| Guvnor

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

What it defines

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

0 of 9 sections shown

9 other sections in this Part — procedural and definitional

s.007 Licensing requirement

s.007 Import into Northern Ireland from the EEA

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.010 Breach of requirement to hold a licence or to act under a third party agreement

s.011 Preconditions to grant of licence

s.012 Duty of designated individual

s.013 Information and confidentiality

s.014 Breach of confidentiality requirement

Part 3

REGULATION OF LICENSED ACTIVITIES

0 of 3 sections shown

3 other sections in this Part — procedural and definitional

s.015 Import and export of tissue and cells

s.016 Directions: Great Britain

s.016 Directions: compliance with first, second, third and fourth Directives as they apply in relation to Northern Ireland

Part 4

OBLIGATIONS OF THE AUTHORITY

0 of 7 sections shown

7 other sections in this Part — procedural and definitional

s.017 Requirement for the Authority to provide information

s.018 Register of licences

s.019 Register of serious adverse events and serious adverse reactions

s.020 Duties of the Authority in relation to serious adverse events and serious adverse reactions

s.020 Duties of the Authority in relation to application of the Single European Code in relation to Northern Ireland

s.020 Inspection of third country premises etc , Northern Ireland

s.020 Third country premises and third country suppliers: report of inspections etc , Northern Ireland

Part 5

INSPECTION, ENTRY, SEARCH AND SEIZURE

0 of 11 sections shown

11 other sections in this Part — procedural and definitional

s.021 Inspection of documents

s.021 Inspection of documents to be held by an importing licence holder , Northern Ireland

s.022 Entry and inspection of premises

s.022 Importing licence holders: requests for inspections , Northern Ireland

s.023 Entry and search in connection with suspected offence

s.024 Execution of warrants

s.025 Seizure in the course of inspection or search

s.026 Powers: supplementary

s.027 Requirements when exercising power of inspection or search

s.028 Enforcement

s.029 Meaning of duly authorised person

Part 6

AMENDMENTS TO THE 2004 ACT

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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

0 of 5 sections shown

5 other sections in this Part — procedural and definitional

s.034 Offences by bodies corporate

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

s.035 Transitional arrangements: storage licences

Schedules

0 of 29 shown

29 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.sch001 It shall be a condition of a licence under this...

s.sch001 Where the Authority grants a licence under this Schedule authorising...

s.sch001 In determining the amounts of any fees to be charged...

s.sch002 In relation to Great Britain, directions shall require that licence...

s.sch002 In relation to donors of tissues or cells who are...

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 In respect of tissue and cell preparation processes, directions shall...

s.sch002 Updated information

s.sch002 Written agreements

s.sch002 In relation to Northern Ireland, directions must require information that...

s.sch002 In relation to Northern Ireland, directions shall require that licence...

s.sch002 Directions given for the purposes of paragraph 1(a) must include...

s.sch002 Directions under paragraph 2(4)(c) to (e) of Schedule 3 to...

s.sch002 In relation to Great Britain, directions shall require licence holders...

s.sch002 Directions must require that importing licence holders are required to—...

s.sch002 In relation to Northern Ireland, directions shall require licence holders...

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 Great Britain, directions shall be given—

s.sch002 In relation to Northern Ireland, directions shall be given—

s.sch002 In giving directions for the purposes of paragraph 7, the...