Clinical trial authorisations
24.—(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)£252, if the amendments relate to one of the parts of the dossier specified in sub-paragraph (2) only ;
(b)£505, if the amendments relate to two parts of the dossier specified in sub-paragraph (2) only; or
(c)£757, 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 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.