New QRD template released on EMA website

At the end of June 2019 EMA published new QRD template (v10.1) for centrally authorized products.

July 11, 2019

At the end of June 2019 EMA published new QRD template (v10.1) for centrally authorized products.

Marketing Authorization Holders are strongly encouraged to update the product information in the next regulatory procedure which affects the summary of product characteristics (SmPC), labelling or package leaflet.

The product information of new MA applications submitted to EMA should follow the new template at latest by Day 181 of the procedure.

For more information and new QRD templates in all European languages visit https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-templates

If you need support from Asphalion, we can help you with the change or revision of the QRD version in your texts. Please contact us [email protected]

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Brexit updates for human use medicinal products approved via MRP/DCP

December 21, 2020

As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.

Javier Febrero Alija – New Regulatory Information Manager

December 17, 2020

Asphalion is excited and proud to officially welcome Javier Febrero Alija to its team as Regulatory Information Manager, expert in Data Management and RIMS.

Season’s Greetings

December 17, 2020

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

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New QRD template released on EMA website

At the end of June 2019 EMA published new QRD template (v10.1) for centrally authorized products.

Search

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Related news and events

Brexit updates for human use medicinal products approved via MRP/DCP

Javier Febrero Alija – New Regulatory Information Manager

Season’s Greetings

About

Team

Partners

CSR

AI Ethic Code

Careers

New QRD template released on EMA website

At the end of June 2019 EMA published new QRD template (v10.1) for centrally authorized products.

Search

Filter by category

Related news and events

Brexit updates for human use medicinal products approved via MRP/DCP

Javier Febrero Alija – New Regulatory Information Manager

Season’s Greetings

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