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

posted by dshah  – India/United Kingdom, 2021-08-31 18:40 (940 d 08:48 ago) – Posting: # 22557
Views: 2,301

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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
76 visitors (0 registered, 76 guests [including 9 identified bots]).
Forum time: 02:28 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5