The Quality and Safety of Organs Intended for Transplantation Regulations 2012 No. 1501

1. Introductory Text

2. PART 1

   1. 1. Citation and commencement

   2. 2. Extent

3. PART 2

   1. 3. Interpretation

   2. 4. Designation of the competent authority

4. PART 3

   1. 5. Licensing requirement

   2. 6. Application of the 2004 Act in relation to licences under Schedule 1

   3. 7. Extension of other provisions of the 2004 Act to Scotland

   4. 8. Breach of requirement to hold a licence

   5. 9. Preconditions to grant of a licence

   6. 10. Duty of the licence holder

   7. 11. Directions

   8. 12. Guidance

5. PART 4 the Authority

   1. 13. Framework and compliance with licensing conditions and directions

   2. 14. Records and reports

   3. 15. Living donors

   4. 16. Serious adverse events and serious adverse reactions

   5. 17. Traceability

   6. 18. Organs sent to another country

   7. 19. European Union network of competent authorities

   8. 20. Requirement for the Authority to provide information

6. PART 5

   1. 21. Arrangements by the Authority for assistance with functions

   2. 22. Offences by bodies corporate

   3. 23. Licences: transitional arrangements

   4. 24. Review

7. PART 6

   1. 25. Amendment of the 2004 Act

   2. 26. Amendment of the 2006 Regulations

   3. 27. Amendment of the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2004

   4. 28. Amendment of the 2007 Regulations

   5. 29. Amendment of the 2006 Scotland Regulations

8. Signature

9. 1. SCHEDULE 1

      Licences for the purposes of regulation 5

      1. 1. The Authority may on application grant a licence for the...

      2. 2. Licensing conditions

      3. 3. It shall be a condition of a licence for a...

      4. 4. It shall be a condition of a licence for the...

      5. 5. It shall be a condition of a licence for the...

      6. 6. It shall be a condition of a licence for the...

      7. 7. Where any of the information specified in part A of...

      8. 8. It shall be a condition of a licence for a...

      9. 9. The conditions in paragraph 8(b) do not apply where transportation...

      10. 10. Fees

   2. SCHEDULE 2

      Directions of the Authority

      1. 1. For the purposes of ensuring consistent compliance with the licensing...

      2. 2. For the purpose of ensuring consistent standards in relation to...

10. Explanatory Note