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RE: Active substance registration
Good afternoon everybody,
I have additional questions on the registration of an active substance:
1. Does the applicant need to fill only the lines of the "Name type" that are pertaining to the medicinal product in Sheet 1 of the Substance Request Form?
2. In case of a cell-derived product (biological medicinal product), does the same information than ATMP need to be provided?
3. Can the request be sent by an external consultant, acting on behalf of the applicant and registered as IRIS Manager for the applicant?
Thank you in advance.
Kind regards,
Lucia
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