Non-EU based consultants

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

Yes and yes. This is from a technical point of view, but keep in mind the legal requirements and procedural rules for each submission category, such as orphan designations and scientific advice.

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

If an applicant is established outside the European Econimic Area (EEA), it is advisable (but not mandatory) to nominate a contact point within the EEA to facilitate communication between the Agency and such applicant. If no SME incentives are sought, a non-EEA organisation is free to use the services of any consultant (be they EEA-based or not).

There are three options for any applicant who is using a consultant to request a scientific advice:

1) The applicant is not registered with IRIS. In that case the IRIS Administrator and the IRIS Manager has to be someone within the consultant company. This would mean that the applicant completely transfers all their dealings with EMA when it comes to procedures (for now scientific advice, orphan designations, parallel distribution, innovation task force meetings, but in future also other procedures) to the consultant.

2) The applicant is registered with IRIS. The IRIS Administrator is someone within the applicant company. The Administrator gives the IRIS Manager privileges to a consultant. The consultant would then be able to initiate, modify, submit and withdraw any of the procedures, including scientific advice requests. However, the consultant would also have access to all the documents/procedures of the applicant company in IRIS.

3) The applicant is registered with IRIS. The IRIS Administrator and IRIS Manager are someone within the applicant company. The IRIS Manager can initiate, modify, submit and withdraw any of the procedures, including scientific advice requests. The Manager can also nominate a contributor from a consultant company. A contributor can modify the request (but cannot initiate, submit or withdraw it) and has access only to the procedure for which he/she has been nominated.

Best regards,
Vladimír Pucovský

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

In response to your questions:

1. Your understanding is correct, but in this case for EMA the Applicant IS the Consultant. Any advice will be addressed to the consultant as the applicant. For Scientific Advice this is not a problem for EMA, but for other procedures it may lead to undesired consequences: for example, in the case of on application for orphan designation, the designation would be granted to the consultant, not the (real) "owner" of the product.
2. Possibility 2 is in fact a variant of case n. two in our initial answer, not case number one. A legal organization in OMS can authorize any IAM User to be IRIS User Admin for the organization, even if that user is not an employee or representative of the organization itself. While this is technically possible, if approved by the organization, it has the potential to create undesirable consequences for the organization itself, of which they need to be aware and accept full responsibility. 
3. An IAM user can apply as in individual, rather than on behalf of an organization. This is built-in in IRIS. To do so, the IAM user needs to have the IRIS Individual User role, to be requested separately. In this case, the applicant is the individual, and fees will be charged to that individual.