Formatted Letter Template | No longer maintained by EMA

As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.

January 9, 2020

As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.

From now on, the use of the XML delivery file generated through the eSubmission Delivery File UI must be used and attached to the submission.

There are several fields in this delivery file that are crucial and must be correctly filled.

Asphalion can support you with your CP applications. In case of any doubt or need, please contact us at eCTD@asphalion.com

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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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Formatted Letter Template | No longer maintained by EMA

As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.

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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

Formatted Letter Template | No longer maintained by EMA

As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.

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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