Tarita Toufexi Ms

We are currently operating under the new fee regulation (Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency), which came into force on January 1^st 2025.

The new fee regulation has introduced changes to Scientific Advice/Protocol Assistance.
Notably, the structure of scientific advice types and associated fees has been simplified. Consequently, distinctions between initial and follow-up requests have been removed, and follow-ups are no longer available as process types in the IRIS system.
However EMA staff are still able to follow the lifecycle of a specific product and previous advices via the RPI that is the link between all pre-authorisation procedures.

We are currently in the process of publishing the updated guidance document.
However, there is already information available on the following webpage, including legal basis, working arrangements and questions & answers (for Scientific Advice please refer to Annex I).
New Fee Regulation (from 1 January 2025) | European Medicines Agency (EMA)


 

Protocol Assistance is provided for a single ODD and the system is designed accordingly to allow only one designation.
If you have questions only on one indication you can select the relevant ODD.
If you have questions on more than one indication, multiple requests should be created.
However there can be exceptions depending on the content of the briefing document (broad advices not indication specific).
For these exceptions please contact directly the Scientific Advice office for guidance at scientificadvice@ema.europa.eu.
     

Response to question 1:

Company A is a non EEA SME holding SME status via an EEA consultancy which itself is also SME. Company A would like to request Scientific Advice for a non-orphan product. Which entity is the applicant for the SA (Company A or Consultancy B)?

Applicant should be the non-EEA SME and linked organisation the EEA SME consultant.

Response to question 2:

Company A is a non EEA SME holding SME status via an EEA consultancy (Consultancy B) which is itself also SME. Company A would like to request Protocol Assistance for their orphan product. The sponsor of this ODD is the Consultancy B. Which entity is the applicant for the SA (Company A or Consultancy B)?

Applicant should be the holder of the orphan designation EEA SME consultant and linked organisation the non-EEA SME company.

Response to question 3:

Company A is a non EEA SME holding SME status via an EEA consultancy which itself is also SME. Both have several linked and partner enterprises as described in their SME applications. Some of these are not active in the pharmaceutical industry and are not registered in OMS.

What information is required in section “Linked organization information”. How to handle linked organisations not listed in OMS?

Same as question 1 for Scientific Advice and question 2 for Protocol Assistance. Organisations not listed in OMS should be registered.

Dear Mr Marcinkevicius,
thank you for your message. If you require assistance/advice on the content of the draft briefing document you can request Scientific Advice or Protoocol Assistance and select Yes in the option preparatory meeting. A teleconference will be arranged following your request to receive support by the assigned Scientific Officer.