A Marketing Authorisation (MA) for a medicinal product intended for the use in all EU/EEA countries may be obtained submitting an application to the European Medicines Agency (EMA) for those products falling within the scope of the centralised procedures (CP).
The EMA is a decentralised body of the European Union situated in London.
Under the centralised procedure, companies submit a single marketing authorisation application to the European Medicines Agency.
At the EMA the Committee for Medicinal Products for Human Use (CHMP) performs the scientific assessment of the applications submitted under the centralised procedure (CP), prepares a final assessment report on the quality safety and efficacy of the medicinal product and provides an opinion on granting the marketing authorisation.
The CHMP is composed of members of all EU/EEA States. The main scientific assessment of an application is performed by any of the EU/ EEA Member States if they have been appointed Rapporteur or Co-Rapporteur on the basis of the best available expertise for a specific procedure. The Rapporteurs conduct the initial assessment that will then in turn be commented by all other Member States. All Member States take part in the discussion of the assessment at CHMP level.
The positive or negative opinion of the CHMP on granting the marketing authorisation (MA) will then be forwarded to the European Commission for formal approval. Once a Marketing Authorisation has been granted by the European Commission, a centralised Marketing Authorisation is valid in all the EU/EEA States for 5 years on a renewable basis.
After the MA has been granted by the European Commission a European Public Assessment Report (EPAR) on the basis of the CHMP final Assessment Report will be made available on the homepage of the EMA.
Obtaining a MA via the centralised procedure is mandatory for all medicinal products for human use derived from biotechnology and other hightechnology processes.
The same applies to all human medicines (that contain new chemical entities and were not yet authorised in the EU/EEA at the time the Regulation 726/2004 came into force) intended for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, as well as to all designated orphan medicines intended for the treatment of rare diseases.
For medicinal products (that contain new chemical entities and were not yet authorised in the EU/EEA at the time the Regulation 726/2004 came into force) that do not fall under any of the above-mentioned categories, companies can submit an application for a centralised marketing authorisation, provided the medicinal product constitutes a significant therapeutic, scientific or technical innovation, or the product is in any other respect in the interest of patient or animal health.
Additional Information for applicants: