Q&As on Safety Features - Version 14

The European Commission (EC) published version 14 of the Q&A´s on Safety features for medicinal products for human use. The amended version, which supersedes version 13, contains a new Q&A 5.9 and revised Q&As 1.6, 1.28, 7.15, 8.9.

New Q&A 5.9

  • During the transition period, can medicinal products destined for the rest of the EU (where safety features are mandatory) be distributed through the territory of Italy or Greece?
    Yes. Directive 2001/83/EC and Commission Delegated Regulation (EU) 2016/161 (CDR) do not prevent the distribution of medicines with safety features.

Revised Q&As 1.6, 1.28, 7.15, 8.9

  • 1.6 Do the rules on the safety features apply to medicinal products intended for research and development trials?
    - Investigational medicinal product (IMPs) manufactured in accordance with the marketing authorization but packaged for a clinical trial (CT) are excluded from the rules on the safety features.
    - Authorized auxiliary medicinal products (AAMPs) must fulfil the requirements of a marketed pack bearing safety features and decommissioned appropriately.
    - If the product is authorized and sourced from the regulated supply chain in the commercial presentations bearing safety features it should be decommissioned in accordance with the CDR before use as IMP or AAMP.

  • 1.28 Is there an obligation for direct suppliers to healthcare institutions to offer aggregation services?
    No. The CDR does not require hospital suppliers to provide aggregation services.

  • 7.15 Are parallel importers/distributors required to comply with Article 33(1) and upload the information in Article 33(2) into the repository system? Should they also upload a list of designated wholesalers?
    In the following two cases parallel traders are obliged to comply with Article 33:
    - If they hold a marketing authorization in the sense of Article 6 of Directive 2001/83/EC, in which case they may also upload the list of wholesalers they have designated in accordance with the CDR; or
    - If they repack/relabel and place new safety features or replace safety features in accordance with Article 47a of Directive 2001/83/EC on the medicinal products they supply. In this case, parallel traders who do not hold a marketing authorization may not designate their own wholesalers and should not upload a list of wholesalers into the repository system.

  • 8.9 Should marketing authorization holders (MAHs) upload the unique identifiers (UIs) for products with 2D barcodes released for sale or distribution before 9 February 2019?
    Yes. According to Article 48 of the CDR, medicines released for sale or distribution before 9 February 2019 without a UI may remain on the EU market until their expiry date, as long as they are not repackaged or relabelled after that date. If they are repackaged or relabelled after 9 February 2019, the manufacturer must place safety features in accordance with Directive 2001/83/EC and the CDR. This transitional measure does not apply for products which were released before 9 February 2019 with a UI. The UIs for such products should be uploaded to the system before the entry into application of the new rules (9 February 2019). This should help to avoid alerts for genuine products released before 9 February due to lack of data in the repository.

The Commission's detailed answers to the new and amended questions can be found in version 14 of the Q&As on Safety Features for Medicinal Products for Human Use.

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