Additional risk minimisation tools — such as educational materials for healthcare professionals, checklists, patient cards or pregnancy prevention programmes (for further details, see the Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)) — are intended to reinforce the risks and risk minimisation measures described in the medicinal product’s product information, and to support and control the implementation of the measures introduced.
These tools are intended to provide structured and targeted information on the safe and appropriate use of the medicinal product, thereby supporting the maximisation and maintenance of the product’s benefit-risk balance.
Accordingly, additional risk minimisation tools support:
a) the reduction, prevention or minimisation of risks associated with the medicinal product;
b) the timely recognition and prevention of adverse reactions, and provide information on the actions to be taken if adverse reactions nevertheless occur;
c) the maximisation and maintenance of the medicinal product’s favourable benefit-risk balance;
d) effective collaboration between the physician and the patient; with the aim of ensuring that treatment is initiated only by an appropriately informed physician and that the prescribed medicinal product is used only by an appropriately informed patient.
The use of additional risk minimisation tools is justified only where the maintenance of a favourable benefit-risk balance cannot be ensured by routine risk minimisation measures alone. The introduction of additional tools is the result of careful consideration. All authorised medicinal products are subject to routine risk minimisation measures, including the Summary of Product Characteristics, the Package Leaflet, the packaging and the conditions of supply. Where these tools are sufficient to ensure that risks arising during the use of the medicinal product can be adequately controlled, no further intervention is required. The introduction of additional risk minimisation tools becomes necessary where the medicinal product has a specific, or an important identified or potential risk, which cannot be adequately addressed by the routine elements listed above. These tools therefore constitute targeted interventions.
Several types of additional risk minimisation measures may be applied simultaneously and may form a complex risk minimisation programme. However, in all cases it must be assessed whether the planned measure is proportionate to the risk. The measure should not impose a disproportionate burden on the healthcare system or its stakeholders in relation to the benefits derived from treatment, and its feasibility in the relevant Member State and healthcare setting should also be considered.
During the design of additional risk minimisation tools and programmes, as well as during their national implementation at Member State level, particular attention should be paid to effectively supporting and strengthening therapeutic collaboration between the physician and the patient.
The effectiveness of additional risk minimisation activities should be evaluated from time to time, using different qualitative and quantitative process and outcome indicators. If these activities do not achieve their objectives, safe use of the medicinal product cannot be assured, and further measures are required to protect patients. Studies assessing the effectiveness of additional risk minimisation measures may be initiated either by the competent authority or by the marketing authorisation holders.
The key elements of additional risk minimisation activities are usually approved by the European Medicines Agency (EMA) or the European Commission; however, additional risk minimisation measures may also be imposed as a condition in decentralised procedures (DCP) or mutual recognition procedures (MRP).
The practical implementation of these measures always falls within the competence of the national competent authorities of the Member States. Accordingly, in Hungary, all additional risk minimisation tools and programmes to be implemented must be submitted to the National Centre for Public Health and Pharmacy (NNGYK) for prior approval. This requirement applies to the initial version of the risk minimisation tool or programme, to any subsequent amendments, and to the re-dissemination of the materials.
On the NNGYK website, the product page of a medicinal product indicates whether an additional risk minimisation tool or programme is associated with the product. The disseminated version of the additional risk minimisation materials approved by the NNGYK, including the version number and the date of approval or acknowledgement, is published on the product page of the NNGYK website, as well as under the menu item “Information > Additional risk minimisation documents for healthcare professionals”. Publication is automatic in all cases, unless the marketing authorisation holder expressly declares that it does not consent to the public disclosure of the given document.
The following question-and-answer section provides detailed information for applicants and marketing authorisation holders regarding the national implementation of additional risk minimisation tools and programmes.
The requirements and recommendations set out below apply from 17/06/2026.
