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Regulatory and procedural guidelines (human and veterinary)
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Latest posts
Last updated 18 days ago
Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance inspections
20 days ago
Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance...
Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance inspections
20 days ago
Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance...
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 1 month 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
about 1 month ago
Introduction to the Compilation of Union procedures on inspections and exchange of...
PRIME eligibility requests: 2025 deadlines for submission and timetable for assessment
about 2 months 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
2 months 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
2 months ago
EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
Management of rapid alerts arising from quality defects risk assessment
2 months ago
Management of rapid alerts arising from quality defects risk assessment
History of changes to the compilation of procedures
2 months 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Superseded - EMA guidance on the use of medicinal products for the treatment of patients exposed to terrorist attacks with chemical agents
3 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Superseded - EMA guidance on the use of medicinal products for the...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
3 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Superseded - EMA guidance on use of medicinal products for the treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism
3 months ago
Superseded - EMA guidance on use of medicinal products for the treatment...