IMPACT OF BREXIT
On 29th February 2024, EMA rolled out the latest version of QRD template v10.4, reflecting current regulatory implications post-Brexit.
In essence, this latest version has purposefully deleted ‘United Kingdom (Northern Ireland)’ from the list of local representatives in the package leaflet to comply with the Windsor Framework for labelling and packaging of medicines.
Furthermore, EMA has implemented the following minor changes:
- replacing hyperlinks from EMA’s previous website;
- correcting details in the list of local representatives for Denmark, in all available language versions, for both QRD and ATMP templates;
- making linguistic amendments to the Norwegian version of the ATMP template;
- replacing the hyperlinks for the mutual recognition procedure, decentralised procedure and referral templates, in all available language versions.
In addition to the main template revision, other annexes and documents were also revised:
- QRD Appendix II (MedDRA terminology to be used in section 4.8 “Undesirable effects” of the Summary of Product Characteristics)
- QRD Appendix IV (Terms and abbreviations for batch number and expiry date to be used on the labelling of human medicinal products)
- QRD Appendix V (Adverse-drug-reaction reporting details)
- ATMP Product Information Template (advanced therapy medicinal products)
- Mutual-recognition, Decentralised, and Referral Product-Information
Template - Guideline on core SmPC, Labelling and Package Leaflet for advanced
therapy medicinal products (ATMPs) containing genetically modified cells