Introductory Text
PART 1 Citation, commencement and extent
1.Citation and commencement
2.Extent
PART 2 Interpretation and designation of the competent authority
3.Interpretation
4.Designation of the competent authority
PART 3 Licensing
5.Licensing requirement
6.Application of the 2004 Act in relation to licences under Schedule 1
7.Extension of other provisions of the 2004 Act to Scotland
8.Breach of requirement to hold a licence
9.Preconditions to grant of a licence
10.Duty of the licence holder
11.Directions
12.Guidance
PART 4 Other obligations of the Authority
13.Framework and compliance with licensing conditions and directions
14.Records and reports
15.Living donors
16.Serious adverse events and serious adverse reactions
17.Traceability
18.Organs sent to or received from another country
19.European Union network of competent authorities
20.Requirement for the Authority to provide information
PART 5 General
21.Arrangements by the Authority for assistance with functions
22.Offences by bodies corporate
23.Licences: transitional arrangements
24.Review
PART 5A Power to amend data sets specified in Schedule 1A in relation to Great Britain
24A.Power for appropriate authority to amend Schedule 1A in relation to Great Britain
24B.Scope and nature of powers
24C.Scrutiny of regulations
PART 6 Amendments to other legislation
25.Amendment of the 2004 Act
26.Amendment of the 2006 Regulations
27.Amendment of the Human Tissue Act 2006 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2004
28.Amendment of the 2007 Regulations
29.Amendment of the 2006 Scotland Regulations
Signature
SCHEDULE 1
Licences for the purposes of regulation 5
1.The Authority may on application grant a licence for the...
2.Licensing conditions
3.It shall be a condition of a licence for a...
4.It shall be a condition of a licence for the...
5.It shall be a condition of a licence for the...
6.It shall be a condition of a licence for the...
7.Where any of the information specified in part A of...
8.It shall be a condition of a licence for a...
9.The conditions in paragraph 8(b) do not apply where transportation...
10.Fees
SCHEDULE 1A
Organ and Donor Characterisation
PART A Minimum data set
1.The information to be collected pursuant to paragraph 5(b)(i) of...
PART B Complementary data set
2.The information to be collected pursuant to paragraph 5(b)(ii) of...
SCHEDULE 2
Directions of the Authority
1.For the purposes of ensuring consistent compliance with the licensing...
2.For the purpose of ensuring consistent standards in relation to...
3.For the purpose of ensuring compliance with the requirements of...
Explanatory Note