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The Medicines (Products for Human Use) (Fees) Regulations 2012

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Marketing authorizations

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5.  Unless paragraphs 6 to 10 apply, the fee payable under regulation 33(3) in connection with the holding of a marketing authorization relating to a medicinal product of a kind described in column 1 of the following table is the applicable fee specified in the corresponding entry in column 2 of that table.

Periodic fees for holding marketing authorization

Column 1

Type of Medicinal Product

Column 2

Fee payable

1. New Active Substance£23,025
2. Parallel Import£300
3. Others
(a)Any product (not being a derivative of a new active substance) in respect of which a marketing authorization has been granted in consequence of a complex application submitted on or after 1st April 1989£9,481
(b)Prescription Only Medicine
(i)Standard Fee£2,371
(ii)Reduced Rate Fee£1,183
(iii)Lower Fee£300
(c)Pharmacy£300
(d)General Sale List£300
(e)Herbal remedy£75
(f)Traditional herbal registrations£75
(g)National homoeopathic product£75
(h)Homoeopathic or anthroposophic product which is the subject of a licence of right£75

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