The following amendments are introduced to the Russian Federal Law “On Circulation of Medicines” with regard to the state registration of medicinal products:
- simplified procedure for registration of medicinal products manufactured outside the Russian Federation, namely, if a foreign manufacturer has no certificate of its compliance with good manufacturing practice (GMP) issued by the federal executive authority, such manufacturer may submit, as part of its registration dossier for medicinal product, a copy of the decision made by the federal executive authority on its inspection;
- clarified grounds for refusal of state registration of medicinal products for human use and medicinal products for veterinary use;
- clarified requirements for documents to be submitted for confirmation of state registration of medicinal products, including biological medicinal products, as well as the procedure for introduction of changes requiring the expert examination of quality of medicinal products to the documents included in the registration dossier for registered medicinal product. Similar rules are also proposed with regard to medicinal products for veterinary use.