Rules of import and export of biomaterials produced during clinical trials of drugs become effective in Russia from September 1 and will expire on September 1, 2028. The relevant Cabinet decree was posted on the official web portal of legal information, – TASS reported.
Rules stipulate that developers of pharmaceuticals, legal entities authorized by them to perform studies, research and educational institutions with their activities providing for the possibility of participating or organizing studies, can import or export biomaterials from Russia.
Organizations should submit an application to the Ministry of Health in order to receive the relevant conclusion. The application should contain details of the trial and its objectives, the name of the state and the entity for planned import or export of biomaterials, and information about such materials and their quantity. Incomplete submission of documents or unreliable data in them can be the cause to turn down import or export of biomaterials.