H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.


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Additional risk minimisation tools (e.g. educational materials)

The aim of additional risk minimisation tools (e.g. information leaflet for physicians, check list, patient alert card, video presenting the correct use of a medicine, pregnancy prevention program etc., for further information please refer to GVP Module XVI) is to provide detailed yet concise guidance about the appropriate way of administration and risks of a medicine, how to recognise adverse drug reactions (ADRs) fast, and how to prevent and treat them, should they occur. The main goal is to reinforce and emphasise the information contained in the product information in order to maximise the benefit-risk balance of a product.

The use of additional risk minimisation tools is only justified when routine measures cannot ensure the favourable benefit-risk ratio of a medicine. Several additional measures may be used simultaneously making up a complex program; however, planned measures should never place a disproportionate burden on the healthcare system and its stakeholders compared to the benefits originating from the treatment. Furthermore, implementation of such measures should be feasible in the concerned member state.

When planning and implementing additional risk minimisation tools or programs, it should be bear in mind that these measures should facilitate and strengthen the cooperation between the patient and the physician as much as possible.

The effectiveness of additional risk minimisation measures should be evaluated from time to time (by using process and outcome indicators). If their goals are not achieved, the safe use of the product cannot be ensured; therefore, further measures need to be implemented in order to protect patients' health.

The key elements of additional risk minimisation measures are mostly approved by the European Medicines Agency (EMA) or the European Commission (EC), or may be agreed upon during decentralised (DC) or mutual recognition (MR) procedures. Implementation of the materials, however, is always the responsibility of national competent authorities. Risk minimisation tools intended for implementation in Hungary should be submitted to OGYÉI for prior approval. This refers to the first version of the risk minimisation tool or program, as well as its updates.

We would like to provide applicants with detailed guidance below on the implementation of additional risk minimisation tools and programs in Hungary in a Question and Answer format.

Updated requirements on the national implementation of additional risk minimisation tools or programs are effective from 20 February 2017.


1. In what circumstances should an additional risk minimisation tool or program be implemented in Hungary, and how to schedule the submission of the application for national approval?

2. Where should the application be submitted and what should it contain?

3. What should be consulted when preparing the content of and assembling risk minimisation tools or programs?

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?

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

6. How can risk minimisation tools be distributed and should the dissemination be recorded?

7. How should updates to risk minimisation tools or programs be managed?

8. What should be done if the product information or the risk minimisation tool of the medicine are updated during an ongoing approval procedure?

9. Are there any special requirements of OGYÉI concerning the version control of risk minimisation tools or programs?

10. Can the MAH publish the risk minimisation tool or program on its website?

11. Where can queries be placed by the MAH?

Last updated: 2018.10.03 13:52