European Risk Management Plans

| Home | | Pharmacovigilance |

Chapter: Pharmacovigilance: Risk Management - a European Regulatory View

A European Guideline on Risk Management for Medicinal Products for Human Use, also published in November 2005, sets out in detail the situations when a risk management plan is required.


EUROPEAN RISK MANAGEMENT PLANS

A European Guideline on Risk Management for Medicinal Products for Human Use, also published in November 2005, sets out in detail the situations when a risk management plan is required. In brief, a risk management plan is required for all new active substances, significant changes to marketing authorisations such as new indications (unless the competent authority agrees it is unnecessary), and when an unex-pected hazard is identified.

The EU Risk Management Plan contains 2 parts:

·   Part I

A safety specification

A pharmacovigilance plan.

·   Part II

An evaluation of the need for risk minimisa-tion activities, and if there is need for additional (i.e., non-routine) activities

A risk minimisation plan.

The sections of the guideline dealing with the safety specification and pharmacovigilance plan build on the relevant text from ICH E2E.

Contact Us, Privacy Policy, Terms and Compliant, DMCA Policy and Compliant

TH 2019 - 2022 pharmacy180.com; Developed by Therithal info.