Drug Safety Q&A gets revision by the European Commission


The medicinal products mentioned in the Commission Delegated Regulation (EU) 2016/161, receives a thoroughly revised Question and Answers on implementing its safety features. The drafted questions and answers format revises an answer from its previous version and possess a set 3 additional questions and answers.

The 3 sets of Q&A mainly raise concerns regarding, which entity is responsible for verifying and decommissioning investigational medicines with safety features used in clinical trials and authorized auxiliary medicinal products, how wholesalers can ensure that medicines they receive without safety features were released prior to the requirement for those features entering into effect on 9 February 2019, and parallel distributors who wish to distribute products with unique identifiers to Greece and Italy and must remove the EU unique identifier and replace it with a Greek or Italian unique identifier.