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Regulatory and procedural guidelines (human and veterinary)
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Last updated 3 days ago
Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors
3 days ago
Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document...
Notice to sponsors on validation and qualification of computerised systems used in clinical trials
21 days ago
Notice to sponsors on validation and qualification of computerised systems used in...
Names of the European Union / European Economic Area countries
2 months ago
Names of the European Union / European Economic Area countries
Tables of non-standard abbreviations to be used in the summary of product characteristics
2 months ago
Tables of non-standard abbreviations to be used in the summary of product...
Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products
2 months ago
Mobile scanning and other technologies in the labelling and/or package leaflet of...
Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products
3 months ago
Question and answer on the information contained within section 5.1 of the...
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
3 months ago
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
Guidance for applicants for the preparation of the precise scope section of the variation application form
3 months ago
Guidance for applicants for the preparation of the precise scope section of...
Validation checklist for Type II quality variations
3 months ago
Validation checklist for Type II quality variations
Plasma Master File (PMF) requirements - questions and answers for PMF holders
4 months ago
Plasma Master File (PMF) requirements - questions and answers for PMF holders
Validation checklist for Type II (non) clinical variations
4 months ago
Validation checklist for Type II (non) clinical variations