European Risk Management Plans
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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.
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