Thursday, 05 December 2019 15.00 - 16.30 h
From 9 February, 2019, onwards, many prescription drugs may only be placed on the market if they bear the required safety features.
The European Commission has published version 9 of the questions and answers on safety features in February 2018. Compared to the previous version, 21 questions and answers have been added, and four answers have been revised. The document now includes a total of 92 questions and answers on safety features.
One of the new questions is the one about the bundling of several individual packagings, for example. If the safety feature is put on the outer packaging, the latter may not be made of cellophane foil or a comparable material.
Another new question is whether it is permitted to place stickers to the outer packaging. Generally, the 2D matrix code must be printed directly on the packaging, using stickers is only admissible for a few justified exceptions.
The question whether a product, which has been exported into a third country, may adopt its original safety feature upon its return to the EU is also a new one. Such a reversal is not admissible under any circumstances. Rather, the imported product needs a new barcode, a new batch number and a new expiration date before it can be released for distribution and sales.
You can find more details in Version 9 of the Questions and Answers on Safety Features for Medicinal Products for Human Use.