# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 15: Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products


(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
£86
21 to 100
£427
101 to 500
£2,131
501 to 1,000
£4,261
1,001 to 2,000
£8,521
2,001 to 5,000
£17,042
5,001 to 10,000
£34,083
10,001 to 15,000
£51,125
15,001 to 20,000
£68,166
20,001 to 25,000
£85,208
25,001 to 30,000
£102,249
30,001 to 35,000
£119,291
35,001 to 40,000
£136,333
40,001 to 45,000
£153,375
45,001 to 50,000
£170,417
Each additional 5,000 above 50,000
£170,417 plus £17,042 for each additional 5,000 special import notices
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
£122
6 to 10
£244
11 to 20
£487
21 to 50
£1,218
51 to 100
£2,435
101 to 200
£,4,869
For each additional 100 special medicinal products notified for import above 200
£4,869 plus £2,435 for each additional 100 special medicinal products notified for import
(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.
(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.

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/4/paragraph/15 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-15
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.