Licensing of pharmaceutical activity in Kazakhstan
Licensing of pharmaceutical activity is a mandatory procedure for implementation of activity related to the production, manufacturing, and sale of medicinal products and medical devices.
01
What types of pharmaceutical activity are subject to licensing?
In accordance with Appendix No. 1 to the Law of the Republic of Kazakhstan on Permits and Notifications, the licensing of medical activity shall comprise the following sub-types of activities:
- Production of medicinal products and medical devices
- Manufacturing of medicinal products and medical devices
- Wholesale and retail trade of medicinal products
02
Licensing stages:
01
Preparation and collection of the licence dossier
02
Submission of an electronic application and the licence dossier for the issuance of a licence for pharmaceutical activity
03
Expert examination of the licence dossier for the compliance with qualification requirements
04
Preventive control, departure of employees of the Department to the facility
05
Signing and issuance of the licence for pharmaceutical activity
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