36067 - Drugs (Answered)

Frank Field
To ask the Secretary of State for Health, if his Department will reconsider the Medicines and Healthcare Products Regulatory Authority exemption which prior to 2013 enabled organisations to send surplus medicines to (a) developing countries and (b) other countries outside of the EEA.

George Freeman

The Medicines and Healthcare products Regulatory Agency is the government body responsible for the safety and licensing of human medicines in the United Kingdom. The supply of a medicine for human use by way of wholesale requires the holding of a wholesale dealer’s licence. Following the transposition of the European Falsified Medicines Directive, the provisions of which are intended to prevent counterfeit medicines from entering the regulated supply chain, this requirement was extended to the export of medicines outside of Europe by way of wholesale from October 2013. The Directive does not allow any exception or exemption from this requirement.