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24.06.2025
STORAGE RULES FOR MEDICINES TO CHANGE THIS FALL
The Russian Ministry of Public Health has approved new Rules for the Storage of Medicines. From September 1, 2025, the Rules will be mandatory for pharmaceutical manufacturers, distributors, pharmacies, as well as for medical institutions.
The head of an entity involved in the circulation of medicines must approve Standard Operating Procedures (also known as SOPs) regulating the processes of medicine storage, maintenance and calibration of measuring instruments and equipment, recordkeeping, reporting and document retention, as well as procedures for receiving and placing medicines. Moreover, oversight to ensure compliance with the SOPs shall be organised. The institution must appoint an individual personally responsible for the implementation and maintenance of the quality system and for updating the SOPs according to the risk category of the facility (within the framework of state supervision in the field of medicine circulation).

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