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AMIce - Public Part - Module Terms for Substances Date: 01. April 2022 Topics: Licensing Type: Article

AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the comprehensive medicinal products information system AMIce, managed and updated by the German drug regulatory authorities BfArM, BVL, and PEI.

AMIce - Public Part - Module Substances Date: 01. April 2022 Topics: Licensing Type: Article

AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the comprehensive medicinal products information system AMIce, managed and updated by the German drug regulatory authorities BfArM, BVL, and PEI.

CHMP Meeting Highlights March 2022 Date: 31. March 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights March 2022

CHMP Meeting Highlights February 2022 Date: 03. March 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights February 2022

CHMP Meeting Highlights January 2022 Date: 03. February 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights January 2022

Variations Date: 25. January 2022 Topics: Licensing Type: Article

On the occasion of the new Variation Regulation (EC) No 1234/2008 which applies since 1 January 2010 a new web page "Variations" has been created and should be considered.

How to register for CTIS? Date: 18. January 2022 Topics: Licensing Type: FAQ

Before using CTIS, users must have an EMA account. Users that have already an EMA account, for example to use Eudravigilance or the substances, products, organisations and referentials database (SPOR) do not need to create a new account. Users that …

How clinical trials will be processed in CTIS? Date: 18. January 2022 Topics: Licensing Type: FAQ

Clinical trial sponsors who want to gain regulatory approval for a clinical trial in one or more EU Member States and EEA countries will submit a single clinical trial application form and supporting dossier through CTIS. The submission of the single …

How to prepare for CTIS? Date: 05. January 2022 Topics: Licensing Type: FAQ

Sponsors can consult the CTIS Sponsor Handbook for guidance on how to prepare for CTIS.

In addition, sponsors can use the CTIS online training programme. The guide to the CTIS training material catalogue, which can be found on the training …

CHMP Meeting Highlights December 2021 Date: 23. December 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights December 2021