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Regulatory and procedural guidelines (human and veterinary)
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Latest posts
Last updated 10 days ago
List of centrally authorised products with safety-related changes to the Product Information
10 days ago
List of centrally authorised products with safety-related changes to the Product Information
EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
11 days ago
EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
Management of rapid alerts arising from quality defects risk assessment
12 days ago
Management of rapid alerts arising from quality defects risk assessment
History of changes to the compilation of procedures
12 days ago
History of changes to the compilation of procedures
Superseded - EMA guidance on the use of medicinal products for the treatment of patients exposed to terrorist attacks with chemical agents
28 days ago
Superseded - EMA guidance on the use of medicinal products for the...
EMA guidance on the use of medicinal products for treatment in case of exposure to chemical agents used as weapons of terrorism, crime, or warfare
28 days ago
EMA guidance on the use of medicinal products for treatment in case...
Superseded - EMA guidance on use of medicinal products for the treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism
28 days ago
Superseded - EMA guidance on use of medicinal products for the treatment...
EMA guidance on the use of medicinal products for treatment and prophylaxis in case of exposure to biological agents used as weapons of terrorism, crime or warfare
28 days ago
EMA guidance on the use of medicinal products for treatment and prophylaxis...
Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months
about 1 month ago
Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal...
Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances which are essential for the treatment of equine species and for which the withdrawal period for equine species shall be six
about 1 month ago
Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal...
Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)
about 1 month ago
Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures...
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final revision 3 of Module XVI on risk minimisation measures and its Addendum II on their effectiveness evaluation, and revision 5 of Annex I on definitions
about 1 month ago
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with...