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Regulatory and procedural guidelines (human and veterinary)
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Last updated 11 days ago
Qualification of novel methodologies for drug development: guidance to applicants
11 days ago
Qualification of novel methodologies for drug development: guidance to applicants
European Medicines Agency guidance for companies requesting scientific advice (veterinary)
11 days ago
European Medicines Agency guidance for companies requesting scientific advice (veterinary)
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance
11 days ago
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance
Advice on implementing measures under Article 106 (6) of Regulation (EU) 2019/6 on veterinary medicinal products – scientific problem analysis and recommendations to ensure a safe and efficient administration of oral veterinary medicinal products via ro
about 1 month ago
Advice on implementing measures under Article 106 (6) of Regulation (EU) 2019/6...
Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions
about 2 months ago
Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions
Explanatory note on general fees payable to the European Medicines Agency as of 1 September 2020
about 2 months ago
Explanatory note on general fees payable to the European Medicines Agency as...
European Medicines Agency privacy statement for EnprEMA network database
2 months ago
European Medicines Agency privacy statement for EnprEMA network database
List of substances and products subject to worksharing for signal management
3 months ago
List of substances and products subject to worksharing for signal management
Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082
4 months ago
Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy...
Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse reactions in animals and humans
4 months ago
Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities...
Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms
4 months ago
Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated...
Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel)
4 months ago
Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms...