Article 231. Production of medicines and medical devices Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. The production of medicines and medical products is a pharmaceutical activity that includes the totality of all work necessary for the serial production of medicines and medical products related to the purchase of raw materials, semi-finished products, equipment, components and a technological process, including the implementation of one of its stages, storage, sale of manufactured products, as well as all types of their accompanying control.
2. The production of medicines on the territory of the Republic of Kazakhstan is carried out by entities in the field of circulation of medicines and medical devices in accordance with the good manufacturing practice (GMP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union and on the basis of a license obtained in accordance with the procedure established by the legislation of the Republic of Kazakhstan.
Subjects in the field of circulation of medicines and medical devices in the manufacture of medicines are required to comply with the requirements of good manufacturing practice (GMP).
3. Stability studies, determination of the shelf life and repeated control of medicines are carried out by the manufacturer of the medicinal product in accordance with the procedure determined by the authorized body.
Stability studies and the determination of the shelf life of medical products are carried out by the manufacturer of medical products in accordance with international standards.
4. Production of medicines and medical devices is prohibited.:
1) those that have not passed state registration in the Republic of Kazakhstan, with the exception of medicines and medical products intended for examination during their state registration, debugging and commissioning of equipment and technological processes, preclinical (non-clinical) and clinical research, contract production and export of medicines and medical products, as well as advanced medicines therapies produced for individual use using autologous biological materials of the patient or his donor, selected directly for him;
2) without a license for the right to manufacture medicines and medical devices;
3) in violation of good manufacturing practices and regulations for the manufacture of medical devices.
5. Manufactured and imported medicines:
1) they should not contain dyes and auxiliary substances prohibited for use in the Republic of Kazakhstan, the list of which is approved by the authorized body.;
2) they must be subject to control in accordance with the regulatory document on the quality of medicines developed by the manufacturer of medicines and agreed upon by the state expert organization during the examination of medicines in accordance with the procedure determined by the authorized body.;
3) must be made from a pharmaceutical substance (active pharmaceutical substance) manufactured under conditions not lower than the requirements of good manufacturing practice (GMP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union and declared during state registration, re-registration and amendments to the registration dossier of the medicinal product.
Medicines produced on the territory of the Republic of Kazakhstan only for export are not subject to state registration and sale in the Republic of Kazakhstan.
6. Manufactured and imported medical devices must be subject to control in accordance with the regulatory document of the medical device submitted by the manufacturer of the medical device during the examination of the medical device for the purposes of state registration, re-registration and amendments to the registration dossier of the medical device.
Medical products manufactured on the territory of the Republic of Kazakhstan only for export are not subject to state registration and sale in the Republic of Kazakhstan.
7. The production and sale of patented medicines and medical devices are carried out in accordance with the legislation of the Republic of Kazakhstan.
8. The manufacture of medical devices intended for diagnosis or treatment should ensure their safety, provide for their use in accordance with their functional purpose and exclude the approach of user errors in interpreting the results of diagnosis or treatment.
9. The manufacturer of medicines ensures that there is at least one authorized person of the manufacturer responsible for performing duties in accordance with the requirements of good manufacturing practice (GMP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union.
President
Republic of Kazakhstan
© 2012. RSE na PHB "Institute of Legislation and Legal Information of the Republic of Kazakhstan" of the Ministry of Justice of the Republic of Kazakhstan
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