Behandling av endringer i markedsføringstillatelser for legemidler til mennesker og dyr: endringsbestemmelser om covid-19-vaksiner


Delegert kommisjonsforordning (EU) 2021/756 av 24. mars 2021 om endring av forordning (EF) nr. 1232/2008 om behandling av endringer i vilkårene for markedsføringstillatelser for legemidler for mennesker og veterinærpreparater

Commission Delegated Regulation (EU) 2021/756 of 24 March 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

Siste nytt

Kommisjonsforordning publisert i EU-tidende 10.5.2021

Nærmere omtale

BAKGRUNN (fra Kommisjonens pressemelding 24.3.2021)

Coronavirus: new procedure to facilitate and speed up approval of adapted vaccines against COVID-19 variants

Today, as an immediate action under the HERA Incubator, the new European bio-defence preparedness plan against COVID-19 variants, the Commission is introducing a measure to speed up the authorisation of adapted COVID-19 vaccines. It will make provisions in the relevant EU legislation to allow companies to focus on gathering the necessary evidence in time and enable the authorisation of adapted vaccines with a smaller set of additional data submitted to the European Medicines Agency.

President of the European Commission, Ursula von der Leyen, said: The HERA Incubator is to strengthen and accelerate the EU response to variants. We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus.”

Commissioner for Health and Food Safety, Stella Kyriakides said: We need to be prepared to adapt vaccines as quickly as possible to respond to new and potentially vaccine-resistant variants. Today we propose fast and flexible solutions to fast-track approvals, without compromising on safety and efficacy. With the HERA Incubator, our goal is to anticipate and be one step ahead.”

Adaptations to active substances of an authorised COVID-19 vaccine may be required to ensure the vaccine's effectiveness against mutations or variants of a virus. Building on the approach for adaptations of human influenza – flu – vaccines, the changes to the Variation Regulation specify which provisions apply to adaptations of the active substance of authorised COVID-19 vaccines. These changes will ensure the streamlined handling of any variation to an authorised vaccine and extend the coverage of the new provisions to all coronaviruses.

The amendment provides a regulatory framework for the handling of changes to the marketing authorisation after the initial marketing authorisation.

Next Steps

As for any delegated regulation, the measure will now go to the European Parliament and Council for scrutiny before entering into force.


The new European bio-defence preparedness plan against COVID-19 variants called “HERA Incubator” is working with researchers, biotech companies, manufacturers and public authorities in the EU and globally to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities.

Speeding up the regulatory approval of adapted vaccines is one of the key actions of the HERA Incubator to boost preparedness, develop vaccines for the variants and increase industrial production.

Taking action now is important as new variants continue to emerge and challenges with scaling up vaccine production are arising. The HERA Incubator will also serve as a blueprint for the EU's long-term preparedness for health emergencies.

For More Information

Commission delegated regulation on the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products

European Medicines Agency guidance on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2

Communication from the Commission to the European Parliament, the European Council and the Council: HERA Incubator: Anticipating together the threat of COVID-19 variants

Safe COVID-19 vaccines for Europeans

EU Coronavirus response



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