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The Human Tissue (Quality and Safety for Human Application) Regulations 2007
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PART 3REGULATION OF LICENSED ACTIVITIES
Import and export of tissue and cells
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.
Directions: compliance with the first, second and third Directives
16.—(1) The Authority shall give directions to licence holders or designated individuals under section 23(1) of the 2004 Act, as applied by regulation 8, in accordance with Schedule 2 for the purpose of securing compliance with the requirements of the first, second and third Directives.
(2) The Authority shall give such other directions to licence holders or designated individuals under section 23(1) of that Act, as applied by regulation 8, as it considers necessary for securing compliance by licence holders and third parties with any requirements of the first, second and third Directives.
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