Variations and renewal application forms update (human and veterinary)

The Notice to Applicants, has been updated with an application form for the submission of variations and renewal.

June 17, 2014

The Notice to Applicants,
volumes 2 and 6 have been updated with the publication of the updated
application form for the submission of variations and renewal.

Volume 2C : Human medicinal products – Regulatory Guidelines

Volume 6C : Veterinary medicinal products – Regulatory Guidelines

The electronic version of the new
variation and renewal application forms are made available by the
European Medicines Agency at http://esubmission.emea.europa.eu/eaf/index.html

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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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Variations and renewal application forms update (human and veterinary)

The Notice to Applicants, has been updated with an application form for the submission of variations and renewal.

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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

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Variations and renewal application forms update (human and veterinary)

The Notice to Applicants, has been updated with an application form for the submission of variations and renewal.

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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