The Medicines (Advisory Bodies) (No. 2) Regulations 2005
These Regulations make amendments to the Medicines Act 1968 (“the Act”), and related legislation, to make further provision in relation to the statutory bodies which provide advice in relation to medicinal products. The Medicines (Advisory Bodies) Regulations 2005 amend the Act, and related legislation, to establish a new body called the Commission on Human Medicines and introduce new procedures for applications for, and decisions in respect of, licences under the Medicines Act 1968 and marketing authorizations under the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994, which are granted in accordance with Directive 2001/83/EC on the Community code relating to medicinal products for human use (“the 2001 Directive”).