New marks on the educational materials approved by the State Agency of Medicines as risk minimisation measures

New marks on the educational materials approved by the State Agency of Medicines as risk minimisation measures

Starting from 25 June 2015 the new mark "Important information for healthcare professionals about risk minimisation of medicines" has to be placed on the educational materials for risk minimisation of medicines (EM) approved by the State Agency of Medicines (SAM) for doctors, pharmacists and other healthcare professionals. On the EM for patients (these materials should be given to the patient only by an appropriate healthcare professional) there is the new mark "Important information for patients about risk minimisation of medicines". New marks must be placed on the first page of each material.

New marks were introduced so that healthcare professionals could quickly identify EM and distinguish them from advertising materials.

In accordance with Article 34.2 of the 8 March 2005 Cabinet of Ministers Regulation No 175 "Regulations for Manufacture and Storage of Prescription Forms, as well as Writing out and Storage of Prescriptions" the doctor must comply with the risk minimisation materials established by the marketing authorisation holder and approved by SAM for safe and effective use of the particular medicines.

Educational materials for risk minimisation of medicines:

• are intended for healthcare professionals and patients in order to minimise and/ or prevent risks related to the use of medicines;
• have to be prepared by marketing authorisation holders (MAHs) refering to medicines for which additional risk minimisation measures have been required;
• have to be approved by SAM.

The list of medicines for which MAHs have prepared and SAM has approved EM is published on the SAM website in Latvian language.

It is the responsibility of the MAH to deliver the SAM approved EM to the appropriate healthcare professionals.

For further information please contact Gunta Paukšena, Senior Expert at the Pharmacovigilance Sector of the Efficacy and Safety Division of the Medicines Marketing Authorisation Department (phone: +371 67078442; e-mail: Gunta.Pauksena@zva.gov.lv).