Updates from the European Medicines Agency (EMA) shed light on the recent revision of the QRD Templates, particularly tailored to comply with QRD template v10.4 updated on 29/02/2024, addressing the regulatory implications post-Brexit.
The QRD Templates are standardized documents used to ensure consistency and clarity in the presentation of product information for medicines.
With the United Kingdom no longer part of the EU, significant changes were necessary to ensure compliance and alignment with new regulatory frameworks. This includes the removal of "United Kingdom (Northern Ireland)" from the list of local representatives in the package leaflet, a move in line with the Windsor Framework for labelling and packaging of medicines.
Regarding the update of QRD template v10.4 (QRD product-information), alongside addressing the Brexit impact, EMA has also
implemented a series of minor yet impactful changes to enhance usability and accuracy:
- Replacing outdated hyperlinks from EMA's previous website.
- Correcting details in the list of local representatives for Denmark across all available language versions of both QRD and ATMP templates.
- Making linguistic amendments to improve the Norwegian version of the ATMP template.
- Updating hyperlinks for the mutual recognition procedure, decentralised procedure, and referral templates across all available language versions.
And guess what? Alongside the main template update, several annexes and documents have also been refreshed, making sure that product information documentation remains top-notch.
Wondering which documents got the makeover treatment? Drumroll, please! Here they are:
- QRD Appendix II (Medical Dictionary for Regulatory Activities 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
- 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
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