The committee advises on the safety and quality of herbal medicines when there's an application for registration, marketing authorisation or product licence.
Role of the committee
The Herbal Medicines Advisory Committee’s (HMAC) terms of reference are to:
- advise on the safety, quality and efficacy, in relation to human use, of:
- herbal medicinal products eligible for registration under the simplified traditional use registration procedure established under European Directive 2004/24/EC
- unlicensed herbal medicinal products (unless it is subject to an application for a marketing authorisation, product licence or a homeopathic certificate of registration)
- advise on the safety, quality and efficacy, in relation to human use, of herbal medicinal products which have a marketing authorisation, product licence or certificate of registration, or which are the subject of an application for such authorisation, licence or certificate, if health ministers or the licensing authority request such advice, or provide the committee with information relating to that product
The role of the committee will concern primarily issues relating to safety and quality, since there is not a requirement for efficacy to be separately demonstrated in relation to registered traditional herbal medicines or unlicensed products sold under Section 12 of the Medicines Act.
However, efficacy is still relevant - under the traditional herbal registration scheme, the pharmacological effects or efficacy of the medicinal product must be plausible on the basis of longstanding use and experience.
See guidance notes to companies on hearings and written representations to the HMAC (PDF, 49.5KB, 10 pages) .
The members of the committee are:
- Professor Philip A Routledge OBE MD FRCP FRCPE FRCGP FFPM FSB FAcadMEd FBTS FBPhS Professor of Clinical Pharmacology and Head of the Department of Pharmacology, Therapeutics and Toxicology, Cardiff University and Honorary Consultant Physician/Clinical Pharmacologist in Cardiff and Vale University Health Board
- Dr Robert C G Bracchi BSc MB BCh MD FRCGP General Practitioner and Honorary Senior Lecturer, Cardiff University
- Dr Paul D Bremner PhD BSc MBA SFHEA Senior Lecturer, De Montfort University
- Ms Alison M Denham MA FNIMH FHEA Herbal Practitioner and Senior Lecturer in Herbal Medicine, University of Central Lancashire, Preston
- Dr Michael R Evans MB ChB Principal in General Practice, St Luke’s Medical Centre Stroud, Clinical Teacher in General Practice, University of Bristol & Faculty Member, British Postgraduate Training in Anthroposophic Medicine
- Dr Shantha B W Godagama DAMS MBAcC MF (hom) MAcF FAMA (UK) Practitioner - Ayurvedic Medicine/Acupuncture, London; President Ayurvedic Medical Association (UK); Director Ayurvedic Medical Centre Hale Clinic London; Board of Directors EHPA AMA (UK)
- Mrs Christine A Gratus BA MBA Lay Representative
- Professor Paul T C Harrison BSc PhD CBiol FSB FRSA FBTS Visiting Professor at Cranfield University and Director of PTCH Consultancy Ltd
- Professor Michael Heinrich MA MSc PhD Professor and Head of Centre for Pharmacognosy & Phytotherapy, School of Pharmacy, University of London
- Mrs Vivienne J Hinks BSc (Hons) MA MIFPA Senior Lecturer, School of Health and Wellbeing, University of Wolverhampton and Aromatherapy Practitioner
- Professor Peter Hylands BPharm PhD FRSC Director, Institute of Pharmaceutical Science, King’s College London
- Professor John Francis Mayberry DSc MD LLM FRCP Consultant Physician, University Hospitals of Leicester NHS Trust; Professor of Gastroenterology, University of Leicester
- Dr Barbara A Pendry PhD BSc (Hons) PGCE MNIMH Principal Lecturer, Herbal Practitioner and Programme Leader for Herbal Medicine at the University of East London
- Dr Deborah J Shaw BSc (Hons) PhD Independent Consultant on Herbal Safety and Pharmacovigilance
- Professor Heather M Wallace PhD FRCPath FRSC FSB FBPharmacolS FBTS European Registered Toxicologist Professor of Biochemical Pharmacology and Toxicology, Division of Applied Medicine, University of Aberdeen
- Dr Jidong Wu MB MSc MATCM Senior Lecturer and Programme Advisor in Traditional Chinese Medicine at Middlesex University
See the final summary minutes for HMAC from 2014, which you can download.
For previous minutes, see the HMAC page on the archived MHRA website
Contact the expert committee support team
Telephone: 020 3080 6000 Email: email@example.com