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Parliamentary question - E-000708/2022(ASW)Parliamentary question

Answer given by Ms Kyriakides on behalf of the European Commission

COVID-19 vaccines have been authorised by the Commission in accordance with the EU pharmaceutical law, including all legal provisions of Regulation (EC) 507/2006[1].

Marketing authorisations for COVID-19 vaccines have been granted by the Commission on the basis of scientific evaluations performed by the European Medicines Agency, i.e. only after their quality, safety and efficacy have been evaluated and a positive benefit-risk balance related to its use has been concluded.

Such Commission Decisions specify the conditions or restrictions regarding the supply and use of the medicine, i.e. whether the medicinal product subject to medical prescription (like for COVID-19 vaccines) or not, or to special and/or restricted prescription.

In the context of the national campaigns of vaccination against COVID-19, it is the responsibility of the physicians to duly inform the patients on the safety, efficacy and quality of the vaccines. Vaccination remains the final choice of each individual after having consulted his doctor in case of any doubts.

With regards to the specific reference to Article 8 of Regulation (EC) 507/2006, the Commission Decisions granting the conditional marketing authorisations clearly specify that they are conditional marketing authorisation.

The summary of the product characteristics (SmPC) and the package leaflet annexed to the Commission Decisions also indicate that the medicinal product has been authorised under a ‘conditional approval’ scheme.

They also specify that the European Medicines Agency will review new information on the medicinal product at least every year and that the SmPC will be updated as necessary. This information can be found on the Union Register of Medicinal Products[2].

Last updated: 22 April 2022
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