Marketing Authorisation

All medicines must be authorised before they can be marketed and made available to patient. Routes of Authorisation:

MRP authorisation

Product is already authorised in any EU country .

DCP authorisation

Product is not athorised yet in any EU country.

National authorisation

Authorisation for one EU country.

Centralised authorisation

Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing-authorisation application. Granted by the European CommissionExternal link icon, the centralised marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. Application should be sent in eCTD format.

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