The Eurasian Economic Commission (EEC) has updated the procedure for registration and examination of medicines. Innovations mainly impact medicines with additional devices for measurement and administration.
As per the revised guidelines, manufacturers must now provide documentation in the registration dossier that verifies the quality and functionality of all supplementary packaging components. Simultaneously, a significant advantage was the elimination of the necessity for separate registration of components like medical devices, greatly streamlining the application process for applicants.
Another significant innovation was the requirement to obtain a separate registration certificate for each new dosage form of the drug.
