Guide to Interchangeable Medicines
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aut-g0115-guide-to-interchangeable-medicines-v7.pdf
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This document has been updated. Click on the link below for a version of the document with changes tracked.
AUT-G0115 Guide to Interchangeable Medicines v7 tracked changes
The Guide to Interchangeable Medicines has been updated following clarification received from the Department of Health that the demonstration of bioequivalence is not required by the Health (Pricing and Supply of Medical Goods) Act 2013. However, the HPRA must be satisfied that there is no difference in bioavailability between any of the medicinal products in a group which may lead to a clinically significant difference in efficacy between them. Additional updates have been made following a request from the Health Services Executive to publish a group of non-prescription, reimbursed medicines.
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