The Blood Safety and Quality Regulations 2005
| Jurisdiction | UK Non-devolved |
| Citation | SI 2005/50 |
| Year | 2005 |
(1) These Regulations may be cited as the Blood Safety and Quality Regulations 2005.(2) Except for regulation 25(1) , which shall come into force on 8th November 2005, these Regulations shall come into force on 8th February 2005.(3) In these Regulations—(1) For the purposes of these Regulations as they apply in relation to Great Britain, the Annex to Commission Directive 2005/62/EC is to be read with the modifications specified in the following paragraphs.(2) Paragraph 2.5 is to be read as if the reference to compliance with the Directives mentioned in that paragraph was a reference to compliance with the requirements which those Directives would require to be imposed if those Directives formed part of domestic law.the requirements of Council Directive 93/42/EEC and Directive 98/79/EC were a reference to the requirements of the Medical Devices Regulations 2002;third countries were a reference to countries other than the United Kingdom.(4) Paragraph 6.1.1 is to be read as if the reference to the requirements set out in Annexes II and III to Directive 2004/33/EC were a reference to the requirements set out in Parts 2 and 3 of the Schedule.(5) Paragraph 6.2.2 is to be read as if the reference to third countries were a reference to countries other than the United Kingdom.(6) Paragraph 6.3.2 is to be read as if the reference to the requirements set out in Annex IV to Directive 2002/98/EC were a reference to the requirements set out in regulation 7(7) .(7) Paragraph 6.3.3 is to be read as if the reference to a test mentioned in Annex IV to Directive 2002/98/EC were a reference to a test for the infections mentioned in regulation 7(7) (c) .the reference to requirements in Article 14 of Directive 2002/98/EC and Commission Directive 2005/61/EC were a reference to the requirements set out in regulation 8;the words “The label for a final blood component shall comply with the requirements of Annex III to Directive 2002/98/EC.” were omitted.(9) Paragraph 6.5.3 is to be read as if the reference to compliance with Article 7 of Directive 2004/33/EC were a reference to compliance with regulation 7(3) (in relation to labelling) , regulation 8 and paragraph 3.2 of Part 4 of the Schedule.(10) Paragraph 6.6.1 is to be read as if the reference to mandatory requirements set out in the Directive were a reference to the requirements set out in these Regulations.(10A) Paragraph 7.1 is to be read as if the reference to “Directive 2003/94/EC” were to “the Good Manufacturing Practice Directive, within the meaning of paragraph (a) of the definition of that term in regulation 8(1) of the Human Medicines Regulations 2012.(11) Paragraph 9.1 is to be read as if the reference to the standards set out in Annex V of Directive 2004/33/EC were a reference to the standards set out in Part 5 of the Schedule.(12) Paragraph 9.2 is to be read as if the reference to regulatory requirements were a reference to the requirements in regulation 12B.(13) Paragraph 10.1 is to be read as if for “according to approved procedures” there were substituted “ and in accordance with the procedures required by the quality system established and maintained by the blood establishment ” .References in regulations 7, 9 and 13, as they apply in relation to Great Britain, to the requirements set out in the Annex to Commission Directive (1) The Secretary of State is designated the competent authority in relation to Northern Ireland for the purposes of the Directive.(2) Subject to the following paragraphs, the requirements of these Regulations apply to the collection and testing of blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when they are intended to be used for transfusion.(3) These Regulations apply without prejudice to the Medical Devices Regulations 2002 (4) These Regulations do not apply to blood stem cells.
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