Terms of reference

Terms of reference for the Commission on Human Medicines.

The Commission on Human Medicines was established in October 2005. Its functions are set out in regulation 10 of the Human Medicines Regulations 2012 (SI 2012/1916).

The functions of the Commission on Human Medicines are:

  • to advise the Health Ministers and the Licensing Authority (LA) on matters relating to human medicinal products including giving advice on the safety, quality and efficacy of human medicinal products where either the Commission thinks it appropriate or where it is asked to do so
  • to consider those applications that lead to LA action as appropriate (eg where the LA has a statutory duty to refer or chooses to do so)
  • to consider representations made (either in writing or at a hearing) by an applicant or by a licence or marketing authorisation holder in certain circumstances
  • to promote the collection and investigation of information about adverse reactions to human medicines so advice can be given

The Commission is similarly involved in respect of medicinal products to which relevant EC legislation applies.