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You are here: Home Sections Marketing authorisation medicines for human use Documents MEB 45: National implementation of additional risk minimisation measures

MEB 45: National implementation of additional risk minimisation measures

An important element of a risk management plan (RMP) is a clear description of the necessary measures in order to minimise the risks when using the medicinal product. A distinction is made between routine risk minimisation measures, and additional risk minimisation measures.

Download "MEB 45: National implementation of additional risk minimisation measures"

PDF document | 30 pages | 507 kB

Policy document | 30-03-2022

Download "MEB 45: Nationale implementatie additionele risicominimalisatie-maatregelen"

PDF document | 31 pages | 553 kB

Policy document | 30-03-2022

Relevant links

  • GVP Module XVI Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 2)
  • European Medicines Agency's Working Group on Quality Review of Documents (QRD) Product information templates
  • Guideline on the readability of the labelling and package leaflet of medicinal products for human use

See also

  • Risk management plan Topic

Belongs to

  • Marketing authorisation – medicines for human use

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