Question

Who has responsibility for signing the declaration statement required as part of a marketing authorisation application in the EU?

1) The marketing team
2) The quality control team
3) The regulatory affairs team
4) The manufacturing team

Answer 1

The regulatory affairs team is responsible for signing the declaration statement for a marketing authorisation application in the EU, ensuring compliance with regulatory standards.

Step-by-step explanation:

The responsibility for signing the declaration statement required as part of a marketing authorisation application in the EU typically falls to the regulatory affairs team. This declaration attests to the completeness and compliance of the application with regulatory standards, and the regulatory affairs team is well-versed in such requirements.

It is important that the application is meticulously reviewed and certified by a competent team member familiar with legal and regulatory mandates to ensure the validity of the submission.