Educational Materials for medicinal products
Educational materials are additional risk minimisation measures that are intended to promote the safe and effective use of the medicinal product, with the aim to supplement the information in the SmPC and PL. Educational materials focus on one or more specific risk related to use of the medicinal product so as to provide clear information on these specific new safety information and describe concisely what actions are required to prevent and minimise the risk.
Educational materials may serve to inform healthcare professionals (e.g. doctors, pharmacists or other healthcare categories) and/or patients and care-givers. For example, educational materials may indicate what a doctor needs to consider before prescribing a medicine for their patient, or to pay attention for specific monitoring criteria that could be required while their patient is on that medicine. Also, in case of a suspension, withdrawal or revocation of a marketing authorisation for safety reasons of a medicinal product; or in case of a restriction of indication, a new contraindication or a change in the recommended doses;
Likewise, educational materials may help in reminding patients about important safety information that they need to be aware of, before and during treatment with a medicine in order to use the medicine safely and effectively. Also, they may provide advice to patients on when to seek for medical advice.
Examples of educational materials for healthcare professionals: healthcare professional guides, dosing and administration guides, prescriber checklists and monitoring charts.
Examples of educational materials for patients: patient alert cards, patient guides and patient reminder cards.
Educational materials are elaborated and distributed by the Marketing Authorisation Holder (MAH) of the medicinal product for a specific medicinal product. They are not implemented for all medicines. As more safety information is gathered through pharmacovigilance activities, new risks may be identified in association with a particular medicine and additional measures might be imposed, in order to improve benefit-risk profile of the medicine.
The need for educational materials is agreed with the NAMMDR and may be decided or at the time of approval of the medicinal product, or at a later time in the lifecycle of the medicinal product.
Educational materials approved by the NAMMDR are listed on the agency website starting 2023. The materials can be downloaded for use by healthcare professionals and patients.
Please note the NAMMDR does not provide hard copies of these materials. If hard copies are required, please contact the relevant MAH for the medicinal product (contact details are provided as part of the specific educational materials).
The NAMMDR has developed instructions to advise MAHs on the submission for approval of educational measures (which are additional risk minimisation measures). These instructions are available here.
Educational materials approved by NAMMDR for medicinal products authorised in Romania are available here.
Queries for the educational materials (which are additional risk minimisation measures) should be sent to the following e-mail address: farmacovigilenta@anm.ro