- Latest available (Revised)
- Point in Time (15/02/2018)
- Original (As made)
The Blood Safety and Quality Regulations 2005
You are here:
- UK Statutory Instruments
- 2005 No. 50
- Regulation 5
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
Changes over time for: Section 5
Alternative versions:
- 08/02/2005- Amendment
- 08/04/2005- Amendment
- 15/02/2018
Point in time
Status:
Point in time view as at 15/02/2018.
Changes to legislation:
There are currently no known outstanding effects for the The Blood Safety and Quality Regulations 2005, Section 5.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Suspension or revocation of authorisationU.K.
This section has no associated Explanatory Memorandum
5.—(1) The Secretary of State may suspend or revoke the authorisation of a blood establishment on one or more of the following grounds—
(a)that the blood establishment has failed, in any material respect, to comply with the requirements of these regulations;
(b)that the collection, testing, processing, storage or distribution of blood or blood components by the establishment cannot be carried out safely;
(c)that any blood or blood components cannot be supplied to hospital blood banks in such a state that they could be safely administered for transfusion; or
(d)that the information given by the blood establishment pursuant to regulation 4(3) was false or incomplete in any material respect.
(2) Subject to paragraph (3), before suspending or revoking the authorisation of a blood establishment, the Secretary of State shall serve a notice on the blood establishment stating that he intends to suspend or revoke its authorisation with effect from the date specified in the notice, which date shall be not less than 7 days from the date on which the notice is served.
(3) Where the Secretary of State considers that it is necessary in the interests of safety, he may, by a notice served on a blood establishment, suspend or revoke its authorisation with immediate effect.
(4) Where—
(a)the blood establishment has failed, in any material respect, to comply with the requirements of these regulations; or
(b)the information given by the blood establishment pursuant to [F1regulation 4(3)] was false or incomplete in any material respect,
and the Secretary of State considers that the failure in question is not sufficiently serious to warrant suspension or revocation of the authorisation of the blood establishment in the first instance, he may serve a notice on the responsible person of the blood establishment in accordance with paragraph (5).
(5) A notice served under this paragraph shall—
(a)identify the requirements of the regulations of which the blood establishment is in breach or, in the case of false and incomplete information, the further information which is required;
(b)identify the action which the blood establishment is required to take; and
(c)give the timescale within which the blood establishment shall take the action identified in sub-paragraph (b).
(6) If the blood establishment fails to comply with the requirements set out in the notice within the specified timescale, the Secretary of State may, by a notice served on the blood establishment, suspend or revoke the authorisation of the blood establishment.
(7) A suspension or revocation pursuant to paragraph (6) shall take effect—
(a)in a case where the Secretary of State considers that it is necessary in the interests of safety, immediately; or
(b)in all other cases, from a date specified in the notice.
(8) Any suspension pursuant to paragraphs (1) or (6) shall be for such period as the Secretary of State shall consider necessary having regard to the reasons for the suspension.
(9) The suspension or revocation of an authorisation under paragraph (1) or paragraph (6) may be total, or may be limited to a particular activity or to one or more activities carried out at a particular site or sites, or to a particular blood component.
Textual Amendments
F1Words in reg. 5(4)(b) substituted (8.4.2005) by The Blood Safety and Quality (Amendment) Regulations 2005 (S.I. 2005/1098), regs. 1(1), 3
Options/Help
Print Options
PrintThe Whole Instrument
PrintThis Section only
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Opening Options
Different options to open legislation in order to view more content on screen at once
Explanatory Memorandum
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Timeline of Changes
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as made version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.