Marketing Authorisation Application in Central Procedure (CP)

Eligibility of evaluation under the Central Procedure

CP is mandatory for human medicinal products that are:

• Developed by using specific biotechnological processes,
•  Medicinal products for the treatment of rare diseases,
•  New active substances used for the treatment of cancer, HIV/AIDS, neurodegenerative diseases, diabetes, viral diseases, autoimmune diseases and other immune dysfunctions.

CP is mandatory for veterinary medicinal products that are:

• Developed by using specific biotechnological processes,
• Intended primarily for use as performance enhancers to promote growth or to increase yields from treated animals,
• Containing active substances that has not been authorised within the EU at the date of submission of the application,
• Biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells,
• Novel therapy veterinary medicinal products.

For some medicinal products, the use of CP is optional if they do not fall under the categories mentioned above. For other medicinal products, it is not possible to obtain approval through CP, and other procedures must be used.

Rapporteurs

National authorities in EU and EEA countries can express interest in being rapporteurs. Rapporteurs evaluate the submitted documentation on behalf of all EU and EEA countries. EMA's expert committees for medicinal products (Committee for Human Medicinal Products, CHMP, and Committee for Veterinary Medicinal Products, CVMP) decide who will serve as rapporteurs.

The assessment

During the procedure, the rapporteurs evaluate the application and prepare assessment reports. Other member states may comment on these reports. The committee assesses whether the documentation in the application meets the requirements and evaluates the benefit-risk balance of the medicinal product for the proposed indication. The committee then makes a recommendation on the outcome of the procedure.

End of the Procedure

The committee prepares an opinion, which is sent to the European Commission, which adopts the formal decision for the procedure. If the opinion is positive, the European Commission will issue a decision on the marketing authorisation valid in all EU member states. For EEA countries, such as Norway, separate national marketing authorisations must be issued within 30 days after the Commission's decision.

In the case of a negative outcome, the applicant may request a re-examination of the application.

Internal shortcuts

More information on the marketing authorisation in centralised procedure can be found at EMA - Human or veterinary regulatory;