AMENDMENTS to FZ-61 of 12.04.2010: AMENDMENTS to the FEDERAL LAW " on CIRCULATION of MEDICINES

the Draft law announced in the may report was signed by the President of the Russian Federation on June 4, 2018 and entered into force on June 15 under the number FZ-140.

Major changes:

1. It is allowed to register one medicinal product produced at one production site under different trade names (with one INN / chemical / grouping name), in the same dosage form and dosage (with the same concentration, activity in units of action or qualitative and quantitative composition of active substances), submitted for state registration by different Holders or Owners of the registration certificate (or the legal entity authorized by them. person.)

2. As part of the registration dossier during registration, re-registration or when making changes, instead of a copy of the Russian GMP certificate, it is allowed to provide a copy of the Decision to conduct GMP inspection. Before registration of results of examination the request for submission of necessary materials (i.e. GMP certificate) is sent to the Applicant. The applicant must submit the requested materials (i.e. GMP certificate) within 180 business days of receiving the request.