Paragraph 13

in article 1 (citation, commencement and interpretation), in paragraph (2), for the definition of “clinical trial exemption” substitute the following definition—

• ““clinical trial” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2003;”; and

in article 3B (prescribing and administration by supplementary prescribers), in paragraph (3), in sub-paragraph (b), in head (ii), for the words from “and—” to the end substitute “ which has been authorised, or is to be treated as having been authorised, by the licensing authority in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2003 ”.