On lack of an answer in this two days, the EMA have a tendency to assume that no oral reasons try questioned
- recommend a wording in case your testimonial are a difference but zero real text is actually proposed of the PRAC Rapporteur / Lead Affiliate County,
- promote a justification should your MAH doesn’t go along with this new PRAC Rapporteur / Affiliate County recommendation to alter, suspend otherwise revoke the latest MA; and/or
- are additional statements otherwise clarification considered called for of the MAH
Brand new MAH’s statements should be submitted according to the PSUR dossier submission conditions in depth from the question “Exactly how should I fill out the solution to an obtain secondary recommendations during the a PSUSA procedure?”.