The Ministry of Health approved the Procedure for Good Pharmacy Practice

According to the updated regulations, the presence of a complaints book will no longer be a mandatory requirement for pharmacies, as it was previously. The new order also contains a provision on the possibility of maintaining quality system documentation in electronic form. Representatives of associations pointed out the need to implement such adjustments. According to the professional community, the updated regulations "turned out to be quite adequate, containing feasible requirements, without additional burden on business," RAAS noted .

The approved regulations exclude special requirements for premises where medicinal products are manufactured. According to the still current version of the regulations from 2016, the surfaces of the walls and ceilings of such premises must be smooth, finished with materials that allow wet cleaning with the use of disinfectants.

"Working on the document was interesting. Firstly, because it became possible to correct the mistakes that were in the initial pharmacy practice. After all, in 2015 the document was written for the first time, so it was not possible to foresee everything. Secondly, due to productive interaction with regulators," explained Svetlana Voskoboinik, Deputy Executive Director for Legal Affairs at RAAS, specifying that during the work "it was possible to reduce the list of documents that make up the quality system," and the ability to maintain documentation in electronic format "eliminated the need to put a stamp" in cases where pharmacy chains completely transferred document flow to digital format.

Svetlana Voskoboinik also emphasized that during the work on the regulations, "the issue of the availability of documents for custom-made pharmacy furniture" was resolved. "This type of equipment, as a rule, does not have a technical passport, so the pharmacy can store the instructions or operating manual issued by the manufacturer," the lawyer explained. According to her, representatives of the RAAS, the National Pharmaceutical Chamber and the Association of Pharmaceutical Institutions "Soyuzpharma" also managed to agree with the relevant departments "on further work to regulate the activities of pharmacy organizations."

The draft of the updated version of the regulation was submitted for public discussion by the Russian Ministry of Health in February 2025. In the explanatory note, the authors of the document indicated that it was developed to bring the legislation of the Russian Federation in the field of circulation of medicines in line with the law of the Eurasian Economic Union (EAEU). However, adjustments to the document were proposed earlier - for example, in 2018, the Ministry of Health intended to oblige persons responsible for the implementation and provision of the quality system to have specialized additional education. The changes were never approved.