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Regulatory and procedural guidelines (human and veterinary)

Get the latest updates from Regulatory and procedural guidelines (human and veterinary) directly as they happen.

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Latest posts

Last updated about 16 hours ago

Timetable: Companion diagnostic initial consultation

about 16 hours ago

Accelerating clinical trials in the EU (ACT EU) - Delivering an EU clinical trials transformation initiative

9 days ago

Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur (according to Regulation (EU) 2019/6)

10 days ago

Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (according to Regulation (EU) 2019/6)

10 days ago

CVMP rules of procedure (according to Regulation (EU) 2019/6)

10 days ago

Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics

about 1 month ago

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 6: Examples for submission of legacy data

about 1 month ago

Mock-ups checklist - Guidance for checking mock-ups

about 1 month ago

Tables of non-standard abbreviations to be used in the summary of product characteristics

about 1 month ago

Names of the European Union / European Economic Area countries

about 1 month ago

Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with Article 17 of Regulation (EC) No 1394/2007

about 2 months ago

Guidance on Irish language derogation ending on 1 January 2022

about 2 months ago

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