Paragraph 4 Requirements
Subject to sub-paragraph (2) below, the applicant shall comply with the requirements set out in Parts 7, 8 and 9 (safety testing and efficacy trials), and shall supply a copy of any certificate issued by a laboratory which carried out a safety test certifying that the test was carried out in conformity with the principles of good laboratory practice as referred to in paragraph 3 of Section A of Part 7.
In the case of an efficacy 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.