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CHMP Meeting Highlights September 2022 Date: 21. September 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights September 2022

Brexit Date: 15. August 2022 Topics: Licensing Type: Article

The United Kingdom (UK) left the European Union (EU) on 31 January 2020. It became a third country on 1 February 2020. A transitional period lasting until 31 December 2020 was established in the agreement on the UK’s withdrawal. During this period – …

CHMP Meeting Highlights July 2022 Date: 29. July 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights July 2022

CHMP Meeting Highlights June 2022 Date: 30. June 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights June 2022

CHMP Meeting Highlights May 2022 Date: 27. May 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights May 2022

CHMP Meeting Highlights April 2022 Date: 28. April 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights April 2022

Medicinal Products Information System AMIce Date: 21. April 2022 Topics: Licensing Type: Article

AMIce contains the approval data of the German drug regulatory authorities BfArM (Federal Institute for Drugs and Medical Devices), PEI ( Paul-Ehrlich-Institut - Federal Institute for Vaccines and Biomedicines) and BVL (Federal Agency for Consumer …

Uploading of requested or revised documents in the context of validation or assessment. Date: 08. April 2022 Topics: Licensing Type: FAQ

If further, corrected or updated documents as part of the application have been requested as further information (RFI), the sponsor must upload them under the originally submitted document files. Uploading the documents as a direct response to the …

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

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

AMIce - Public Part - Module Medicinal Products 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 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