Pharmaceutical Activity License
We provide comprehensive support for obtaining a pharmaceutical activity license — from document preparation to the issuance of the final license.
Pharmaceutical Activity License
— a permit issued by the authorized state body granting the right to carry out pharmaceutical activities within the territory of the Republic of Kazakhstan in accordance with applicable legislation.
This license is required for the manufacturing, compounding, storage, wholesale, and retail distribution of medicinal products and medical devices.
This license is required for the manufacturing, compounding, storage, wholesale, and retail distribution of medicinal products and medical devices.
Activities Subject to Licensing
Manufacturing of medicinal products
Manufacturing of medical devices
Wholesale distribution of medicinal products
Retail distribution of medicinal products
Production of medicinal products
Production of medical devices
Steps to Obtain a Pharmaceutical Activity License
Premises Inspection and Assessment
The premises are inspected to assess compliance with sanitary and epidemiological requirements. Equipment availability and overall operational readiness are also evaluated.
Dossier Review
Verification of the completeness of the document package, compliance of personnel with qualification requirements, and provision of recommendations and necessary corrections.
Pre-Submission Site Visit
Assessment of the premises’ readiness prior to the official inspection by the government authority.
Obtaining the Conclusion
Issuance of the license.
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