The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

Amendment of Schedule 3 to the principal Regulations

9.—(1) Schedule 3 to the principal Regulations (periodic fees for licences) shall be amended in accordance with the following paragraphs of this regulation.

(2) In Part I (interpretation), in the definition of “limited use drug”in paragraph 1, for the words “paragraph 5 of Chapter III of Part 3 of the Annex to the Council Directive 75/318/EEC” there shall be substituted “paragraph 5 of Schedule 2 to the Applications Regulations”.

(3) In Part III (periodic fees for licences)—

(a) in paragraph 4, for sub-paragraph (4) there shall be substituted the following sub-paragraph—

“(4) Where a product licence is surrendered and at the same time another product licence held by the licence holder is varied so as to include in that other licence the provisions of the surrendered licence—

(a) where the varied licence relates to a new active substance, the fee payable in respect of the varied licence shall, for each fee period mentioned in sub-paragraph (1) above, be that specified at entry 1 of the Table in paragraph 1;

(b) in all other cases, the fee payable in respect of the varied licence shall, for each fee period mentioned in sub-paragraph (3) above, be that specified at entry 2(a) of that Table.”;

(b) in sub-paragraph 2(a) of paragraph 8, after “that pharmacy” there shall be inserted “or, where the licence does not relate to anything done in a registered pharmacy, where the licence holder’s total turnover of the sale by way of wholesale dealing of licensed medicinal products does not exceed £30,000.”.