The Blood Safety and Quality Regulations 2005

UK Statutory Instrument 2005 No. 50 — creates 8 criminal offences.

8offences created

0recorded in force

0revoked

Made: 13 January 2005
In force from: 8 February 2005
Extent: Not stated
Subject: Education, social security, pensions and public services
Made under: European Communities Act 1972, Finance Act 1973

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

These Regulations impose safety and quality requirements on human blood collection and storage. The requirements apply to blood transfusion services in England, Scotland, Wales and Northern Ireland. Many of the provisions of the Regulations also apply to hospital blood banks. The Regulations implement Directive 2002/98/EC of the European Parliament and Council of 27 January 2003 setting out the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (“the Directive”) – see OJ L 33, 8.2.2003, p30. They also implement Commission Directive 2004/33/EC – see, OJ L91, 30.3.2004, p25, which contains certain technical requirements relating to blood standards. Regulation 2 provides that the Secretary of State is to be the competent authority for the purposes of the Directive and outlines the scope of the Regulations. Regulation 3 prohibits the carrying on of certain activities relating to blood, unless they are a person authorised by the Secretary of State to act as a blood establishment or carried out by hospital blood banks or persons acting on behalf of an authorised blood establishment or a hospital blood bank. Regulation 4 sets out the procedures to be followed in respect of an application for authorisation and regulation 5 sets out the circumstances tin which the Secretary of State may suspend or revoke such authorisation. Regulations 6 to 8 impose requirements on blood establishments, including requirements relating to “responsible persons” at blood establishments (regulation 6) and the labelling of blood (regulation 8). Regulations 9 and 10 impose requirements on persons responsible for management of hospital blood banks, including requirements to provide information to the Secretary of State (regulation 10). Regulation 11 provides for the service of notices on hospital blood banks by the Secretary of State requiring them to undertake certain actions where they contravene the requirements of these regulations or where there are concerns as to safety. Regulation 12 makes provision for objections to suspensions and revocations of blood establishment authorisations and to notices served on blood establishments and hospital blood banks by the Secretary of State under regulations 5 and 11. Regulation 13 prohibits the import of blood or blood components which do not meet the standards of safety and quality equivalent to those specified in Part 5 of the Schedule to the Regulations. Regulation 14 imposes restrictions on the disclosure of information obtained under the Regulations. Regulations 15 to 21 provide for enforcement and related matters, including powers of inspection notices to provide information, offences and penalties for breaches of the Regulations. Regulation 22 provides for fees payable in relation to blood establishment authorisations and inspections of blood establishments and blood banks. Regulation 23 provides that in the event of a specific epidemiological situation such as a disease outbreak, which necessitates the adoption of deferral criteria additional to those specified in Part 3 of the Schedule, the Secretary of State is to notify the Commission and blood establishments, who are to adopt any additional deferral criteria specified by the Secretary of State. Regulation 24 makes transitional provision for blood establishments and hospital blood banks so that they may continue to operate under existing provisions until 8th November 2005. Regulation 25 makes consequential amendments. A Regulatory Impact Assessment and a Transposition Note have been prepared for these Regulations and a copy of each has been placed in the library of each House of Parliament. Copies of the Regulatory Impact Assessment and the Transposition Note are published on the Department of Health’s website (www.dh.gov.uk) and can be obtained from room 631B SKH, Department of Health, Skipton House, 80 London Road, London SE1 6LH.

Offences created by this instrument

Any person who contravenes any of the following provisions— a regulation 4(9); b regulation 6, other than regulation… regulation 18 · Status not determined · Mixed — some elements strict, some not
Any person who contravenes any of the following provisions— a regulation 3(1) b regulation 7; c regulation 9; d… regulation 18(1) · Status not determined · Strict liability
Any person who contravenes any of the following provisions— a regulation 4(9); b regulation 6, other than regulation… regulation 18(2) · Status not determined · Strict liability
Any person who fails to comply with a notice of suspension or revocation of his authorisation served pursuant to… regulation 18(3) · Status not determined · Strict liability
Any person who knowingly sells or supplies blood or any blood component which is not labelled in accordance with the… regulation 18(4) · Status not determined · Requires proof of a state of mind
Any person who contravenes the requirements of any notice served by the Secretary of State under regulation 11(1),… regulation 18(5) · Status not determined · Strict liability
Any person who— a contravenes regulation 14; or b discloses any information referred to in regulation 14(1) to which… regulation 18(6) · Status not determined · Strict liability
Subject to paragraph (5)— a any person who— i intentionally obstructs an inspector, or; ii without reasonable cause… regulation 18(7) · Status not determined · Requires proof of a state of mind

What Parliament said about it

Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.

Draft Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 Commons · General Committees · 19 December 2018 · The Parliamentary Under-Secretary of State for Health and Social Care (Steve Brine)
I beg to move, That the Committee has considered the draft Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019. It is nice to see you, Mr Sharma. The draft regulations are made under powers in the European Union (Withdrawal) Act 2018 to make the necessary amendments to the UK’s Blood Safety and Quality Regulations 2005. The instrument will correct those regulations to ensure that the UK is prepared in the unlikely event that it leaves the EU without a deal on 29 March next year. The UK regulations set out the safety and quality requirements that cover all steps in the blood…
Medical Devices (Northern Ireland Protocol) Regulations 2021 Lords · Grand Committee · 12 July 2021 · Lord Bhatia (Non-Afl) [V]
My Lords, the changes that the EU MDR introduces will affect medical device economic operators in Northern Ireland, estimated to be about 300, and any prospective UK notified bodies. This instrument does not implement the EU MDR itself, but updates the statute book to allow us to implement the EU MDR effectively and addresses areas of national decision to align with policy that applies in the rest of the UK. Specifically, these areas of national decision allow for the continued practice of allowing the reprocessing of single-use devices, if reprocessors adhere to the requirements of an…
Draft Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations Commons · General Committees · 12 May 2025 · Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
It is a pleasure to serve under your chairmanship, Sir Desmond. The draft regulations will make amendments to the Medical Device Regulations 2002, the Blood Safety and Quality Regulations 2005 and the Medical Devices (Northern Ireland Protocol) Regulations 2021. The core changes made by the draft regulations will include modifying the fees charged to manufacturers, suppliers and relevant stakeholders involved in medical device approval and blood safety monitoring. These amendments will align with updated economic assessments on the operational needs of regulatory bodies. They follow an…
Health Bill (Thirteenth sitting) Commons · Public Bill Committees · 7 July 2026 · Karin Smyth
I thank the hon. Lady for her comments. The purpose of the new clauses is to support our life sciences and medicine sector, in order to make that more streamlined. She will be aware of the proposals about the negative and affirmative procedure. If there were particular issues of scrutiny, normal parliamentary rules and processes would apply if Members wanted to raise any particular issue. Question put and agreed to. New clause 91 accordingly read a Second time, and added to the Bill. New Clause 92 Medical Devices Regulations 2002: mutual recognition agreements “(1) The Medical Devices…

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