Regulatory Open Forum

dear all,

good day and nice to connecting to this important for me forum for RA issues.

we have received CMDH referral questions for a product and i have heard that these should also be uploaded in a portal / gateway, of EMA.

at the end of the questions, it is mentioned that information of uploading may be found on

http://esubmission.ema.europa.ru

htttpss://www.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/referral-procedures-regulatory-procedural-guidance (referral submissions section).

has anyone experience on this? any help / advise / reply is really much appreciate it.

thank you very much

Dear anon

I'd be suspicious of the domain name - either a typo or a phishing attempt.

You can find the CMDH site here:

https://www.ema.europa.eu/en/committees/working-parties-domains/coordination-group-mutual-recognition-decentralised-procedures-human-cmdh