The procedure for matters relating to additional risk minimisation tools/programmes changed as of 01/04/2026. From this date, the initial documentation for matters relating to additional risk minimisation tools/programmes must be submitted exclusively by electronic means, via the Company Gateway, to the official electronic storage space of the NNGYK [KRID identifier: 346558928 (OGYEIEUGY)].
Following initiation of the procedure, further correspondence concerning additional risk minimisation tools/programmes should be sent to the electronic mailbox of the Pharmacovigilance Department (FVF): farmakovigilancia@nngyk.gov.hu.
The submission should indicate the name of the medicinal product, the active substance, and whether the submission concerns a first submission, an amendment (content-related or administrative), or a request for re-dissemination of the materials. The records management code for additional risk minimisation submissions is 3306, which should be indicated in the subject line of all correspondence.
For large documents, the use of the web-based transfer platform available at the following link is recommended: https://transfer.ogyei.gov.hu. The platform allows the upload and download of large files. Its use is recommended for sharing files larger than 5 MB. The maximum size of the files to be shared is 1 GB. Each upload remains available in the system for 14 days, after which it is automatically deleted.
The submission should include the following:
- The textual draft of the risk minimisation materials in Hungarian, in Word format, and, where available, in English in any format, using a readable font size, irrespective of the final format in which the tool/programme will be implemented, for example as a brochure, video, website or presentation.
- A detailed communication/dissemination plan adapted to the Hungarian healthcare setting. This should include:
- the materials intended for dissemination, and, in the case of programmes, the details of the programme preferably presented by means of a flowchart;
- the target populations of the additional risk minimisation measure, such as physicians, nurses, patients or pharmacists;
- the timetable for the procedure relating to the additional risk minimisation programme, including, for example, the planned timing of dissemination, the planned timing of re-dissemination, the first planned time point for effectiveness evaluation, and measures to ensure continuity;
- the target group and approximate number of healthcare professionals intended to be informed; and
- the method of dissemination. Several and alternative dissemination methods may be used where this better ensures coverage of the target population, for example through healthcare professional and/or patient organisations, journals, conferences, tools used at the point of dissemination or care, and training activities.
- The obligation or regulatory procedure as part of which approval is requested, for example CMDh consensus, European Commission decision, documentation from international authorisation procedures such as MR/DC procedures, or reference to the decision of a national competent authority. The relevant decision should be attached, and the procedure identifier should be indicated.
- The elements of the additional risk minimisation programme and the approved key elements. These elements should be copied from the approved risk management plan (RMP) or assessment report, with precise source references, and submitted in a separate document.
- The graphical draft (print-ready format) of the risk minimisation tools, which may be in Hungarian or English, or a collection of the graphical/visual elements planned to be included in the final material, such as tables, illustrations or logos. In the latter case, the planned location of these elements within the document should be indicated.
- In the case of a re-dissemination submission, the justification for why re-dissemination is considered necessary, as well as the date of the most recent dissemination.
- In the case of an amendment submission, the reason for the amendment, whether it affects the key elements, and the relevant documents marked with Word track changes, including the Hungarian and English textual drafts, the elements of the risk minimisation programme, and the approved key elements. The submission should also indicate which risk minimisation element is affected by the change.
- Where the RMP or PI Annex D requires user/readability testing (user testing), a declaration should be provided, together with a proposal for how the testing is to be carried out. It is recommended, where possible, that the testing be performed using already approved or revised materials.
- The envelope intended for dissemination of the additional risk minimisation material, or the draft email, depending on the method of dissemination. For recommendations on the envelope format, see the section “How may additional risk minimisation materials be disseminated and does dissemination need to be documented?”. In the case of physical dissemination, the draft cover letter should always be submitted.
- Whether the medicinal product is already on the market, or the planned date of placing it on the market. Assessment may only start after completion of the relevant marketing authorisation procedure.
- A declaration as to whether the medicinal product participates in a public procurement procedure.
- Any planned cooperation with another marketing authorisation holder, where relevant. If the implementation of the additional risk minimisation programme/tool simultaneously concerns several marketing authorisation holders in Hungary, the applicant should declare whether cooperation with other marketing authorisation holders is planned.
- A draft plan for measuring the effectiveness of the additional risk minimisation programme, where such an evaluation is planned in Hungary, or where the medicinal product concerned is authorised only in Hungary.
- The name and contact details of the contact person. Where the submission is not made by the marketing authorisation holder or by the person responsible for pharmacovigilance, an authorisation statement confirming the right to submit the application should also be attached in addition to identifying the contact person.
If the submitted documentation is incomplete, meaning that it does not contain any of the items listed above, the submission is not valid and the approval procedure will not be initiated. The marketing authorisation holder has 30 days to remedy the deficiencies.
The above set of requirements can be downloaded in checklist format here.
Please note that the NNGYK assesses and approves only the national implementation of obligations arising from already completed regulatory procedures. Approval cannot be granted for matters that are still under an ongoing procedure. In such cases, preliminary consultation may be requested from the NNGYK within the framework of scientific/professional advice (see point 1), but an assessment submission may not be submitted and will not be assessed.
Marketing authorisation holders are further reminded that, in the performance of the duties of administrative bodies, the language of communication is Hungarian. Submissions should therefore be submitted in Hungarian. Where a foreign-language document is attached, its Hungarian translation should also be provided.
