Regulation 4 Insertion of regulation 2A of the Homoeopathic Regulations

After regulation 2 of the Homoeopathic Regulations insert the following regulation—

“Responsibility for Member States' functions in relation to homoeopathic medicinal products

2A.

(1)

In so far as they relate to homoeopathic medicinal products to which these Regulations apply 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 provisions of the 2001 Directive shall, subject to paragraph (2), be performed by the licensing authority.

(2)

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.”.