Members to the MHRA Committee HMAC

Job summary

The Medicines and Healthcare products Regulatory Agency (MHRA) is looking to appoint two experts to the Herbal Medicines Advisory Committee (HMAC).

This is for a toxicologist (not requiring a formal or specific interest in herbal medicine) anda specialist in phytochemistry and pharmaceutical quality and standards, including quality assurance of herbal medicinal products.

Main duties of the job

Members of HMAC are required to:

possess or develop a working knowledge and understanding of the UK and any relevant European medicines regulatory procedures in relation to herbal medicines

attend all scheduled and unscheduled meetings of HMAC (and to be present for the whole meeting)

consider, comment and contribute by drawing on their individual expertise and judgement, as appropriate, on all agenda items and to assist HMAC to frame clear and unequivocal advice to the MHRA in accordance with HMACs terms of reference

be able and prepared to speak on a range of relevant issues and not just on their own areas of specialism

provide formal and informal advice to the MHRA between meetings when required

contribute to and ensure that HMACs advice takes account of a wider view of risk - benefit, particularly as it is perceived by patients, carers and other members of the public

About us

The HMAC (the Committee) was established on 30 October 2005 under section 4 of the Medicines Act 1968. The functions of the Committee are now set out in Part 1 of Schedule 11 to the Human Medicines Regulations 2012. It is an MHRA Expert Committee.

The terms of reference are to give advice on the safety, quality and efficacy in relation to human use, of:

(a) herbal medicinal products eligible for registration under the simplified traditional use registration procedure set out in Part 7 of the Human Medicines Regulations 2012 and;

(b) unlicensed herbal medicinal products (unless it is subject to an application for a marketing authorisation, product licence or a homeopathic certificate of registration).

The primary role of the Committee will be 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 241 of the Human Medicines Regulations. 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 long-standing use and experience.