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Part 3 Clinical investigations under Regulation (EU) 2017/745

Original text. Later amendments are not shown.

  1. 11Ethical review of clinical investigations
  2. 12Prior authorisation of clinical investigations by the Secretary of State
  3. 13Arbitration following the refusal of a clinical investigation application
  4. 14Damage compensation in relation to clinical investigations
  5. 15Retention of documentation relating to clinical investigations
  6. 16Clinical investigation fees
  7. 17Clinical investigations not carried out for a purpose specified in Article 62(1)