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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 3 days ago

European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes

about 1 month ago

European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance...

Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)

about 1 month ago

Rules of procedure for the Patients and Consumers Working Party (PCWP) and...

IRIS guide to registration and RPIs

about 1 month ago

IRIS guide to registration and RPIs

European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008

about 2 months ago

European Medicines Agency procedural advice on recommendations on unforeseen variations according to...

Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004

2 months ago

Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in...

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

2 months ago

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