Division 2 ESSENTIALLY SIMILAR MEDICINAL PRODUCTSF1

1. a))

   Applications based upon Article 10(1) (a) (i) (essentially similar products) shall contain the data described in Modules 1, 2 and 3 of Part I of this Annex provided the applicant has been granted the consent of the holder of the original marketing authorisation to cross refer to the content of his Modules 4 and 5.

2. b))

   Applications based upon Article 10(1) (a) (iii) (essentially similar products i.e. generics) shall contain the data described in Modules 1, 2 and 3 of Part I of this Annex together with data showing bio-availability and bio-equivalence with the original medicinal product provided the latter is not a biological medicinal product (see Part II, 4 Similar biological medicinal products).

For these products the non-clinical/clinical overviews/summaries shall particularly focus on the following elements:

• the grounds for claiming essential similarity;

• a summary of impurities present in batches of the active substance(s) as well as those of the finished medicinal product (and where relevant decomposition products arising during storage) as proposed for use in the product to be marketed together with an evaluation of these impurities;

• an evaluation of the bio-equivalence studies or a justification why studies were not performed with respect to the guideline on ‘ Investigation of Bio-availability and Bio-equivalence ’ ;

• an update of published literature relevant to the substance and the present application. It may be acceptable for articles in ‘ peer review ’ journals to be annotated for this purpose;

• every claim in the summary of product characteristics not known from or inferred from the properties of the medicinal product and/or its therapeutic group should be discussed in the non clinical/clinical overviews/summaries and substantiated by published literature and/or additional studies.

• if applicable, additional data in order to demonstrate evidence on the equivalence of safety and efficacy properties of different salts, esters or derivatives of an authorised active substance should be provided by the applicant when he claims essential similarity.