The Commission Q&A document has been updated

The European Commission has updated its Questions & Answers document. The Q&A gives insight into how the Commission interprets some aspects of medicines verification.

The European Commission has released Version 11 of Safety Features for Medicinal Products for Human Use Q&A.

In this article we have outlined the revisions and changes for you. The full Q&A is available at:

https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/qa_safetyfeature_en.pdf

New Q&As: 5.8, 6.8. and 8.8.

Questions 1.23, 7.15, 8.4 and 8.7 have been revised.

Q 1.23. The use of a transparent sticker for an antitampering device is ok if placed over the 2d matrix if it doesn’t impact on readability. Transparent stickers may not be placed over human readable information as this must remain intact, even after the package has been opened.
(Wording revised, previous version read, “… information must remain intact even after the ATD is broken”.)
Q 5.8. NEW A wholesaler can not request another wholesaler to verify for them in case of distribution outside the EU. The verification must be done by the wholesaler who intends to distribute.
Q 6.8. NEW In healthcare institutions it is not necessary to check the antitamper device at the same time as verification, as long as the anti-tamper device is checked before distribution to the public.
Q 7.15. Parallel importers/distributors must comply with Article 33 and upload a list of wholesalers into the repository system if they hold an MAH as outlined by Article 6 and if they repack/relabel and therefore place a new antitamper device. In this case, the decommissioning must be performed by the parallel importer/distributor, and not the wholesaler they received the product from.
(Term directive written in full, not shortened to DIR)
Q 8.4. Parallel importers/distributors must comply with Article 40 and 42 if they hold an MAH as outlined by Article 6 and if they repack/relabel and therefore place a new antitamper device. In this case, the decommissioning must be performed by the parallel importer/distributor, and not the wholesaler they received the product from.
(Term directive written in full, not shortened to DIR)
Q 8.7. Operators who supply medicinal products on the ground of Article 126a (Cyprus clause) must have a manufacturing authorisation and/or a wholesale distribution authorisation and/or a parallel import license. They are therefore subject to the obligations laid down in Commission Delegated Regulation (EU) 2016/161 for manufacturers and/or wholesale distributors and/or parallel importers/distributors. In addition, should those operators place or replace the safety features in accordance with Article 47a of Directive 2001/83/EC on the medicinal products they supply, they need to comply with Articles 33, 40 and 42 of Commission Delegated Regulation (EU) 2016/161.
(‘Parallel import/distribution license’ for legal entities changed to ‘parallel import license’)
Q 8.8. NEW In the case of replacement of the safety features by parallel traders, the decommissioning of the original unique identifier can not be carried out by the wholesaler from whom they receive the product.