13/14 March 2024
The European Commission has published a new version of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use" - now the 18th version.
Four new Questions & Answers (Q&As) have been added to the paper. Three Questions and Answers have been revised. Of interest is the clarification regarding the application of safety features by a contract manufacturer, like, for example, printing of the unique identifier (2D-barcode).
Also in response to requests from stakeholders such as the European QP Association (EQPA), it has now been clarified in Q&A 4.6 that the placing of safety features can be outsourced to another manufacturer. The prerequisite for this is compliance with the requirements set out in Chapter 7 of the EU-GMP Guideline. The contracted manufacturer must have a manufacturing authorisation (MIA) and must be included in the marketing authorisation. It is also important that the contracting manufacturer makes "a statement confirming compliance with Annex 16 Appendix 1 of the EU GMP Guidelines available to the Qualified Person certifying the final product". The answer to question 2.14 was also revised in this respect.
And what about use outer packaging carrying a unique identifier (UI) which has been placed by a packaging materials provider? This is possible. The following was clarified here with the revision of the answer to question 4.4: