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 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.
Schedules
Browse 15 other Schedules — structural / supplementary
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...
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...
Browse 32 other sections — procedural / definitional / commencement
Citation and commencement
Extent
Interpretation
Designation of the competent authority
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
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
Arrangements by the Authority for assistance with functions
Offences by bodies corporate
Licences: transitional arrangements
Review
Power for appropriate authority to amend Schedule 1A in relation to Great Britain
Scope and nature of powers
Scrutiny of regulations
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
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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Regulators
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