- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol). This item of legislation is currently only available in its original format.
Statutory Instruments
Fees And Charges
Health And Safety
Made
25th February 2010
Laid before Parliament
4th March 2010
Coming into force
1st April 2010
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.
1.—(1) These Regulations may be cited as the Blood Safety and Quality (Fees Amendment) Regulations 2010 and shall come into force on 1st April 2010.
(2) In these Regulations, “the principal Regulations” means the Blood Safety and Quality Regulations 2005(4).
2.—(1) Regulation 22 of the principal Regulations (fees) is amended as follows.
(2) In paragraph (2)—
(a)in sub-paragraph (a), for “£3,044” substitute “£3,074”;
(b)in sub-paragraph (b), for “£513” substitute “£518”; and
(c)in sub-paragraph (c), for “£458” substitute “£463”.
(3) In paragraph (2A)(b), for “£487” substitute “£492”.
(4) In paragraph (3)—
(a)in sub-paragraph (a), for “£2,557” substitute “£2,583”; and
(b)in sub-paragraph (b), for “£1,279” substitute “£1,292”.
(5) In paragraph (3A), for “£676” substitute “£683”.
(6) In paragraph (3C)(c), for “£487” substitute “£492”.
(7) In paragraph (5)—
(a)in sub-paragraph (a), for “£2,557” substitute “£2,583”; and
(b)in sub-paragraph (b), for “£1,279” substitute “£1,292”.
(8) In paragraph (5B)—
(a)in sub-paragraph (a), for “£2,557” substitute “£2,583”; and
(b)in sub-paragraph (b), for “£1,279” substitute “£1,292”.
(9) In paragraph (5C)—
(a)in sub-paragraph (a), for “£2,557” substitute “£2,583”; and
(b)in sub-paragraph (b), for “£1,279” substitute “£1,292”.
(10) Before paragraph (6) insert—
“(5E) The fee payable by a blood establishment or a person who is responsible for the management of a hospital blood bank who gives a notification under regulation 12(1) of its desire to make written representations to, or appear before and be heard by, a person appointed by the Secretary of State, is £10,000.
(5F) The Secretary of State will refund to that person—
(a)60% of that fee if the person withdraws the notification two weeks before the commencement of the hearing before the person appointed;
(b)100% of that fee if, in respect of the hearing before a person appointed, the decision notified by the Secretary of State is—
(i)not to suspend or revoke, as the case may be, the authorisation pursuant to regulation 5;
(ii)to withdraw any notice served pursuant to regulation 4(8), 5 or 11; or
(iii)to overturn the refusal of authorisation or the imposition of any condition pursuant to regulation 4(5).”.
(11) After paragraph (7)(iib) insert—
“(iic)the fee payable pursuant to paragraph (5E) shall be payable at the time the notification is given;”.
(12) In paragraph (9), for “The Secretary of State” substitute “Save in respect of the fee payable under paragraph (5E), the Secretary of State”.
Signed by authority of the Secretary of State for Health
Mike O’Brien
Minister of State,
Department of Health
22nd February 2010
We consent
Tony Cunningham
Steve McCabe
Two of the Lords Commissioners of Her Majesty’s Treasury
25th February 2010
(This note is not part of the Regulations)
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(5) and related Commission Directives(6).
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 1%. It also introduces a new fee for applications under regulation 12(1) of the principal Regulations to make written representations to, or appear before and be heard by, a person appointed by the Secretary of State.
An impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ and copies have been placed in the libraries of both Houses of Parliament.
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 European Union 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.
S.I. 2005/50, as amended by S.I. 2005/1098, 2532 and 2898, 2006/2013, 2007/604, 2008/525 and 941 and 2009/372 and 3307.
OJ No. L33, 8.2.2003, p.30 to which amendments have been made by Regulation (EC) No. 596/2009 of the European Parliament and of the Council (OJ No. L188, 18.7.2009, p.14).
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).
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.
Mae Memoranda Esboniadol yn nodi datganiad byr o ddiben Offeryn Statudol ac yn rhoi gwybodaeth am ei amcan polisi a goblygiadau polisi. Maent yn ceisio gwneud yr Offeryn Statudol yn hygyrch i ddarllenwyr nad oes ganddynt gymhwyster cyfreithiol, ac maent yn cyd-fynd ag unrhyw Offeryn Statudol neu Offeryn Statudol Drafft a gyflwynwyd ger bron y Senedd o Fehefin 2004 ymlaen.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys