Version 15 of the Q&As on Safety Features

The European Commission (EC) published version 15 of the Q&A´s on Safety features for medicinal products for human use. The amended version, which supersedes version 14, contains the new Q&As 3.7, 5.10, 8.10 and the revised Q&A 1.6.

New Q&As 3.7, 5.10, 8.10

  • 3.7 Who should verify and decommission medicines with safety features that are to be used in clinical trials (CTs) as investigational medicinal products (IMPs) or authorized auxiliary medicinal products (AxMPs)?
    The unique identifier (UI) on medicines in their commercial presentations bearing safety features should be verified and decommissioned before use as authorized IMPs or AxMPs.
    - For medicines repackaged or relabelled for use in CTs, the manufacturer holding the manufacturing and importation authorization should verify and decommission the UI before repackaging or relabelling.
    - For medicines that are not repackaged or relabelled, the person entitled or authorized to supply to the public who supplies the medicinal product for subsequent use in a CT should verify and decommission the UI.
    - In some cases, Member States may require wholesalers to verify and decommission UIs on medicines supplied for CTs.
  • 5.10 How can a wholesalers be sure that medicines they receive without safety features have been batch released prior to the entry into application of the safety features (9 February 2019)?
    Marketing authorization holders and manufacturers may only place medicines released before 9 February 2019 on the EU market without safety features. Wholesalers may request that manufacturers include the batch release date in the delivery note of non-serialized medicines in order to confirm that the medicines were released before the safety features became mandatory.
  • 8.10 During the transition period, do parallel traders need to decommission the UI on medicines they repackage or relabel for Greece or Italy?
    Yes, manufacturers removing safety features should verify the authenticity of the EU UI and decommission it before replacing it with a Greek or Italian UI. 

Revised Q&A 1.6

  • 1.6 Do the rules on the safety features apply to medicinal products intended for research and development trials?
    Medicinal products intended for research and development trials and not yet granted a marketing authorization are excluded from the rules on the safety features. Authorized medicinal products have to fulfil the requirements up to the moment it becomes known which batch / unit will be used for research and development trials. In practice, there are two possible situations:

    1. The product is manufactured for known use in a CT
    An IMP that is manufactured in accordance with the marketing authorization but is packaged for a CT (not in the commercial presentation) is excluded from the rules on the safety features. The manufacturer would be required to hold a manufacturing and importation authorization covering IMPs and the IMP certified under that authorization in accordance with the CT application. Authorized AxMPs cannot be manufactured under a manufacturing and importation authorization covering IMPs and must therefore fulfil the requirements of a marketed pack bearing safety features and decommissioned appropriately.

    2. The product is authorized and sourced from the regulated supply chain
    Medicines in their commercial presentations bearing safety features should be decommissioned before use as IMPs or authorized AxMPs.

The Commission's detailed answers to the new and amended questions can be found in version 15 of the Q&As on Safety Features for Medicinal Products for Human Use.

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