- recommend a text in case your recommendation try a version but no specific wording try suggested by PRAC Rapporteur / Head Associate Condition,
- bring an excuse whether your MAH will not trust brand new PRAC Rapporteur / Associate State testimonial to vary, suspend or revoke the fresh MA; and/otherwise
- were additional comments or explanation deemed called for of the MAH
New MAH’s comments is registered according to the PSUR dossier entry requirements detail by detail about concern How shall I submit the answer to a request for second information during good PSUSA processes?.
Should your PRAC adopts a referral on the restoration out of the new revenue authorisation, such recommendation is not sent towards CHMP otherwise CMDh and you will the process ends up on adoption of your own PRAC testimonial
In case there is significant conflict on the PRAC Rapporteur’s/Lead Affiliate Country’s proposed Recommendation as stated on the updated analysis declaration, the fresh new MAH is contact the product Head (to possess Hats) otherwise Exposure Management Expert (getting NAPs only) zero after than simply one or two business days adopting the acknowledgment of report. Read More