Luisa Pachés-Samblás Dr

Many thanks for your explanation.
Luisa Pachés

Thank you for your response. It is very useful.

Regarding the first option, I guess it can be divided into two:
1. The applicant is not registered in IRIS and the consultant submits the SA request in their own name (not on behalf of the real applicant). Then, the consultant would become the applicant. I assume this a possibility with the consent of the real applicant. I understand that the EMA would then send the invoice to the consultant as applicant.
2. The applicant is not registered in IRIS and the consultant requests IRIS administrator rights from this applicant by enclosing the IRIS user admin affiliation letter signed by the applicant. Therefore, the consultant would submit the SA request on behalf of the applicant and the EMA invoice would be sent directly to the applicant. 

Regarding options 1 & 2 in your response, my only worry is that the consultant would be able to access all documents/procedures of the applicant. This is usually ok for small companies. However, there will be concerns for bigger companies. Is there any way to give IRIS managing rights to individuals, as consultants, for certain projects only?

Many thanks in advance for your time.
Luisa

Thank you for your response.
As a veterinary consultant my question was to do with Scientific Advice requests.
I understand that a non-EU consultancy cannot get SME status and therefore, cannot submit SA requests on behalf of non-EU organisations with SME status.
However, if SME status does not apply, can a non-EU consultant submit SA requests on behalf of non-EU organisations without the need for these organisations to get IRIS registration?
Many thanks.
Luisa

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

Hello,

Can non-EU consultants act as IRIS industry contributors?

Can non-EU consultants submit SA requests on behalf of non-EU applicants?

Thank you. 
Luisa Pachés