Article 233. Wholesale and retail sale of medicines and medical devices Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. The wholesale sale of medicines and medical products is carried out by entities in the field of circulation of medicines and medical products that have received an appropriate license for wholesale sale in pharmacy warehouses or have notified of the start of activities through a warehouse of medical products in accordance with the procedure established by the Law of the Republic of Kazakhstan "On Permits and Notifications".
2. Retail sale of medicines and medical products is carried out by entities in the field of circulation of medicines and medical products that have received an appropriate license for retail sale in pharmacies, pharmacy points, mobile pharmacy points or notified of the start of activities through optical and medical device stores in accordance with the procedure established by the Law of the Republic of Kazakhstan "On Permits and Notifications".
3. Entities in the field of circulation of medicines and medical devices engaged in the retail sale of medicines comply with the requirements of good pharmacy practice (GPP) on a voluntary basis.
Entities in the field of circulation of medicines and medical devices engaged in the wholesale sale of medicines are required to comply with the requirements of good Distribution Practice (GDPR).
Entities in the field of circulation of medicines and medical devices that have received a license or notified of the start of their activities in accordance with the procedure established by the Law of the Republic of Kazakhstan "On Permits and Notifications" are allowed to wholesale and retail goods not related to medicines and medical devices in accordance with the list approved by the authorized body.
4. Wholesale and retail sale of medicines and medical products is prohibited.:
1) those who have not passed the state registration in the Republic of Kazakhstan;
2) the quality of which is not confirmed by a certificate of conformity in accordance with the procedure established by the legislation of the Republic of Kazakhstan in the field of healthcare;
3) not complying with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare;
4) expired;
5) medical workers in healthcare organizations, with the exception of the retail sale of medicines and medical devices in rural settlements in the cases provided for in paragraph 6 of this Article.;
6) through temporary storage warehouses for medicines and medical devices.
4-1. The wholesale and retail sale of bulk products of medicines or medical devices is prohibited, with the exception of the wholesale sale of bulk products of medicines or medical devices used by entities in the field of circulation of medicines and medical devices for the manufacture of medicines.
5. Over-the-counter sale of medicines intended for medical prescription is prohibited. Prescriptions are written out in paper and/or electronic forms.
The shelf life of a prescription in paper form for a medicinal product is at least thirty calendar days, with the exception of a prescription for a medicinal product containing narcotic drugs, psychotropic substances, precursors and toxic substances, which is stored for one year, for a medicinal product dispensed under the guaranteed volume of free medical care and (or) compulsory social health insurance, the shelf life of which is two years.
The rules for classifying medicines, taking into account the active substances included in their composition, into the categories of over-the-counter and prescription medicines, the rules for prescribing, accounting and storing prescriptions are approved by the authorized body.
6. In rural settlements where there are no pharmacies, individuals and legal entities can sell medicines and medical products through pharmacy points in healthcare organizations providing primary health care, consulting and diagnostic services, and mobile pharmacy points. In the absence of pharmacy outlets, the retail sale of medicines and medical devices can be carried out through healthcare organizations that provide primary health care, consultative and diagnostic assistance. In the absence of specialists with pharmaceutical education for the retail sale of medicines and medical devices, specialists with medical education who have been trained to sell them are allowed.
7. Medicines and medical devices imported and manufactured in the territory of the Republic of Kazakhstan before the expiration of the registration certificate are used, handled and operated in the territory of the Republic of Kazakhstan without restrictions.
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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