Isha Arora Dr.

Isha Arora

Joined: 4/27/2020

  • RE: Q&A on Scientific Advice submissions in IRIS

    Wed, 14 Oct 2020 10:27:30 GMT – Q&A on Scientific Advice submissions in IRIS
    In regards to Q&A 41, it is stated that "There is no need anymore for a Letter of Authorization".
    • Is this applicable to SA procedures only or to all procedures submission via IRIS ?
    • It is understood that EMA considers that once the organization has provided an IRIS Industry Manager role to a person, it implicitly implies that the person is authorized to submit on behalf of the organization. Can you please confirm ?
    • If the above is correct, why at the end of each submission, the below ticking box is required ? Why is this ticking box needed if Letter of Authorization is not needed and if it has been already defined per IRIS registration that the person is authorized to submit ?
    • There is a general legal concern on what is needed to support ticking the box "is authorised on behalf of the applicant" (both from an individual and a company stand-point) ?