Counterfeit Protection: 13th Version of Questions & Answers Paper published

The European Commission has published version 13 of the Questions & Answers document regarding the implementation of the rule on safety features for medicinal products for human use. Compared to the previous version NO 12, the new version of the EU Commission's Q&As relating to the Anti-Counterfeiting Directive 2011/62/EU and the Delegated Regulation (EU) 2016/161 contains the following new questions and answers as well as the revised question and answer No. 5.7:

  • 1.24
    If a medicinal product carries more than one batch number, e.g. if the medicinal product consists of an active component and a solvent, only the batch number of the active substance needs to be encoded in the verification system.
  • 1.25
    What status should be assigned for a pack intended for repackaging or re-labelling for the purpose of using it as an authorized investigational  medicinal product (IMP) or authorized auxiliary medicinal  product? The pack should be decommissioned as “SUPPLIED” when repackaging or re-labelling for use as an authorized IMP or authorized auxiliary medicinal product.
  • 1.26
    Regardless of their place of manufacture, medicinal products manufactured exclusively for the Greek or Italian market, are not required to bear safety features in Greece or Italy during the transitional period.
  • 1.27
    However, during the transitional period, manufacturers located in Greece or Italy can place the safety features on medicines intended for the rest of the EU/EAA.
  • 1.28
    Regarding direct supplying to healthcare facilities, the safeguards outlined in the "Expert Group paper on implementation of the Falsified Medicines Directive in the hospital setting" should be met.
  • 2.22
    The human-readable abbreviations (PC, SN, Lot, EXP, NN) should comply with the provisions of the QRD-template. Batch number and expiry date should correspond to the abbreviations provided in Appendix IV of the current QRD-template.
  • 3.6
    A medicinal product with only one of the safety features (either the unique identifier (UI) or the anti-tampering device, ATD) that has been released for sale before February 9, 2019, and has not been repackaged or relabelled may remain on the market until their expiry date.
  • 4.5
    It is emphasized that the manufacturer is responsible for ensuring that the UI is readable and complete. Accordingly, the 2D barcode must be checked in a suitable way for readability and correctness of the information. In addition, manufacturers must work closely with marketing authorization holders to ensure that all relevant information on the UI has been uploaded before it is released for sale or distribution.
  • 5.7 (revised)
    A medicinal product with a damaged or unreadable 2D code may only be further distributed if the verification of the authenticity of the UI can be performed using the human readable code. If this is not the case, e.g. if the human readable code is damaged or absent, the wholesaler should not further distribute the product. This requirement is independent of whether the verification was mandatory or voluntarily performed by the wholesaler.
  • 8.9
    Packs released without UI before 9 February 2019 may remain on the EU market until their expiry date, as long as they are not repackaged or re-labelled in between. However, for products already released with UI before 9 February 2019, the UIs for such products should be uploaded to the system before 9 February 2019 to avoid alerts due to lack of data in the repository.

The Commission's detailed answers to the new and amended questions can be found in version 13 of the Q&As on Safety Features for Medicinal Products for Human Use.

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