Summary

EU SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS – VERSION 9

The European Commission Directorate-General for Health and Food Safety has prepared Question and Answers document to address questions regarding 2019 requirements for Safety Features for Medicinal Products for Human Use per Articles 47a, 54(o), 54a of Directive 2001/83/EC and, and Commission Delegated Regulation (EU) No 2016/161, which details the characteristics of the safety features, how medicine authenticity should be verified and by whom. The delegated Regulation, and the new medicine verification system it lays down, will apply as of 9th February 2019.

The Q&A document is Version 9.0 February 2018.

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