Centralised marketing authorisation procedure

The centralised procedure makes it possible to obtain, through a single application filed with the European Medicines Agency, a marketing authorisation valid throughout the European Union. It is governed by Regulation (EC) No 726/2004. The scientific assessment is carried out by the Agency, but the authorisation is a decision of the European Commission, which has the same effects in each Member State as a national authorisation and which the States of the European Economic Area adopt through corresponding decisions.

Scope of the procedure

The procedure is mandatory for medicinal products developed by certain biotechnological processes, such as recombinant DNA technology or the production of monoclonal antibodies, for advanced therapy medicinal products, for orphan medicinal products and for medicinal products containing a new active substance intended to treat, in particular, cancer, diabetes, acquired immune deficiency syndrome, neurodegenerative disorders, autoimmune diseases and viral diseases. It is optional for other new active substances, for medicinal products constituting a significant innovation or of interest to patients at Union level, and for generics of medicinal products authorised under this procedure.

Conduct of the assessment

The Committee for Medicinal Products for Human Use appoints a rapporteur and a co-rapporteur from among its members and delivers its opinion within 210 days, excluding clock stops. Questions put to the applicant stop the clock, so that the actual length of the procedure generally exceeds a year. The applicant may request a re-examination of the opinion. The Commission then adopts its decision, in principle within 67 days of the opinion. That decision may be challenged by an action for annulment before the General Court of the European Union.

Interaction with patents

The Agency does not examine the patent position and does not make the authorisation of a generic conditional on patent expiry, since EU law has no patent linkage mechanism. The date of the centralised authorisation does, however, count for calculating protection periods. It triggers regulatory data protection and market protection for the reference medicinal product. For the supplementary protection certificate, the Court of Justice of the European Union takes the date on which the Commission’s decision was notified to its addressee, not the date of the decision itself.

Key points

The centralised procedure leads to a single authorisation for the whole Union, granted by the Commission on the opinion of the Agency. It is mandatory for biotechnological, advanced therapy and orphan medicinal products, and for new active substances in the major therapeutic areas. The authorisation says nothing about patents, but its date governs the timetable of regulatory protection and the duration of the supplementary protection certificate. The exact date of notification of the decision, which serves as the reference for calculating the certificate, should be recorded.

---

This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

Pharmaceutical patents and medicines regulation · Pharma case law · Tell us about your situation