Version 19 of the Q&As on Safety Features

The European Commission published version 19 of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Compared to the previous version 18b, the new version contains one new Q&A and three revised Q&As.

New Q&A

  • 1.29 Do the unique identifiers (UIs) of reference and retention samples taken from stock in compliance with Annex 19 of the EU GMP Guidelines and uploaded to the EMVS have to be decommissioned? If yes, to what status?
    Generally, the serial numbers of packs that are taken from a batch and stored as reference / retention samples should not be uploaded in the EMVS. When a pack is taken from a batch and stored as a reference / retention sample after upload to the EMVS it should be decommissioned as “SAMPLE”. Samples taken voluntarily from a batch by a wholesaler (i.e. out of the scope of Annex 19) should be decommissioned as “DESTROYED”.

Revised Q&As

  • 1.22 In case of parallel-traded packs, can parallel traders cover or remove the safety features of the original pack?
    Parallel traders covering or removing the existing safety features are required to place equivalent safety features.
    The new UI should comply with the requirements of the Member State where the medicine is intended to be placed on the market.
    Furthermore, if the product code and/or batch number of the parallel-traded product changes compared to the original product, parallel traders must place a new UI after first decommissioning the original one. When placing an equivalent UI, parallel traders are required to fulfil, the obligations laid down in Commission Delegated Regulation (EU) 2016/161 concerning the uploading and up to date keeping of the new UI information in the repository system. In all cases, traceability must be maintained.

  • 5.8 Can a wholesaler request another wholesaler to verify the authenticity and decommission the UIs for medicinal products they intend to distribute outside the EU on their behalf?
    The wholesaler who physically holds the medicinal products and intends to distribute these products outside the EU must verify the authenticity and decommission the UIs. This obligation cannot be delegated to another wholesaler, as the audit trail would not reflect the reality of the supply chain.

  • 7.19 Can a marketing authorization holder (MAH) delegate the uploading of the information laid down in Article 33(2) of Commission Delegated Regulation (EU) 2016/161?
    MAHs may delegate the uploading of the information according to Article 33(2) (e.g. data elements of the UI, coding scheme, name and address of the manufacturer placing the safety features and of the MAH, etc.) to third parties by means of a written agreement. The MAH remains legally responsible for these tasks. In all cases, the MAH must ensure the accuracy, confidentiality and data integrity. This includes, for example, procedures for  
    - ensuring that uploaded data and actual batch properties correspond (such as, batch number, expiry dates, destination market, batch size),
    - securing data exchange with the subcontractor,
    - ascertaining that data to be uploaded has not been corrupted in any way.
    Data uploading performed by means of infrastructures, hardware and software that are physically located outside the EEA is strongly discouraged.

For more information please see version 19 of the "Safety features for medicinal products for human use - Questions & Answers".

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