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

posted by dshah – India/ United Kingdom, 2021-08-31 16:40 (23 d 19:22 ago) – Posting: # 22557
Views: 476

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.

Complete thread:

 Admin contact
21,694 posts in 4,535 threads, 1,541 registered users;
online 6 (1 registered, 5 guests [including 4 identified bots]).
Forum time: Friday 12:02 CEST (Europe/Vienna)

Tortured data will confess to anything.    Fredric Menger

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz