E-DRUG: Well Established Use (2)
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The comments of Dr Lisman are very valid and particularly critical in terms of the recent accession states to Europe. I believe that the original intention was to allow the continued sale of "unique" products, specifically mixtures where there was no brand-certain analgesics, flu remedies, cough mixtures etc. all consisting of known drug substances.
It was not intended as a get out clause for retaining a product on the market where there is a brand product and a bioequivalence could be established. As Dr Kisman points out, this could leave on the market two generic products with the same INN but one has been demonstrated to be bioequivalent to the brand product and the other has been re-registered under WEU. At this moment, it is my understanding, the patient, and indeed the Pharmacist, has no simple way of knowing which is which. This could potentially lead to generic substitution between non bio-equivalent products.
If I am wrong I hope someone will correct me.
Malcolm Ross
Dr. Malcolm S.F. Ross
Director of Research and Development [Special Projects]
Polpharma
Starogard-Gdanski
Poland
malcolm.ross@polpharma-group.co
[Details added by moderator. BS]