Hello,
After having listened to the webinar on how to submit veterinary SA request applications, I have the following comments/questions regarding the use of regulatory consultants:
I believe the first step would be to add the consultant as an IRIS industry contributor of the organisation through EMA account management. Is that correct?
It looks like a regulatory consultant cannot initiate a SA request for a client in IRIS, as the option of creating a new submission can only be done by the applicant. It is then when the applicant can choose a consultant in the contributors window.
According to the EMA account management site, the IRIS industry contributor can only edit applications via the IRIS platform. They cannot create a new submission or submit/withdraw an existing one.
This means that from now on, consultants won’t be able to submit SA requests on behalf of clients anymore, is that correct?
Can you explain what the function of the contributor is if they cannot do anything to the SA request application, please?
There are many regulatory consultants out there who prepare and submit SA requests on behalf of clients. However, it looks like this will not be possible any more.
I believe that this is going to be a huge administrative burden for companies, especially small companies, as it is much easier preparing a letter of authorisation for the consultant than going through the EMA account management registration and IRIS portal. We have many clients from small companies who don’t even have a Eudralink account.
Do the EMA foresee any changes to the IRIS portal so consultants can continue preparing and submitting SA requests on behalf of clients?
Many thanks in advance.
Luisa
