June 19, 2018
Roszdravnadzor: Amendments to the Federal Law on the Circulation of Medicinal Products
Federal Law No. 140-FZ dated June 04, 2018 On Amendments to the Federal Law On the Circulation of Medicinal Products entering into force on June 15, 2018 has been designed to amend the procedure for the submission of documents for the purpose of the state registration of medicinal products, confirmation of the state registration, and introduction of amendments into the documents contained in the registration dossier.
The Federal Law introduces part 3 of Article 65 concerning the suspension of the use of medicinal products in the event that non-compliance with the requirements of the rules of good manufacturing practices and (or) violations of licensing requirements are discovered during the inspection of the manufacturer of medicinal products or licensing monitoring in the field of manufacturing of medicinal products that led or may lead to the manufacture of medicinal products intended for medical use that caused or are likely to cause death or harm to human health.
