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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 14 days ago

Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance inspections

16 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

16 days ago

Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance...

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