EMA:
Regulatory and procedural guideline: Procedural guidance for variant strain(s) update to vaccines for protection against human coronavirus (updated)
Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry (updated):
Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated):
Tracked
Clean
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
Tracked
Clean
Transfer of marketing authorisation: questions and answers (updated)
Renewal and annual re-assessment of marketing authorisation (updated)
Type-II variations: questions and answers (updated)
Pre-authorisation guidance (updated)
Extensions of marketing authorisations: questions and answers (updated)