| Guvnor

Enforced by: HTA
Status: Amended (in force with amendments)
Penalty ceiling: Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Licence Holder3

Plus 2 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Licence Holder — also bound by 225 other Acts

Petroleum (Current Model Clauses) Order 1999 318 duties

The Petroleum Licensing (Exploration and Production) (Seaward and Landward Areas) Regulations 2004 123 duties

Human Medicines Regulations 2012 83 duties

Space Industry Regulations 2021 68 duties

The Petroleum (Production) (Landward Areas) Regulations 1991 65 duties

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

Part 1

Citation, commencement and extent

0 of 2 sections shown

2 other sections in this Part — procedural and definitional

s.001 Citation and commencement

s.002 Extent

Part 2

Interpretation and designation of the competent authority

0 of 2 sections shown

2 other sections in this Part — procedural and definitional

s.003 Interpretation

s.004 Designation of the competent authority

Part 3

Licensing

0 of 8 sections shown

8 other sections in this Part — procedural and definitional

s.005 Licensing requirement

s.006 Application of the 2004 Act in relation to licences under Schedule 1

s.007 Extension of other provisions of the 2004 Act to Scotland

s.008 Breach of requirement to hold a licence

s.009 Preconditions to grant of a licence

s.010 Duty of the licence holder

s.011 Directions

s.012 Guidance

Part 4

Other obligations of the Authority

0 of 8 sections shown

8 other sections in this Part — procedural and definitional

s.013 Framework and compliance with licensing conditions and directions

s.014 Records and reports

s.015 Living donors

s.016 Serious adverse events and serious adverse reactions

s.017 Traceability

s.018 Organs sent to or received from another country

s.019 European Union network of competent authorities

s.020 Requirement for the Authority to provide information

Part 5

General

0 of 4 sections shown

4 other sections in this Part — procedural and definitional

s.021 Arrangements by the Authority for assistance with functions

s.022 Offences by bodies corporate

s.023 Licences: transitional arrangements

s.024 Review

Part 5

Power to amend data sets specified in Schedule 1A in relation to Great Britain

0 of 3 sections shown

3 other sections in this Part — procedural and definitional

s.024 Power for appropriate authority to amend Schedule 1A in relation to Great Britain

s.024 Scope and nature of powers

s.024 Scrutiny of regulations

Part 6

Amendments to other legislation

0 of 5 sections shown

5 other sections in this Part — procedural and definitional

s.025 Amendment of the 2004 Act

s.026 Amendment of the 2006 Regulations

s.027 Amendment of the Human Tissue Act 2006 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2004

s.028 Amendment of the 2007 Regulations

s.029 Amendment of the 2006 Scotland Regulations

Schedules

5 of 15 shown

s.sch001 It shall be a condition of a licence for a... Regulated

Manage procurement equipment to sterilisation standards and have proceduresLicence Holder

s.sch001 It shall be a condition of a licence for the... Regulated

Characterise deceased donors and organs before transplantationLicence Holder

s.sch001 Where any of the information specified in part A of... Regulated

Conduct risk-benefit analysis when donor information is unavailableLicence Holder

s.sch002 For the purposes of ensuring consistent compliance with the licensing... Regulated

Other duties (1) — Crown / regulator

Authority must issue directions on organ transplant safety standardsStatutory regulator

s.sch002 For the purpose of ensuring compliance with the requirements of... Regulated

Other duties (1) — Crown / regulator

HTA must specify information transmission requirements for cross-border organ exchangesStatutory regulator

10 other schedules

s.sch001 The Authority may on application grant a licence for the...

s.sch001 Fees

s.sch001 Licensing conditions

s.sch001 It shall be a condition of a licence for the...

s.sch001 It shall be a condition of a licence for a...

s.sch001 The conditions in paragraph 8(b) do not apply where transportation...

s.sch001a The information to be collected pursuant to paragraph 5(b)(i) of...

s.sch001a The information to be collected pursuant to paragraph 5(b)(ii) of...

s.sch002 For the purpose of ensuring consistent standards in relation to...

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.