HMA/EMA Statement on Approval of Vaccines

According to EU legislation (Regulation 726/2004) most COVID-19 vaccines fall under the scope of the centralised procedure since they are produced by biotechnological processes for which the centralised procedure is mandatory (as listed in Annex 1 to the Regulation). For other types of vaccines currently under development, such as those composed of whole-inactivated virus or live attenuated virus, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) network encourage marketing authorisation holders to submit their applications through the centralised procedure in order to ensure that those vaccines reach all Member States at the same time, with no unfair access in the Union. This is possible according to Article 3.2 of the above-mentioned Regulation:

“Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Union in accordance with the provisions of this Regulation, if:

• (a) the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Union; or
• (b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients or animal health at Union level.”

In such a procedure, EMA’s Committee for Medicinal Products for Human Use (CHMP), which is composed of national experts, carries out a scientific assessment of the application and gives a recommendation on whether the medicine should be authorised or not. This procedure, subsequently finalised by the European Commission’s decision, gives all EU Member States, as well as those in the European Economic Area, the possibility of access to thoroughly and effectively evaluated medicines at the same time and ensures centralised safety monitoring across their life cycle.

In accordance with predefined standards for quality, safety and effectiveness that adequately protect EU patients and all people who receive medicines or vaccines, EMA in close cooperation with NCA experts in scientific committees, uses accelerated procedures to speed up the process. The goal is to deliver assessments of high-quality applications in the shortest possible timeframes while ensuring robust scientific opinions. Therefore, COVID-19 vaccine applications should be assessed via the centralised procedure and, in addition to the centralised procedure itself, EMA’s scientific advice mechanism should be used whenever necessary, to advise developers on the quality, safety and efficacy requirements that must be met to enter the European market.

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