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.