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”.