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

posted by dshah  – India/United Kingdom, 2021-08-31 16:40 (300 d 13:14 ago) – Posting: # 22557
Views: 1,624

Dear Shahajan Baig!
There is no RLD in EU region. Applicant can use a reference medicinal product (RMP) authorized in European reference product or the intended market of application, provided that any other requirements for the application type is fulfilled.
For MHRA after Brexit- please visit https://www.gov.uk/guidance/reference-medicinal-products-rmps
for further information.
Regards,
DShah

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