What would breach regulation 18(3) of The Blood Safety and Quality Regulations 2005?

Being served with a notice under the Blood Safety and Quality Regulations 2005 and doing nothing by the date it specifies. Doing part of what the notice requires, where it required all of it. Disagreeing with the notice and ignoring it, rather than using whatever appeal the instrument provides.

Criminal offences

Q: Is regulation 18(3) of The Blood Safety and Quality Regulations 2005 a strict liability offence?

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that a person meant to do it, knew about it, or was careless.

regulation 18(3) of The Blood Safety and Quality Regulations 2005

Status not determined
Strict liability
Education, social security, pensions and public services

This offence was read from the text as made, and no revised version was available, so a later revocation could not be ruled out. Check the current text at legislation.gov.uk.

What the provision says

3 Any person who fails to comply with
a notice of suspension or revocation of his authorisation served pursuant to regulation 5, save where the operation of that notice has been suspended pursuant to regulation 12, or has been withdrawn or revoked by the Secretary of State, shall be guilty of an offence.

Text as made, from legislation.gov.uk. © Crown copyright, reused under the Open Government Licence v3.0. This is the text as originally made; later amendments are not shown here.

Who it binds, and what has to be proved

Binds: a person
Conduct: failing to comply with a notice or direction
Fault element: Strict liability
Burden of proof: No statutory defence — prosecution proves everything

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that a person meant to do it, knew about it, or was careless.

Intention, knowledge and carelessness are irrelevant to guilt. They may still matter a great deal to sentence.

The provision states no defence, so the prosecution bears the burden on every element of the offence.

Classifier’s reasoning: no word of intention, knowledge, recklessness or negligence in the offence or its provision.

What would breach regulation 18(3)?

These are illustrations, not law. They are generated from the provision’s own words to show the shape of the offence. Whether any particular conduct is caught depends on the full text, on any amendment since, and on the facts.

Being served with a notice under the Blood Safety and Quality Regulations 2005 and doing nothing by the date it specifies.
Doing part of what the notice requires, where it required all of it.
Disagreeing with the notice and ignoring it, rather than using whatever appeal the instrument provides.

Penalty

Mode of trial: Not determined
Maximum fine: Not determined
Maximum prison (summary): Not determined

no penalty is stated in this instrument; it may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence.

No penalty was determined from this instrument. It may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence. Absence of a figure here is not evidence that the offence carries no penalty.

Sentencing

Offences of this kind are usually sentenced under the guidelines below. This is a mapping by subject, not a finding about this provision, and the links go to a search of the Sentencing Council’s own site.

Reduction in sentence for a guilty plea: definitive guideline All courts in England and Wales · in force from 1 June 2017
The sliding scale of credit for pleading guilty, from one third at the first stage of proceedings downwards.
General guideline: overarching principles All courts in England and Wales · in force from 1 October 2019
The guideline a court uses when there is no offence-specific guideline, which is the position for the overwhelming majority of offences created by statutory instrument. It sets out how culpability and harm are assessed from first principles.
Totality: definitive guideline All courts in England and Wales
How to sentence more than one offence at once so that the total is just and proportionate - frequently in point here, because regulatory prosecutions commonly charge several breaches of the same instrument.

Prosecution figures

No published per-offence figure was found for this provision, and it could not be matched to a Ministry of Justice offence code. Offences created by statutory instrument very largely do not have one. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status: Status not determined
Made: 13 January 2005
In force from: 8 February 2005
Extent: Not stated

How this was established: read from the text as made; no revised version available, so later revocation could not be ruled out.

What the instrument is for

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.

Read the full note and every offence in this instrument

What Parliament said

Mentions of this instrument in Hansard. Parliamentary material is reused under the Open Parliament Licence v3.0.

Draft Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 Commons · 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…
Medical Devices (Northern Ireland Protocol) Regulations 2021 Lords · 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.…
Draft Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations Commons · 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…
Health Bill (Thirteenth sitting) Commons · 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…

Other offences in the same instrument

How this was identified as an offence

Everything above rests on the judgement that this provision creates a criminal offence, rather than mentioning one. That judgement is made by rule, from the words of the provision, and this is the rule that made it — with a confidence of 0.92.

Basis: the provision says a person is “guilty of an offence”
Confidence: 0.92 of 1.00

A provision that states a penalty for an offence created elsewhere can read very like one that creates an offence, and the rules can mistake the one for the other. If the text quoted above sets a penalty for something made an offence by another provision, treat the classification on this page with that in mind, and read the instrument.

Check the source

This provision on legislation.gov.uk The authoritative text. Check it before relying on anything here.
The Blood Safety and Quality Regulations 2005 Every offence this instrument creates, and its explanatory note
Education, social security, pensions and public servicesOther offences on the same subject
Offences created in 2005