Regulation 6 Amendment of Schedule 3 to the principal Regulations

In paragraph 1 (interpretation) of Part I of Schedule 3 (periodic fees) to the principal Regulations, in the definition of “maintenance fee”, in sub-paragraph (b) for “the relevant calendar year” substitute “that period”.

For paragraph 3 (derivatives of new active substances) of Part III (periodic fees for marketing authorizations and licences) of Schedule 3 to the principal Regulations substitute—

“3

Subject to paragraph 4, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 14(3) shall be—

(a)

where it has a different route of administration from that of the new active substance, £4,800;

(b)

in any other case, £3,400.”.

In paragraph 4 (transitional arrangements for periodic fees) of Part III of Schedule 3 to the principal Regulations omit sub-paragraphs (1) and (2).

In Part IV (marketing authorizations for which a single periodic fee is payable) of Schedule 3 to the principal Regulations omit paragraph 2 (homoeopathic or anthroposophic products).