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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 10 days ago

Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 August 2022

10 days ago

Draft guideline on the application of Article 34 of Regulation (EU) 2019/6 - Classification of veterinary medicinal products (prescription status)

20 days ago

Appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report

29 days ago

Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides residues in food of animal origin

about 1 month ago

Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms

about 2 months ago

Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations

about 2 months ago

Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations

about 2 months ago

Compilation of quality review of documents (QRD) on stylistic matters in product information

2 months ago

Public consultation concerning the physical attendance and the location of personal residency of the qualified person

3 months ago

Annex VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials

3 months ago

Annex IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO)

3 months ago

Annex VI to procedure for conducting GCP inspections requested by the CHMP: Record keeping and archiving of documents

3 months ago

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