The Law of Ukraine On Circulation of Drugs, Psychotropic Substances, Their Analogs and Precursors in Ukraine

The Law of Ukraine On Circulation of Drugs, Psychotropic Substances, Their Analogs and Precursors in Ukraine

Date of Entry into Force: March 30, 1995

The Law of Ukraine “On Circulation of Drugs, Psychotropic Substances, Their Analogs and Precursors in Ukraine” (hereinafter referred to as “the Law”) taking into account international obligations of Ukraine regulates public relations in the field of circulation of drugs, psychotropic substances, their analogs and precursors, determines authorities of bodies of executive power, rights and duties of legal entities and citizens that participate in such circulation on the territory of Ukraine.

Taking into account their use in medicinal practice and depending on the degree of their danger for health, which they may cause in case of misuse of them, depending on applied control measures over their circulation, drugs, psychotropic substances and precursors are included into the respectively numbered lists of tables of the Register: - table I contains especially dangerous drugs and psychotropic substances included into the lists N 1 and N 2, which circulation in Ukraine is prohibited according to the legislation, as well as drugs and psychotropic substances included into the list N 3, which circulation in Ukraine is permitted only for the purposes envisaged by Article 7 of this Law; - table II contains drugs and psychotropic substances included into the lists N 1 and N 2, which circulation in Ukraine is limited and as regards to which control means are set according to the legislation; - table III contains drugs and psychotropic substances included into the lists N 1 and N 2, which circulation in Ukraine is limited and as regards to which exception of some control means is allowed according to the legislation; - table IV contains precursors included into the lists N 1 and N 2, which circulation in Ukraine is limited and as regards to which control means are set according to the legislation.

Circulation of drugs, psychotropic substances and precursors included into the list N 1 of table IV of the Register on the territory of Ukraine is permitted only with the purpose of use in medicinal practice, for scientific research work, expert or operative search activity, for educational purposes according to the procedure set by this Law, and in case envisaged by it - according to the procedure set by normative legal acts of the Cabinet of Ministers of Ukraine and appropriate central bodies of executive power.

Preparations that contain drugs or psychotropic substances shall be subject to the same control measures as drugs or psychotropic substances which are contained in them. As regards to the preparations that contain a few drugs or psychotropic substances as regards to which different regime of control is set, they shall be subject to those control measures that apply to those substances or preparations which shall be subject to stricter control measures. Drugs (psychotropic) medications that contain small quantities of drugs or psychotropic substances and precursors, included into the respective tables of the Register, from which these preparations or substances cannot be extracted easily in the quantities that allow their misuse, may be excluded from the sphere of application of some control measures over their circulation. Control measures over circulation of drugs (psychotropic) medications and procedure for their use are set by the Cabinet of Ministers of Ukraine. Limit permissible quantity of drugs, psychotropic substances and precursors that are contained in drugs (psychotropic medications) is set by the Cabinet of Ministers of Ukraine upon submission of the specially authorized body of executive power in the field of healthcare. Activity connected with circulation of drugs, psychotropic substances, except for the psychotropic substances included into the list N 2 of table III of the Register) and precursors included into the list N 1 of table IV of the Register), is performed by the enterprises of state and communal ownership at presence of licenses for conducting respective types of activity, unless otherwise is envisaged by this Law. Activity connected with production, manufacturing, storage, transportation, acquisition, delivery, wholesale trade, import, export, destruction of psychotropic substances included into the list N 2 of table III of the Register, drugs (psychotropic medications) indicated in part three of Article 5 of this Law is performed by the enterprises of all ownership forms that produce medications or psychotropic substances at presence of license for carrying out respective types of activity.

Licenses for carrying out activity connected with circulation of drugs, psychotropic substances and precursors are issued at presence of appropriate material technical base, qualified personnel, conditions for ensuring of registration and safe keeping of drugs, psychotropic substances and precursors. Licenses for carrying out activity connected with circulation of drugs, psychotropic substances and precursors are issued by the Cabinet of Ministers of Ukraine or authorized by it central body of executive power upon agreement with the Ministry of Internal Affairs, unless otherwise is envisaged by this Law. The procedure for issue of licenses for carrying out activity connected with circulation of drugs, psychotropic substances and precursors is set by the Cabinet of Ministers of Ukraine.

Circulation of analogs of drugs and psychotropic substances on the territory of Ukraine is prohibited.

Development of new drugs or psychotropic substances is permitted only with the purpose of application in medical practice or for scientific research work. Development of new drugs or psychotropic substances with the purpose of use in medical practice is performed by the state scientific research institutes at presence of license for this type of activity on the basis of the state order pursuant to the legislation on medicines. Clinical researches of developed new drugs or psychotropic substances that are to be used in medical practice and their state registration are conducted according to the legislation on medicines.

Import, export or transit of drugs, psychotropic substances and precursors is performed according to the certificate (separate permit) issued by the specially authorized central body of executive power in the field of healthcare for each such case regardless whether it refers to one or several drugs, psychotropic substances or precursors. The procedure for issue of certificate and its form are set by the Cabinet of Ministers of Ukraine. A copy of certificate attested according to the set procedure is added to each consignment of cargo and sent to the government of state-importer. Import, export or transit of drugs, psychotropic substances and precursors is performed only through the customs bodies determined by the State Customs Service of Ukraine. During transit transportation over the territory of Ukraine of drugs, psychotropic substances and precursors a copy of certificate is transferred by the state-exporter to the State Customs Service of Ukraine. The consignment of drugs, psychotropic substances and precursors that are transported through the territory of Ukraine in transit, shall not be unpacked and processed, if it can change the nature of drugs, psychotropic substance or precursor.

Transportation of drugs, psychotropic substances and precursors on the territory of Ukraine may be performed by the enterprises and institutions of state and communal ownership that carry out activity connected with circulation of drugs, psychotropic substances and precursors, as well as by enterprises, institutions and organizations of all ownership forms at presence of license for this type of activity. Transportation of drugs, psychotropic substances and precursors on the territory of Ukraine may be performed under condition of preservation of safety of the transported cargo. Transportation of drugs, psychotropic substances and precursors is conducted on the basis of documents of strict accountability.

The citizens have the right to acquire drugs or psychotropic substances included into tables II and III of the Register only by doctor's prescription. Retail trade of drugs, psychotropic substances included into tables II and III of the Register and precursors included into the list N 1 of table IV of the Register, which may be used in medical practice, is performed through drug stores of state and communal ownership form at presence of license for this type of activity.

Activity connected with circulation of precursors included into the list N 1 of table IV of the Register is conducted according to the procedure set by Article 6 of this Law. Legal entities of all ownership forms may carry out activity connected with circulation of precursors included into the list N 2 of table IV of the Register at presence of license for this type of activity. Entrepreneurs (legal entities) shall not accumulate in their disposal the quantity of precursors included into the list n 10 of the Register that exceeds their production needs. Retail trade enterprises shall not carry out wholesale trade in precursors included into the list N 1 of table IV of the Register.

Legal entities that carry out activity connected with circulation of drugs, psychotropic substances and precursors shall present according to the form and procedure set by the Cabinet of Ministers of Ukraine the following information about: - quantity of drugs, psychotropic substances and precursors that are produced, manufactured, imported into the territory of Ukraine or exported thereof, quarterly; - quantity of planted and (or) used plants included into the list and quantity of drugs, psychotropic substances and precursors that are produced, manufactured, imported into the territory of Ukraine or exported thereof, and are sold or used, annually, with indication of the remains of drugs, psychotropic substances and precursors for the end of year.

Operations conducted in the process of activity related to circulation of drugs, psychotropic substances and precursors shall be registered in special journals. Registration journals shall be kept for ten years after introduction into them of the last record. The procedure for keeping registration journals is set by the Cabinet of Ministers of Ukraine.