• recommend a text in case the recommendation try a version but zero exact text try advised by PRAC Rapporteur / Head Member State,
• bring a reason if your MAH does not accept new PRAC Rapporteur / Representative County recommendation to alter, suspend otherwise revoke this new MA; and/otherwise
• is even more comments or clarification considered needed because of the MAH

The fresh new MAH’s comments is going to be recorded as per the PSUR dossier entry requirements in depth throughout the question How shall I submit the solution to a request for second guidance during the a good PSUSA processes?.

In the event of significant argument towards the PRAC Rapporteur’s/Lead Representative State’s advised Testimonial as previously mentioned about upgraded comparison statement, the new MAH should contact the merchandise Head (for Hats) otherwise Exposure Management Expert (to own NAPs simply) no after than simply one or two working days following the acknowledgment of one’s statement. Continua a leggere