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The Medicines (Products for Human Use) (Fees) Regulations 2013 (revoked)
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- UK Statutory Instruments
- 2013 No. 532
- SCHEDULE 2
- PART 2
- Paragraph 25
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Version Superseded: 01/04/2016
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Fees where application includes reclassificationU.K.
This section has no associated Explanatory Memorandum
25.—(1) Unless paragraph 27 applies, where an application, other than a major application, includes a reclassification element and—
(a)the reclassification falls within the category of application described in paragraph 15(a), an amount of £13,324 is payable in addition to the amount payable under paragraph 24 in respect of that application; or
(b)the reclassification falls within the category of application described in paragraph 15(b), an amount of £9,069 is payable in addition to the amount payable under paragraph 24 in respect of that application.
(2) For the purposes of this paragraph, an application includes a reclassification element if—
(a)in the case of an application falling within the category described in paragraph 15(a), the medicinal product in question is to be available in the United Kingdom only from a pharmacy, unless there is an analogous medicinal product available in the United Kingdom only from a pharmacy or on general sale; or
(b)in the case of an application falling within the category described in paragraph 15(b), the medicinal product in question is to be available in the United Kingdom on general sale, unless there is an analogous medicinal product also so available.
(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorisation or a European Union marketing authorisation and which—
(a)has the same active ingredient, route of administration and use,
(b)has the same strength or a higher strength,
(c)has the same dosage or daily dosage, or a higher dosage or daily dosage, and
(d)is for sale or supply at the same quantity or a greater quantity,
as the medicinal product in relation to which the application is made.
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