Vaccine platform technology master file (vPTMF) submission letter template
Vaccine platform technology master file (vPTMF) submission letter template
Vaccine platform technology master file (vPTMF) submission letter template
Procedural advice for vaccine platform technology master file (vPTMF) certification - Procedural Guidance
Procedural advice for veterinary vaccine antigen master file (VAMF) certification
Procedural advice for vaccine platform technology master file (vPTMF) certification
Referral: Levamisole-containing medicinal products, levamisole, associated names: Decaris,Levamisol Arena Article 31 referrals Under evaluation, 28/11/2025
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Guidance for stepwise PIPs (sPIPs)
Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine, Date of authorisation: 21/12/2020, Revision: 57, Status: Authorised
Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 November 2025, 09:00 (CET) to 28 November 2025, 13:00 (CET)
Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine, Date of authorisation: 06/01/2021, Revision: 60, Status: Authorised