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 12 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

Revised Q&As: 1.20 and 2.21

Q 1.20 

If a pack bearing the safety features is lawfully opened, can it be resealed? 

(Wording revised, Answer: “Yes, in certain circumstances.” now reads, “In certain circumstances…”)

Q 2.21

Is it acceptable to use stickers to replace the unique identifier on the outer/immediate packaging?

(Added text: Answer: - “Competent national authorities authorize it due to the marketing authorization or to safeguard public health and ensure continued supply.” has extended to, “Competent national authorities authorize it due to the marketing authorization, including for parallel import or to safeguard public health and ensure continued supply.”)