5. What should be done if the applicant disagrees with OGYÉI’s request for correction?

If the applicant disagrees with the correction requests of OGYÉI, this should be clearly indicated and justified in the material. If the Pharmacovigilance Department accepts the justification of the MAH, final mock-ups may be produced and the procedure continues as usual. If the justification of the applicant cannot be accepted, controversial issues should be discussed in a teleconference (TC). Participants of the TC are at least 2 assessors from the Pharmacovigilance Division and the applicant. Setting the date of the TC and sending the agenda is managed via email. The applicant records the minutes of the TC based on the agenda items which is reviewed and approved by the Pharmacovigilance Division. The final mock-up of the risk minimisation tool is produced according to the agreement reached in the TC.

Please note that any further consultations or multiple exchange of emails will not be possible.