Paragraph 5 Requirements
(1)
Subject to sub-paragraph (2) below, the applicant shall comply with the requirements set out in Part 4 (pre-clinical and clinical testing).
(2)
In the case of a trial of a product conducted in the United Kingdom, unless the trial is one under which the product is not to be identified, the labelling of any container and package of the product shall comply with the requirements contained in regulations relating to such product made under section 85(1) of the Act for the time being in forcef1.