possession or control. Wholesale of therapeutic products to ships or aircraft without wholesaler’s licence

56.—(1) A person may supply by wholesale any therapeutic product to a ship without holding a wholesaler’s licence, if the therapeutic product is not registered and is imported in accordance with the requirements in regulation 5(1)(b)(iv).

(2) Therapeutic products for research or non‑clinical purposes

A person may supply by wholesale any therapeutic product to an aircraft without holding a wholesaler’s licence, if the therapeutic product is not registered and is imported in accordance with the requirements in regulation 5(1)(b)(v).

57.—(1) A manufacturer’s licence is not required for the manufacture of a therapeutic product, if the manufacture —

(a) is solely for — (i) the purpose of scientific education or research and development; or (ii) a non-clinical purpose; and (b) is not for any supply to the public.

(2)

A manufacturer of a therapeutic product for any of the purposes mentioned in paragraph (1)(a)(i) or (ii) is not required to maintain records of manufacture in compliance with regulation 31.

(3)

A person may supply a therapeutic product for any of the purposes mentioned in paragraph (1)(a)(i) or (ii) without holding a wholesaler’s licence if there is no supply of the therapeutic product to the public.

PART 8 Prescribed exceptions

EXCEPTIONS — SUPPLY OF THERAPEUTIC PRODUCTS WITHOUT REGISTRATION

58.—(1) For the purposes of section 15(1) of the Act and without prejudice to any other provision in these Regulations, the prescribed exceptions to the prohibition in that section against the supply of a health product that is not registered, are the following:

(a) [Deleted by S 811/2023 wef 18/12/2023] (b) the supply of a therapeutic product compounded under regulation 46 by a specified healthcare service licensee (other than an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee) at any approved permanent premises, temporary premises or approved conveyance of the specified healthcare service licensee to any of the following: (i) [Deleted by S 811/2023 wef 18/12/2023] (ii) another approved permanent premises, temporary premises or approved conveyance of that specified healthcare service licensee; (iii) any approved permanent premises, temporary premises or approved conveyance of another specified healthcare service licensee (other than an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee); [S 436/2023 wef 26/06/2023] (c) the supply of a therapeutic product compounded under regulation 46 by a specified healthcare service licensee (other than an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee) to a patient of a qualified practitioner, who is a personnel of any specified healthcare service licensee; [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] (ca) the supply of a therapeutic product compounded under regulation 46 by a specified healthcare service licensee who is an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee at any approved permanent premises, temporary premises or approved conveyance, for the use of a patient of a qualified practitioner and, if the supply for this purpose involves the supply by the specified healthcare service licensee to — (i) [Deleted by S 811/2023 wef 18/12/2023] (ii) another approved permanent premises of the specified healthcare service licensee; or (iii) any approved permanent premises of another specified healthcare service licensee, the Authority’s approval for the supply has been obtained under regulation 46(5); [S 436/2023 wef 26/06/2023] (d) the supply of a therapeutic product that has been compounded at a licensed retail pharmacy in accordance with, and supplied for the purposes mentioned in, regulation 48; (e) the supply of a therapeutic product by a qualified practitioner to the qualified practitioner’s patient; (f) the supply of a therapeutic product by a licensed importer to a specified healthcare service licensee in accordance with the requirements in regulation 5(1)(b)(i); [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] (g) the supply by a specified healthcare service licensee of a therapeutic product that is imported under regulation 51(1) to a patient of a qualified practitioner, who is a personnel of the specified healthcare service licensee; [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] (h) the supply of a therapeutic product by a holder of a pharmacy licence pursuant to a valid prescription given by a qualified practitioner for the use of the qualified practitioner’s patient under regulation 51(2); (i) the supply of a therapeutic product by a person, who has imported the therapeutic product under regulation 52, to a member of the person’s family; (j) the supply of a therapeutic product for use on a ship or an aircraft in accordance with the requirements in regulation 5(1)(b)(iv) or (v), respectively; (k) the supply of a therapeutic product for — (i) the purpose of scientific education or research and development; or (ii) a non-clinical purpose, provided there is no supply of the therapeutic product to the public; (l) the supply by wholesale of a therapeutic product that does not contain a psychotropic substance or is not a controlled drug and is — (i) manufactured solely for export; or (ii) imported solely for re-export; (m) the export of any therapeutic product, subject to the approval of the Authority under regulation 8 or 9, where applicable.

(2) Supply of therapeutic products compounded under contractual agreement with licensed manufacturer

In paragraph (1)(l), “controlled drug” has the same meaning as in the Misuse of Drugs Act 1973. [S 436/2023 wef 31/12/2021]

59.—(1) Without limiting any other provision in these Regulations, the prohibition in section 15(1) of the Act against the supply of a health product, unless the health product is registered, does not apply to a therapeutic product that is compounded in accordance with paragraph (2) and is supplied in any of the following cases:

(a) by a licensed manufacturer of the therapeutic product to — (i) [Deleted by S 811/2023 wef 18/12/2023] (ii) a specified healthcare service licensee for the use of a patient of the specified healthcare service licensee; (b) [Deleted by S 811/2023 wef 18/12/2023] (c) by a specified healthcare service licensee to a patient of the specified healthcare service licensee.

(2)

For the purposes of paragraph (1), the therapeutic product must be compounded — (a) under an agreement between the licensed manufacturer of the therapeutic product and the specified healthcare service licensee mentioned in paragraph (1)(a)(ii) or (c); [S 811/2023 wef 18/12/2023] (b) in accordance with the chemical composition and the written instructions of a qualified practitioner who is a personnel of — (i) [Deleted by S 811/2023 wef 18/12/2023] (ii) the specified healthcare service licensee mentioned in paragraph (1)(a)(ii) or (c) (as the case may be) for the use solely by or in connection with the patient mentioned in that paragraph; (c) in premises approved by the Authority; and (d) in accordance with the terms and conditions specified in the manufacturer’s licence held by the licensed manufacturer of the therapeutic product.

(3) Previously registered therapeutic products

Paragraph (2)(b) does not apply to prohibit the supply of a therapeutic product that is not registered to any patient of a specified healthcare service licensee mentioned in paragraph (1)(a)(ii) or (c), if the requirements mentioned in paragraph (2)(a), (c) and (d) are satisfied and the compounding consists only of repacking for the purpose of dispensing the therapeutic product. [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023]

60. A supplier of a registered therapeutic product may continue to supply the therapeutic product, before its expiry date, by administration to a person or by retail sale, despite a cancellation of its registration and despite the prohibition in section 15(1) of the Act against the supply of a health product that is not registered, if —

(a) the cancellation of the registration is either made by the Authority under section 37(2) of the Act or upon the application of the registrant under section 37(3) of the Act; (b) the supplier has taken possession of the therapeutic product before the cancellation of its registration; and (c) the Authority does not direct a recall of the therapeutic product from the market.

PART 8A Manufacture, import and supply of emergency therapeutic product 60A.—(1) For the purposes of section 12(1) of the Act and without prejudice to regulations 30, 31, 33, 34 and 35, the manufacture of an emergency therapeutic product for or on behalf of the Government is a prescribed exception to the prohibition in that provision against the manufacture of a therapeutic product without a licence.

EXCEPTION — EMERGENCY THERAPEUTIC PRODUCTS [S 969/2020 wef 01/12/2020]

(2)

For the purposes of section 13(1) of the Act and without prejudice to regulations 30, 33, 34 and 35, the import of an emergency therapeutic product for or on behalf of the Government is a prescribed exception to the prohibition in that provision against the import of a therapeutic product without a licence.

(3)

For the purposes of section 14(1) of the Act and without prejudice to regulations 30, 32, 34 and 35, the supply by wholesale of an emergency therapeutic product for or on behalf of the Government is a prescribed exception to the prohibition in that provision against the supply by wholesale of a therapeutic product without a licence.

(4)

For the purposes of section 15(1) of the Act and without prejudice to regulations 30, 32, 34 and 35, the supply of an emergency therapeutic product for or on behalf of the Government is a prescribed exception to the prohibition in that provision against the supply of a therapeutic product that is not registered.

(5)

In this regulation — “civil defence emergency” means a civil defence emergency declared under section 102(1) of the Civil Defence Act 1986; [S 436/2023 wef 31/12/2021] “emergency therapeutic product” means a therapeutic product that is for such time designated by the Minister as an emergency therapeutic product for the purposes of this regulation, where — (a) the therapeutic product is needed — (i) to treat any medical condition resulting from a civil defence emergency; (ii) to prevent the spread or possible outbreak of an infectious disease; or (iii) to treat an infectious disease or any medical condition associated with an infectious disease, where the medical condition or infectious disease is potentially serious or life-threatening; and (b) in the opinion of the Authority, there is — (i) preliminary scientific evidence that the therapeutic product has the potential — (A) to treat the medical condition resulting from the civil defence emergency; (B) to prevent the spread or possible outbreak of the infectious disease; or (C) to treat the infectious disease or any medical condition associated with the infectious disease, as the case may be; and (ii) ongoing scientific evidence that the potential benefits of the therapeutic product outweigh the known risks of the therapeutic product, to a person on whom the therapeutic product is used; “infectious disease” has the meaning given by section 2 of the Infectious Diseases Act 1976. [S 436/2023 wef 31/12/2021] [S 969/2020 wef 01/12/2020]

PART 9 MISCELLANEOUS Certification of therapeutic products intended for export

61.—(1) The Authority may, on the application of a person who intends to export a therapeutic product, issue to the person a certificate certifying —

(a) in a case where the therapeutic product is registered under the Act, that it is so registered; or (b) in a case where the therapeutic product is not so registered, that it complies with such standards or requirements as may be specified in the certificate.

(2) Certificate of manufacturing standard of therapeutic products

An application for a certificate under paragraph (1) must — (a) be made in the form and manner specified on the Authority’s website; and (b) be accompanied by the relevant fee. [S 458/2022 wef 01/07/2022]

62.—(1) The Authority may, on the application of a person who manufactures a therapeutic product (called the manufacturer) and on being satisfied, after completion of an assessment of conformity, that the manufacturer conforms to an applicable Good Manufacturing Practice Standard, issue a GMP Certificate to the manufacturer subject to any terms and conditions as the Authority thinks fit.

(2)

Every GMP Certificate issued is valid for a period specified in the certificate, being not longer than 3 years starting on the date of commencement of the assessment mentioned in paragraph (1).

(3)

An application for a GMP Certificate must — (a) be made in the form and manner specified on the Authority’s website; and (b) be accompanied by the relevant fee. [S 458/2022 wef 01/07/2022]

(4) Certificate of distribution standard of therapeutic products

In this regulation — “GMP Certificate” means a certificate issued by the Authority to certify compliance with an applicable Good Manufacturing Practice Standard; “Good Manufacturing Practice Standard” means the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products and any other good manufacturing practice standard approved by the Authority. [S 458/2022 wef 01/07/2022]

63.—(1) The Authority may, on the application of a person who distributes a therapeutic product and on being satisfied, after completion of an assessment of conformity, that the person conforms to an applicable Good Distribution Practice Standard, issue a GDP Certificate to the person subject to any terms and conditions as the Authority thinks fit.

(2)

Every GDP Certificate issued is valid for a period specified in the certificate, being not longer than 3 years starting on the date of commencement of the assessment mentioned in paragraph (1).

(3)

An application for a GDP Certificate must — (a) be made in the form and manner specified on the Authority’s website; and (b) be accompanied by the relevant fee. [S 458/2022 wef 01/07/2022]

(4) Other certificates or documents

In this regulation — “GDP Certificate” means a certificate issued by the Authority to certify compliance with an applicable Good Distribution Practice Standard; “Good Distribution Practice Standard” means the Authority’s Guidance Notes on Good Distribution Practice and any other good distribution practice standard approved by the Authority. [S 458/2022 wef 01/07/2022]

64. The Authority may, on the application of any person and upon payment of the relevant fee, issue such other certificate or document to the applicant as the Authority thinks fit. Product quality surveillances

[S 458/2022 wef 01/07/2022]

65.—(1) The Authority may at any time conduct a product quality surveillance for the purposes of ensuring that a therapeutic product is not a non-compliant health product within the meaning of section 48(a) of the Act.

(2)

The Authority may require a manufacturer, supplier, licensee or registrant of a therapeutic product to furnish, without charge, any number of samples of the therapeutic product for evaluation by the Authority in the product quality surveillance.

(3) Non-compliant therapeutic products

A person who fails to comply with a requirement of the Authority under paragraph (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

66. For the purposes of section 48(a)(iii) of the Act, a therapeutic product is considered as being non-compliant if it fails to comply with the product quality characteristics, specifications and labelling approved by the Authority — Confidential information

(a) at the time of the registration of the therapeutic product; or (b) under regulation 42.

67. For the purposes of section 66(2)(d) of the Act, the Authority may disclose any confidential information relating to the quality,

safety or efficacy of a therapeutic product, if — (a) that disclosure is, in the opinion of the Authority, necessary to protect the health or safety of members of the public; or (b) that disclosure is to a Government department or statutory body in order to enable the Government department or statutory body to perform its public functions.

68. [Deleted by S 458/2022 wef 01/07/2022]

FIRST SCHEDULE PSYCHOTROPIC SUBSTANCES

1. The following substances: Allobarbital

Alprazolam Amineptine [Deleted by S 219/2017 wef 01/05/2017] Aminorex Amobarbital Barbital Bromazepam Brotizolam Butalbital Butobarbital Camazepam Cathine Chlordiazepoxide Clobazam Clonazepam Clonazolam Clorazepate Clotiazepam Regulation 2(1) FIRST SCHEDULE — continued Cloxazolam Cyclobarbital Delorazepam Diazepam Diclazepam Estazolam Ethchlorvynol Ethinamate Ethyl loflazepate Etilamfetamine Etizolam Fencamfamin Fenproporex Flualprazolam Flubromazolam Fludiazepam Flurazepam Glutethimide Halazepam Haloxazolam Ketazolam Lefetamine Loprazolam Lorazepam Lormetazepam Mazindol Medazepam Mefenorex Meprobamate FIRST SCHEDULE — continued Mesocarb Methylphenobarbital Methyprylon Midazolam Nitrazepam Nordazepam Oxazepam Oxazolam Pemoline Pentazocine Pentobarbital Phenazepam Phenobarbital Phentermine Pinazepam Prazepam Secbutabarbital Temazepam Tetrazepam Vinylbital Zolpidem [S 681/2023 wef 01/11/2023]

2. The stereoisomeric forms or salts of the substances specified in paragraph 1, wherever the existence of such stereoisomeric forms or salts is possible.

[S 681/2023 wef 01/11/2023]

3. Any preparation of a product containing one or more of the substances specified in paragraph 1 or 2.

SECOND SCHEDULE Regulations 10(1), 46(2) and 48(2)

PART 1

ACTIVE INGREDIENTS IN PRESCRIPTION-ONLY MEDICINES (±)-4-ethyl-2, 5-dimethoxy-α-phenethylamine (2C-E) 2-Deoxy-2-[18F] fluoro-d-glucose 2-Phenylcinchoninic acid; 2‑salicylcinchoninic acid 3-Di-n-butylaminomethyl-4,5,6-trihydroxyphthalide 5-Phenylhydantoin Abacavir Abatacept Abciximab Abemaciclib Abiraterone Abrocitinib Acalabrutinib Acamprosate Acarbose Acebutolol Aceclofenac Acemetacin Acepromazine Acetanilide Acetazolamide Acetohexamide Acetorphine Acetylcarbromal Acetylcysteine Acetyldigoxin SECOND SCHEDULE — continued Acetyldihydrocodeine Acetylmethadol Acetylstrophanthidin Acipimox Acitretin Aclidinium Acrivastine Actinomycins Acyclovir Adalimumab Adapalene Adefovir Adicillin Adiphenine Adrenaline Adrenocorticotropic hormone (ACTH) Afatinib Aflibercept Agalsidase alfa Agalsidase beta Agomelatine Alatrofloxacin Albutrepenonacog alfa Alcaftadine Alclofenac Alclometasone Alcuronium Aldesleukin Aldosterone SECOND SCHEDULE — continued Alectinib Alefacept Alemtuzumab Alendronic acid Alfacalcidol Alfentanil Alfuzosin Algestone Alglucosidase alfa Alirocumab Aliskiren Allobarbitone Allopurinol Allylisopropylacetylurea Allyloestrenol Allylprodine Alminoprofen Almitrine Alogliptin Alosetron Alpelisib [Deleted by S 681/2023 wef 01/11/2023] Alphacetylmethadol Alphachloralose Alphadolone Alphameprodine Alphamethadol Alphaprodine Alphaxalone SECOND SCHEDULE — continued Alprazolam Alprenolol Alprostadil Alseroxylon Alteplase Altretamine Amantadine Ambenonium Ambrisentan Ambroxol Ambuside Ambutonium Ametazole Amethocaine [Deleted by S 219/2017 wef 01/05/2017] Amidopyrine Amifostine Amikacin Amiloride Amineptine Aminocaproic acid Aminoglutethimide Aminolevulinic acid Aminophylline Aminopterin Aminorex Amiodarone Amisulpride Amitriptyline SECOND SCHEDULE — continued Amivantamab Amlodipine Ammonium lactate Amoxycillin Amphetamine Amphomycin Amphotericin B Ampicillin Amprenavir Amrinone Amsacrine (M-AMSA) Amylobarbitone Amylocaine Anagrelide Anastrozole Ancrod Androsterone Angiotensin amide Anidulafungin Anileridine Anistreplase Antazoline Apalutamide Apixaban Apomorphine Apraclonidine Apramycin Apremilast Aprepitant SECOND SCHEDULE — continued Aprobarbitone Aprotinin Aripiprazole Arotinolol Arsenic trioxide Arsphenamine Arteether Artemether Artemisinin Artesunate Articaine Asciminib Asenapine Aspoxicillin Astemizole Asunaprevir Atazanavir Atenolol Atezolizumab Atomoxetine Atorvastatin Atosiban Atovaquone Atracurium Atropine Auranofin Avanafil Avelumab Avibactam SECOND SCHEDULE — continued Axitinib Azacitidine Azacyclonol Azaperone Azapropazone Azasetron Azatadine Azathioprine Azelaic acid Azelastine Azidamphenicol Azidocillin Azilsartan Azithromycin Aztreonam Bacampicillin Bacitracin Baclofen Baloxavir marboxil Bambermycin Bamipine Barbitone Barbituric acid Baricitinib Basiliximab Becaplermin Beclamide Beclomethasone Befunolol SECOND SCHEDULE — continued Bekanamycin Belantamab mafodotin Belimumab Bemegride Benactyzine Benapryzine Benazepril Bendamustine Bendrofluazide Benethamine penicillin Benfluorex Benoxaprofen Benperidol Benralizumab Benserazide Benzamidosalicylic acid Benzathine penicillin Benzbromarone Benzethidine Benzhexol Benzilonium Benzocaine Benzoctamine Benzoestrol Benzphetamine Benzquinamide Benzthiazide Benztropine Benzylfentanyl SECOND SCHEDULE — continued Benzylmorphine Benzylpenicillin Besifloxacin Betahistine Betameprodine Betamethadol Betamethasone Betaprodine Betaxolol Bethanechol Bethanidine Betiatide Bevacizumab Bevonium Bezafibrate Bezitramide Bicalutamide Bicisate Bictegravir Bifonazole Bilastine Bimatoprost Biperiden Bisoprolol Bleomycin Blinatumomab Boceprevir Boldenone undecenoate Bopindolol SECOND SCHEDULE — continued Bortezomib Bosentan Botulinum toxin Brentuximab Bretylium Brexipiprazole Brigatinib Brimonidine Brinzolamide Brolamfetamine Bromazepam Bromhexine Bromocriptine Bromodiphenhydramine Bromvaletone Brotizolam Budesonide Bufexamac Buflomedil Buformin Bumadizone calcium Bumetanide Bunazosin Buphenine Bupivacaine Bupranolol Buprenorphine Bupropion Burosumab SECOND SCHEDULE — continued Buserelin Buspirone Busulphan Butacaine Butalbital Butamirate Butanilicaine Butizide Butobarbitone Butoconazole Butriptyline Butropium Butylchloral hydrate Cabazitaxel Cabergoline Cabimicina Cabotegravir Cabozantinib Calcipotriol Calcitonin Calcitriol Calcium barbiturate Calcium carbimide Calcium dobesilate Calfactant Camazepam Canagliflozin Canakinumab Candesartan SECOND SCHEDULE — continued Candicidin Capecitabine Capmatinib Capreomycin Captodiame Captopril Caramiphen Carbachol Carbamazepine Carbenicillin Carbenoxolone Carbetocin Carbidopa Carbimazole Carboplatin Carboprost Carbromal Carbutamide Carfecillin Carfentanil Carfilzomib Cariprazine Carisoprodol Carmustine Carperidine Carprofen Carteolol Carvedilol Caspofungin SECOND SCHEDULE — continued Cathine Cathinone Cefaclor Cefadroxil Cefamandole Cefatrizine Cefdinir Cefepime Cefixime Cefodizime Cefoperazone Cefotaxime Cefotiam Cefoxitin Cefpirome Cefprozil Cefsulodin Ceftaroline Ceftazidime Ceftibuten Ceftizoxime Ceftolozane Ceftriaxone Cefuroxime Celecoxib Cephalexin Cephaloglycin Cephaloram Cephaloridine SECOND SCHEDULE — continued Cephalothin Cephazolin Cephradine Ceritinib Cerivastatin Certolizumab Cetrorelix Cetuximab Chenodeoxycholic acid Chloral hydrate Chlorambucil Chloramphenicol Chlorcyclizine Chlordiazepoxide Chlormadinone Chlormerodrin Chlormethiazole Chlormezanone Chlormidazole Chlorothiazide Chloroquine Chlorpheniramine Chlorphenoxamine Chlorphentermine Chlorpromazine Chlorpropamide Chlorprothixene and other derivatives of 9‑methylenethiazanthene Chlorquinaldol Chlortetracycline SECOND SCHEDULE — continued Chlorthalidone and other derivatives of o-chlorobenzene sulphonamide Chlorzoxazone Cholestyramine Choline Theophyllinate Chorionic gonadotrophin Chromium [51CR] Chromomycin A Ciclacillin Ciclesonide Ciclopirox Cilastatin Cilazapril Cilostazol Cimetidine Cinacalcet Cinchocaine Ciprofibrate Ciprofloxacin Cisapride Cisatracurium Cisplatin Citalopram Citicoline Cladribine Clarithromycin Clavulanic acid Clebopride Clemastine Clemizole SECOND SCHEDULE — continued Clenbuterol Clidinium Clindamycin Clioquinol Clobazam Clobenzorex Clobetasol Clobetasone Clobutinol Clodronic acid Clofarabine Clofazimine Clofedanol Clofibrate Clomiphene Clomipramine Clomocycline Clonazepam Clonazolam Clonidine Clonitazene Clopamide Clopenthixol Clopidogrel Cloprostenol Clorazepate Clorexolone Clorprenaline Clostebol SECOND SCHEDULE — continued Clostridiopeptidase A Clotiazepam Clotrimazole Cloxacillin Cloxacillin benzathine Cloxazolam Cloxiquine Clozapine Cobicistat Cobimetinib Codeine Co-dergocrine mesylate Colchicine Colestipol Colimycin Colistin Corifollitropin alfa Corticorelin Cortisone Crisaborole Crisantaspase Crizotinib Cropropamide Crotethamide Cyclandelate Cyclarbamate Cyclizine Cyclobarbitone Cyclofenil SECOND SCHEDULE — continued Cyclopenthiazide Cyclopentolate Cyclophosphamide Cycloserine Cyclosporin Cyclothiazide Cycrimine Cyproheptadine Cyproterone Cytarabine Dabigatran Dabrafenib Dacarbazine Daclatasvir Daclizumab Dacomitinib Dactinomycin Dalfopristin Dalteparin Danazol Danthron Dantrolene Dapagliflozin Dapoxetine Dapsone Daptomycin Daratumumab Darbepoetin alfa Darolutamide SECOND SCHEDULE — continued Darunavir Dasabuvir Dasatinib Daunorubicin Davesomeran Debrisoquine Deferasirox Deferiprone Deferoxamine Degarelix Dehydroemetine Dehydroepiandrosterone (DHEA) Delapril Delmadinone Delorazepam Demecarium Demeclocycline Demoxytocin Denosumab Deoxycholic acid Deoxycortone Deptropine Deserpidine [Deleted by S 681/2023 wef 01/11/2023] Desfluorotriamcinolone Desflurane Desipramine Deslanoside Desloratadine SECOND SCHEDULE — continued Desmopressin Desogestrel Desomorphine Desonide Desoxymethasone Desvenlafaxine Dexamethasone Dexamphetamine Dexetimide Dexfenfluramine Dexketoprofen Dexlansoprazole Dexmedetomidine Dexrazoxane [Deleted by S 681/2023 wef 01/11/2023] Dextromoramide Dextropropoxyphene Dextrorphan Dextrothyroxine Diacetylmorphine Diacetylnalorphine Diamorphine Diampromide Diazepam Diazoxide Dibekacin Dibenzepin Dibucaine Dichloralphenazone SECOND SCHEDULE — continued Dichlorophenarsine Dichlorphenamide Diclazepam Diclofenac Dicloxacillin Didanosine Dienoestrol Dienogest [Deleted by S 681/2023 wef 01/11/2023] Diethylcarbamazine Diethylthiambutene Difelikefalin Difenoxin Diflucortolone Diflunisal Digoxin Dihydralazine Dihydroartemisin Dihydrocodeine Dihydrocodeinone Dihydroergotamine Dihydroergotoxine Dihydroetorphine Dihydromorphine Dihydrostreptomycin Diloxanide Diltiazem Dimenhydrinate Dimercaprol SECOND SCHEDULE — continued Dimethindene Dimethisoquin Dimethisterone Dimethothiazine Dimethoxanate Dimethpyrindene Dimethyl 4-sulphamoylphenyl phosphorothioate Dimethyl fumarate Dimethyl sulphoxide Dimethylthiambutene Dimethyltubocurarine Dinitronaphthols Dinitrothymols Dinoprost Dinoprostone Dioxaphetyl butyrate Diperodon Diphenidol Diphenylpyraline Dipipanone Dipivefrin Diprophylline Dipyridamole Dipyrone Dirithromycin Disopyramide Distigmine Disulfiram Disulphamide SECOND SCHEDULE — continued Dithienylallylamines Dobutamine Docetaxel Dolutegravir Domperidone Donepezil Dopamine Doravirine Doripenem Dorzolamide Dostarlimab Dothiepin Doxapram Doxazosin Doxepin Doxofylline Doxorubicin Doxycycline Doxylamine Dronedarone Droperidol Drospirenone Drostanolone Drotebanol Drotrecogin alfa Dulaglutide Duloxetine Dupilumab Durvalumab SECOND SCHEDULE — continued Dutasteride Dydrogesterone Dyflos Ebastine Econazole Ecothiopate Ectylurea Eculizumab Edoxaban Edoxudine Edrophonium Efalizumab Efavirenz Elasomeran Elbasvir Eletriptan Eltrombopag Elvitegravir Embramine Embutramide Emedastine Emepronium Emicizumab Empagliflozin Emtricitabine Emylcamate Enalapril Enalaprilat Encainide SECOND SCHEDULE — continued Enflurane Enfortumab vedotin Enfuvirtide Enoxaparin Entacapone Entecavir Entrectinib Enzalutamide Eperisone Ephedrine Epicillin Epimestrol Epinastine Epioestriol Epirubicin Epithiazide Eplerenone Epoetin alfa Epoetin beta Epoprostenol Eprosartan Eptacog alfa Eptifibatide Eptinezumab Eravacycline Erdafitinib Erdosteine Erenumab Ergometrine SECOND SCHEDULE — continued Ergotamine Ergotoxine Eribulin Erlotinib Ertapenem Ertugliflozin Erythrityl tetranitrate Erythromycin Erythropoietin Escitalopram Esketamine Esmolol Esomeprazole Estazolam Estramustine Etafedrine Etanercept Etelcalcetide Ethacrynic acid Ethambutol Ethamivan Ethamsylate Ethchlorvynol Ethebenecid Ethiazide Ethinamate Ethinyloestradiol Ethionamide Ethisterone SECOND SCHEDULE — continued Ethoglucid Ethoheptazine Ethopropazine Ethosuximide Ethotoin Ethyl biscoumacetate Ethyl loflazepate Ethyl p-piperidinoacetylaminobenzoate Ethylacetanilide Ethylmorphine Ethylnoradrenaline Ethyloestrenol Ethylstibamine Ethynodiol Etidronic acid Etilamfetamine Etizolam Etodolac Etofenamate Etofibrate Etofylline Etomidate Etonitazene Etonogestrel Etoposide Etoricoxib Etorphine Etoxeridine Etravirine SECOND SCHEDULE — continued Etretinate Everolimus Evolocumab Exametazime Exemestane Exenatide Ezetimibe Famciclovir Famotidine Fampridine Famprofazone Famtozinameran Faricimab Fazadinium Febuxostat Fedratinib Felbinac Felodipine Felypressin Fencamfamin Fenclofenac Fenetylline Fenfluramine Fenofibrate Fenoprofen Fenoterol Fenoverine Fenpipramide Fenpiprane SECOND SCHEDULE — continued Fenproporex Fentanyl Fenticonazole Feprazone Ferric carboxymaltose Ferric derisomaltose Ferucarbotran Fexofenadine Filgrastim Fimasartan Finasteride Finerenone Fingolimod Flavomycin Flavoxate Flecainide Flibanserin Floxuridine Flualprazolam Fluanisone Flubromazolam Fluclorolone Flucloxacillin Fluconazole Flucytosine Fludarabine Fludiazepam Fludrocortisone Flufenamic acid SECOND SCHEDULE — continued Flugestone Flumazenil Flumedroxone Flumethasone Flumethiazide Flunisolide Flunitrazepam Fluocinolone Fluocinonide Fluocortolone Fluopromazine Fluoro-2-deoxy-d-glucose Fluoroacetamide Fluoroacetanilide Fluorometholone Fluorouracil Fluothane Fluoxetine Fluoxymesterone Flupenthixol Fluperolone Fluphenazine Fluprednidene Fluprednisolone Fluprostenol Flurandrenolone Flurazepam Flurbiprofen Fluspirilene SECOND SCHEDULE — continued Flutamide Flutemetamol Fluticasone Fluvastatin Fluvoxamine Follicle stimulating hormone (FSH) Follitropin alfa Follitropin delta Fondaparinux Formestane Formosulphathiazole Formoterol Fosamprenavir Fosaprepitant Foscarnet Fosfestrol Fosfomycin Fosinopril Fotemustine Framycetin Fremanezumab Frusemide Ftorafur Fulvestrant Fumagillin Furaltadone Furazolidone Furethidine Fusafungine SECOND SCHEDULE — continued Fusidic acid Gabapentin Gadobenic acid Gadobutrol Gadodiamide Gadopentetic acid Gadoteric acid Gadoversetamide [Deleted by S 681/2023 wef 01/11/2023] Gadoxetic acid Galantamine Galcanezumab Gallamine Gallium Ganciclovir Ganirelix Gatifloxacin Gefitinib Gemcitabine Gemeprost Gemfibrozil Gemtuzumab ozogamicin Gentamicin Gestodene Gestrinone Gestronol Gilteritinib Gimeracil Glafenine SECOND SCHEDULE — continued Glecaprevir Glibenclamide Glibornuride Gliclazide Glimepiride Glipizide Gliquidone Glucagon Glutethimide Glyceryl trinitrate Glycopyrrolate Glycopyrronium Glymidine Golimumab Gonadorelin Goserelin Gramicidins Granisetron Grazoprevir Grepafloxacin Griseofulvin Guanethidine Guanoclor Guanoxan Guselkumab Hachimycin Halazepam Halcinonide Halofantrine SECOND SCHEDULE — continued Halometasone Haloperidol and other 4-substituted derivatives of N-(3-p-fluorobenzoylpropyl) piperidine Haloprogin Halothane Haloxazolam Heparin Heparin calcium Heptabarbitone Heptaminol Hexamethonium Hexamethylmelamine Hexapropymate Hexobarbitone Hexoestrol [Deleted by S 681/2023 wef 01/11/2023] Histrelin acetate Homatropine Homochlorcyclizine Hydralazine Hydrochlorothiazide Hydrocodone Hydrocortisone Hydromorphinol Hydromorphone Hydroquinone Hydroxychloroquine Hydroxycinchoninic Hydroxyprogesterone SECOND SCHEDULE — continued Hydroxyquinoline Hydroxyurea Hydroxyzine Hygromycin B Hyoscine Ibacitabine Ibandronic acid Ibrutinib Ibuprofen Idarubicin Idarucizumab Idelalisib Idoxuridine Idrocilamide Idursulfase Ifenprodil Ifosfamide Iloprost Imatinib Imidapril Imiglucerase Imipenem Imipramine Imiquimod Inclisiran Indacaterol Indapamide Indinavir Indium pentetreotide SECOND SCHEDULE — continued Indobufen Indomethacin Infliximab Inotuzumab ozogamicin Interferons Iodixanol Iodine-131 Ioflupane Ipilimumab Ipratropium Iprindole Iproniazid Irbesartan Irinotecan Isatuximab Isavuconazonium Isepamicin Isoaminile Isocarboxazid [Deleted by S 681/2023 wef 01/11/2023] Isoetharine Isoflurane Isomethadone (isoamidone) Isoniazid Isoprenaline Isopropamide Isopyrin Isosorbide Isothipendyl SECOND SCHEDULE — continued Isotretinoin Isoxicam Isoxsuprine Isradipine Itopride Itraconazole Ivabradine Ivermectin Ixabepilone Ixazomib Ixekizumab Kanamycin Kanendomycin Ketamine Ketanserin Ketazolam Ketobemidone Ketoconazole Ketoprofen Ketorolac Ketotifen Labetalol Lacidipine Lacosamide Lafutidine Lamivudine Lamotrigine Lanreotide Lansoprazole SECOND SCHEDULE — continued Lanthanum carbonate Lapatinib Laronidase Laropiprant Larotrectinib L-Asparaginase Latanoprost Latanoprostene Laudexium Ledipasvir Lefetamine Leflunomide Lemborexant Lenalidomide Lenograstim Lenvatinib Lepirudin Lercanidipine Letermovir Letrozole [Deleted by S 681/2023 wef 01/11/2023] Leuprorelin Levamisole Levamphetamine Levetiracetam Levobunolol Levocabastine Levocetirizine Levodopa SECOND SCHEDULE — continued Levofloxacin Levomethamphetamine Levomethorphan Levomoramide Levonorgestrel Levorphanol Levosimendan Levothyroxine Lidoflazine Lignocaine Linagliptin Lincomycin Linezolid Lipegfilgrastim Liothyronine Liraglutide Lisdexamfetamine Lisinopril Lisuride Lithium carbonate Lixisenatide Lodoxamide Lofentanil Lofepramine Lomefloxacin Lomustine Lonazolac Lonoccog alfa Lopinavir SECOND SCHEDULE — continued Loprazolam Loracarbef Lorazepam Lorlatinib Lormetazepam Losartan Loteprednol Lovastatin Loxoprofen L-Pyroglutamyl-L-histidyl-L-proline amide Lubiprostone Luliconazole Lumefantrine Lurasidone Lurbinectedin Luspatercept Luteinising hormone Lutetium-177 Lutropin alfa Lymecycline Lynoestrenol Lypressin Lysuride Macitentan Mafenide Mangafodipir Mannitol hexanitrate Mannomustine Maprotiline SECOND SCHEDULE — continued Maraviroc Mavacamten Mazindol Mebanazine Mebezonium Mebhydrolin Mebutamate Mecamylamine Meclastine Meclofenamic acid Meclofenoxate Mecloqualone Meclozine Medazepam Medigoxin Medrogestone Medroxyprogesterone Mefenamic acid Mefenorex Mefloquine Mefruside Megestrol [Deleted by S 681/2023 wef 01/11/2023] Melengestrol Melitracen Meloxicam Melphalan Memantine Menotrophin SECOND SCHEDULE — continued Mepenzolate Mephenesin Mephentermine Mepivacaine Mepolizumab Meprobamate Mepyramine Mequitazine Mercaptopurine Meropenem Mesalazine MESNA (2-mercaptoethane sulfonate sodium) Mesocarb Mesoridazine Mestanolone Mesterolone Mestranol Metabutethamine Metaiodobenzylguanidine (I-131) Metaraminol Metaxalone Metazocine Metergoline Metformin Methacycline Methadone Methadyl acetate Methallenoestril Methandienone SECOND SCHEDULE — continued Methandriol Methantheline Methapyrilene Methaqualone Metharbitone Methdilazine Methenolone Methicillin Methimazole Methisoprinol Methixene Methocarbamol Methohexitone Methoin Methoserpidine Methotrexate Methotrimeprazine Methoxamine Methoxsalen Methoxyflurane Methoxyphenamine Methsuximide Methyclothiazide Methyl aminolevulinate Methylaminoheptane Methylamphetamine Methyldihydromorphine Methyldopa Methyldopate SECOND SCHEDULE — continued Methylephedrine Methylergometrine Methylnaltrexone Methylpentynol Methylphenidate Methylphenobarbitone Methylprednisolone Methylsulphonal Methyltestosterone Methylthioninium Methylthiouracil Methyprylone Methysergide Metipranolol Metoclopramide Metolazone Metomidate Metopon Metoprolol Metronidazole Mexiletine Mianserin Mibefradil Micafungin [Deleted by S 681/2023 wef 01/11/2023] Micronomicin Midazolam Midecamycin Midodrine SECOND SCHEDULE — continued Midostaurin Mifepristone Miglitol Milrinone Miltefosine Minaprine Minocycline Minoxidil (other than topical preparations) Mirabegron Mirtazapine Misoprostol Mithramycin Mitobronitol Mitomycins Mitopodozide Mitotane Mitoxantrone Mivacurium Mizolastine m-Nitrophenol; o-Nitrophenol; p-Nitrophenol Moclobemide Moexipril Molgramostim Molindone Mometasone Monofluoroacetic acid Montelukast Morazone Morinamide SECOND SCHEDULE — continued Moroctocog alfa Moroxydine Morphine Moxalactam Moxifloxacin Moxonidine Mupirocin Muromonab-CD3 Mustine and any other N-substituted derivatives of di-(2-chloroethyl) amine Mycophenolic acid Myrophine Myrtecaine Nabumetone N-Acetylaspartyl glutamic acid; spaglumic acid Nadolol Nadroparin Nafarelin Nafcillin Naftidrofuryl Naftifine Nalbuphine Nalidixic acid Nalmefene Nalorphine Naloxone Naltrexone Nandrolone Naproxen Naratriptan SECOND SCHEDULE — continued Natalizumab Natamycin Nateglinide [Deleted by S 681/2023 wef 01/11/2023] Nealbarbitone Nebivolol Necitumumab Nedocromil Nefazodone Nefopam Nelfinavir Neoarsphenamine Neomycin Neostigmine Nepafenac Neratinib Netarsudil Netilmicin Netupitant Nevirapine Nialamide Niaprazine Nicardipine Nicergoline Nicocodine Nicodicodine Nicomorphine [Deleted by S 681/2023 wef 01/11/2023] Nicoumalone SECOND SCHEDULE — continued Nifedipine Nifuroxazide Nifurzide Nikethamide Nilotinib Nilvadipine Nimesulide Nimetazepam Nimodipine Nimorazole Nintedanib Niraparib Niridazole Nisoldipine Nitrazepam Nitrendipine Nitric oxide Nitrofurantoin Nitrofurazone Nitromin Nitroprusside Nitroxoline Nivolumab Nizatidine Nomegestrol Nometasone Nomifensine Nonacog alfa Noracymethadol SECOND SCHEDULE — continued Noradrenaline Noramidopyrine Norbuprenorphine Norcodeine Nordazepam Norelgestromin Norethandrolone Norethisterone Norethynodrel Norfloxacin Norgestimate Norgestrel Norketamine Norlevorphanol Normethadone Normorphine Norpipanone Nortriptyline Novobiocin Noxythiolin Nusinersen Nystatin Obinutuzumab Ocriplasmin Octacosactrin Octocog alfa Octreotide Oestradiol Oestriol SECOND SCHEDULE — continued Oestrone Ofatumumab Ofloxacin Olanzapine Olaparib Oleandomycin Olmesartan Olodaterol Olopatadine Olsalazine Omalizumab Ombitasvir Omeprazole Omidenepag Ondansetron Opipramol Orciprenaline Orelabrutinib Orlistat Ornidazole Orphenadrine Orthocaine Oseltamivir Osimertinib Ospemifene Oteracil Oxaliplatin Oxamniquine Oxandrolone SECOND SCHEDULE — continued Oxantel Oxatomide Oxazepam Oxazolam Oxcarbazepine Oxedrine Oxidronic acid Oxiracetam Oxolinic acid Oxomemazine Oxophenarsine Oxpentifylline Oxprenolol Oxybuprocaine Oxybutynin Oxycodone Oxymesterone Oxymetazoline Oxymetholone Oxymorphone Oxypertine Oxyphenbutazone Oxyphencyclimine Oxyphenonium Oxytetracycline Oxytocin Ozanimod p-Aminobenzoic acid Paclitaxel SECOND SCHEDULE — continued Palbociclib Paliperidone Palivizumab Palonosetron Pamidronate [Deleted by S 681/2023 wef 01/11/2023] Pancuronium Panitumumab Panobinostat Pantoprazole Paraldehyde Paramethadione Paramethasone Parecoxib Pargyline Paricalcitol Paritaprevir Parnaparin Paromomycin Paroxetine Pasireotide Pazopanib Pecilocin Pefloxacin Pegaptanib Pegaspargase Pegfilgrastim Peginterferon Pegvisomant SECOND SCHEDULE — continued Pemafibrate Pembrolizumab Pemetrexed Pemoline Pempidine Penamecillin Penciclovir Penethamate Penfluridol Penicillamine Penicillin G; benzylpenicillin Penicillin V; phenoxymethylpenicillin Pentaerythritol tetranitrate Pentamidine Pentazocine Penthienate Pentobarbitone Pentolinium Pentoxifylline Perampanel Perfluorobutane Perfluoropropane Pergolide Perhexiline Pericyazine Perindopril Perphenazine Pertuzumab SECOND SCHEDULE — continued Pethidine Pethidinic acid Phenacaine Phenacemide Phenacetin Phenaglycodol Phenazepam Phenazocine Phenbenicillin Phenbutrazate Phencyclidine Phendimetrazine Phenelzine Phenethicillin Phenethylamine Phenetidylphenacetin Pheneturide Phenformin Phenglutarimide Phenindamine Phenindione Pheniramine Phenmetrazine Phenobarbitone Phenoperidine Phenothiazine Phenoxybenzamine Phenoxypropazine Phenprocoumon SECOND SCHEDULE — continued Phensuximide Phentermine Phentolamine Phenylbutazone Phenylmethyl barbituric acid Phenylpropanolamine Phenytoin Phthalylsulphacetamide Phthalylsulphathiazole Physostigmine Pibrentasvir Picrotoxin Pilocarpine Pimecrolimus Piminodine Pimozide Pinazepam Pioglitazone Pipecuronium Pipemidic acid Pipenzolate Piperacillin Piperazine oestrone sulphate Piperidolate Pipothiazine Pipradrol Piracetam Pirenoxine Pirenzepine SECOND SCHEDULE — continued Pirfenidone Piribedil Piritramide Piroxicam Pirprofen Pitavastatin Pivmecillinam Pizotifen Plerixafor Polatuzumab vedotin Poldine Polidexide Polymethylene-bistrimethylammonium salts Polymyxins Polyoestradiol Polythiazide Pomalidomide Ponatinib Posaconazole Practolol Pralatrexate Pralidoxime Pralsetinib Pramipexole Prasugrel Pravastatin Prazepam Praziquantel Prazosin SECOND SCHEDULE — continued Prednicarbate Prednisolone Prednisone Pregabalin Prenoxdiazine Prenylamine Prilocaine Procaine Primaquine Primidone Prindolol Probenecid Probucol Procainamide Procaine penicillin Procarbazine Prochlorperazine Procyclidine Profenone Progesterone Proguanil Prolintane Promazine Promestriene Promethazine Promoxolane Pronethalol Propafenone Propanidid SECOND SCHEDULE — continued Propantheline Proparacaine Propicillin Propiomazine Propiram Propiverine Propofol Propoxyphene Propranolol Propylhexedrine Propylthiouracil Propyromazine Proquamezine Proquazone Prostaglandins Protamine Prothionamide Prothipendyl Protirelin Protriptyline Proxymetacaine Proxyphylline Prucalopride Pyrathiazine Pyrazinamide Pyridinolcarbamate Pyridostigmine Pyrimethamine Pyritinol SECOND SCHEDULE — continued Pyrovalerone Pyrrobutamine Quetiapine Quinagolide Quinalbarbitone Quinapril Quinestradol Quinestrol Quinethazone Quinidine Quinine Quinupristin Rabeprazole Racecadotril Racemethorphan Racemoramide Racemorphan Radium-223 Rafoxanide Raloxifene Raltegravir Raltitrexed Ramipril Ramucirumab Ranibizumab Ranitidine Ranolazine Rasagiline Rasburicase SECOND SCHEDULE — continued Raubasine Raxtozinameran Razoxane Reboxetine Regorafenib Remdesivir Remifentanil Repaglinide Reserpine Retapamulin Reteplase Retigabine Retinoic acid Revefenacin Reviparin Rhodamine B Ribavirin Ribociclib Rifamide Rifampicin Rifapentine Rifaximin Rilmenidine Rilpivirine Riluzole Rimegepant Rimexolone Rimiterol Riociguat SECOND SCHEDULE — continued Ripasudil Ripretinib Risankizumab Risdiplam Risedronic acid Risperidone Ristocetin Ritodrine Ritonavir Rituximab Rivaroxaban Rivastigmine Rizatriptan Rocuronium Rofecoxib Rolitetracycline Romiplostim Romosozumab Ropinirole Ropivacaine Rosiglitazone Rosoxacin Rosuvastatin Rotigotine Roxatidine Roxithromycin Rufinamide Rupatadine Rurioctocog alfa pegol SECOND SCHEDULE — continued Ruxolitinib Sacituzumab govitecan Sacubitril Safinamide Salazosulphadimidine Salbutamol Salmefamol Salmeterol Santonin Saquinavir Sarilumab Satralizumab Saxagliptin Secbutobarbitone Secnidazole Secobarbital Secukinumab Selegiline Selexipag Selinexor Selumetinib Semaglutide Sermorelin Sertaconazole Sertraline Sevelamer Sevoflurane Sibutramine Sildenafil SECOND SCHEDULE — continued Siltuximab Silver sulphadiazine Simeprevir Simfibrate Simoctocog alfa Simvastatin Siponimod Sirolimus Sisomicin Sitagliptin Sodium apolate Sodium aurothiomalate Sodium dihydroazapentacene Sodium fluoride Sodium iodide [I-131] Sodium molybdate [99Mo] Sodium oxidronate Sodium pertechnetate Sodium picosulphate Sodium pyrophosphate Sodium tetradecyl sulphate Sodium valproate Sodium zirconium Sofosbuvir Solifenacin Somatostatin Somatropin Sorafenib Sotalol SECOND SCHEDULE — continued Sotorasib Sparfloxacin Spectinomycin Spiramycin Spironolactone Stanolone Stanozolol Stavudine Stilboestrol Streptokinase Streptomycin Streptozocin Strontium [89Sr] Styramate Succinylsulphathiazole Sucroferric oxyhydroxide Sufentanil Sugammadex Sulbactam Sulbenicillin Sulfabenzamide Sulfacytine Sulfametopyrazine Sulfametrole Sulindac Sulphabromomethazine Sulphacetamide Sulphachlorpyridazine Sulphadiazine SECOND SCHEDULE — continued Sulphadicramide Sulphadimethoxine Sulphadimidine Sulphadoxine Sulphaethidole Sulphafurazole Sulphaguanidine Sulphaloxic acid Sulphamerazine Sulphamethazine Sulphamethizole Sulphamethoxazole Sulphamethoxydiazine Sulphamethoxypyridazine Sulphametopyrazine Sulphamonomethoxine Sulphamoxole Sulphanilamide Sulphaphenazole Sulphapyrazole Sulphapyridine Sulphaquinoxaline Sulphasalazine Sulphasomidine Sulphathiazole Sulphathiourea Sulphatolamide Sulphaurea Sulphinpyrazone SECOND SCHEDULE — continued Sulphomyxin Sulphonal Sulpiride Sulprostone Sultamicillin Sulthiame Sumatriptan Sunitinib Suprofen Suxamethonium Suxethonium bromide Syrosingopine Tacrine Tacrolimus Tadalafil Tafamidis Tafluprost Talampicillin Talazoparib Taliglucerase alfa Tamoxifen Tamsulosin Tapentadol Tazarotene Tazobactam Teclothiazide Tedizolid Tegafur Tegaserod SECOND SCHEDULE — continued Tegoprazan Teicoplanin Telbivudine Telithromycin Telmisartan Temazepam Temozolomide Temsirolimus Tenecteplase Teniposide Tenofovir Tenonitrozole Tenoxicam Tepotinib Terazosin Terbinafine Terbutaline Terconazole Terfenadine Teriflunomide Teriparatide Terlipressin Tertatolol Testosterone Tetrabenazine Tetracaine Tetracosactide Tetracyclines Tetrahydrocannabinol SECOND SCHEDULE — continued Tetrazepam Tetrofosmin Tezepelumab Thalidomide Thallium Thebacon Thenalidine Thenyldiamine Theofibrate Theophylline Thiabendazole Thiacetazone Thialbarbitone Thiamazole Thiambutosine Thiamphenicol Thiazinamium Thiethylperazine Thiocarlide Thioguanine Thiopentone Thiopropazate Thioproperazine Thioridazine Thiotepa Thiothixene Thiouracil Thymalfasin Thymoxamine SECOND SCHEDULE — continued [Deleted by S 681/2023 wef 01/11/2023] Thyrotrophin Thyroxine Tiagabine Tianeptine Tiapride Tiaprofenic acid Tibolone Ticagrelor Ticarcillin Ticlopidine Tiemonium Tigecycline Tigloidine Tilidine Tiludronic acid Timepidium Timolol Tinidazole Tinzaparin Tioconazole Tiotropium Tipiracil Tirilazad Tirofiban Tirzepatide Tixocortol Tizanidine Tobramycin SECOND SCHEDULE — continued Tocainide Tocilizumab Tofacitinib Tofenacin Tolazamide Tolazoline Tolbutamide Tolcapone Tolmetin Toloxatone Tolperisone Tolpropamine Tolterodine Tolvaptan Topiramate Topotecan Toremifene Tosufloxacin Tozinameran Trabectedin Tramadol Trametinib Tranexamic acid Tranylcypromine Trastuzumab Travoprost Trazodone Treosulphan Tretamine SECOND SCHEDULE — continued Tretinoin Triacetyloleandomycin Triamcinolone Triamterene Triaziquone Triazolam Tribenoside Tribromethyl alcohol Trichomycin Triclofos sodium Tricyclamol Trienbolone Trientine Trifarotene Trifluoperazine Trifluorothymidine Trifluperidol Trifluridine Triflusal Trihexyphenidyl Trimebutine Trimegestone Trimeperidine Trimeprazine Trimetaphan Trimetazidine Trimethoprim Trimetrexate Trimipramine SECOND SCHEDULE — continued Trimustine Tripamide Tripelennamine Triptorelin Tromantadine Tropicamide Tropisetron Trospium Trovafloxacin Troxidone Tubocurarine Tucatinib Turoctocog alfa Tybamate Tylosin Ulipristal Umeclidinium Unoprostone Upadacitinib Uramustine Urapidil Urea [13C] Urea [14C] Ureamycin Urethane Urokinase Ursodeoxycholic acid Ustekinumab Valaciclovir SECOND SCHEDULE — continued Valbenazine Valdecoxib Valganciclovir Valproic acid Valsartan Vancomycin Vardenafil Varenicline Vasopressin Vecuronium Vedolizumab Velaglucerase alfa Velpatasvir Vemurafenib Venetoclax Venlafaxine Verapamil Vericiguat Vernakalant Verteporfin Vidarabine Vigabatrin Vilanterol Vildagliptin Viloxazine Vinbarbitone Vinblastine Vincristine Vindesine SECOND SCHEDULE — continued Vinflunine Vinorelbine Vinpocetine Vinylbital Viomycin Virginiamycin Vismodegib Vonoprazan Voriconazole Vortioxetine Voxilaprevir Warfarin Xamoterol Xipamide Xylazine Xylometazoline Yttrium-90 Zafirlukast Zalcitabine Zanamivir Zanubrutinib Zidovudine Zipeprol Ziprasidone Zofenopril Zolendronic acid Zolmitriptan Zolpidem Zopiclone SECOND SCHEDULE — continued Zoxazolamine Zuclopenthixol Note: The stereoisomeric forms or salts of the substances specified in Part 1, wherever the existence of such stereoisomeric forms or salts is possible, are also active ingredients for the purpose of this Part. [S 681/2023 wef 01/11/2023] [S 219/2017 wef 01/05/2017]

PART 2

CLASSES OF THERAPEUTIC PRODUCTS

1. Anti-toxins

2. Anti-venoms

3. Insulins

4. Plasma derivatives

5. Androgen, oestrogen or progestogen hormones

6. Vaccine antigens

[S 681/2023 wef 01/11/2023]

PART 3

ACTIVE INGREDIENTS IN PHARMACY-ONLY MEDICINES Albendazole Alverine Amorolfine Amyl nitrite Bambuterol Benzydamine Brompheniramine Buclizine Butyl aminobenzoate Carbinoxamine SECOND SCHEDULE — continued Carbocysteine Cetirizine Cinnarizine Dexchlorpheniramine Dextromethorphan Dicycloverine Diphenhydramine Diphenoxylate Flunarizine Isoconazole Levodropropizine Loperamide Loratadine Mebendazole Mebeverine Miconazole Naphazoline Nicotine Oxethazaine Parachlorophenol Phenyltoloxamine Pholcodine Podophyllum resin Podophyllotoxin Policresulen Procaterol Pseudoephedrine Sodium cromoglycate Tetrahydrozoline SECOND SCHEDULE — continued Tolnaftate Triprolidine Tyrothricin Note: The stereoisomeric forms or salts of the substances specified in Part 3, wherever the existence of such stereoisomeric forms or salts is possible, are also active ingredients for the purpose of this Part. [S 681/2023 wef 01/11/2023] THIRD SCHEDULE Regulations 11(d) and 12(b) First column Second column Third column Class of persons Type of prescription‑only medicine Conditions

1. The owner or the master of a ship which does not carry a doctor on board as part of her crew

2. Persons requiring prescription-only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or under any written law with respect to the medical treatment of their employees

3. An Independent Duty Corpsman (IDC) deployed on Republic of

All prescription-only medicines Such prescription-only medicines as specified in the relevant written law All prescription-only medicines listed in the IDC Medications List The supply must be necessary for the treatment of persons on the ship The supply — (a) must be for the purpose of enabling the persons to comply with any requirements made by or under any written law; and (b) is subject to such conditions and is to be made in such circumstances as specified in the relevant written law An IDC — (a) must not administer the prescription- only medicines to First column Second column Third column Class of persons Type of prescription‑only medicine Conditions Singapore Navy (RSN) vessels who has been authorised by the Chief Navy Medical Officer to administer prescription-only medicines approved by the Chief Navy Medical Officer FOURTH SCHEDULE any person other than personnel on board RSN vessels when the vessels are out at sea, or on military operations and exercises; (b) must carry out the administration of the prescription-only medicines in accordance with IDC clinical protocols approved by the Chief Navy Medical Officer; and (c) must keep proper records of the IDC’s administration of the prescription-only medicines Regulation 20(2) First column Second column Substance Term to be used

1. Tartrazine tartrazine (Code E102) tartrazine (Code 102)

tartrazine (Code FD and C Yellow No. 5)

2. Benzoic acid benzoic acid

benzoic acid (Code E210)

3. Sodium benzoate sodium benzoate

sodium benzoate (Code E211) FIFTH SCHEDULE Regulation 20(3) CAUTIONARY INFORMATION TO BE LABELLED ON THERAPEUTIC PRODUCTS First column Second column Therapeutic product Cautionary information

1. Therapeutic product containing aspirin or acetylsalicylic acid for oral administration

2. Therapeutic product containing any of the following substances for oral administration:

(a) Diphenoxylate (b) Loperamide (c) The following anti‑histamine substances: Antazoline Azatadine Bamipine Bromodiphenhydramine Bromopheniramine Buclizine Carbinoxamine Chlorcyclizine Chlorpheniramine Cinnarizine Clemastine Clemizole Cyclizine Cyproheptadine Dexchlorpheniramine Caution: Not to be given to persons below 16 years of age except under the direction of a doctor. Caution: This may cause drowsiness. If affected, do not drive or operate machinery. FIFTH SCHEDULE — continued First column Second column Therapeutic product Cautionary information Dimethpyrindene Diphenhydramine Diphenylpyraline Doxylamine Embramine Flunarizine Homochlorcyclizine Isothipendyl Levocabastine Mebhydrolin Meclastine Meclozine Mepyramine Mequitazine Methdilazine Oxatomide Oxomemazine Phenindamine Pheniramine Phenyltoloxamine Promethazine Pyrathiazine Pyrrobutamine Thenalidine Thenyldiamine Thiazinamium Tolpropamine FIFTH SCHEDULE — continued First column Second column Therapeutic product Cautionary information Tripelennamine Triprolidine SIXTH SCHEDULE [Deleted by S 458/2022 wef 01/07/2022] SEVENTH SCHEDULE Regulation 52(1)(b) First column Second column Therapeutic product Maximum amount allowed

1. Codeine; its salts (a) Oral liquid preparation — not exceeding 15 mg per 5 ml and not exceeding 240 ml in quantity

(b) Solid preparation — not exceeding 30 mg per dosage unit and not exceeding 20 dosage units in quantity

2. Dextromethorphan (a) Oral liquid preparation — not exceeding 15 mg per 5 ml and not exceeding 240 ml in quantity

(b) Solid preparation — not exceeding 30 mg per dosage unit and not exceeding 20 dosage units in quantity [S 732/2021 wef 01/10/2021] Made on 14 July 2016. KANDIAH SATKUNANANTHAM Chairman, Health Sciences Authority, Singapore. [HSA 401:04/05-000; HSA/LPPD/711:12/61-000; AG/LLRD/SL/122D/2010/13 Vol. 12] (To be presented to Parliament under section 72(5) of the Health Products Act).