Administrative enforcement actions in case of incompliance with GMP

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Presentation transcript:

Administrative enforcement actions in case of incompliance with GMP

Actions in case of incompliance with GMP (Russia vs EAEU)   Russia EAEU GENERAL Decline license issue (reissue) Assignments Administrative liability License suspension Licensing issues are in the competence of the EAEU member countries SPECIAL Suspension of the drug use Suspension of an authorized person certification decision (option) Suspension of registration certificate Restriction of use of the pharmaceuticals Recall (cancellation) of registration certificate Actions to stop drug supply and to remove it from circulation .

Circulation - ... shipping, sale, transfer, application... Suspension of the drug use: controversial issues SUSPENSION of: Part 1 Art. 65 Circulation Part 2 Art. 65 Use Part 3 Art. 65 Use Part 4 Art. 65 Sale and application Treatment of life-threatening conditions?? Circulation - ... shipping, sale, transfer, application... Application?? Application Sale

IS THE SUSPENSION JUSTIFIED? Suspension of the drug use: controversial issues RESOLUTION/GMP CERTIFICATE DETECTION OF INCOMPLIANCE DATE OF MANUFACTURE SHELF LIFE of 2-3 years IS THE SUSPENSION JUSTIFIED?

THANK YOU FOR YOUR ATTENTION!