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Regulatory and procedural guidelines (human and veterinary)
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Last updated about 16 hours 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 16 hours ago
Guidance on the details of the classification of variations requiring assessment according...
Introduction to the Compilation of Union procedures on inspections and exchange of information
1 day ago
Introduction to the Compilation of Union procedures on inspections and exchange of...
PRIME eligibility requests: 2025 deadlines for submission and timetable for assessment
16 days ago
PRIME eligibility requests: 2025 deadlines for submission and timetable for assessment
List of centrally authorised products with safety-related changes to the Product Information
29 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
29 days ago
EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
Management of rapid alerts arising from quality defects risk assessment
about 1 month ago
Management of rapid alerts arising from quality defects risk assessment
History of changes to the compilation of procedures
about 1 month 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Superseded - EMA guidance on the use of medicinal products for the treatment of patients exposed to terrorist attacks with chemical agents
about 2 months 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Superseded - EMA guidance on the use of medicinal products for the...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
about 2 months 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Superseded - EMA guidance on use of medicinal products for the treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism
about 2 months 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Superseded - EMA guidance on use of medicinal products for the treatment...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
about 2 months 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 2 months ago
Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal...