# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 39: Variation of marketing authorisations


(1) Subject to sub-paragraph (3) and paragraph 39A , if an application to vary a marketing authorisation of a kind described in sub-paragraph (2) is—
(a) the first application to vary a marketing authorisation;
(b) made within 5 years of the date of grant of the marketing authorisation; and
(c) an application to authorise use of the medicinal product in a new therapeutic area,
the fee payable for that application is the fee payable under regulation 19(1) together with the difference between that fee and the fee which would have been payable if the application had been a major application.
(2) In this paragraph a marketing authorisation is one which has been granted in accordance with an application to which point 6 of Part II of Annex I to the 2001 Directive applies or which is an orphan marketing authorisation.
(3) Sub-paragraph (1) and (2) shall not apply where the first application for variation of the marketing authorisation relates to a therapeutic area, in respect of which the applicant would be entitled (had the applicant not already held a marketing authorisation) to apply for a marketing authorisation to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of a medicinal product which meets the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations.

---
Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/39 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-39
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.