# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 15: Marketing authorizations


Subject to paragraphs 17 to 19 and 26 to 28, the fee payable under regulation 18(1) in connection with an application for a variation of a marketing authorization of a kind described in column 1 of the following table is—
(a) if the application is an eCTD format application, the fee specified in the corresponding entry in column 2 of that table;
(b) if the application is not an eCTD format application, the fee specified in the corresponding entry in column 3 of that table.
Fees for applications for variations of marketing authorizations
Column 1
Kind of application
Column 2
Fee payable if in eCTD format
Column 3
Fee payable for application not in eCTD format
1. Application where, for the purposes of Commission Regulation (EC) No. 1084/2003, the United Kingdom is the reference Member State as defined in Article 3.4 of that Regulation
(a)
Type IA Application
£278
£292
(b)
Type IB Application
£556
£583
(c)
Type II Application
£900
£944
(d)
Type II Complex Variation Application
£14,586
£15,298
(e)
Extended Type II Complex Variation Application
£36,290
£38,062
2. Other variation applications
(a)
BROMI Self Certification Application
£176
£178
(b)
Type IA Application
£180
£188
(c)
BROMI Type 1A Application
£180
£188
(d)
Type 1B Application
£280
£296
(e)
BROMI Type 1B Application
£280
£296
(f)
Type II Application
£744
£778
(g)
Type II Complex Variation Application
£8,412
£8,824
(h)
Extended Type II Complex
Variation Application
£25,962
£27,228
(i)
Reclassification variation
Application
£8,264
£8,666

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Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/15 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-15
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.