UK Statutory Instrument
2012
United Kingdom
The Quality and Safety of Organs Intended for Transplantation Regulations 2012
These Regulations implement Directive 2010/53/EC of the European Parliament and of the Council of 7th July 2010 on standards of quality and safety of human organs intended for transplantation (“the Directive”). These Regulations impose quality and safety requirements in relation to the procurement and transplantation of organs intended for transplantation.
At a glance
Enforced by
What's here
1 compliance obligation
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Licence Holder 1
Other Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Licence Holders also bound by 221 other Acts (top 5 shown)
- Petroleum (Current Model Clauses) Order 1999 1999 317 duties
- The Petroleum Licensing (Exploration and Production) (Seaward and Landward Areas) Regulations 2004 2004 123 duties
- Human Medicines Regulations 2012 2012 76 duties
- Space Industry Regulations 2021 2021 68 duties
- The Petroleum (Production) (Landward Areas) Regulations 1991 1991 65 duties
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Part 1 — Citation, commencement and extent
Browse 2 other sections in this Part — procedural / definitional / commencement
Extent
Part 2 — Interpretation and designation of the competent authority
Browse 2 other sections in this Part — procedural / definitional / commencement
Interpretation
Designation of the competent authority
Part 3 — Licensing
Browse 8 other sections in this Part — procedural / definitional / commencement
Licensing requirement
Application of the 2004 Act in relation to licences under Schedule 1
Extension of other provisions of the 2004 Act to Scotland
Breach of requirement to hold a licence
Preconditions to grant of a licence
Duty of the licence holder
Directions
Guidance
Part 4 — Other obligations of the Authority
Browse 8 other sections in this Part — procedural / definitional / commencement
Framework and compliance with licensing conditions and directions
Records and reports
Living donors
Serious adverse events and serious adverse reactions
Traceability
Organs sent to or received from another country
European Union network of competent authorities
Requirement for the Authority to provide information
Part 5 — General
Browse 4 other sections in this Part — procedural / definitional / commencement
Arrangements by the Authority for assistance with functions
Offences by bodies corporate
Licences: transitional arrangements
Review
Part 5A — Power to amend data sets specified in Schedule 1A in relation to Great Britain
Browse 3 other sections in this Part — procedural / definitional / commencement
Power for appropriate authority to amend Schedule 1A in relation to Great Britain
Scope and nature of powers
Scrutiny of regulations
Part 6 — Amendments to other legislation
Browse 5 other sections in this Part — procedural / definitional / commencement
Amendment of the 2004 Act
Amendment of the 2006 Regulations
Amendment of the Human Tissue Act 2006 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2004
Amendment of the 2007 Regulations
Amendment of the 2006 Scotland Regulations
Schedules
It shall be a condition of a licence for the...
- Characterise deceased donors and organs before transplantation Licence Holder
Browse 14 other Schedules — structural / supplementary
The Authority may on application grant a licence for the...
Fees
Licensing conditions
It shall be a condition of a licence for a...
It shall be a condition of a licence for the...
It shall be a condition of a licence for the...
Where any of the information specified in part A of...
It shall be a condition of a licence for a...
The conditions in paragraph 8(b) do not apply where transportation...
The information to be collected pursuant to paragraph 5(b)(i) of...
The information to be collected pursuant to paragraph 5(b)(ii) of...
For the purposes of ensuring consistent compliance with the licensing...
For the purpose of ensuring consistent standards in relation to...
For the purpose of ensuring compliance with the requirements of...
Official guidance
Authoritative sources published by regulators or government explaining this legislation.
- What is a HTA licence | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- HTA Legislation: Powers, Consent and Licensing | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- How to make changes to your licence | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- The Quality and Safety of Organs Intended for Transplantation: A Documentary Framework | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Organ donation and transplantation | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Material covered by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Legislation | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
- Code E: Annex A - Legislative background and context | Human Tissue Authority (opens in a new tab) from HTA Detailed Guidance
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
Human Tissue Authority
Statutory regulator for activities involving human tissue and organs. Licenses establishments that store and use human tissue for purposes including research, transplantation, …
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Browse legislation
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Regulators
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