The Blood Safety and Quality (Fees Amendment) Regulations 2009

Made: 23rd February 2009

Laid before Parliament: 3rd March 2009

Coming into force: 1st April 2009

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 (Fees Amendment) Regulations 2009 and shall come into force on 1st April 2009.

• (2) In these Regulations “the principal Regulations” means the Blood Safety and Quality Regulations 2005[^f00004].

Amendment of regulation 22 of the principal Regulations

2

• (1) Regulation 22 of the principal Regulations (fees) is amended as follows.

• (2) In paragraph (2)—

• (a) in sub-paragraph (a), for “£2,927” substitute “£3,044”;

• (b) in sub-paragraph (b), for “£493” substitute “£513”; and

• (c) in sub-paragraph (c), for “£440” substitute “£458”.

• (3) In paragraph (2A), in sub-paragraph (b) for “£468” substitute “£487”.

• (4) In paragraph (3)—

• (a) in sub-paragraph (a), for “£2,452” substitute “£2,557”; and

• (b) in sub-paragraph (b), for “£1,226” substitute “£1,279”.

• (5) In paragraph (3A), for “£650” substitute “£676”.

• (6) In paragraph (3C)(c), for “£468” substitute “£487”.

• (7) In paragraph (5)—

• (a) in sub-paragraph (a), for “£2,452” substitute “£2,557”; and

• (b) in sub-paragraph (b), for “£1,226” substitute “£1,279”.

• (8) In paragraph (5B)—

• (a) in sub-paragraph (a), for “£2,452” substitute “£2,557”; and

• (b) in sub-paragraph (b), for “£1,226” substitute “£1,279”.

• (9) In paragraph (5C)—

• (a) in sub-paragraph (a), for “£2,452” substitute “£2,557”; and

• (b) in sub-paragraph (b), for “£1,226” substitute “£1,279”.

Signed

Signed by authority of the Secretary of State for Health.

Dawn Primarolo — Minister of State, — Department of Health — 9th February 2009

We consent

Tony Cunningham — Dave Watts — Two of the Lords Commissioners of Her Majesty’s Treasury — 23rd February 2009

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations amend the Blood Safety and Quality Regulations 2005 (S.I.2005/50) (“the principal Regulations”), which implement Directive 2002/98/EC of the European Parliament and of the Council setting out the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components[^f00005] and related Commission Directives[^f00006].

Regulation 2 amends regulation 22 of the principal Regulations to increase the fees payable by blood establishments and hospital blood banks or facilities in relation to authorisation, operation, and haemovigilance. The overall average fee increase is around 4%.

An impact assessment of the effect that this instrument will have on the costs of the business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

Footnotes

[^f00001]: 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 the Secretary of State as regards Scotland.

[^f00002]: 1973 c.51.

[^f00003]: S.I. 2004/3037.

[^f00004]: S.I. 2005/50, as amended by S.I. 2005/1098, 2532 and 2898, 2006/2013, 2007/604 and 2008/525 and 941.

[^f00005]: OJ No. L33, 8.2.2003, p.30.

[^f00006]: Commission Directive 2004/33/EC (OJ No. L91, 30.3.2004, p.25), 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).