The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make further amendments to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994, the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 in connection with the transposition of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (“the 2001 Directive”) and Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Regulation 2 amends the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 to disapply the labelling requirements in Schedule 5 to those Regulations (which are supplementary to the requirements in Title V of the 2001 Directive) to antiviral medicines in solutions for children under one year of age whilst a disease which poses a serious risk, or potentially poses a serious risk, to human health is pandemic or imminently pandemic where the medicine is for the purpose of treating that disease. Instead of the disapplied requirements, the container of the medicine needs to be labelled to show only the name of the child to be treated, the date on which the medicine was dispensed and the necessary and usual instructions for proper use.

Regulation 3 amends the Medicines for Human Use (Clinical Trials) Regulations 2004 to allow for notice of urgent safety measures (taken in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety and the circumstances giving rise to those measures) to be given as soon as possible to the licensing authority and an ethics committee established under Part 2 of those Regulations during a period in which a disease is pandemic and is a serious risk to human health or potentially a serious risk to human health.

Regulation 4 of these Regulations amends regulation 8 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 to enable the wholesale distribution of unauthorised medicinal products in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation which could cause harm. It also incidentally corrects an erroneous reference in paragraph (3)(b) of that regulation to Article 5(2) of the 2001 Directive.

An Impact Assessment has been prepared in respect of these Regulations which is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.