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A separate investigation procedure for violations in the circulation of medicines is introduced

Healthcare & pharmain forcePublished 13/11/2026

Who is affected

Manufacturers, marketing authorization holders, importers and distributors of medicines and medical devices, pharmacy and medical organizations.

What changes

An independent procedure for investigating violations in the field of circulation of medicines and medical devices, separate from routine state control, is introduced into the Code "On Public Health and the Healthcare System". Starting next year, operational response measures and risk-based sampling without prior notice to the subject will be added to it.

List of changes

A separate investigation of violations in the field of circulation of medicines and medical devices is introduced
The authorized body is empowered to approve the rules for conducting such investigations
During the investigation, the subject is obliged to provide documents, materials and explanations, including electronic data
The subject is obliged to provide access to digital systems and facilities related to the investigation
Sampling of medicines, medical devices, raw materials and components is provided for
The results are formalized by an act, information that does not constitute a legally protected secret is published within ten working days after the end of the investigation
Starting January 1, 2027, operational response measures are introduced: suspension of production and sales, suspension, recall and withdrawal of products from circulation
Starting January 1, 2027, risk-based sampling without prior notice to the subject is introduced
Costs for sampling and laboratory testing are assigned to the manufacturer and the marketing authorization holder

Effective date

From September 7, 2026 - the main body, upon expiration of sixty calendar days after the first official publication. Certain provisions, including operational response measures and risk-based sampling, - from January 1, 2027.

Details and status

For further details and to check the status, please contact us. This material is for information only and does not constitute legal advice.

Source

https://prg.kz/document/?doc_id=36040595

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