7. Types of Marketing Authorisation Applications

The applicant for an MA is not required to provide the results of non-clinical tests and clinical trials if the applicant can demonstrate that the medicine is a generic medicine of a reference medicine which is or has been authorised under Article 6 of Directive 2001/83/EC for not less than 8 years in a Member State or in the Union.

A generic medicine is defined as having:

• the same qualitative and quantitative composition in active substance(s) as the reference medicine,
• the same pharmaceutical form as the reference medicine,
• and whose bioequivalence with the reference medicine has been demonstrated by appropriate bioavailability studies, meaning that the generic product will interact with the body in a similar manner as the reference medicine.

This type of application refers to information contained in the dossier of the authorisation of the reference medicine. A marketing authorisation for the reference medicine has been granted on the basis of a complete dossier in accordance with article 8(3), 10a, 10b or 10c of Directive 2001/83/EC.

Legal Basis: Article 10 (1,2) of Directive 2001/83 (EC)