Medicinal products concerned by centralised public procurement procedures and procedures involving itemised reimbursement
In the case of medicinal products concerned by public procurement procedures, the additional risk minimisation materials may be assessed and approved on an expedited basis, having regard to the strict deadlines or specific distribution requirements. The applicant must indicate this request to the authority already at the time of submission.
In such cases, the NNGYK also supports the development of joint materials, since, where the winner of the public procurement procedure changes, and provided that the content and key elements of the additional risk minimisation materials remain unchanged, continuity of patient information should be maintained. In such cases, there is no need to provide patients with new copies; the documentation previously received, provided that its content is identical, remains valid and applicable, thereby avoiding possible confusion arising from parallel information.
Where joint additional risk minimisation materials are used, the dissemination obligation primarily lies with the winner of the public procurement procedure. At the same time, the other marketing authorisation holders concerned are also required to participate in the development and submission of the joint materials, thereby ensuring that the conditions laid down in their respective marketing authorisations are fulfilled on their part.
Approval confirms fulfilment of the additional risk minimisation measures imposed as a condition in the marketing authorisation in the context of participation in public procurement procedures or tenders.
Individual import of a medicinal product upon request in the interest of patient care deserving special consideration
If the marketing authorisation holder is not aware that the medicinal product concerned is being supplied to a patient in Hungary, and does not plan to market the product in the foreseeable future, the additional risk minimisation tool/programme does not need to be implemented in Hungary. In such cases, the NNGYK should nevertheless be informed, and the NNGYK will acknowledge the information.
However, where the patient receives the product, which is otherwise not intended to be marketed, within the framework of an individual import procedure, the additional risk minimisation material/tool must be implemented and submitted for approval if this comes to the knowledge of the marketing authorisation holder. In such cases, the NNGYK waives the requirement for a print-ready format; it is sufficient to prepare a simplified format.
Harmonisation and joint implementation of additional risk minimisation tools
In the case of medicinal products that are on the market, the range of other marketing authorisation holders marketing products with the same active substance should be examined. In line with GVP Module XVI, the NNGYK expressly encourages cooperation between marketing authorisation holders, as well as the development and dissemination of uniform, joint additional risk minimisation tools. The primary purpose of this measure is to reduce the administrative and operational burden on the healthcare system.
The approved joint documents are published on the official NNGYK website under the menu item for additional risk minimisation documents intended for healthcare professionals. It should be emphasised that publication on the website does not exempt marketing authorisation holders from the dissemination obligation laid down in the marketing authorisation.
Content requirements for joint risk minimisation materials:
Nomenclature: Where a joint additional risk minimisation tool is prepared for several medicinal products containing the same active substance, the material may refer only to the international non-proprietary name (INN) of the active substance. The documentation may not contain the trade names or invented names of the medicinal products concerned.
Objectives: When developing joint materials, the main considerations should be consistency, enhancement of patient safety and optimal use of resources, while avoiding parallel processes and unnecessary information overload.
Alignment with the reference medicinal product: The content of the materials must always be aligned with the approved risk minimisation tools of the reference medicinal product, that is, the originator product, through harmonisation.
Support for the healthcare system: Harmonised documentation significantly reduces the information burden on physicians and pharmacists, as it relieves them from having to manage parallel materials that are essentially identical in content but different in form.
Management of divergent materials: Where a joint additional risk minimisation tool/material cannot be implemented for a given active substance, the materials submitted by the different marketing authorisation holders must be consistent in content and as similar as possible in order to maintain patient safety. This is essential to avoid misinterpretation, therapeutic errors and to ensure the communication of consistent safety messages.
Presentation of marketing authorisation holders: For the presentation of the marketing authorisation holders participating in the joint development, a separate document should always be submitted, listing the names and contact details of the marketing authorisation holders and the names of the relevant medicinal products. The NNGYK publishes the list of marketing authorisation holders on its website together with the additional risk minimisation materials.
