Definitions of terms

Location:
1. Definitions of terms
In force from:
15.07.2019
  • Educational materials targeting healthcare professionals – an important communication for healthcare professionals, distributed in order to reduce risks and hence improve the risk/benefit ratio of the respective medicinal product. The materials supplement, specify or broaden information on the pharmaceutical contained in the SmPC that are relevant to the procedures and measures necessary for the safe use of the medicinal product and for the prevention of adverse reactions thereto or to mitigate their consequences. The obligation to develop and distribute EM is imposed on the basis of a decision adopted by EMA, CMDh or the national drug agency (SÚKL), or on the basis of the marketing authorisation holder´s proposal for measures to mitigate risks. The objective and content of EM shall be described in detail in the Risk Management Plan (RMP).
  • Educational materials for patients – an important communication for the patients supplementing, specifying or broadening information about the medicinal product contained in the PIL. The materials concern procedures and measures necessary for the safe use of the medicinal product and for the prevention of adverse reactions thereto or to mitigate their consequences, so as to improve the risk/benefit ratio of the medicinal product. The obligation to develop and distribute EM is imposed on the basis of a decision adopted by EMA, CMDh or the national drug agency (SÚKL), or on the basis of the marketing authorisation holder´s proposal for measures to mitigate risks. The objective and content of EM shall be described in detail in the Risk Management Plan (RMP).
  • Patient Alert Card – an important communication for the patient or healthcare professionals on the medicinal product taken by the patient, on procedure(s) completed by the patient in relation with the use of the medicinal product, and on situations where certain safety risks could develop (e.g. possible interactions, teratogenic nature of the active substance, increased risk of adverse reaction incidence, etc.). The obligation to develop and distribute a Patient Alert Card shall be described in detail in the Risk Management Plan (RMP).