5/6 June 2024
The European Commission recently published version 18b of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".
Compared to the previous version 18, the new version 18b contains a revised Q&A 1.14.
In December 2020 ISO 21976 has been transferred into an EN ISO Standard: EN ISO 21976:2020 "Packaging - Tamper verification features for medicinal product packaging". Thus, there is now one document for Europe and the whole world. Consequently, EN 16679 has been replaced by EN ISO 21976 and the EU-Commission adapted their reference in the Q & A document accordingly:
1.14. Question: Are there any mandatory specifications for the anti-tampering device?
Answer: In accordance with Article 54(o) of Directive 2001/83/EC and Article 3(2)(b) of Commission Delegated Regulation (EU) 2016/161, an anti-tampering device has to allow the verification of whether the packaging of the medicinal product has been tampered with.
There are no other mandatory specifications. The standard EN ISO 21976:2020 “Packaging – Tamper verification features for medicinal product packaging” is available for manufacturers to consider.
For more information please also read Version 18b of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".