EC: Q&As on Safety Features – New Version
The European Commission (EC) has published a new version 21 of its Q&As on safety features for medicinal products for human use. Four new questions have been added.
In brief, these are the new questions and answers:
What are the safety features?
The safety features consist of two elements placed on the packaging of a medicinal product: a unique identifier, an anti-tempering device (ATD).
If a pack bearing the safety features is lawfully opened (e.g. by parallel traders/manufacturers replacing the leaflet under the supervision of national competent authorities), can it be resealed (e.g. by applying a new ATD on top of the old, broken ATD)?
Yes, such package can be resealed (e.g. by applying a new ATD on top of the original, broken ATD) provided the requirements in Article 47a (1) of Directive 2001/83/EC are fulfilled. This implies, for example, that the authenticity of the unique identifier and the integrity of the ATD on the original pack were verified as authentic before breaking the original ATD/pack and that the replacement of the ATD is carried out in accordance with applicable GMP principles.
Is it possible for manufacturers/wholesales/parallel traders to market/supply medicinal products with a packaging showing visible signs of opening/intrusion, but where the ATD has been replaced by a new ATD in accordance with Article 47a of Directive 2001/83/EC?
Yes, this is possible if the presence of visible signs of opening on the packaging are consistent with legal repackaging of that medicinal product by a parallel importer or by a parallel distributor.
Is it acceptable to use stickers to place the unique identifier on the outer/immediate packaging?
For medicinal products subject to parallel import and parallel distribution it is possible to use a sticker (adhesive label) provided that the sticker cannot be removed without being damaged and that the sticker complies with the printing quality requirements set out in the Commission Delegated Regulation (EU) 2016/161.
Replacement of the unique identifier must be carried out in accordance with applicable GMP principles.
Full details can be found in the Q&A document.
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