Bioequivalence and Bioavailability Forum • RLD identification in EU region in view of Brexit

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

posted by dshah – India/United Kingdom, 2021-08-31 18:40 (961 d 07:12 ago) – Posting: # 22557
Views: 2,362

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:

RLD identification in EU region in view of Brexit shahajan baig 2021-08-31 14:49
- RLD identification in EU region in view of Brexitdshah 2021-08-31 16:40
  - MHRA: No ‘own’ BE GL? Helmut 2021-09-24 15:36
- RLD identification in EU region in view of Brexit Ohlbe 2021-09-09 22:55
  - RLD identification in EU region in view of Brexit shahajan baig 2021-09-10 16:44
    - No ‘RLD’ in the EEA Helmut 2021-09-10 20:22