Introduction and recap [1]

A marketing authorisation (MA) defines the terms under which a medicinal product (hereinafter ‘medicine’) can be placed on the market in the EU. A marketing authorisation is composed of:

  • a decision granting the MA issued by the relevant authority; and
  • a technical dossier with the data submitted by the applicant in accordance with Articles 8(3) to 11 of Directive 2001/83/EC and its Annex I (national MAs), Articles 6(1,2) of Regulation (EC) No 726/2004 (Union or centralised MAs), or Article 7 of Regulation (EC) No 1394/2007 (advanced therapy medicinal products).

Recap (please see also Course 5 Lesson 1):

National authorisations

Union authorisation
  • granted by the competent authorities of the Member States (MSs) for medicines which are placed exclusively on their markets. An application must be submitted to the competent authority of the respective MS.;
  • national authorisations for the same medicine in more than one MS:
    • the marketing authorisation holder (MAH) holds a MA in a MS:
      the applicant/MAH must submit an application in the MS using the mutual recognition procedure (MRP). The MSs concerned should then recognise the MA already granted by the reference Member State and authorise the marketing of the product on their national territory.
    • no MA has been granted in the Union:
      the decentralised procedure (DCP) can be used and an application submitted in all MSs to obtain a MA at the same time, and one MS chosen as reference Member State (RMS). Based on the assessment report from the RMS and comments by the concerned Member State(s) (CMSs), a MA should be granted in accordance with the decision taken by the RMS and CMS.

Marketing authorisation is valid throughout the Union, It is granted via the centralised procedure for medicines:

  • referred to in the Article 3(1), Annex 1 of Regulation (EC) No 726/2004 (mandatory scope);
  • referred to in Article 3(2) of Regulation (EC) No 726/2004, relating to products containing new active substances, products constituting a significant therapeutic, scientific or technical innovation or products for which the granting of a Union authorisation would be in the interest of patients at Union level (“optional” or “Generic/Hybrid”scope).
  • a generic/hybrid medicinal product of a centrally authorised medicinal product (Article 3(3))

An application must be submitted to the EMA.

The scientific evaluation of the application is carried out within the Committee for Medicinal Products for Human Use (CHMP) of the EMA, and a scientific opinion is prepared. The opinion is sent to the European Commission which adopts the Decision and grants a marketing authorisation.

The MA must contain the summary of product characteristics (SmPC) according to Article 11 of Directive 2001/83/EC and the labelling and the package leaflet (PL) according to Articles 54, 55, 59, 63.