Committee on Safety of Medicines(redirected from Committee on the Safety of Medicines)
Commission on Human MedicinesA body established by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2005, which combines the functions of the Committee on Safety of Medicines and the Medicines Commission.
Commission on Human Medicines duties:
• 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)).
• 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.
• 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.
• 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.