News about GMP/cGMP

07.01.2022

EC: Updated Q&A on Safety Features, Version 19

EC: Updated Q&A on Safety Features, Version 19

The European Commission published Version 19 of the Q&A on safety features for medicinal products in late December 2021.

What's new?

  • Question 1.29: Do the unique identifiers of reference and retention samples taken from stock in compliance with Annex 19 of the EU GMP Guidelines5 and uploaded to the EMVS have to be decommissioned? If yes, to what status?
    Answer: Yes, if a sample of a batch is taken as reference or retention sample after uploading in EMVS, it should be decommissioned as "sample". If a sample is taken voluntarily by a wholesaler that fall outside the scope of Annex 19, they should be decommissioned as "destroyed".

What has been updated?

  • Question 1.22: In the case of parallel-traded packs, can parallel traders cover or remove the safety features of the original pack?
  • Answer:
    Yes. Parallel traders who cover or remove the existing safety features are required to apply equivalent safety features in accordance with Article 47a of Directive 2001/83/EC. If the product code or/and batch number change, the original one must be decommissioned as a first step. The new individual identifier should comply with the requirements of the Member State where the medicinal product is to be placed on the market. In any case, traceability must be maintained in the final storage system.

 

  • Question 5.8: Can a wholesaler request another wholesaler to verify the authenticity and decommission the unique identifiers for medicinal products they intend to distribute outside the EU on their behalf?
    Answer: No, this obligation cannot be delegated, as the audit trail would not reflect the reality of the supply chain.

 

  • Question 7.19: Can a marketing authorisation holder delegate the uploading of the information laid down in Article 33(2) of Commission Delegated Regulation (EU) 2016/161?
    Answer: Yes, this is possible if there is a written agreement between both parties. However, the legal responsibility will remain with the MAH. He must ensure the accuracy, confidentiality, and integrity of the data uploaded into the system.

Source:

EC: Q&A Safety Features, Version 19


 

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