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Russian’s Roszdravnadzor Approved the Procedure for Sampling Quality Control of Medicines

13 October 2015

Approved the procedure for sampling of compliance of medicines for medical use and pharmaceutical substances with the requirements of the Pharmacopoeia monograph.

Sampling is carried out by Roszdravnadzor or its territorial bodies. Established the list of officials authorized to exercise control.

Sampling of medicines includes:

  1. The processing of data provided by subjects of circulation of medicines;
  2. Sampling of medicinal products;
  3. Decision making on further public circulation of the relevant medicinal product
  4. Decision making on the transfer of medicines on batch sampling quality control in case of repeated revealing of discrepancy of quality of the product requirements.

In the Order Addendum there are recommended samples of documents:

  1. Requirements to provide samples of medicines for medical use and documents confirming the quality of medicines for medical use;
  2. Protocol for sampling of medicines;
  3. Decisions on the conformity of the samples to the standard documentation;
  4. Decisions to discontinue circulation of a series of medicinal products;
  5. Decisions about future public circulation batch of medicines, the quality of which meets the requirements;
  6. Decisions about the transfer and withdrawal of the medicine to/from batch sampling quality control;
  7. Decisions to suspenduse of the medicine.

Provisions of the Procedure relating to mandatory notification about the series and batches of medicines coming in public circulation in Russian Federation for Roszdravnadzor shall become effective three months after the date of its publication.

The Order of Roszdravnadzor №5539 dated 07.08.2015 "On approval of Procedure of sampling quality control of medicines for medical use" was registered in Ministry of Justice of Russia # 39263 dated 09.10.2015.


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