Risk minimisation measures (RMM)

Risk minimisation measures (RMM) are interventions intended to reduce the occurrence, severity and / or impact of adverse reactions of medicines. Adverse reactions are commonly known as side effects.

RMM aim to support healthcare professionals and patients to address the risks associated with medicines in patient care.

For information on pharmacovigilance, see:

Pharmacovigilance: post-authorisation

Risk minimisation tools

Risk minimisation measures (RMM) use routine tools and, where needed, additional tools.

Examples of additional RMM tools include patient cards and mandatory training for healthcare professionals.

Routine risk minimisation tools

The key routine tools are:

the summary of product characteristics (SmPC);
and the package leaflet.

They represent the two major elements of the product information required for all medicines marketed in the EU.

The SmPC includes a description of the risk and intended actions for risk minimisation. The package leaflet for patients also reflects this information.

EMA and national competent authorities publish SmPCs and package leaflets online.

Other routine tools include:

issuing the medicine in an appropriate pack size;
clarifying that the product is legally available only with a medical prescription.

Additional risk minimisation tools

Additional tools help manage specific risks related to medicines.

These tools emphasise the risk-related information and the intended actions for risk minimisation.

They are also meant to support patients and healthcare professionals in following the intended actions.

Additional tools include the following solutions, which can be used on their own or in combination:

Educational or safety advice tools - such as patient cards or guides on risk minimisation for patients or healthcare professionals
Risk minimisation control tools - such as requirements for healthcare professionals to complete specific training before prescribing, dispensing or administering a medicine

National repositories

Most national competent authorities publish materials in their official languages on how to apply additional RMM tools to relevant medicines.

EU Members States and countries in the European Economic Area (EEA) approve materials per medicine.

Use the online resources (including search results) listed in the table below to find these materials:

EU Member State	Medicine repository
Austria	No repository available
Belgium	https://www.afmps.be/fr/humain/medicaments/medicaments/bon_usage/programme_de_gestion_de_risques/rma (FR) https://www.fagg.be/nl/MENSELIJK_gebruik/geneesmiddelen/geneesmiddelen/goed_gebruik_geneesmiddel/risicobeheerprogramma/rma (NL) https://www.famhp.be/en/MENSELIJK_gebruik/geneesmiddelen/geneesmiddelen/goed_gebruik_geneesmiddel/risicobeheerprogramma/rma (EN)
Bulgaria	No repository available
Croatia	https://www.halmed.hr/Farmakovigilancija/Mjere-minimizacije-rizika-MMR/ (HR) https://www.halmed.hr/en/Farmakovigilancija/Mjere-minimizacije-rizika-MMR/ (EN)
Cyprus	https://www.phs.moh.gov.cy/human-search/home.xhtml (GR) https://www.phs.moh.gov.cy/human-search/home.xhtml?lang=en (EN)
Czechia	Search results (CZ)
Denmark	https://laegemiddelstyrelsen.dk/da/godkendelse/godkendelse-af-medicin/laegemidler-med-uddannelsesmateriale-edumat/dansk/ (DK) https://laegemiddelstyrelsen.dk/en/licensing/licensing-of-medicines/medicinal-products-with-educational-material-edumat/english/ (EN)
Estonia	https://www.ravimiregister.ee/publichomepage.aspx (EE) https://www.ravimiregister.ee/en/PublicHomePage.aspx (EN)
Finland	https://fimea.fi/valvonta/laaketurvatoiminta/laakevalmisteen-riskienminimoinnin-lisamateriaali (FI) https://fimea.fi/en/supervision/pharmacovigilance/additional-risk-minimisation-material-for-medicinal-product (EN)
France	https://ansm.sante.fr/documents/reference/mesures-additionnelles-de-reduction-du-risque-marr (EN)
Germany	https://www.bfarm.de/DE/Arzneimittel/Pharmakovigilanz/Risikoinformationen/Schulungsmaterial/_functions/Schulungsmaterial_Formular.html?queryResultId=null&pageNo=0 (DE) https://www.pei.de/DE/arzneimittelsicherheit/schulungsmaterial/schulungsmaterial-node.htlm (DE) https://www.pei.de/EN/medicine-safety/educational-material/educational-material-node.html (EN)
Greece	https://services.eof.gr/human-search/home.xhtml (GR) https://services.eof.gr/human-search/home.xhtml?lang=en (EN)
Hungary	No repository available
Ireland	Search results (EN)
Italy	For selected additional risk minimisation measures only: https://www.aifa.gov.it/misure-di-minimizzazione-del-rischio (IT) https://www.aifa.gov.it/misure-di-gestione-del-rischio (IT) https://www.aifa.gov.it/en/web/guest/misure-di-gestione-del-rischio (EN)
Latvia	https://dati.zva.gov.lv/zalu-registrs/ (LV) https://dati.zva.gov.lv/zalu-registrs/en (EN)
Lithuania	https://vapris.vvkt.lt/vvkt-web/public/medications (LT) https://vapris.vvkt.lt/vvkt-web/public/medications?lang=en (EN)
Luxembourg	The additional risk minimisation materials applicable in Luxembourg are mostly identical to those published by the competent authorities in Belgium, or, for some medicinal products, by the competent authorities in France or Germany
Malta	https://medicinesauthority.gov.mt/rmm (EN)
Netherlands	Search results (NL)
Poland	https://rejestry.ezdrowie.gov.pl/rpl/search/public (PL)
Portugal	https://www.infarmed.pt/web/infarmed/materiais-educacionais (PT)
Romania	https://www.anm.ro/medicamente-de-uz-uman/farmacovigilenta/materiale-educationale/ (RO)
Slovakia	https://www.sukl.sk/hlavna-stranka/slovenska-verzia/bezpecnost-liekov/edukacne-materialy?page_id=4795 (SK)
Slovenia	https://www.jazmp.si/dokumenti/ (SI)
Spain	cima.aemps.es/cima/materiales.do (ES)
Sweden	No repository available
EEA Member State
Iceland	https://www.serlyfjaskra.is (IS)
Liechtenstein	No repository available
Norway	No repository available