7. Types of Marketing Authorisation Applications

1.6. Fixed combination application

The combination of active substances within a single pharmaceutical form of administration according to the legal basis is a so-called 'fixed combination'.

For medicines containing active substances used in already authorised products but not yet used in combination, the results of new non-clinical tests or new clinical trials relating to that combination have to be provided. However, it is not  necessary to provide scientific references relating to each individual active substance.

A full dossier, comprising all the information of modules 1 to 5, has to be provided for the fixed combination. Any absence of specific fixed combination data should be justified in the non-clinical and/or clinical Overviews. It is possible to include information on the individual substances (literature or actual data), especially in order to justify the absence of certain specific data on the combination.

Legal basis: Article 10b of Directive 2001/83 (EC)