Authorisation procedures - The centralised procedure
Marketing authorisations granted under the "centralised procedure" allow the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.
Such authorisation is granted by the European Commission following the scientific assessment of the application by the European Medicines Agency.
The centralised procedure is laid down in Regulation (EC) No 726/2004 compulsory for:
- Products derived from biotechnology
- Orphan medicinal products
- Medicinal products for human use which contain an active substance authorised in the Union after 20 May 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes.
It can also apply to all medicinal products:
- That contain an active substance not authorised before 20 May 2004,
- Constituting a significant therapeutic scientific or technical innovation, or
- For which an EU authorisation would be in the interest of patients.
Under the centralised procedure, a company may only obtain one marketing authorisation per medicinal product. However, in specific cases a company may apply for a duplicate marketing authorisation. Requests to submit an application for a duplicate should be sent to the Commission (via SANTE-PHARMACEUTICALS-B5@ec.europa.eu).
The review process
Companies wishing to market a medicinal product that is eligible for the centralised authorisation procedure, submit their application directly to the European Medicines Agency (EMA). The EMA is responsible for the validation and scientific evaluation of the application.
The EMA's Committee for Medicinal products for Human Use (CHMP) carries out a scientific assessment of the application and give a recommendation on whether the medicine should be authorised or not. A favourable opinion is accompanied by a draft summary of the product's characteristics, the package leaflet, and the proposed text for the packaging.
The time limit for the evaluation procedure is 210 days, subject to extensions if additional questions need to be addressed. Within 15 days of the adoption, the EMA will forward its opinion to the European Commission to start the decision-making phase.
Within 15 days a draft implementing decision is sent by the Commission to the Standing Committee on Medicinal Products for Human Use, allowing for its scrutiny by EU countries. These have fifteen days to return their linguistic comments, and 22 days for substantial ones. Once a favourable opinion is reached, the draft decision is adopted via an empowerment procedure. The adoption of the decision should take place within 67 days of the opinion of the EMA.
The Commission's Secretariat-General then notifies the decision to the marketing authorisation holder. The decision is subsequently published in the Community Register.
Marketing authorisations are initially valid for five years. Applications for renewal must be made to the EMA at least six months before this five-year period expires.