Can the Application of Safety Features be outsourced?

Recommendation

11/12 February 2025
Heidelberg, Germany

Combination Products
Medicinal Products/Drugs meet Medical Devices

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:

Checks on the legibility and correctness of the information in the data matrix code must be carried out before release for sale.
When using pre-printed packaging, a signed delimitation of responsibility agreement ("written agreement among the parties establishing the corresponding responsibilities") must be available (in accordance with Chapter 7 of the EU-GMP guidelines)
The packaging materials provider should be audited and qualified.
Upon receipt of the pre-printed packaging materials, appropriate checks on the quantity and quality of the UIs in line with EU-GMP principles should be performed.