Vladimir Pucovsky

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