Citation, commencement and interpretation

1.–(1) These regulations may be cited as the Blood Safety and Quality (Fees Amendment) Regulations 2008 and shall come into force on 1^st April 2008.

(2) In these Regulations "the principal Regulations" means the Blood Safety and Quality Regulations 2005(4).

Amendment of regulation 22 of the principal Regulations

2.–(1) Regulation 22 of the principal Regulations is amended as follows.

(2) In paragraph (2)–

(a) in sub-paragraph (a), for "£2,688" substitute "£2,927";

(b) in sub-paragraph (b), for "£449" substitute "£493";

(c) in sub-paragraph (c), for "£387" substitute "£440".

(3) In paragraph (2A), in sub-paragraph (b) for "£432" substitute "£468".

(4) In paragraph (3), for sub-paragraphs (a) - (f) substitute the following sub-paragraphs–

"(a) for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £2,452; and

(b) for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of £1,226, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.".

(5) In paragraph (3A), for "£600" substitute "£650".

(6) In paragraph (3C), in sub-paragraph (c), for "£432" substitute "£468".

(7) In paragraph (5), for sub-paragraphs (a) - (c) substitute the following sub-paragraphs–

"(a) for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £2,452; and

(b) for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of £1,226, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.".

(8) In paragraph (5B), for sub-paragraphs (a) - (c) substitute the following sub-paragraphs–

"(a) for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £2,452; and

(b) for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of £1,226, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.".

(9) In paragraph (5C), for sub-paragraph (a) - (c) substitute the following sub-paragraphs–

"(a) for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £2,452; and

(b) for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of £1,226, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.".

(10) Omit paragraph (5D).

(11) In paragraph (6) omit the definitions of "major site", "minor site", "regular inspection" and "standard site".

(12) After paragraph (6) insert the following–

"(6A) For the purposes of this regulation if an inspection is carried out by more than one inspector, the time taken by the Secretary of State to carry out the inspection is the aggregate of times taken by each inspector in carrying out the inspection at the site.".

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations further amend the Blood Safety and Quality Regulations 2005 ("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 and increases the fees payable by blood establishments and hospital blood banks or facilities in relation to authorisation, operation, and haemovigilance. It introduces new methods of calculating the rates, and new rates for inspections. The overall average fee increase is around 8%.

A full regulatory 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 and copies have been placed in the libraries of both Houses of Parliament.