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Paragraph 44 Clinical trial authorisations

Original text. Later amendments are not shown.

(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.