The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019

Document Number:2019 No. 4
 
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Statutory Instruments

Exiting The European Union

Health And Safety

Made

8 th January 2019

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 2018(1).

In accordance with paragraph 1(1) of Schedule 7 to that Act, a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.

Citation and commencement

  1. These Regulations may be cited as the Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 and come into force on exit day.

    Amendment of the Blood Safety and Quality Regulations 2005

  2. The Blood Safety and Quality Regulations 2005(2) are amended as follows.

  3. In regulation 1 , in paragraph (3)—

    (a) insert in the appropriate places the following definitions—

    ““good practice guidelines” means the 19 th edition of the Good Practice Guidelines for Blood Establishments Required to Comply with Directive 2005/62/EC(3);”;

    ““quality system” means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management and, for this purpose, “quality management” means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment;”;

    (b) in the definition of “third country” for “a Member State” substitute “the United Kingdom”.

  4. After regulation 1 insert—

    “Modification of provisions of the Annex to Commission Directive 2005/62/EC

    1 A.—(1) For the purposes of these Regulations, 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.

    (3) Paragraph 4.3 is to be read as if the reference to—

    (a) 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(4);

    (b) 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).

    (8) Paragraph 6.5.2 is to be read as if—

    (a) 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;

    (b) 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)...

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