4. How long does it take to assess the application, what criteria are taken into account, and how is the applicant notified on the start and end of the procedure?

All submissions arriving via emails are acknowledged following validation check by the Pharmacovigilance Division within 3 business days. During validation, colleagues are checking whether the application contains all documents and information that are required for the assessment and approval (please refer to Q2 and the checklist).

If the application is incomplete, it cannot be validated and the applicant is asked to submit the missing documents. Invalid submissions will not be processed until completion. If the application is valid, the applicant will receive an email indicating the start of the procedure and the deadline of OGYÉI response.

Applicants are asked to follow-up their submission (check whether it was made to the correct email address or whether a notification was sent on the submission) and/or send an enquiry to farmakovigilancia@nngyk.gov.hu, if no acknowledgment is received within 3 business days.

OGYÉI assesses valid applications within 30 business days (this includes assessment of possible promotional content). Please note that OGYÉI reviews the draft material based on promotional (whether it contains promotional elements) as well as pharmacovigilance aspects (presence of key elements), however, it does not review the correctness of the overall Hungarian translation. MAHs are responsible for the correctness and clarity of the text and its adherence to the rules of the Hungarian language.

If considered necessary, OGYÉI request amendments in the submitted material within the above mentioned timeframe. The applicant is notified in an email about the corrections requested. If the MAH agrees with the proposed changes, the materials should be amended accordingly, and a final mock-up (e.g. a pdf) of the risk minimisation tool should be submitted to OGYÉI. The Pharmacovigilance Department compares the final version with the proposed changes and in case of full conformance, the risk minimisation tool or program is approved within 3 business days. Otherwise, the material will be returned for correction. Thus, the risk minimisation tool or program is considered approved after assessment and acceptance of the final mock-up, and the MAH is notified thereof in an email.

If approval cannot be issued within 90 calendar days following the start of the procedure, OGYÉI closes the procedure which can be restarted only by submitting a new application. In this case, OGYÉI investigates whether the MAH omitted to comply with its legal obligations regarding risk minimisation measures. If the MAH did omit to fulfil its obligations, OGYÉI initiates the appropriate procedure.