Authorisation procedures - The centralised procedure
The "centralised procedure" for authorising medicinal products is laid down in Regulation (EC) No 726/2004.
The centralised procedure, which came into operation in 1995, allows applicants to obtain a marketing authorisation that is valid throughout the EU. It is compulsory for medicinal products manufactured using biotechnological processes, for orphan medicinal products and for human products containing a new active substance which was not authorised in the Community before 20 May 2004 (date of entry into force of Regulation (EC) No 726/2004) and which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes. The centralised procedure is also mandatory for veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth of treated animals or to increase yields from treated animals.
The centralised procedure is optional for any other products containing new active substances not authorised in the Community before 20 May 2004 or for products which constitute a significant therapeutic, scientific or technical innovation or for which a Community authorisation is in the interests of patients or animal health at Community level.
When a company wishes to place on the market a medicinal product that is eligible for the centralised procedure, it sends an application directly to the European Medicines Agency, to be assessed by the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Medicinal Products for Veterinary Use (CVMP).
The procedure results in a Commission decision, which is valid in all EU Member States. Centrally-authorised products may be marketed in all Member States.
Applications from persons or companies seeking "orphan medicinal product designation" for products they intend to develop for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union are reviewed by the Committee for Orphan Medicinal Products (COMP).
The Committee on Herbal Medicinal Products (HMPC) is responsible for establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. It is also responsible for establishing Community herbal monographs.
What happens once the pharmaceutical company has submitted its application for a marketing authorisation?
Full copies of the marketing authorisation application file are sent to a rapporteur and a co-rapporteur designated by the competent EMA scientific committee. They co-ordinate the EMA's assessment of the medicinal product and prepare draft reports.
Once the draft reports are prepared (other experts might be called upon for this purpose), they are sent to the CHMP or CVMP, whose comments or objections are communicated to the applicant. The rapporteur is therefore the privileged interlocutor of the applicant and continues to play this role, even after the marketing authorisation has been granted.
The rapporteur and co-rapporteur then assess the applicant's replies, submit them for discussion to the CHMP or CVMP and, taking into account the conclusions of this debate, prepare a final assessment report. Once the evaluation is completed, the CHMP gives a favourable or unfavourable opinion as to whether to grant the authorisation. When the opinion is favourable, it shall include the draft summary of the product's characteristics, the package leaflet and the texts proposed for the various packaging materials.
The time limit for the evaluation procedure is 210 days (the application formalities and the detailed procedure are described in the Notice to Applicants which is available in EudraLex).
The EMA then has fifteen days to forward its opinion to the Commission. This is the start of the second phase of the procedure: the decision-making process. The Agency sends to the Commission its opinion and assessment report, together with annexes containing:
- the summary of product characteristics (Annex 1);
- the particulars of the manufacturing authorisation holder responsible for batch release, the particulars of and the manufacturer of the biological active substance and the conditions of the marketing authorisation (Annex 2); and
- the labelling and the package leaflet (Annex 3).
The annexes are translated into the 22 other official languages of the EU.
During the decision-making process, the Commission services verify that the marketing authorisation complies with Union law.
The Commission has fifteen days to prepare a draft decision. The medicinal product is assigned a Community registration number, which will be placed on its packaging if the marketing authorisation is granted. During this period, various Commission directorates-general are consulted on the draft marketing authorisation decision.
The draft decision is then sent to the Standing Committee on Medicinal Products for Human Use, or the Standing Committee on Veterinary Medicinal Products (Member States have one representative each in both of these committees) for their opinions. The Rules of Procedure of these Committees are available here:
- Rules of Procedure for the Standing Committee on Veterinary Medicinal Products (Examination procedure)
- Rules of Procedure for the Standing Committee on Veterinary Medicinal Products (Regulatory procedure with Scrutiny)
- Standing Committee on Medicinal Products for Human Use (Examination procedure)
- Standing Committee on Medicinal Products for Human Use (Regulatory procedure with Scrutiny)
Member States have fifteen days to return their linguistic comments and 22 days for scientific and technical ones. This procedure is conducted in writing but if a duly justified objection is raised by one or more Member States, the committee holds a plenary meeting to discuss it.
When the opinion is favourable, the draft decision is adopted via the empowerment procedure.
The Commission's Secretariat-General then notifies the Commission Decision to the marketing authorisation holder. The decision is then published in the Community Register.
Marketing authorisations are valid for five years. Applications for renewal must be made to the EMA at least six months before this five-year period expires.