§ Mr. Simon HughesTo ask the Secretary of State for Health what statutory responsibility applies to the licensing authority in respect of the protection of public health from unsafe medicines. [14296]
§ Mr. MaloneFunctions of the competent authorities of member states in respect of the licensing of medicinal products for human use are laid down in directive 65/65/EEC and subsequent EC legislation. For the United Kingdom, these functions fall to the licensing authority and these obligations and licensing requirements are set out in SI 1994/3144, the Medicines Acts and other relevant subordinate legislation. The requirements are intended to ensure that unsafe medicines are not marketed, and to safeguard public health.