Amendment of regulation 8 of the Homoeopathic Regulations
9.—(1) Regulation 8 of the Homoeopathic Regulations (duration and renewal of certificates) is amended as follows.
(2) In paragraph (1)—
(a)before “A certificate of registration” insert “Subject to paragraph 2A,”; and
(b)omit the words from “or the date from which” to the end.
(3) In paragraph (2)—
(a)after “the licensing authority” insert “in accordance with the provisions of the 2001 Directive”; and
(b)omit the words from “for five years” to the end.
(4) After paragraph (2) insert the following paragraph—
“(2A) A certificate of registration shall cease to be valid if the homoeopathic medicinal product in respect of which it was granted is not placed on the market in the UK for a period of three consecutive years.”.
(5) Omit paragraphs (3) and (4).
(6) After paragraph (4) insert the following paragraph—
“(5) Schedule 5 shall have effect to regulate the procedure for receiving advice and representations before renewing or refusing to renew a certificate of registration.”.