News about GMP/cGMP

02.07.2021

EC:Updated Version 18B of Q&A on Safety Features

EC:Updated Version 18B of Q&A on Safety Features

The European Commission published version 18B of the Q&A on safety features for medicinal products in late May 2021. In the 34-page document, question 1.14 "Are there mandatory specifications for tamper evidence?" was updated.


The adjustment was made due to the new citation of EN ISO standard 21976:2020 "Packaging - Tamper verification features for medicinal product packaging" as a reference for consideration by manufacturers. The ISO standard has international validity. Previously, the document named the CEN standard EN 16679:2014 "Tamper Verification Features for medicinal product packaging" with Europe-wide relevance.


Source:

EC: Q&A on Safety features


 

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