A medicinal product may only be placed on the Swedish market when a marketing authorisation has been issued by the Medical Products Agency (national authorisation) or when an authorisation has been granted for the entire Community (a Community authorisation).
Centralised authorisation procedure
A company can seek centralised approval which means an authorisation is valid throughout the European Union and Norway, Iceland and Lichtenstein. In this case the application is dealt with administratively by The European Medicines Agency (EMEA). Two committees of the EMEA, The Committee for Medicinal Products for Human Use (CHMP) and The Committee for Medicinal Products for Veterinary Use (CVMP) are responsible for the assessment of the products.
The member states nominate two experts (one representative and one alternate) to each committee. The committee appoints a rapporteur and co-rapporteur to independently evaluate the application. Based on the assessment the committee adopts an opinion, which is forwarded to the European Commission for decision on community marketing authorisation.
More information about the centralised procedure can be found on EMEA's website and The European Commission´s website.
Mutual recognition procedures (MR)
This procedure is based on the mutual recognition by concerned Member State(s) of a national marketing authorisation granted by the reference Member State. The concerned Member State refers to the reference Member State that issued the national marketing authorisation on which the mutual recognition procedure is based.
At the end of the mutual recognition procedure, a national marketing authorisation will be issued in the concerned Member State(s). The harmonisation is maintained through the procedures of Regulation (EC) No 1084/2003 for the examination of variations and the use of the decentralised and mutual recognition procedures for extensions and renewals.
Decentralised procedure (DCP)
Evaluation of the operation of marketing authorisation procedures has revealed the need to revise the mutual recognition procedure in order to improve the opportunities for cooperation between Member States. Therefore, Directive 2004/27/EC has introduced the decentralised procedure and the coordination group, which is responsible to settle any disagreements arising from the decentralised and mutual recognition procedures.
For medicinal products not falling within the mandatory scope of the centralised procedure, the applicant may request one or more concerned Member State(s) to approve a draft assessment report, summary of product characteristics (SPC), labelling and package leaflet as proposed by the chosen reference Member State. An application is submitted to the competent authorities of the reference Member State and the concerned Member State(s), together with the information and particulars referred to in Articles 8, 10, 10a, 10b, 10c, and 11 of Directive 2001/83/EC.
The applicant must give an assurance that the dossier, including the proposed SPC, labelling and package leaflet, is identical as submitted in all Member States concerned (reference Member State and concerned Member State). Differences in proposed prescription status and names of the medicinal product are acceptable, in line with national rules in force.
At the end of the decentralised procedure with a positive agreement, a national marketing authorisation will be issued in the reference Member State and the concerned Member State. The harmonisation is maintained through the procedures of Regulation (EC) No 1084/2003 for the examination of variations and the use of the decentralised and mutual recognition procedures for extensions.