Bioequivalence and Bioavailability Forum

Dear Aga
Definition of generic Drug: same API, same route of adminsitration, same strength(s)
In consequence your test product is no generic product according to Article 8(3) 2001/83/EC = no generic application. However, you can submit your product as a hybrid application.

Hybrid applications under Article 10(3) of Directive 2001/83/EC differ from generic applications in that the results of appropriate pre-clinical tests and clinical trials will be necessary in the following three circumstances:

• where the strict definition of a ‘generic medicinal product’ is not met;
  
• where the bioavailability studies cannot be used to demonstrate bioequivalence;
  
• where there are changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration of the generic product compared to the reference medicinal product.

In such cases the results of tests and trials must be consistent with the data content standards required in the Annex to the Directive 2001/83/EC as amended by Directive 2003/63/EC.
These applications will thus rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. Some guidance on the appropriate additional studies required is indicated in Annex IV of the Chapter 1 of the Notice to Applicants.
The type of applications mentioned above refer to information that is contained in the dossier of the authorisation of the reference medicinal product, for which a marketing authorisation has been granted in the Union on the basis of a complete dossier in accordance with article 8(3), 10a, 10b or 10c of Directive 2001/83/EC.

If you can demonstrate bioequivalence between your 40 mg-test product given twice (i.e. 80 mg dose) vs 80 mg-reference and if the test product is intended to be given in the same dose as the reference you will not need to provide additional data.

I hope this helps.