The reference medicinal product is a medicinal product which has been granted a marketing authorisation by a Member State or by the Commission on the basis of a complete dossier, i.e. with the submission of quality, pre-clinical and clinical data in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC and to which the application for marketing authorisation for a generic/hybrid medicinal product refers, by demonstration of bioequivalence, usually through the submission of the appropriate bioavailability studies.
Applicants will have to identify in the application form for the generic/hybrid medicinal product the reference medicinal product (product name, strength, pharmaceutical form, MAH, first authorisation, Member State/Community), as follows:
The medicinal product which is or has been authorised in the EEA, used as the basis for demonstrating that the data protection period defined in the European pharmaceutical legislation has expired (see Question 12). This reference medicinal product, identified for the purpose of calculating expiry of the period of data protection, may be for a different strength, pharmaceutical form, administration route or presentation than the generic/hybrid medicinal product.
The medicinal product, the dossier of which is cross-referred to in the generic/hybrid application (product name, strength, pharmaceutical form, MAH, marketing authorisation number). This reference medicinal product may have been authorised through separate procedures and under a different name than the reference medicinal product identified for the purpose of calculating expiry of the period of data protection. The product information of this reference medicinal product will, in principle, serve as the basis for the product information claimed for the generic/hybrid medicinal product.
The medicinal product (product name, strength, pharmaceutical form, MAH, Member State of source) used for the bioequivalence study(ies) (where applicable).
For inquiries, please contact Mag. Markus Pongratz email@example.com or 0043 50555 36647
Created: 08.03.2009 | Page last modified: 21.01.2015