The Human Tissue (Quality and Safety for Human Application) Regulations 2007

1. Introductory Text

2. PART 1

   1. 1. Citation and commencement

   2. 2. Extent and application

   3. 3. Designation of the competent authority

   4. 4. References to Directives

   5. 5. Interpretation of other terms

   6. 6. References to third party agreements etc

3. PART 2

   1. 7. Licensing requirement

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

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

   4. 10. Breach of requirement to hold a licence or to act under a third party agreement

   5. 11. Preconditions to grant of licence

   6. 12. Duty of designated individual

   7. 13. Information and confidentiality

   8. 14. Breach of confidentiality requirement

4. PART 3

   1. 15. Import and export of tissue and cells

   2. 16. Directions: compliance with the first, second and third Directives

5. PART 4

   1. 17. Requirement for the Authority to provide information

   2. 18. Register of licences

   3. 19. Register of serious adverse events and serious adverse reactions

   4. 20. Duties of the Authority in relation to serious adverse events and serious adverse reactions

6. PART 5

   1. 21. Inspection of documents

   2. 22. Entry and inspection of premises

   3. 23. Entry and search in connection with suspected offence

   4. 24. Execution of warrants

   5. 25. Seizure in the course of inspection or search

   6. 26. Powers: supplementary

   7. 27. Requirements when exercising power of inspection or search

   8. 28. Enforcement

   9. 29. Meaning of duly authorised person

7. PART 6

   1. 30. Remit of the Authority

   2. 31. Exclusion from licensing requirement of section 16

   3. 32. Interpretation of Part 2 of the 2004 Act

   4. 33. Applications under Schedule 3 to the 2004 Act

8. PART 7

   1. 34. Offences by bodies corporate

   2. 35. Transitional arrangements: storage licences

9. Signature

10. 1. SCHEDULE 1

       Licences for the purposes of regulation 7

       1. Power to grant licence

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

       2. Characteristics of licences

          1. 2. A licence under this Schedule may authorise the carrying-on of...

          2. 3. A licence— (a) shall designate an individual as the designated...

          3. 4. A licence — (a) shall specify the premises (other than...

          4. 5. It shall be a condition of a licence under this...

       3. Fees

          1. 6. In determining the amounts of any fees to be charged...

    2. SCHEDULE 2

       Directions for securing compliance with the first, second and third Directives

       1. Traceability and coding system

          1. 1. Directions shall require that licence holders adopt such systems as...

          2. 2. Directions given for the purposes of paragraph 1 shall include...

       2. Reporting obligations

          1. 3. Directions under paragraph 2(4)(c) to (e) of Schedule 3 to...

       3. Serious adverse events and serious adverse reactions

          1. 4. Directions shall require licence holders to adopt such—

       4. Third party agreements and termination of licensed activities

          1. 5. For the purpose of securing compliance with the requirements of...

       5. Procurement and use of tissue or cells

          1. 6. Directions shall specify the requirements to be met by all...

          2. 7. Directions shall be given— (a) for the purpose of securing...

          3. 8. In giving directions for the purposes of paragraph 7, the...

       6. Selection criteria and laboratory tests required for donors of tissues and cells

          1. 9. In relation to donors of tissues or cells who are...

          2. 10. In relation to donors of tissues or cells who are...

          3. 11. Directions shall, in respect of all donors of tissues or...

       7. Donation and procurement procedures and reception at the tissue establishment

          1. 12. In respect of— (a) donation and procurement procedures, and

       8. Requirements for holding a licence under Schedule 1

          1. 13. Directions shall be given for the purpose of securing compliance...

       9. Requirements for holding a licence under Schedule 1 for tissue and cell preparation processes

          1. 14. In respect of tissue and cell preparation processes, directions shall...

    3. SCHEDULE 3

       Appropriate statements

11. Explanatory Note