XVI.A.1. Terminology

Definitions are presented in GVP Annex 1, including the following developed for this Module:

XVI.A.1.1. Risk minimisation measure

Risk minimisation measure’ (RMM) is defined, for the purpose of this GVP Module, as an intervention intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicinal product, or to reduce their severity or impact on the patient should an adverse reaction occur.

The term ‘RMM’ is an umbrella term covering the following terms referred to in the legislation: ‘measures for ensuring the safe use of a medicinal product to be included in its risk management system’, ‘measures to prevent or minimise the risks associated with the medicinal product’, ‘interventions designed to prevent or minimise risks relating to a medicinal product’, ‘risk minimisation activities relevant to the risk-benefit assessment’, ‘regulatory action following consideration of options for risk minimisation and prevention’, and ‘other conditions or restrictions with regard to the safe and effective use of a medicinal product’.

Conceptually, a RMM consists of two components:

• RMM messages: the key information (i.e. not the full wording) about the risk and the actions intended to be taken by the healthcare professional or the patient for minimising the risk; and
• RMM tool: the tool by which the RMM messages are disseminated and adherence to the intended actions for risk minimisation is supported and/or controlled, belonging either to the category of routine or additional RMM tools (see XVI.B.2.).

RMM messages can be verbally explicit or non-verbal implicit (e.g. a restricted pack size as a RMM tool may imply e.g. the message that overdose is a specific risk to be avoided or that medical supervision of the treatment with this medicinal product is required; also a risk minimisation control programme, e.g. a traceability system or healthcare facility accreditation required for using a given medicinal product, carry implicit messages for the target audience); however, there will always be verbal messages at least in the product information and, if applicable, in further RMM materials.

For a specific medicinal product, a RMM material is the final individual RMM with its full wording in the local language(s) as approved by the competent authorities.

XVI.A.1.2. Patient

‘Patient’ is defined, for the purpose of this GVP Module, as an individual using or considering the use of a medicinal product (including (healthy) individuals using vaccines and other medicinal products not intended to treat or alleviate a disease) as well as the embryo/foetus/child who may be adversely affected by a medicinal product at conception, in utero or through breastfeeding, and an individual who may be adversely affected through occupational, accidental or illegal5 exposure to a medicinal product.

For the ease of reading, the term also includes parents, other carers, as well as patient and consumer representatives and organisations, as they may also be target populations of RMM (see XVI.A.1.4.).

XVI.A.1.3. Healthcare professionals

‘Healthcare professionals’ are defined, for the purposes of this GVP Module, as persons providing professional healthcare6 to individual patients.

For the ease of reading, the term also includes healthcare professional representatives and organisations (including learned societies and clinical guideline working groups), as they may be target populations of RMM (see XVI.A.1.4.).

For the purpose of this GVP Module, the term ‘healthcare professional’ does not include those who are qualified as a healthcare professional but work as employees of a marketing authorisation holder or a competent authority.

XVI.A.1.4. Target population (risk minimisation measure)

‘Target population (risk minimisation measure)’ is defined, for the purposes of this GVP Module, as the group of individuals who are intended to either receive given RMM materials, be aware of the RMM messages and take the actions intended for risk minimisation, or to provide for systems in healthcare settings supporting that intended actions are taken.

When using this term, the definitions of patients (see XVI.A.1.2.) and healthcare professionals (see XVI.A.1.3.) apply, and subgroups of these populations may be specified further, where applicable. For the ease of reading, the term is abbreviated to target population (for definitions of ‘target population’ for the purposes of other GVP Modules, see GVP Annex I).