As in EU, the Educational materials in Slovenia are defined as an additional risk mitigation measure for the safe and effective use of the medicinal product and are an obligation of the holder. They are determined by Annex II of the Commission Implementing Decision, the RMP or as a consequence of the conditions of the marketing authorisation pursuant to Articles 21a, 22a or 22 or laid down in Article 127a of Directive 2001/83/EC of the European Parliament and of the Council of 6.11.2001
The purpose of risk mitigation measures is to prevent or reduce the frequency of adverse reactions at treatment with medicinal products, or to reduce their severity or impact on the patient if an side effect occurs. Most risks are adequately addressed through regular risk reduction measures, which are implemented for all medicinal products and include the Summary of the product characteristics, the Package leaflet, Labelling, pack size and form, and the route of dispensing. However, in certain cases, the regular pharmacovigilance measures are not sufficient and additional risk mitigation measures are introduced.
Additional measures are accepted where they are essential to ensure the safe and effective use of the medicinal product. Additional risk mitigation measures focus on the most important or newly identified risks. These can be avoided or their impact reduced through additional measures, thus achieving the most favourable benefit-risk ratio of the medicinal product.
Educational materials may be for Healthcare professionals or patients. They shall be prepared by the MAH and shall take into account the guidelines on good pharmacovigilance practice GVP Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators, GVP Module XVI Addendum I – Educational materials, GVP Module V – Risk management systems, GVP Product or Population- Specific Considerations II: Biological medicinal products and GVP Products – or- Population Specific Considerations IV: Paediatric population, published on the EMA website , and the Regulations.
The Instructions for submitting the application for reviewing the Educational material issued by the JAZMP should also be followed.
Irrespective of the type of marketing authorisation procedure, the implementation of additional risk mitigation measures takes place at national level. The distribution plan is always agreed at national level.
The distribution of Educational material shall be carried out by the MAH after the consent of the JAZMP has been received and only in the case where the medicinal product is present on the market of the Republic of Slovenia or is about to enter the market. The distribution of Educational material shall be carried out completely separately from the activities of advertising of the medicinal product.
Where there are several medicinal products on the market in the Republic of Slovenia with an active substance for which Educational material is to be prepared, or where there are medicinal products on the market in the Republic of Slovenia with a temporary authorisation, it is advisable that the Holders join together to prepare joint Educational material.
In addition to the submission of the Educational material, a proposal for a distribution plan should be prepared, including the target groups, the method and timing of distribution of the Educational material.
The target groups shall be the recipients of the Educational material. The materials shall be distributed to individual Healthcare professionals (by name) who shall then distribute the materials to the patients.
The primary mode of distribution is in physical form (hard copy for texts and electronic media (CD, USB stick) for audio/video recordings). Appropriate records of the distribution and receipt of the Educational materials should also be kept for all methods of distribution.
Regarding the distribution time frame it should be taken into account that the distribution of Educational materials should be carried out before the medicinal product is on the market (the time between distribution and the product’s arrival on the market should not be too long, e.g. one month to 14 days before the medicinal product is on the market).
The distribution of Educational material should be carried out periodically until the risks are considered to be well understood and incorporated into the standard clinical practice, i.e. when additional risk mitigation measures are no longer required.
The latest approved versions of the materials for which the Marketing authorisation holder agrees to publish are published on the JAZMP website.
Source: Jazmp web page, the Instructions for submitting the application for reviewing the Educational material, from 17.6.2021.