7. Types of Marketing Authorisation Applications

Where module 4 (safety - non-clinical tests) and/or module 5 (efficacy - clinical studies) of the application consist of a combination of reports of limited non-clinical tests and/or clinical studies carried out by the applicant and of bibliographical references*.

All other Module(s) are in accordance with the structure of the Full dossier (this can also be called ‘Full mixed application’). A justification should be given for providing literature references instead of results of certain tests/trials, and why the references can replace study reports, and how the results presented fulfil the requirements as set out in the Annex I to Directive 2001/83/EC. The competent authority shall accept the proposed format on a case-by-case basis.

Legal basis: Annex I Part II section 7 of Directive 2001/83 (EC):

* Bibliographical references: published pharmaco-toxicological information including scientifically accepted monographs and clinical trials, as well as results of post marketing experience gained by widespread clinical use in humans.