Regulation 26 Amendment of Schedule 4
Schedule 4 (periodic fees for licences) is amended as follows.
In paragraph 5 (marketing authorisations), in column 2 (fee payable) of the table (periodic fees for holding a marketing authorisation)—
in entry 1, for “£9,710” substitute “£10,681”,
in entry 2, for “£307” substitute “£338”,
in entry 3(a), for “£9,710” substitute “£10,681”,
in entry 3(b)(i), for “£2,428” substitute “£2,671”,
in entry 3(b)(ii), for “£1,211” substitute “£1,332”,
in entries 3(b)(iii), (c) and (d), for “£307” substitute “£338”, and
in entries 3(e) to (h), for “£76” substitute “£84”.
In paragraph 6 (marketing authorisation: where Part 2 of the Act applies), for “£307” substitute “£338”.
In paragraph 7 (marketing authorisation: derivatives)—
in sub-paragraph (a), for “£9,710” substitute “£10,681”, and
in sub-paragraph (b), for “£6,554” substitute “£7,209”.
In paragraph 11(1) and (2) (manufacturer’s licences or manufacturing authorisations), for “£468” substitute “£515”.
In paragraph 12 (wholesale dealer’s licences)—
in sub-paragraph (1), for “£288” substitute “£317”, and
in sub-paragraph (2), for “£172” substitute “£189”.
For paragraph 15(1), substitute—
“(1)The additional amount referred to in paragraphs 11(3) and 14 in relation to any fee period is—
(a)the fee specified in the entry in column 2 of Table 1 (additional periodic fee in connection with notices for imported special medicinal products) corresponding to the estimated number of special import notices for that fee period specified in column 1, and
(b)the fee specified in the entry in column 2 of Table 2 (additional periodic fee in connection with the number of different special medicinal products imported) corresponding to the estimated number of different special medicinal products imported for that fee period specified in column 1.
Table 1
Additional periodic fee in connection with notices for imported special medicinal products
Column 1 Column 2 Number of special import notices Additional amount 1 to 20 £70 21 to 100 £350 101 to 1,000 £2,400 1,001 to 5,000 £12,000 5,001 to 20,000 £30,000 20,001 to 50,000 £60,000 50,001 to 100,000 £120,000 100,001 or more £200,000 Table 2
Additional periodic fee in connection with the number of different special medicinal products notified for import
Column 1 Column 2 Number of different special medicinal products notified for import Additional amount 1 to 5 £100 6 to 10 £200 11 to 20 £400 21 to 50 £1,000 51 to 100 £2,000 101 to 200 £4,000 For each additional 100 special medicinal products notified for import above 200 £2,000 ”
After paragraph 15(2), insert—
“(3)For the purposes of this paragraph, the estimated number of different special medicinal products notified for import 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.”.
In paragraph 16 (traditional herbal registrations), for “£76” substitute “£84”.