Regulation 2 Responsibility for Member States' functions under the Regulations and Directives

In so far as they relate to relevant medicinal products and fall to be performed by, or by any authority of, the United Kingdom, the functions of a Member State, or of the competent authority of a Member State, under any of the relevant Community provisions shall, subject to paragraph (2), be performed by the licensing authority.

Paragraph (1) shall not apply in so far as any such functions fall to be performed by the exercise of any powers or duties which are conferred by any provision of these Regulations, or by any provision of the Act as applied by these Regulations, on a person or body other than the licensing authority.