2007 No. 604
The Blood Safety and Quality (Amendment) Regulations 2007
Made
Laid before Parliament
Coming into force
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 19721 and section 56(1) and (2) of the Finance Act 19732.
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 origin3.
The Treasury has consented to the making of these Regulations as required by section 56(1) of the Finance Act 1973.
Citation, commencement and interpretation1
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 20054.
Amendment of regulation 12B of the principal Regulations2
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 Regulations3
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 Regulations4
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
We consent,
(This note is not part of the Regulations)