Scientific advice in IRIS- Applicant and linked organisation information

Rainer Paffenholz
Posted Wed, 21 Oct 2020 11:23:54 GMT by Rainer Paffenholz Dr
Can you please clarify the following:

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)?

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)?

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?
Answer
Tarita Toufexi
Posted Wed, 28 Oct 2020 11:02:24 GMT by Tarita Toufexi Ms
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.

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