Marketing Authorisations (MA)

See also Notice to Applicants , Volume 2 A, Chapters 1,3 and 4

Centrally authorised medicinal products (EU authorisations)

The central procedure for medicinal products is utilised when authorisations are sought for the whole EEA, e.g. for biotechnological medicinal products, medicinal products for specific diseases and other innovative medicinal products. The applications are sent to the European Medicinal products Agency (EMEA). Two scientific committees, one for human medicinal products and the other for veterinary medicinal products, CHMP (Committee for Medicinal Products for Human Use) and CVMP (Committee for Medicinal Products for Veterinary Use) assess the applications. Each Member State appoints one expert and one alternative for each committee. Each committee can also nominate up to five additional experts in order to cover a larger expert area. Experts from two member states from the corresponding committee are chosen for assessing each application and to write an assessment report (Rapporteur and Co-rapporteur). The other experts of the committees can comment on the assessment reports. The committees then finally issue a scientific opinion on the application within 210 days. This opinion is then forwarded to the European Commission, which makes the final decision. Marketing authorisations issued by the Commission are valid in all the Member States of the EU. Other states, such as Iceland, being members of EEA but not EU, obtain additional thirty days to issue a corresponding marketing authorisation.

Nationally authorised medicinal products, mutual recognition and decentralised procedure

Applicants can choose a Member State to assess the application dossier (Reference Member State, RMS) and states where the medicinal products are intended to be placed on the market (Concerned Member States, CMS).

The Mutual Recognition Procedure (MR) is used when a marketing authorisation has been granted for a medicine in any of the EEA states. The applicant negotiates with a state, which has granted a national marketing authorisation to write an assessment report based on the application file, i.e. to become a RMS. That assessment report is then sent along with the application dossier to the CMSs. The procedure takes 90 days if there is no dispute between the states. After the procedure has been concluded the CMSs have 30 days to review translations of texts and to issue a marketing authorisation in respective states.

The Decentralised Procedure (DC) is most often applied when the medicine has not been nationally authorised before in any state. The application is then sent concurrently to the state responsible for the assessment report (RMS) and other CMSs. The Decentralised Procedure takes 210 days in absence of disputes. After the

procedure has been concluded the CMSs have 30 days to review translations of texts and to issue a marketing authorisation in respective states.

The CMS is expected to accept the authorisations made by the RMS, unless it deems the medicine a risk to public health in its state. If a CMS raises such a health concern, the disagreement is referred to a specific committee, comprised of representatives from the medicinal products agencies from all the Member States, CMDh/CMDv (Coordination Group for Mutual Recognition and Decentralised Procedure human/veterinarian, Further information.

If the dispute cannot be settled in these committees, it is referred to the scientific committees of the EMEA.

The CMDh committee which handles issues on human medicinal products convenes once every month in the EMEA premises in London for discussing matters related to the MR procedure and applications and in a like manner the CMDv deals with veterinary medicinal products.

Nationally authorised medicinal products, one Member State only

National authorisations, which are valid for Iceland only are usually granted when the applicant applies for a new strength or a pharmaceutical form of a medicine that originally received a national authorisation.

The Agency issues a national authorisation within 210 days from receipt of the application. The Experts of the Agency assess the quality, safety and risk of the medicine. If these issues are in order a national authorisation is granted.

Application form for marketing authorisations

Application form, Human

(User Guide for the Application Form)

Application form, Veterinary