- propose a text if the recommendation try a version but zero exact wording try recommended because of the PRAC Rapporteur / Head Associate County,
- provide an excuse in the event the MAH doesn’t agree with the PRAC Rapporteur / Associate County recommendation to vary, suspend or revoke the brand new MA; and/otherwise
- tend to be more statements otherwise clarification deemed required because of the MAH
Brand new MAH’s comments are going to be submitted as per the PSUR dossier submission standards outlined throughout the concern Just how will I fill in the answer to an ask for second advice throughout the an excellent PSUSA procedure?.