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

posted by dshah  – India/United Kingdom, 2021-08-31 18:40 (458 d 07:33 ago) – Posting: # 22557
Views: 1,786

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
22,426 posts in 4,694 threads, 1,600 registered users;
13 visitors (0 registered, 13 guests [including 6 identified bots]).
Forum time: 01:14 CET (Europe/Vienna)

The art of medicine consists in amusing the patient
while nature cures the disease.    Voltaire

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