The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020
| Jurisdiction | UK Non-devolved |
| Citation | SI 2020/1304 |
| Year | 2020 |
2020 No. 1304
Exiting The European Union
Health And Safety
The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020
Made 18th November 2020
Coming into force in accordance with regulation 1
The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1) and 8C of the European Union (Withdrawal) Act 20181.
A draft of this instrument has been approved by a resolution of each House of Parliament, in accordance with paragraphs 1 and 8F2of Schedule 7 to the European Union (Withdrawal) Act 2018.
Citation and commencement
1. These Regulations may be cited as the Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020 and come into force immediately before IP completion day.
Amendment of the Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019
2. The Blood Safety and Quality (Amendment) (EU Exit) Regulations 20193are amended as follows.
Substitution of regulation 3
3. For regulation 3 substitute—
“3. In regulation 1, in paragraph (3)—
(a) after the definition of “qualified health professional” insert —
““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 or hospital blood bank;”;
(b) for the definition of “third country”, substitute—
““third country” means—
(a) in relation to the import of blood or blood components into Great Britain, a country other than the United Kingdom; and
(b) in relation to the import of blood or blood components into Northern Ireland, a country other than Northern Ireland or a member State;”.”.
Amendment of regulation 4
4. In regulation 4—
(a) in regulation 1A as inserted by regulation 4, in paragraph (1), after “these Regulations” insert “as they apply in relation to Great Britain”;
(b) in regulation 1B as inserted by regulation 4, after “and 13” insert “, as they apply in relation to Great Britain,”.
Substitution of regulation 5
5. For regulation 5 substitute—
“5. In regulation 2—
(a) for the heading substitute “Designation of the competent authority for Northern Ireland and scope of the Regulations”;
(b) for paragraph (1) substitute—
“(1) The Secretary of State is designated the competent authority in relation to Northern Ireland for the purposes of the Directive.”.”.
Amendment of regulation 6
6. In regulation 6, for the inserted text substitute—
“—
in relation to Great Britain, in one or more establishments authorised under regulation 4, or in a country where the safety and quality standards for establishments authorised in that country are equivalent to those for establishments authorised under regulation 4, to undertake activities relating to the collection or testing (or both) of blood and blood components, or to their preparation, storage or distribution;
in relation to Northern Ireland, in one or more establishments authorised in a member State, or under regulation 4, to undertake such activities.”.
Amendment of regulation 7
7. In regulation 7—
(a) for paragraph (a) substitute—
“(a)
“(a) for paragraph (1)(b) substitute—
“(b) establish and maintain a quality system for blood establishments—
in relation to Great Britain, that is based on the principles of good practice, which meets the standards and requirements set out in the Annex to Commission Directive 2005/62/ECand which gives effect to the Good Practice Guidelines for Blood Establishments Required to Comply with Directive 2005/62/ECpublished in the 20th edition of the Guide to the preparation, use and quality assurance of blood components4;
in relation to Northern Ireland, that is based on the principles of good practice, which complies with the Community standards and requirements set out in the Annex to Commission Directive 2005/62/ECand which gives effect to the requirements in respect of the use of good practice guidelines set out in Article 2.2 of that Directive;”;”;
(b) in paragraph (1A) inserted by paragraph (b), for the words “For the purposes of” substitute “In relation to Great Britain, for the purposes of”.
Amendment of regulation 9
8. In regulation 9—
(a) for paragraph (a) substitute—
“(a)
“(a) for paragraph (1)(b) substitute—
“(b) establish and maintain a quality system for the hospital blood bank—
in relation to Great Britain, that is based on the principles of good practice, which meets the standards and requirements set out in the Annex to Commission Directive 2005/62/ECand which gives effect to the Good Practice Guidelines for Blood Establishments Required to Comply with Directive 2005/62/ECpublished in the 20th edition of the Guide to the preparation, use and quality assurance of blood components;
in relation to Northern Ireland, that is based on the principles of good practice, which complies with the Community standards and requirements set out in the Annex to Commission Directive 2005/62/ECand which gives effect to the...
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