UK Statutory Instrument SI 2007/1523 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 …

Read it on legislation.gov.uk (opens in a new tab)
Enforced by
HTA
Status
Amended (in force with amendments)
Penalty ceiling
Prosecution 3 of 40 obligations carry an unlimited fine. 1 carries different penalties and 36 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Licence Holder7 Any Person5 Trader2 Director or Officer1

Plus 25 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 245 other Acts
Any Person — also bound by 2684 other Acts
Trader — also bound by 864 other Acts
Companies Act 2006 244 duties
Companies Act 1985 85 duties
Director or Officer — also bound by 482 other Acts
Companies Act 2006 126 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, EXTENT AND INTERPRETATION

0 of 11 sections shown
11 other sections in this Part — procedural and definitional
s.001 Citation and commencement
s.002 Extent and application
s.003 Designation of the competent authority
s.004 References to Directives
s.004 Modifications to the first, second, third and fourth Directives: general
s.004 Modifications to the first Directive
s.004 Modifications to the second Directive
s.004 Modifications to the third Directive
s.004 Modifications to the fourth Directive
s.005 Interpretation of other terms
s.006 References to third party agreements etc
Part 2

LICENSING OF ACTIVITIES RELATING TO THE USE OF TISSUE FOR HUMAN APPLICATION

6 of 9 sections shown
s.007 Licensing requirement Regulated
  • Hold an HTA licence before storing, importing or processing human tissue/cellsAny Person
s.007 Import into Northern Ireland from the EEA Regulated
  • You must only import EEA tissue/cells for human use into NI from authorised sourcesAny Person
s.010 Breach of requirement to hold a licence or to act under a third party agreement Prosecution
  • Carry out human tissue activity without a licence or third party agreementAny Person

Unlimited fine

s.012 Duty of designated individual Regulated
  • Ensure licensed human tissue activities comply with HTA requirementsTrader
s.013 Information and confidentiality Regulated
  • Keep donor/recipient information secure, accurate and confidentialLicence Holder
s.014 Breach of confidentiality requirement Prosecution
  • Disclose confidential information in breach of regulation 13Any Person

Unlimited fine

3 other sections in this Part — procedural and definitional
s.008 Application of the 2004 Act in relation to licences under Schedule 1
s.009 Extension of other provisions of the 2004 Act to Scotland
s.011 Preconditions to grant of licence
Part 3

REGULATION OF LICENSED ACTIVITIES

2 of 3 sections shown
s.016 Directions: Great Britain Regulated
Other duties (1) — Crown / regulator
  • HTA must give compliance directions to licence holdersStatutory regulator
s.016 Directions: compliance with first, second, third and fourth Directives as they apply in relation to Northern Ireland Regulated
Other duties (1) — Crown / regulator
  • HTA must give directions to licence holders and designated individuals in Northern IrelandStatutory regulator
1 other section in this Part — procedural and definitional
s.015 Import and export of tissue and cells
Part 4

OBLIGATIONS OF THE AUTHORITY

7 of 7 sections shown
s.017 Requirement for the Authority to provide information Regulated
Other duties (1) — Crown / regulator
  • HTA must provide information requested by Secretary of State or Scottish MinistersStatutory regulator
s.018 Register of licences Regulated
Other duties (1) — Crown / regulator
  • HTA must maintain a public register of licencesStatutory regulator
s.019 Register of serious adverse events and serious adverse reactions Regulated
Other duties (1) — Crown / regulator
  • HTA must keep and publish register of serious adverse events and reactionsStatutory regulator
s.020 Duties of the Authority in relation to serious adverse events and serious adverse reactions Regulated
Other duties (1) — Crown / regulator
  • Authority must manage serious adverse events and notify relevant partiesStatutory regulator
s.020 Duties of the Authority in relation to application of the Single European Code in relation to Northern Ireland Regulated
Other duties (1) — Crown / regulator
  • HTA must assign EU tissue establishment codes and update EU compendium recordsStatutory regulator
s.020 Inspection of third country premises etc , Northern Ireland Regulated
Other duties (1) — Crown / regulator
  • HTA must act on EEA requests to inspect imports or revoke/vary licencesStatutory regulator
s.020 Third country premises and third country suppliers: report of inspections etc , Northern Ireland Regulated
Other duties (1) — Crown / regulator
  • HTA must provide requested inspection and enforcement informationStatutory regulator
Part 5

INSPECTION, ENTRY, SEARCH AND SEIZURE

7 of 11 sections shown
s.021 Inspection of documents to be held by an importing licence holder , Northern Ireland Regulated
Other duties (1) — Crown / regulator
  • HTA must arrange inspection of NI importers' documents when an EEA state asksStatutory regulator
s.022 Entry and inspection of premises Regulated
Other duties (1) — Crown / regulator
  • HTA must inspect licensed premises at least every two yearsStatutory regulator
s.022 Importing licence holders: requests for inspections , Northern Ireland Regulated
Other duties (1) — Crown / regulator
  • HTA must arrange inspections requested by EEA competent authoritiesStatutory regulator
s.024 Execution of warrants Regulated
Other duties (1) — Crown / regulator
  • HTA officers must follow warrant procedure when searching premisesStatutory regulator
s.025 Seizure in the course of inspection or search Regulated
Other duties (1) — Crown / regulator
  • HTA inspectors must leave a statement when they seize items during inspection or searchStatutory regulator
s.027 Requirements when exercising power of inspection or search Regulated
Other duties (1) — Crown / regulator
  • HTA inspectors must show ID and provide written inspection reportsStatutory regulator
s.028 Enforcement Prosecution
  • Fail to comply with HTA requirement or obstruct enforcementAny Person

Unlimited fine

4 other sections in this Part — procedural and definitional
s.021 Inspection of documents
s.023 Entry and search in connection with suspected offence
s.026 Powers: supplementary
s.029 Meaning of duly authorised person
Part 6

AMENDMENTS TO THE 2004 ACT

0 of 4 sections shown
4 other sections in this Part — procedural and definitional
s.030 Remit of the Authority
s.031 Exclusion from licensing requirement of section 16
s.032 Interpretation of Part 2 of the 2004 Act
s.033 Applications under Schedule 3 to the 2004 Act
Part 7

GENERAL

2 of 5 sections shown
s.034 Offences by bodies corporate Regulated
  • Face personal prosecution for a corporate offence if you consented or neglectedDirector or Officer
s.035 Transitional arrangements: storage licences Regulated
Other duties (1) — Crown / regulator
  • HTA must arrange inspection of transitional storage licence premises within two yearsStatutory regulator
3 other sections in this Part — procedural and definitional
s.034 Powers to make regulations in relation to standards of quality and safety, Great Britain
s.034 Scope and nature of powers
s.034 Scrutiny of regulations
Schedules

Schedules

16 of 29 shown
s.sch001 It shall be a condition of a licence under this... Regulated
  • Carry out licensed activities only under the designated individual's supervision and at approved premisesLicence Holder
s.sch001 Where the Authority grants a licence under this Schedule authorising... Regulated
Other duties (1) — Crown / regulator
  • HTA must issue certificate of authority to designated individualStatutory regulator
s.sch001 In determining the amounts of any fees to be charged... Regulated
Other duties (1) — Crown / regulator
  • HTA must consider application costs when setting licence feesStatutory regulator
s.sch002 In relation to Great Britain, directions shall require that licence... Regulated
  • Adopt traceability systems required by HTA directionsLicence Holder
s.sch002 In relation to donors of tissues or cells who are... Regulated
Other duties (1) — Crown / regulator
  • HTA must set donor selection criteria for living donorsStatutory regulator
s.sch002 In respect of tissue and cell preparation processes, directions shall... Regulated
Other duties (1) — Crown / regulator
  • HTA must issue directions for tissue and cell preparation processesStatutory regulator
s.sch002 Updated information Regulated
  • Obtain HTA approval before substantial import changes and notify of changesLicence Holder
s.sch002 In relation to Northern Ireland, directions shall require that licence... Regulated
  • Adopt traceability and coding systems for human tissue (Northern Ireland)Licence Holder
s.sch002 Directions given for the purposes of paragraph 1(a) must include... Regulated
  • Ensure third parties keep Annex VI donor/tissue recordsTrader
s.sch002 In relation to Great Britain, directions shall require licence holders... Regulated
Other duties (1) — Crown / regulator
  • HTA must require licence holders to report adverse events and recall affected productsStatutory regulator
s.sch002 Directions must require that importing licence holders are required to—... Regulated
  • Report serious adverse events from third-country suppliers to HTALicence Holder
s.sch002 In relation to Northern Ireland, directions shall require licence holders... Regulated
  • Set up serious adverse event reporting and product recall systemsLicence Holder
s.sch002 In relation to Great Britain, directions shall be given— Regulated
Other duties (1) — Crown / regulator
  • HTA must issue directions on donation information and adverse event reportingStatutory regulator
s.sch002 In giving directions for the purposes of paragraph 7, the... Regulated
Other duties (1) — Crown / regulator
  • HTA must require designated individuals to keep records and report SAEs/SARsStatutory regulator
s.sch002 In relation to donors of tissues or cells who are... Regulated
Other duties (1) — Crown / regulator
  • HTA must set deceased donor selection criteria in directionsStatutory regulator
s.sch003 An appropriate statement for the purposes of regulation 24 must... Regulated
Other duties (1) — Crown / regulator
  • HTA inspectors must give a complete 'appropriate statement' before using entry/search powersStatutory regulator
13 other schedules
s.sch001 The Authority may on application grant a licence for the...
s.sch001 A licence under this Schedule may authorise the carrying-on of...
s.sch001 A licence— (a) shall designate an individual as the designated...
s.sch001 A licence — (a) shall specify the premises (other than...
s.sch002 Directions shall, in respect of all donors of tissues or...
s.sch002 In respect of— (a) donation and procurement procedures, and
s.sch002 Directions shall be given for the purpose of securing compliance...
s.sch002 Written agreements
s.sch002 In relation to Northern Ireland, directions must require information that...
s.sch002 Directions under paragraph 2(4)(c) to (e) of Schedule 3 to...
s.sch002 For the purpose of securing compliance with the requirements of...
s.sch002 Directions shall specify the requirements to be met by all...
s.sch002 In relation to Northern Ireland, directions shall be given—

Help complying

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Human tissue authorisation in Scotland

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