The UK has opted in favour of an emergency use authorisation of the COVID-19 vaccine from Biontech/Pfizer. In Germany, the path of a European, centralised marketing authorisation procedure was chosen. The regulatory framework conditions are described briefly in the following sections.
Beside the conditional marketing authorisation (CMA) in the EU, which permits an accelerated centralised marketing authorisation procedure with conditions and providing that further, post-marketing authorisation data are collected for the vaccine product, individual EU members states have regulatory instruments at a national level enabling them to procure and use non-authorised medicines in connection with a threat to public health. Regulations for each of these procedures are laid down in the national legislation.
Such national rules create the option of temporally limited marketing and use of a non-authorised medicinal product in keeping with the national law applicable in the individual member states. Besides, they meet the specific national needs within the responsibility of the respective member state. In some countries, such an approval is granted. It is called an emergency use authorisation. Such an authorisation can be granted in connection with the emergency situation caused by a pandemic situation in the member state affected.
A legal basis permitting this type of marketing of medicinal products also exists in Germany. The Statutory Regulation for Ensuring the Supply of Products of Medical Needs (Medizinischer Bedarf Versorgungssicherstellungsverordnung, MedBVSV) permits the central provision of medical supplies by the Federal Government for use by the population during the Corona pandemic. Pursuant to Section 3 (Exceptions to the German Medicines Act and the Medicines Commerce Regulation for the Provision and Use pursuant to Section 2), the sale of non-authorised, non-approved medicinal products procured pursuant to Section 2 para 1 is possible. An assessment from the competent senior federal authority – the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines – is obtained for this decision. For this purpose, the Paul-Ehrlich-Institut would have to establish that the quality of the medicinal product is ensured and that a favourable risk/benefit ratio with regard to the prevention or treatment of the respective disease can be expected from its used based on the state of medical knowledge.
The UK has decided in favour of the national route of an emergency use authorisation. In Germany, access to COVID-19 vaccines will be ensured via a centralised European marketing authorisation. At present, it can be assumed that first marketing authorisations of COVID-19 vaccines will be performed shortly within a conditional marketing authorisation by the European Commission.
Several vaccine products are currently undergoing the rolling review procedure in Europe, which makes an accelerated marketing authorisation possible. In the meantime, the Biontech/Pfizer and Moderna Companies have submitted an application for a conditional marketing authorisation with the European Medicines Agency (EMA). The data are currently reviewed by medical experts, including experts of the Paul-Ehrlich-Institut.
The Paul-Ehrlich-Institut will be responsible for the evaluation of all data required for a marketing authorisation or a conditional marketing authorisation coordinated by the EMA in a marketing authorisation procedure, or will support such a procedure. It can be expected that the evaluations of the vaccine products by the Committee for Medicinal Products of Human Use (CHMP) at the EMA can be completed in December 2020 or early January 2021, and that a clear statement concerning the risk/benefit profile can be made based on the evaluation of the data required for this. The CHMP will make a recommendation to the European Commission on this basis. The European Commission will then decide on the marketing authorisation.
Updated: 07.12.2020
