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

21 compliance obligations, 1 practical guide

Penalty landscape

4 of 21 obligations carry up to 2 years imprisonment. 17 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 17
  • Director or Officer 1

Plus 3 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 2338 other Acts (top 5 shown)
Directors and Officers also bound by 425 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.

Schedules

Browse 5 other Schedules — structural / supplementary
s.schedule/part/1/paragraph/wrapper1n2

Definitions

s.schedule/part/2/paragraph/wrapper2n2

Part A – Information to be provided to prospective donors of blood or blood components

s.schedule/part/2/paragraph/wrapper3n2

Part B – Information to be obtained from donors by blood establishments at every donation

s.schedule/part/3/paragraph/wrapper4n2

Duration of deferral period

s.schedule/part/3/paragraph/wrapper5n2

However, the following deferral periods shall apply for the infections...

s.001

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.012

Requirement that facilities retain certain data

  • Establish blood unit tracking and retain records for 30 years Any Person
s.012

Requirement to report serious adverse reactions and events

  • Report and record serious adverse blood transfusion reactions and events Any Person
s.013

Import of blood and blood components into Northern Ireland

  • Ensure safety standards when importing blood into Northern Ireland Any Person
s.015

Inspections, etc.

Other duties (1) — Crown / regulator
  • MHRA must inspect blood establishments at least every two years Crown / Minister / Government department
s.016

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.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.023

Specific epidemiological situations in relation to Northern Ireland

  • Adopt and comply with emergency blood donation deferral and testing criteria Any Person
Browse 42 other sections — procedural / definitional / commencement
sch.

Acceptance criteria for donors of whole blood and blood components

sch. para. 1

sch. para. 1

sch. para. 10

sch. para. 10

sch. para. 15

sch. para. 15

sch. para. 16

sch. para. 16

sch. para. 2

TRANSPORT AND DISTRIBUTION

sch. para. 2n14

sch. para. 2n14

sch. para. 6

sch. para. 6

sch. para. 9

sch. para. 9

s.001

Age and body weight of donors Age 18 to 65...

s.001

Haemoglobin levels in donor's blood Haemoglobin For females ≥ 125...

s.001

Protein levels in donor's blood Protein ≥ 60 g/l The...

s.001

Platelet levels in donor's blood Platelets Platelet number greater than...

s.002

Deferral criteria for donors of whole blood and blood components

s.002

Temporary deferral criteria for donors of allogeneic donations

s.002

Infections

s.002

Exposure to risk of acquiring a transfusion-transmissible infection — Endoscopic...

s.002

Vaccination Attenuated viruses or bacteria 4 weeks Inactivated/killed viruses, bacteria...

s.002

Other temporary deferrals Pregnancy 6 months after delivery or termination,...

s.002

Deferral for particular epidemiological situations Particular epidemiological situations (e.g. disease...

s.002

Deferral criteria for donors of autologous donations Serious cardiac disease...

s.003

Autologous blood and blood components must be clearly identified as...

s.003

Autologous blood and blood components must be labelled as required...

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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Regulators

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