Serialization - Version 21 of the Q&As on Safety Features

The European Commission published version 21 of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. The new version contains four new Q&As compared to the previous version 20, which mainly cover the tasks of parallel traders when dealing with safety features during repackaging.

New Q&As

  • 1.1 What are the safety features? (i.e., Unique Identifier (UI) and Anti-Tampering Device (ATD))

  • 1.20 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 provided the following requirements are fulfilled:
    - The authenticity of the UI and the integrity of the ATD on the original pack were verified as authentic before breaking the original ATD/pack.
    - The replacement of the ATD is conducted in accordance with GMP principles and is subject to supervision by the competent authority.
    - The replacement ATD must make it possible to verify that the outer packaging of a medicinal product has not been unlawfully opened between the time at which that medicinal product is repackaged and that at which it is supplied to the public. Thus, it must be evident for everybody that a new ATD has been placed and by whom (i.e., the repackager of the medicinal product must be clearly stated on the outer packaging).

  • 1.21 Is it possible for manufacturers/wholesalers/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to market/supply medicinal products with a packaging showing visible signs of opening/intrusion, but where the ATD has been replaced by a new ATD?
    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.

  • 2.21 Is it acceptable to use stickers to place the UI on the outer/immediate packaging?
    As a rule the UI must be printed on the packaging. However, 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 fulfils the quality of the printing requirements set out in Commission Delegated Regulation (EU) 2016/161. The replacement of the UI must be conducted in accordance with GMP principles.

For more information please see version 21 of the "Safety features for medicinal products for human use - Questions & Answers".

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