On lack of an answer inside two days, the brand new EMA have a tendency to think that no dental reasons is actually requested
- suggest a wording if the testimonial is actually a variation however, no appropriate wording try recommended of the PRAC Rapporteur / Direct Representative Condition,
- bring a reason should your MAH cannot agree with brand new PRAC Rapporteur / Associate County testimonial to alter, suspend otherwise revoke the new MA; and/or
- is more comments otherwise explanation deemed expected of the MAH
The brand new MAH’s statements might be recorded according to the PSUR dossier submission conditions detailed in the question Just how shall We complete the answer to an obtain second information throughout a beneficial PSUSA process?.
