ASEAN BE Guideline [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2025-01-22 12:40 (19 d 11:29 ago) – Posting: # 24343
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Hi RP,

❝ […] I have been unable to find the relevant Reference Product of Tripolidine for Malaysia.

Being “unable to find” is insufficient as a justification – make sure that it was either not registered or registered and is no more marketed in Malaysia. Then a foreign comparator can be used under certain conditions. See Section 3.1.2 of the applicable guideline:

PS: RLD is an [image]-term applicable only in Trumpistan. :-D

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