The Medicines for Human Use (Fees Amendments) Regulations 2006

Amendment of the Homoeopathic Regulations

5.  In Schedule 2 to the Homoeopathic Regulations (fees for applications for the grant of certificates of registration), in paragraph 3—

(a) after the definition of “formulation” insert—

““homoeopathic marketing authorization” means a marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations(1) in respect of a national homoeopathic medicinal product;”;

(b) after the definition of “mutual recognition procedure incoming application” insert—

““national homoeopathic product” has the meaning given by regulation 4(1B) of the Marketing Authorisation Regulations;”;

(c) in the definition of “repeat formulation”, in paragraph (a)—

(i) in sub-paragraph (i), after “certificate of registration” insert “or a homoeopathic marketing authorization”,

(ii) in sub-paragraph (ii), after “certificate of registration” insert “or the homoeopathic marketing authorization”; and

(d) in the definition of “repeat stock”, in paragraph (a)—

(i) in sub-paragraph (i), after “certificate of registration” insert “or a homoeopathic marketing authorization”, and

(ii) in sub-paragraph (ii)—

(aa) after “a certificate of registration” insert “or a homoeopathic marketing authorization”, and

(bb) after “the certificate of registration” insert “or homoeopathic marketing authorization”.

(1)

See the definition of “Marketing Authorisation Regulations” in section 132(1) of the Medicines Act 1968 (c. 67), as inserted by S.I. 2005/1094.