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Introductory Text
PART 1 CITATION, COMMENCEMENT, EXTENT AND INTERPRETATION
1.Citation and commencement
2.Extent and application
3.Designation of the competent authority
4.References to Directives
5.Interpretation of other terms
6.References to third party agreements etc
PART 2 LICENSING OF ACTIVITIES RELATING TO THE USE OF TISSUE FOR HUMAN APPLICATION
7.Licensing requirement
8.Application of the 2004 Act in relation to licences under Schedule 1
9.Extension of other provisions of the 2004 Act to Scotland
10.Breach of requirement to hold a licence or to act under a third party agreement
11.Preconditions to grant of licence
12.Duty of designated individual
13.Information and confidentiality
14.Breach of confidentiality requirement
PART 3 REGULATION OF LICENSED ACTIVITIES
15.Import and export of tissue and cells
16.Directions: compliance with the first, second and third Directives
PART 4 OBLIGATIONS OF THE AUTHORITY
17.Requirement for the Authority to provide information
18.Register of licences
19.Register of serious adverse events and serious adverse reactions
20.Duties of the Authority in relation to serious adverse events and serious adverse reactions
PART 5 INSPECTION, ENTRY, SEARCH AND SEIZURE
21.Inspection of documents
22.Entry and inspection of premises
23.Entry and search in connection with suspected offence
24.Execution of warrants
25.Seizure in the course of inspection or search
26.Powers: supplementary
27.Requirements when exercising power of inspection or search
28.Enforcement
29.Meaning of duly authorised person
PART 6 AMENDMENTS TO THE 2004 ACT
30.Remit of the Authority
31.Exclusion from licensing requirement of section 16
32.Interpretation of Part 2 of the 2004 Act
33.Applications under Schedule 3 to the 2004 Act
PART 7 GENERAL
34.Offences by bodies corporate
35.Transitional arrangements: storage licences
Signature
SCHEDULE 1
Licences for the purposes of regulation 7
Power to grant licence
1.The Authority may on application grant a licence for the...
Characteristics of licences
2.A licence under this Schedule may authorise the carrying-on of...
3.A licence— (a) shall designate an individual as the designated...
4.A licence — (a) shall specify the premises (other than...
5.It shall be a condition of a licence under this...
Fees
6.In determining the amounts of any fees to be charged...
SCHEDULE 2
Directions for securing compliance with the first, second and third Directives
Traceability and coding system
1.Directions shall require that licence holders adopt such systems as...
2.Directions given for the purposes of paragraph 1 shall include...
Reporting obligations
3.Directions under paragraph 2(4)(c) to (e) of Schedule 3 to...
Serious adverse events and serious adverse reactions
4.Directions shall require licence holders to adopt such—
Third party agreements and termination of licensed activities
5.For the purpose of securing compliance with the requirements of...
Procurement and use of tissue or cells
6.Directions shall specify the requirements to be met by all...
7.Directions shall be given— (a) for the purpose of securing...
8.In giving directions for the purposes of paragraph 7, the...
Selection criteria and laboratory tests required for donors of tissues and cells
9.In relation to donors of tissues or cells who are...
10.In relation to donors of tissues or cells who are...
11.Directions shall, in respect of all donors of tissues or...
Donation and procurement procedures and reception at the tissue establishment
12.In respect of— (a) donation and procurement procedures, and
Requirements for holding a licence under Schedule 1
13.Directions shall be given for the purpose of securing compliance...
Requirements for holding a licence under Schedule 1 for tissue and cell preparation processes
14.In respect of tissue and cell preparation processes, directions shall...
SCHEDULE 3
Appropriate statements
An appropriate statement for the purposes of regulation 24 must...
Explanatory Note