Содержимое (Table of Contents)
Russian Government permits to register new medicines without Russian GMP certificate.
Foreign manufacturers, which did not receive Russian GMP certificate, could submit documentation for new registration of drugs without GMP certificate. Applicant instead of GMP certificate should provide decision from Ministry of Industry and trade about performing of GMP inspection.
Above statements are included in draft of amendments to federal Law 61 “About Drugs Circulation”.
Registration of Drugs
It will be permitted for applicant to include copy of decision about performing of GMP inspection instead of copy of GMP certificate issued by the Ministry of Industry and Trade (MoIT).
But, decision about state registration of drugs (Approval), could be received only after submission of Russian GMP. If dossier doesn’t contain copy of Russian GMP, Ministry of Health (MoH) should sent deficiency letter to applicant with requirement to provide Russian GMP and applicant should provide it in 180 days deadline.
If MoIT reject in issuing if GMP certificate, MoH could reject an approval. (Applicant could submit the dossier again with already received Russian GMP certificate and in this case result of previous expertise will be accepted by MoH).
Breaking of GMP standards could lead to interruption in Marketing Authorization (MA) validity. If during inspection or license control MoIT observe breaking of manufacturing rules, which could be classified as dangerous for live and health or if manufacturer did not revise deficiencies which were observed during last inspection.
Renewal (Confirmation of Registration)
During procedure of Renewal, manufacturer which has not GMP issued by Russian Health Authorities could provide GMP certificate issued by country-manufacturer and guarantee letter from MAH to perform GMP inspection and get Russian GMP certificate during 3 years after submission of application for Renewal.
For variation which required quality or risk\benefit expertise applicant should provide Russian GMP certificate or guarantee letter to perform GMP inspection during 3 years after submission of application for variation.
In accordance to draft of above amendments should be enforced from 1 of January 2017.
MA – Marketing authorization
MoH – Ministry of Health (issued drugs approval)
MoIT – Ministry of Industry and Trade (Issue Russian GMP)
MAH – Marketing Authorization Holder