Mandatory eCTD for National Applications in Austria

From 1st January 2018, new National applications in Austria, must be submitted in eCTD format.

December 12, 2016

Please note that from 1st January 2018, new National applications in Austria, must be submitted in eCTD format.

Submissions of variation and renewal applications of purely national products have to comply with eCTD format from 1st January 2019.

For more information: http://www.basg.gv.at/en/eservices/ectdvnees/

ASPHALION has extensive experience of eCTD publishing and can assist you during the procedure. If you need support do not hesitate to contact us!

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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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Mandatory eCTD for National Applications in Austria

From 1st January 2018, new National applications in Austria, must be submitted in eCTD format.

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

Careers

Mandatory eCTD for National Applications in Austria

From 1st January 2018, new National applications in Austria, must be submitted in eCTD format.

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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