Summary
The European Parliament has approved a new regulation to accelerate the update of vaccines, particularly for COVID-19 variants. This allows developers to submit some data after an initial approval is granted. 9 28.04.2021
Other
health
pharmacy
Key points
- The regulation enables faster updates to vaccine authorisations.
- It focuses on human influenza and coronavirus vaccines to address new virus variants.
- The regulation is based on specific provisions within the Community code relating to medicinal products for human use.
- Developers can submit certain clinical or pharmaceutical data after the initial approval is granted.
Documents (PDFs)
RECOMMENDATION FOR A DECISION to raise no objections to the Commission delegated regulation of 24 March 2021 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
Non-objection to a delegated act: Examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
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