1. Administrative enforcement actions in case of incompliance with GMP

2. 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 .

3. 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

4. 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?

5. THANK YOU FOR YOUR ATTENTION!