The EEC Council has accepted the correctives to the Rules of pharmaceutical inspections established by resolution No.83 dated the 3rd of November, 2016. The new edition of the document allows to associate completely the results of pharmaceutical inspections by the EAEU inspectors and accept them mutually in the EAEU countries. This is the statement of Victor Nazarenko, the EEC minister of technical control.
The corrections make it possible to perform inspections at the same time as submitting of the registration dossier. The national GMP certificates will also be accepted for national manufactures. For foreign manufacturers, the inspection documents will be accepted without repeated inspections.
In addition to the actual inspection rules based on the wide experience, the new edition sets the list of privileges, rights and duties of the parties involved into the inspection process, as well as the reasons for denial of GMP certification.
The changes covered also the quality management system for the devices with various risk class. An authorized body of an EAEU country or its subordinate organization should for now act as an inspector.
The EEC supposes that this measure leads to unification of the manufacture inspection results and affects positively availability of the medical devices at the market.