rererence product marketed only in some members states [Design Issues]

posted by shakeel.salam – India, 2016-03-11 11:36 (3263 d 21:12 ago) – Posting: # 16095
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Dear Sanjeith

Reference must be made to a product which is or has been authorised in the Union, (i.e. a marketing authorisation has been granted for the reference medicinal product, but it may have ceased to exist) and in accordance with the Union law

In case, the reference medicinal product is no more produced and placed on the Union market, demonstration of the bioequivalence with the reference medicinal product through bioavailability studies should however be performed on batches which have been authorised within the Union.

As per Helmut 50 mg capsules are marketed in Ireland and 10/25/50 mg capsules in the UK.

a reference medicinal product in another Member State should be identified, so-called the European reference medicinal product.

the applicant has to identify in the application form the name of the Member State in which the reference medicinal product is or has been authorised. It is also a prerequisite that the period of data exclusivity has expired in the Member Stateof the reference medicinal product

And I completely agree as per ElMaestro directive 2001/83 10.2b

The various immediate-release oral pharmaceutical forms are considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the detailed 'guideline on the investigation of bioequivalence'

hope this clarifies.

regards
shakeel

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