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Statutory Instruments

2007 No. 1523

human tissue

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

Made

24th May 2007

Coming into force

for the purposes of regulation 1(3)

25th May 2007

for all other purposes

5th July 2007

Contents

Go to Preamble

  1. 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. 5. Interpretation of other terms

    6. 6. References to third party agreements etc

  2. PART 2

    LICENSING OF ACTIVITIES RELATING TO THE USE OF TISSUE FOR HUMAN APPLICATION

    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

  3. PART 3

    REGULATION OF LICENSED ACTIVITIES

    1. 15. Import and export of tissue and cells

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

  4. 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. PART 5

    INSPECTION, ENTRY, SEARCH AND SEIZURE

    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

  6. 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

  7. PART 7

    GENERAL

    1. 34. Offences by bodies corporate

    2. 35. Transitional arrangements: storage licences

    1. SCHEDULE 1

      Licences for the purposes of regulation 7

    2. SCHEDULE 2

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

    3. SCHEDULE 3

      Appropriate statements

Go to Explanatory Note

The Secretary of State is a Minister designated for the purposes of section 2(2) of the European Communities Act 1972(1) in relation to health protection measures regulating the use of material of human origin(2);

A draft of this instrument was laid before Parliament in accordance with paragraph 2(2) of Schedule 2 to that Act and approved by a resolution of each House of Parliament;

Accordingly the Secretary of State, in exercise of the powers conferred by section 2(2) of that Act, makes the following Regulations:—

(2)

SI 2004/3037. In relation to measures in these Regulations relating to health protection measures regulating the use of material of human origin, the power of the Secretary of State under section 2(2) of the European Communities Act 1972 is exercisable in relation to Scotland by virtue of section 57(1) of the Scotland Act 1998 (c.46). Back [2]

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