UK Statutory Instrument 2005 United Kingdom

Blood Safety and Quality Regulations 2005

What this means for your business

1 guides
Enforced by
MHRA
Applies to
United Kingdom
On this page
1 practical guide
Read full text on legislation.gov.uk

Practical guidance

Our guides explain how to comply with the requirements above.

Sections and provisions

38 classified provisions from this legislation.

Duties 15

  • s.6 The responsible person for a blood establishment
  • s.7 Blood establishment requirements notification referred
  • s.8 Labelling of blood and blood components and traceability A blood establishment
  • s.9 Hospital blood bank requirements notification referred
  • s.10 Requirement for hospital blood banks to provide information to the Secretary of State
  • s.13 Import of blood and blood components into Great Britain
  • s.14 Disclosure of information by blood establishments and hospital blood banks discrepancies relating
  • s.16 Records to be kept by the Secretary of State The Secretary of State
  • s.22 Fees fee
  • s.23 Specific epidemiological situations in relation to Great Britain
  • Import of blood and blood components into Northern Import of blood and blood components into Northern Ireland
  • Requirement that facilities retain certain data Requirement that facilities retain certain data
  • 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
  • Requirement to report serious adverse reactions an Requirement to report serious adverse reactions and events
  • Specific epidemiological situations in relation to Specific epidemiological situations in relation to Northern Ireland

Offences and penalties 3

  • s.18 Criminal offences
  • s.19 Penalties
  • s.21 Offences by bodies corporate and Scottish partnerships

Powers 6

  • s.4 Authorisation of a blood establishment
  • s.5 Suspension or revocation of authorisation
  • s.11 Service of notices relating to hospital blood banks
  • s.15 Inspections, etc.
  • s.17 Powers of entry, etc.
  • Regulations relating to the quality and safety of Regulations relating to the quality and safety of blood and blood components

Definitions 3

  • Definitions Definitions
  • Scope and nature of powers Scope and nature of powers
  • Scrutiny of regulations made by the Scottish Minis Scrutiny of regulations made by the Scottish Ministers

Exemptions 5

  • s.2 Designation of the competent authority for Northern Ireland and scope of the Regulations
  • s.3 Requirement for authorisation
  • s.12 Objections to suspensions, revocations etc
  • s.20 Defence of due diligence
  • s.24 Transitional provisions