RLD identification in EU region in view of Brexit [Regulatives / Guidelines]

posted by shahajan baig  – India, 2021-08-31 16:49 (1049 d 12:50 ago) – Posting: # 22556
Views: 3,239

Dear Member,

Hope everyone is safe and healthy in this pandemic situation.

I wanted to know about RLD identification & selection in EU region since we do not have any specific source like in USFDA which provides the orange book data or OGD guidance. Also, we don't have several product-specific guidance in EU regions. Ao in such conditions how can we identify & select RLD in EU region? Also please guide me about how Brexit impacted DCP and CP in EU union for the selection of RLD.

A response will be highly appreciated



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