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eCTD Industry Update (29 June 2022) – EMA

July 20, 2022
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onix

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)

PreveCTD Industry Update (29 June 2022)
eCTD Industry Update (13 July 2022)Next
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