15.—(1) The Authority shall give such directions to licence holders or designated individuals under section 23(1) of the 2004 Act, as applied by regulation 8, as it considers necessary for the purpose of securing that all imports of tissue and cells intended for human application from countries which are not EEA states meet standards of quality and safety equivalent to those provided for in these Regulations.
(2) In giving any directions for the purposes of paragraph (1) the Authority shall have regard to ensuring traceability.