The Federation Council has decided to amend the Federal Law “On the Circulation of Medicines.” The purpose of these amendments is to establish uniform rules for the medicines regulation on the territory of the Eurasian Economic Union (EAEU), including both medical and veterinary drugs.
According to the document, federal executive bodies will be responsible for providing information on the registration and re-registration of the drug, making changes to the registration dossier, as well as procedures related to registration. This data will be transmitted to the Eurasian Economic Commission through the information system of the Eurasian Economic Union. A unified register of registered medicines of the EAEU will be created.
The provision of services, including the examination of medicines and their state registration, will be carried out through electronic document management on the portal of state services or through a unified state information system in the field of healthcare.
In addition, changes have been made to reduce the deadlines for state registration of veterinary drugs. Now, this process will take 120 working days instead of 160. The developer or authorized applicant must submit an application and the necessary documents through the portal of state services, and then state registration will be carried out within 40 working days instead of the previous 60. The deadline for submitting an application for confirmation of state registration remains unchanged – 180 days before the expiration of the registration certificate. Changes have also been made to the section on the suspension of the use of veterinary drugs.
The discussion of the document takes place on the page of the Legal Portal of the EAEU.
