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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 17 days ago

Guidance on Irish language derogation ending on 1 January 2022

17 days ago

Guidance on Irish language derogation ending on 1 January 2022

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications

21 days ago

EU Implementation Guide (IG) on veterinary medicines product data in the Union...

Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)

26 days ago

Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)

European Medicines Agency Write PMS API implementation Guide (zip)

27 days ago

European Medicines Agency Write PMS API implementation Guide (zip)

European Medicines Agency Write PMS API implementation Guide

27 days ago

European Medicines Agency Write PMS API implementation Guide

Procedure for the preparation of European Union herbal monographs and European Union list entries and appointment of HMPC rapporteurs and peer-reviewers

about 1 month ago

Procedure for the preparation of European Union herbal monographs and European Union...

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

about 1 month ago

IRIS guide for applicants - How to create and submit scientific applications...

Good practice guidance for communication to the public on medicines’ availability issues

2 months ago

Good practice guidance for communication to the public on medicines’ availability issues

European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications

2 months ago

European Medicines Agency procedural advice for users of the centralised procedure for...