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19.08.2022 (Обновлено: 26.08.2022 10:27)

EAEU improved Pharmaceutical Inspection Rules

On August 19, the Eurasian Economic Commission's Council adopted a new version of the Rules for Pharmaceutical Inspections.

"The new edition ensures full comparability of the results of pharmaceutical inspections by inspectors of the EAEU countries and their mutual recognition," Viktor Nazarenko, EEC Minister in charge of Technical Regulation, noted. "The document allows for parallel inspections with the submission of a marketing authorization application for the issuance of a registration certificate, the recognition of national GMP certificates for national production facilities and the recognition of inspection documents for foreign production facilities without repeating their inspections."

The new edition takes into account the experience of the law enforcement practice accumulated by the pharmaceutical inspectorates of the EAEU countries, updated the rules for the inspection of pharmaceutical production, providing admission to the market of pharmaceutical manufacturers, as well as established an exhaustive list of powers of inspectors, rights and obligations of subjects of the inspection process, grounds for refusing to issue a GMP certificate.