UK Statutory Instrument 2005 United Kingdom

Blood Safety and Quality Regulations 2005

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At a glance

Enforced by

MHRA

What's here

19 compliance obligations, 1 practical guide

Penalty landscape

4 of 19 obligations carry up to 2 years imprisonment. 15 have no criminal penalty — flagged in the list below.

Who this Act binds

Business-side actors with duties under this Act, ranked by how often they appear.

  • Any Person 16
  • Director or Officer 1

Plus 2 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.

Relevant guidance

Practical guides for businesses affected by this Act, ordered by how closely they engage with it.

Direct — cites this Act

1 guides

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.

Any Person also bound by 749 other Acts (top 5 shown)
Directors and Officers also bound by 224 other Acts (top 5 shown)

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.

s.018

Criminal offences

2 years imprisonment
  • Breach of core blood safety regulations (regs 3,7,9,13,23(2),12A,12B) Any Person
s.019

Penalties

2 years imprisonment
  • Breach of blood safety and quality standards Any Person
s.022

Fees

  • Pay required fees for blood establishment and hospital blood bank operations Any Person
s.import of blood and blood components into northern

Import of blood and blood components into Northern Ireland

  • Ensure safety standards when importing blood into Northern Ireland Any Person
s.modification of provisions of the annex to commiss

Modification of provisions of the Annex to Commission Directive 2005/62/EC

  • Maintain quality and safety standards for blood and blood components Any Person
s.requirement that facilities retain certain data

Requirement that facilities retain certain data

  • Establish blood unit tracking and retain records for 30 years Any Person
s.requirement that the secretary of state communicat

Requirement that the Secretary of State communicate certain information in respect of Northern Ireland to other competent authorities

Other duties (1) — Crown / regulator
  • Secretary of State must share safety info regarding Northern Ireland blood Crown / Minister / Government department
s.requirement to report serious adverse reactions an

Requirement to report serious adverse reactions and events

  • Report and record serious adverse blood transfusion reactions and events Any Person
s.specific epidemiological situations in relation to

Specific epidemiological situations in relation to Northern Ireland

  • Adopt and comply with emergency blood donation deferral and testing criteria Any Person
Browse 19 other sections — procedural / definitional / commencement
s.definitions

Definitions

s.references to the requirements set out in the anne

References to the requirements set out in the Annex to Commission Directive 2005/62/EC

s.regulations relating to the quality and safety of

Regulations relating to the quality and safety of blood and blood components

s.scope and nature of powers

Scope and nature of powers

s.scrutiny of regulations made by the scottish minis

Scrutiny of regulations made by the Scottish Ministers

s.scrutiny of regulations made by the secretary of s

Scrutiny of regulations made by the Secretary of State

s.scrutiny of regulations made by the welsh minister

Scrutiny of regulations made by the Welsh Ministers

Read the full Act on legislation.gov.uk (opens in a new tab)

Official guidance

Authoritative sources published by regulators or government explaining this legislation.

Enforcement and responsible bodies

The regulators that administer or enforce this legislation.

MHRA

Medicines and Healthcare products Regulatory Agency

Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.

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Browse legislation

Find other UK business legislation with related guidance.

Regulators

Learn more about the bodies that enforce this legislation.