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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:
In the Order Addendum there are recommended samples of documents:
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.