Revised: 22 March 2016
Committees
Medicines Adverse Reactions Committee
Terms of reference
The Medicines Adverse Reactions Committee (MARC) is a technical advisory committee established under section 8 of the Medicines Act 1981 to advise the Minister of Health on the safety of approved medicines.
The terms of reference of the Medicines Adverse Reactions Committee are as follows:
- To provide expert advice to the Director-General of Health and Minister of Health in relation to the safety or efficacy of a medicine that is the subject of a notice issued under section 36 of the Medicines Act 1981.
- To consider information about the safety of medicines (including
vaccines) that is referred to the Committee by Medsafe and provide expert
advice to the Minister of Health and Medsafe on:
- the interpretation of the information
- the significance of the information in relation to the risk-benefit profile of the medicines
- whether a regulatory intervention under the Medicines Act 1981 is desirable to minimise the risks from use of the medicine.
Meetings
The Medicines Adverse Reactions Committee (MARC) meets four times a year in Wellington and generally for a full day. Secretarial support is provided by Medsafe.
Membership
The Medicines Adverse Reactions Committee (MARC) comprises up to 13 members with any of the following:
- substantial clinical experience and national credibility in one or more of the following: clinical pharmacology, general medicine, paediatrics, general practice and other medical specialties (eg, cardiology)
- a tertiary qualification and extensive experience in epidemiology
- a tertiary qualification and extensive experience in clinical pharmacy
- experience in representing consumer interests.
The MARC also includes one representative from the New Zealand Pharmacovigilance Centre. Members are appointed for a three year term, which may be renewed once for a further three years. Medsafe is always willing to hear from suitably experienced candidates who are willing to be considered for appointment by the Minister of Health, even during a period when specific appointments are not being sought
