Richard Crane Dr.

Dear Dr. Batista,

Thank you for your reply. Should this extra information be entered as additional rows in Sheet 1 of the Substance Request Form, or provided to the EMA Service Desk as a separate document?

We are also unsure how to complete Sheet 2 of the Excel form, entitled 'nature of the active substance (levels 2 and 3)'. This is not fully explained in section 7.2 of the IRIS Guide to Registration (EMA/31242/2019). Is the applicant supposed to put check marks in column B perhaps?

And in the case of an ATMP, are the categories in Sheet 2 intended to match the ATMP classification? Thus for example, a cell therapy with genetic modification (such as a CAR-T) would be classified as 'gene therapy', whereas one without genetic modification would be 'cell therapy'. Any guidance would be appreciated.

Thank you!

Good afternoon! Can anybody advise how to complete the form for registering an active substance, in the case of an ATMP? In most cases, there will be no chemical name or CAS number, and the company may not yet have a proposed INN. What is the minimum amount of information needed for the form to be successfully accepted?