Commission On Human Medicines - Terms of Reference

Terms of Reference

The duties of the Commission which came into being on 30 October 2005 are set out in Section 3 of the Medicines Act 1968, as amended by the Medicines (Advisory Bodies) Regulations 2005 and include the following:

  • to advise ministers on matters relating to human medicinal products (except those that fall under the remit of Advisory Board on the Registration of Homoeopathic Products (ABRH) and Herbal Medicines Advisory Committee (HMAC))
  • to advise the licensing authority (LA) where the LA has a duty to consult the Commission or where the LA chooses to consult the Commission including giving advice in relation to the safety, quality and efficacy of human medicinal products
  • to consider representations made in relation to the Commission’s advice (either in writing or at a hearing) by an applicant or by a licence or marketing authorisation holder
  • to promote the collection and investigation of information relating to adverse reactions for human medicines (except for those products that fall within the remit of ABRH or HMAC) for the purposes of enabling such advice to be given.

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