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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 19 days ago

Guidance on paediatric submissions

19 days ago

The linguistic review process of product information in the centralised procedure - veterinary

28 days ago

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

about 1 month ago

Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency

about 2 months ago

Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)

2 months ago

Guidance document on voting in the framework of discussion and adoption of CHMP opinions

2 months ago

PRIME eligibility requests: 2024 deadlines for submission and timetable for assessment

3 months ago

Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period

3 months ago

Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products

3 months ago

Scientific advice under Art.107(6) of Reg.(EU)2019/6 for establishment of a list of antimicrobials which shall not be used in accordance with Art. 112, 113 and 114 or which shall only be used in accordance with these articles subject to certain conditions

3 months ago

Guidance on paediatric submissions

4 months ago

Good practices for industry for the prevention of human medicinal product shortages

5 months ago

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