# The Medicines (Products for Human Use) (Fees) Regulations 2012, Paragraph 44: Clinical trial authorisations


(1) The fee payable under regulation 19(1) in connection with a notice of amendment relating to amendment to the dossier accompanying a request for authorisation to conduct a clinical trial is—
(a) £265 if the amendments relate to one of the parts of the dossier specified in sub-paragraph (2) only;
(b) £530 if the amendments relate to two parts of the dossier specified in sub-paragraph (2) only; or
(c) £795 if the amendments relate to all three parts of the dossier specified in sub-paragraph (2) only.
(2) The parts of the dossier specified in sub-paragraph (1) are—
(a) the part containing the summaries of the chemical, pharmaceutical and biological data relating to the medicinal product tested or used in the trial;
(b) the part containing the summaries of the non-clinical, pharmacological and toxicology data on that product; and
(c) the part containing the summaries of the available data from previous clinical trials of, and human experience with, that product.

---
Source: https://www.legislation.gov.uk/nisr/2012/134/schedule/2/paragraph/44 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-44
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.