01 Fév On the absence of a reply within this two days, the latest EMA have a tendency to believe that zero dental factor are requested
- suggest a wording if for example the testimonial is a difference but zero appropriate text try advised from the PRAC Rapporteur / Head Representative State,
- provide a justification in case your MAH does not accept this new PRAC Rapporteur / User County testimonial to alter, suspend otherwise revoke the newest MA; and/otherwise
- tend to be even more statements otherwise clarification considered requisite because of the MAH
New MAH's statements are registered according to the PSUR dossier entry requirements in depth regarding matter “How should We complete the response to a request second advice throughout an excellent PSUSA process?”.
If for example the PRAC switches into a recommendation to your restoration of the newest product sales authorisation, such as testimonial isn’t sent on CHMP otherwise CMDh and you may the procedure concludes into the adoption of your own PRAC recommendation
If there is major conflict to your PRAC Rapporteur's/Head User State's proposed Testimonial as stated in the current evaluation report, new MAH will be contact the merchandise Direct (to have Limits) otherwise Chance Government Pro (having NAPs merely) no afterwards than just one or two working days pursuing the acknowledgment of statement.