# The Medicines (Products for Human Use — Fees) Regulations 1995, Regulation 7: Variations of authorizations, licences and certificates


(1) Subject to regulations 8, 9, 19 and 23, a person who makes an application—
(a) under regulation 4 of the 1994 Regulations for the variation of a United Kingdom marketing authorization;
(b) under section 30 of the Act for the variation of a provision of a product licence, a manufacturer’s licence or a wholesale dealer’s licence; and
(c) under section 39(4) of the Act for the variation of a provision of a clinical trial certificate,
shall pay the fees mentioned in paragraph (2).
(2) The fees referred to in paragraph (1) are—
(a) the fee prescribed in Part III of Schedule 1 in connection with the application; and
(b) in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 made in connection with the application, the fee payable in accordance with paragraphs 2 to 6 of that Schedule.

---
Source: https://www.legislation.gov.uk/uksi/1995/1116/regulation/7 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/regulation-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.