Friday, 15 October 2021 10.00 - 11.30 h
As of 9th February 2019, many prescription medicines in Europe will only be marketable if they meet the required safety features.
The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. Compared to the previous version, 5 new questions and answers have been added and 12 revised. In total, the document now comprises 97 questions and answers on safety features.
New questions are - for example - whether it is possible to re-seal packs opened by parallel traders, and whether it is possible to market medicinal products where the anti-tampering device (ATD) has been replaced by a new ATD but with a packaging showing visible signs of opening.
The answer to the first question is "Yes, in certain circumstances" it is possible if the new ATD completely seals the pack and covers any visible signs of the original, broken ATD.
However, the answer to the second question is "No, this is not allowed". The manufacturer has to place an equivalent ATD which should ensure that the pack is perfectly re-sealed and no signs of the original, broken ATD are visible.
For more detailed information please see the complete document entitled "Safety Features for Medicinal Products for Human Use, Questsions and Answers, Version 10" from July 2018 .