of October 27, 2016 No. 365
About approval of the general technical regulation about safety of medicines
According to the Law of the Republic of Uzbekistan "About technical regulation", for the purpose of establishment of single requirements to safety of medicines the Cabinet of Ministers decides:
1. Approve the General technical regulation about safety of medicines according to appendix and enact it after six months from the date of official publication.
2. Take into consideration that, according to requirements of the Law of the Republic of Uzbekistan "About technical regulation", with enforcement of technical regulations earlier accepted regulating documents on standardization on products specified in them and services lose binding character and acquire voluntariness of application in accordance with the established procedure.
3. To the Uzstandart agency together with authorized bodies to take measures for cancellation of binding character and ensuring voluntariness in case of application of regulating documents on standardization of safety of medicines, from the date of enforcement of the General technical regulation approved by this resolution in accordance with the established procedure.
4. To the Ministry of Health of the Republic of Uzbekistan, SAC Uzfarmsanoat to provide to the Uzstandart Agency together with National broadcasting company of Uzbekistan:
broad informing the population, bodies of the public and economic board, subjects of business activity about the purposes, content and procedure for application of the approved General technical regulation;
carrying out in November, 2016 republican seminar on explanation of the established requirements to safety of medicines in case of their development, production, marking, packaging, transportation, storage, realization and destruction.
5. To the Ministry of Health of the Republic of Uzbekistan together with the interested ministries and departments to bring the regulatory legal acts adopted by them into accord with this resolution in a month.
6. To impose control of execution of this resolution on the deputy prime minister of the Republic of Uzbekistan Ikramov A. I.
Prime Minister of the Republic of Uzbekistan
Shavkat Mirziyoev
Appendix to the resolution of the Cabinet of Ministers of October 27, 2016 No. 365
1. This General technical regulation about safety of medicines (further - the Technical regulation) establishes requirements to safety of medicines in case of their development, production, marking, packaging, transportation, storage, realization and destruction.
2. Subjects to regulation of the Technical regulation are the medicines registered and permitted in accordance with the established procedure by the Ministry of Health of the Republic of Uzbekistan to application in medical practice.
3. In the Technical regulation the following terms and determinations are used:
safety of medicines - the characteristic of medicines based on comparative analysis of their efficiency and risk assessment of damnification to health;
validation - documentary confirmation of the fact that the processes which are carried out within the established requirements can effectively be performed also with the reproduced results;
excipient - any substance which is part of medicine, except for medicinal substance;
contamination - undesirable entering of impurity of chemical or microbic origin or alien substances into initial material, either intermediate or ready-made product in the course of development, productions, transportations, storages and realization;
medicines - the means received on the basis of medicinal substances (substances) and excipients, medicinal substances (substances), medicines allowed for use in medical practice for prevention, diagnostics and treatment of diseases and also for change of condition and functions of human body;
marking - the texts, trademarks, symbol and drawings containing information for the consumer and applied on labels, labels, stickers (stickers), medicine packaging;
number of series - the digital, alphabetic or alphanumeric reference allowing to identify specifically series of medicine and to determine the complete sequence of production and control operations;
the regulating documentation - the documentation approved in accordance with the established procedure by Head department on quality control of medicines and medical equipment of the Ministry of Health of the Republic of Uzbekistan establishing regulations, characteristics, test methods (control) and sampling of medicines;
general pharmacopoeian clause - general requirements to quality of medicines, products of medical appointment, to medicinal vegetable raw materials, to control methods of their quality, standard samples, reactants applied in case of quality control of medicines, to the packaging materials used in production of medicines;
orphan medicines - orphan medicines for treatment of rare diseases;
series - the certain amount of initial raw materials, packaging materials and products subjected to processing in one or in a number of consecutive engineering procedures in such a way that it is possible to expect uniformity of products;
the trademark - the designation registered in accordance with the established procedure serving for difference of medicines of one producers from homogeneous products of other producers;
the trade name of medicine - the name under which medicine is registered;
medicine packaging - means or complex of the means providing protection of medicine against the damages and losses in case of their address and also protecting the environment from pollution;
pharmacopoeian Article - quality requirements of certain medicine, product of medical appointment, medicinal vegetable raw materials, excipient;
medicinal angro-product - the medicine made and realized in large packing, and also used for further production (production) of finished pharmaceutical products.
4. The medicines registered and allowed for use in medical practice in accordance with the established procedure in the Republic of Uzbekistan shall have the corresponding registration certificate, the regulating documentation and the certificate of conformity.
5. The list of the indicators of chemical and biological safety which are subject to obligatory determination in case of assessment of conformity of medicines are given in appendix to the Technical regulation.
Limit rates on indicators of chemical and biological safety are established in regulating documentations.
6. Development of medicines includes search of active agents new pharmacological, the subsequent studying of their properties, preclinical and clinical trials, standardization, development of production technologies of medicinal substances, structures and production technologies of medicines.
7. In case of development of medicines the main indicators safety of medicine by implementation of proper assessment of potential risks of harmful effects of medicine on human body, and also on its efficiency shall be determined and ensured.
8. In the course of development of medicines rules on preclinical testing of safety of pharmacological means and the requirements to personnel, rooms, the equipment, documentation, providing and quality control established by the Ministry of Health of the Republic of Uzbekistan shall be followed.
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