No ‘RLD’ in the EEA [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-09-10 22:22 (449 d 15:03 ago) – Posting: # 22566
Views: 1,357

Hi Shahajan,

❝ […] I wanted to know if there will be no RLD available in EU region…


Lacking an ‘Orange Book’, there is no ‘Reference Listed Drug’ in the European Economic Area.
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Read Ohlbe’s post again.

❝ …for a parenteral solution so how can we proceed for biowaiver for the particular parenteral product because for biowaiver we need to prove similarity between active substances as per GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **) which states that: […]



Can you be more specific? ‘Parenteral’ is any route of administration which is not oral.
Only – given certain conditions – for aqueous intravenous solutions a biowaiver is possible.

❝ So how would we proceed in such cases?? shall we proceed with an available different dosage form of the same strength??


See above.

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