Statutory Instruments
2007 No. 604
health and safety
The Blood Safety and Quality (Amendment) Regulations 2007
Made
28th February 2007
Laid before Parliament
7th March 2007
Coming into force
1st April 2007
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972( 1 ) and section 56(1) and (2) of the Finance Act 1973( 2 ).
The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to health protection measures regulating the use of material of human origin( 3 ).
The Treasury has consented to the making of these Regulations as required by section 56(1) of the Finance Act 1973.
Citation, commencement and interpretation
1. —(1) These Regulations may be cited as the Blood Safety and Quality (Amendment) Regulations 2007 and shall come into force on 1st April 2007.
(2) In these Regulations, “the principal Regulations” means the Blood Safety and Quality Regulations 2005 ( 4 ).
Amendment of regulation 12B of the principal Regulations
2. In regulation 12B of the principal Regulations (requirement to report serious adverse reactions and events), in paragraph (4), for sub-paragraph (c) substitute the following sub-paragraph—
“ (c) submits a complete report to the Secretary of State on serious adverse events in any calendar year by no later than 1st April in the following calendar year, using the format set out in Section C of Part 8 of the Schedule. ” .
Amendment of regulation 16 of the principal Regulations
3. In regulation 16 (records to be kept by Secretary of State)—
(a) in paragraph (1), in sub-paragraph (c), for “regulation 7(1)(e)” substitute “regulation 12B”; and
(b) in paragraph (2), in sub-paragraph (a), for “regulation 9(1)(f)” substitute “regulation 12B”.
Amendment of regulation 22 of the principal Regulations
4. —(1) Regulation 22 of the principal Regulations (fees) shall be amended as follows.
(2) In paragraph (2)—
(a) in sub-paragraph (a), for “£2,444” substitute “£2,688”;
(b) in sub-paragraph (b), for “£400” substitute “£449”; and
(c) in sub-paragraph (c), for “£304” substitute “£387”.
(3) In paragraph (2A), in sub-paragraph (b), for “£375” substitute “£432”.
(4) In paragraph (3)—
(a) in sub-paragraph (a), for “£8,729” substitute “£13,153”;
(b) in sub-paragraph (b), for “£5,557” substitute “£8,402”;
(c) in sub-paragraph (c), for “£2,698” substitute “£4,120”;
(d) in sub-paragraph (d), for “£1,518” substitute “£2,353”;
(e) in sub-paragraph (e), for “£4,048” substitute “£6,143”; and
(f) in sub-paragraph (f), for “£7,590” substitute “£11,449”.
(5) In paragraph (3A), for “£400” substitute “£600”.
(6) In paragraph (3C), in sub-paragraph (c), for “£375” substitute “£432”.
(7) In paragraph (5)—
(a) in sub-paragraph (a), for “£759” substitute “£1,126”;
(b) in sub-paragraph (b), for “£2024” substitute “£3,071”; and
(c) in sub-paragraph (c), for “£3795” substitute “£5,724”.
(8) In paragraph (5B)—
(a) in sub-paragraph (a), for “£2,000” substitute “£2,996”;
(b) in sub-paragraph (b), for “£3,000” substitute “£4,494”; and
(c) in sub-paragraph (c), for “£4,000” substitute “£5,992”.
(9) In paragraph (5C)—
(a) in sub-paragraph (a), for “£500” substitute “£750”;
(b) in sub-paragraph (b), for “£1,250” substitute “£1,875”; and
(c) in sub-paragraph (c), for “£2,000” substitute “£3,000”.
Signed by authority of the Secretary of State for Health
Caroline Flint
Minister of State
Department of Health
28th February 2007
We consent,
Frank Roy and Claire Ward
Two of the Lords Commissioners of Her Majesty’s Treasury
28th February 2007
1972 c.68 . Under section 57(1) of the Scotland Act 1998 (c.46) , despite the transfer to Scottish Ministers of functions in relation to implementing obligations under Community law in relation to devolved matters, the functions of the Secretary of State in relation to implementing these obligations continues to be exercisable by him as regards Scotland.
S.I. 2005/50 , as amended by S.I. 2005/1098 and 2898 and 2006/2013 .
OJ No. L33, 8.2.2003, p.30.
Commission Directive 2004/33/EC (OJ No. L91, 30.3.2004), Commission Directive 2005/61/EC (OJ No. L256, 1.10.2005, p.32) and Commission Directive 2005/62/EC (OJ No. L256, 1.10.2005, p.41).