The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007

Amendment of Schedule 3 to the Medicines Fees Regulations

9.—(1) Part III of Schedule 3 to the Medicines Fees Regulations (periodic fees for marketing authorizations and licences) is amended as follows.

(2) In the table in paragraph 1—

(a) in column (1), at the end insert the following entry—

“(h) Homoeopathic or anthroposophic product which is the subject of a licence of right”;

(b) in column (2), at the end insert the following entry—

“2(h) £68”.

(3) In paragraph 7, after sub-paragraph (2), insert the following sub-paragraph—

“(3) The fee payable under regulation 14(3) in connection with the holding of a manufacturer’s licence which relates to the import of exempt imported products from a third country shall be the fee payable in accordance with sub-paragraph (1) and an additional amount calculated in accordance with paragraph 9B.”.

(4) In paragraph 8, in sub-paragraph (1), for “paragraph 9” substitute “paragraphs 9 and 9A”

(5) After paragraph 9, insert the following paragraphs—

“9A.   The fee payable under regulation 14(3) in connection with the holding of a wholesale dealer’s licence which relates to exempt imported products shall be the fee payable in accordance with paragraphs 8 and 9 and an additional amount calculated in accordance with paragraph 9B.

Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products

9B.— (1) The additional amount referred to in paragraphs 7(3) and 9A in relation to any fee period shall be the fee specified in the entry in column 2 of the following table corresponding to the estimated number of special import notices for that fee period specified in column 1.

Column 1 Number of special import notices	Column 2 Additional amount
1 to 100	£100
101 to 1,000	£500
1,001 to 10,000	£5,000
10,001 to 25,000	£17,000
25,001 to 50,000	£37,000
50,001 to 100,000	£75,000
100,001 to 150,000	£125, 000
150,001 to 200,000	£175,000
200,001 or more	£250,000

(2) For the purposes of this paragraph, the estimated number of special import notices for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.”.