Holders of existing marketing authorisations granted via the centralised procedure for ATMPs containing genetically modified cells must update the product information annexes with the next regulatory procedure affecting the product information. Ongoing marketing authorisation applications must align their product information as early as possible, and by Day 181 of the procedure at the latest. This new guideline provides a template for ATMPs containing genetically modified cells which is made available in English and all the other EU languages.Īny new marketing authorisation granted via the centralised procedure for ATMPs containing genetically modified cells must comply with the guideline.
New Guideline on Core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells. You’re free to concentrate on your ideas while Writer makes them look great. It is simple enough for a quick memo, yet powerful enough to create complete books with contents, diagrams, indexes, etc. *Additional linguistic corrections in the Czech, Danish, German, Estonian, Hungarian, Italian, Lithuanian and Slovenian language templates have been implemented. Writer has everything you would expect from a modern, fully equipped word processor. Since 28 June 2019, applicants need to complete Annex II and present a draft of this together with the summary of product characteristics (SmPC), labelling and package leaflet when submitting the product information annexes as part of their marketing authorisation application. Holders of existing conditional marketing authorisations granted via the centralised procedure must update the product information annexes with the next regulatory procedure affecting the product information, and at the latest with the annual renewal, to comply with the revised QRD template. Ongoing marketing authorisation applications must align their product information to the revised QRD template v10.3 as early as possible, and by Day 181 of the procedure at the latest. QRD template v10.3 has been revised in September 2022 solely* to include guidance in Annex II section C for conditional marketing authorisations.Īny new marketing authorisation granted via the centralised procedure as a conditional marketing authorisation must comply with the revised QRD template v10.3.
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