V.A. Introduction

Location:
V.A.
In force from:
31.03.2017

V.A. Introduction

A medicinal product is authorised on the basis that in the specified indication(s), at the time of authorisation, the risk-benefit balance is judged to be positive for the target population. Generally, a medicinal product will be associated with adverse reactions and these will vary in terms of severity, likelihood of occurrence, effect on individual patients and public health impact. However, not all adverse reactions and risks will have been identified at the time when an initial marketing authorisation is granted and some will only be discovered and characterised in the post-authorisation phase. The aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. To this end, the RMP contains:

  1. the identification or characterisation of the safety profile of the medicinal product, with emphasis on important identified and important potential risks and missing information, and also on which safety concerns need to be managed proactively or further studied (the ‘safety specification’);
  2. the planning of pharmacovigilance activities to characterise and quantify clinically relevant risks, and to identify new adverse reactions (the ‘pharmacovigilance plan’);
  3. the planning and implementation of risk minimisation measures, including the evaluation of the effectiveness of these activities (the ‘risk minimisation plan’).

As knowledge regarding a medicinal product’s safety profile increases over time, so will the risk management plan change.

Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR) include provisions for post-authorisation safety studies and post-authorisation efficacy studies to be a condition of the marketing authorisation in certain circumstances [REG Art 9(4)(cb) and (cc), REG Art 10a(1)(a) and (b), DIR Art 21a(b) and (f), DIR Art 22a(1)(a) and (b)] and for these studies to be included in the risk management system [REG 14a, DIR Art 22c(1), IR Art 30(1)(d)]. The legislation also includes provisions for additional risk minimisation activities to be included in the risk management system as a condition to the marketing authorisation [REG Art 9(4)(ca), DIR Art 21a(a)]. Marketing authorisation applicants are encouraged to plan from very early on in a product’s life cycle how they will further characterise and minimise the risks associated with the product in the post-authorisation phase.

Guidance on templates and submission of RMPs is kept up-to-date on the Agency’s website (1) .

This Module includes the principles of risk minimisation and should be read in conjunction with GVP Module XVI and GVP Module XVI Addendum I on educational materials. In this Module, all applicable legal requirements are referenced in the way explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”.

The following articles provide the main references in relation to the legal basis for risk management but additional articles may also be relevant: