UK Statutory Instrument
2007
United Kingdom
The Human Tissue (Quality and Safety for Human Application) Regulations 2007
These Regulations implement in part Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, as well as Commission Directive 2006/17/EC and Commission Directive 2006/86/EC laying down technical requirements in relation to Directive 2004/23/EC (“the Directives”). These Regulations impose safety and quality requirements in relation to human tissue and cells intended for human application, including stem cells and cell lines grown outside the body. These Regulations do not apply to reproductive cells, embryos outside the human body, organs and blood. Show full description Show less
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 29 other Schedules — structural / supplementary
A licence under this Schedule may authorise the carrying-on of...
A licence— (a) shall designate an individual as the designated...
A licence — (a) shall specify the premises (other than...
It shall be a condition of a licence under this...
Where the Authority grants a licence under this Schedule authorising...
In determining the amounts of any fees to be charged...
In relation to Great Britain, directions shall require that licence...
In relation to donors of tissues or cells who are...
Directions shall, in respect of all donors of tissues or...
In respect of— (a) donation and procurement procedures, and
Directions shall be given for the purpose of securing compliance...
In respect of tissue and cell preparation processes, directions shall...
Updated information
Written agreements
In relation to Northern Ireland, directions must require information that...
In relation to Northern Ireland, directions shall require that licence...
Directions given for the purposes of paragraph 1(a) must include...
Directions under paragraph 2(4)(c) to (e) of Schedule 3 to...
In relation to Great Britain, directions shall require licence holders...
Directions must require that importing licence holders are required to—...
In relation to Northern Ireland, directions shall require licence holders...
For the purpose of securing compliance with the requirements of...
Directions shall specify the requirements to be met by all...
In relation to Great Britain, directions shall be given—
In relation to Northern Ireland, directions shall be given—
In giving directions for the purposes of paragraph 7, the...
In relation to donors of tissues or cells who are...
An appropriate statement for the purposes of regulation 24 must...
Browse 50 other sections — procedural / definitional / commencement
Citation and commencement
Extent and application
Designation of the competent authority
References to Directives
Modifications to the first, second, third and fourth Directives: general
Modifications to the first Directive
Modifications to the second Directive
Modifications to the third Directive
Modifications to the fourth Directive
Interpretation of other terms
References to third party agreements etc
Licensing requirement
Import into Northern Ireland from the EEA
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 or to act under a third party agreement
Preconditions to grant of licence
Duty of designated individual
Information and confidentiality
Breach of confidentiality requirement
Import and export of tissue and cells
Directions: Great Britain
Directions: compliance with first, second, third and fourth Directives as they apply in relation to Northern Ireland
Requirement for the Authority to provide information
Register of licences
Register of serious adverse events and serious adverse reactions
Duties of the Authority in relation to serious adverse events and serious adverse reactions
Duties of the Authority in relation to application of the Single European Code in relation to Northern Ireland
Inspection of third country premises etc , Northern Ireland
Third country premises and third country suppliers: report of inspections etc , Northern Ireland
Inspection of documents
Inspection of documents to be held by an importing licence holder , Northern Ireland
Entry and inspection of premises
Importing licence holders: requests for inspections , Northern Ireland
Entry and search in connection with suspected offence
Execution of warrants
Seizure in the course of inspection or search
Powers: supplementary
Requirements when exercising power of inspection or search
Enforcement
Meaning of duly authorised person
Remit of the Authority
Exclusion from licensing requirement of section 16
Interpretation of Part 2 of the 2004 Act
Applications under Schedule 3 to the 2004 Act
Offences by bodies corporate
Powers to make regulations in relation to standards of quality and safety, Great Britain
Scope and nature of powers
Scrutiny of regulations
Transitional arrangements: storage licences
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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