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

1. Introductory Text

2. PART 1 CITATION, COMMENCEMENT, EXTENT AND INTERPRETATION

   1. 1. Citation and commencement

   2. 2. Extent and application

   3. 3. Designation of the competent authority

   4. 4. References to Directives

   5. 4A. Modifications to the first, second, third and fourth Directives: general

   6. 4B. Modifications to the first Directive

   7. 4C. Modifications to the second Directive

   8. 4D. Modifications to the third Directive

   9. 4E. Modifications to the fourth Directive

   10. 5. Interpretation of other terms

   11. 6. References to third party agreements etc

3. PART 2 LICENSING OF ACTIVITIES RELATING TO THE USE OF TISSUE FOR HUMAN APPLICATION

   1. 7. Licensing requirement

   2. 7A. Import into Northern Ireland from the EEA

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

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

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

   6. 11. Preconditions to grant of licence

   7. 12. Duty of designated individual

   8. 13. Information and confidentiality

   9. 14. Breach of confidentiality requirement

4. PART 3 REGULATION OF LICENSED ACTIVITIES

   1. 15. Import and export of tissue and cells

   2. 16. Directions: Great Britain

   3. 16A. Directions: compliance with first, second, third and fourth Directives as they apply in relation to Northern Ireland

5. PART 4 OBLIGATIONS OF THE AUTHORITY

   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

   5. 20A. Duties of the Authority in relation to application of the Single European Code in relation to Northern Ireland

   6. 20B. Inspection of third country premises etc , Northern Ireland

   7. 20C. Third country premises and third country suppliers: report of inspections etc , Northern Ireland

6. PART 5 INSPECTION, ENTRY, SEARCH AND SEIZURE

   1. 21. Inspection of documents

   2. 21A. Inspection of documents to be held by an importing licence holder , Northern Ireland

   3. 22. Entry and inspection of premises

   4. 22A. Importing licence holders: requests for inspections , Northern Ireland

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

   6. 24. Execution of warrants

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

   8. 26. Powers: supplementary

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

   10. 28. Enforcement

   11. 29. Meaning of duly authorised person

7. PART 6 AMENDMENTS TO THE 2004 ACT

   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 GENERAL

   1. 34ZA. Powers to make regulations in relation to standards of quality and safety, Great Britain

   2. 34ZB. Scope and nature of powers

   3. 34ZC. Scrutiny of regulations

   4. 34. Offences by bodies corporate

   5. 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...

          5. 5A. Where the Authority grants a licence under this Schedule authorising...

       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, third and fourth Directives

       1. Traceability and coding system

          1. 1. In relation to Great Britain, directions shall require that licence...

          2. 1ZA. In relation to Northern Ireland, directions shall require that licence...

          3. 1A. In relation to Northern Ireland, directions must require information that...

          4. 2. Directions given for the purposes of paragraph 1(a) must 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. In relation to Great Britain, directions shall require licence holders...

          2. 4ZA. In relation to Northern Ireland, directions shall require licence holders...

          3. 4A. Directions must require that importing licence holders are required to—...

       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. In relation to Great Britain, directions shall be given—

          3. 7A. In relation to Northern Ireland, directions shall be given—

          4. 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...

          2. 15. Updated information

          3. 16. Written agreements

    3. SCHEDULE 3

       Appropriate statements

       1. An appropriate statement for the purposes of regulation 24 must...

11. Explanatory Note