News about GMP/cGMP


Q&A to Safety Features in new Version 13

In January 2019, the European Commission published a new version 13 of the Questions and Answers document on Safety Features for Medicinal Products for Human Use. Nine new questions were added and one question was revised.

The Q&A document should be seen as a supplement to the Anti-Counterfeiting Directive 2011/62/EU and the Delegated Regulation (EU) 2016/161, which will enter into force on 9 February 2019.

Questions 1.24- 1.28, 2.22, 3.6, 4.5 and 8.9 were newly added to the Q&A, which has now grown to 30 pages. Answers are given to questions on

  • drugs containing more than one component, such as an active ingredient and a solvent, and the correct encoding of the batch number,
  • the repackaging and re-labelling of authorised investigational medicinal products or authorised auxiliary medicinal products, and
  • the handling of medicinal products intended for the Greek or Italian market or manufactured in Greece or Italy.

Question 5.7, dealing with unreadable or damaged 2D Data Matrix code and its wholesale distribution on the market, has been revised.


EC: Q&A on safety features