text:
Citation, commencement, application and interpretation
1
1
These Regulations may be cited as the Markets in Financial Instruments Directive (Consequential Amendments) Regulations 2007 and come into force on 1st November 2007.
2
Regulations 2, 4, 5 and 7 have effect for financial years ending on or after 1st November 2007, subject to regulation 8.
3
In these Regulations, “financial year” has the same meaning as in section 223 of the Companies Act 1985 or in Northern Ireland in Article 231 of the Companies (Northern Ireland) Order 1986 .
Amendments to the Companies Act 1985
2
1
The Companies Act 1985 is amended as follows.
2
In section 247A (cases in which special provisions for small and medium-sized companies do not apply) —
a
in subsection (1B)(b), for “an ISD investment firm” substitute “a MiFID investment firm”;
b
in subsection (2)(ba), for “an ISD investment firm” substitute “a MiFID investment firm”.
3
In section 248 (exemption for small and medium-sized groups), in subsection (2)(ba) , for “an ISD investment firm” substitute “a MiFID investment firm”.
4
In section 249AA (dormant companies), in subsection (3)(a) , for “an ISD investment firm” substitute “a MiFID investment firm”.
5
In section 249B (cases where exemptions from audit for certain small companies not available), in subsection (1)(b) , for “an ISD investment firm” substitute “a MiFID investment firm”.
6
In section 262 (minor definitions relating to Part 7), in subsection (1) —
a
omit the definition of “ISD investment firm”;
b
at the appropriate place insert —
“MiFID investment firm” means an investment firm within the meaning of Article 4.1.1 of Directive 2004/39/ EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments , other than —
a company to which that Directive does not apply by virtue of Article 2 of that Directive,
a company which is an exempt investment firm within the meaning of regulation 4A(3) of the Financial Services and Markets Act 2000 (Markets in Financial Instruments) Regulations 2007 , and
any other company which fulfils all the requirements set out in regulation 4C(3) of those Regulations;
.
7
In section 262A (index of defined expressions) —
a
omit the entry for “ISD investment firm”;
b
at the appropriate place insert —
MiFID investment firm section 262(1)
.
Amendments to the Companies Act 2006
3
1
The Companies Act 2006 is amended as follows.
2
In section 384 (companies excluded from the small companies regime) —
a
in subsection (1)(b), for “an ISD investment firm” substitute “a MiFID investment firm”;
b
in subsection (2)(d), for “an ISD investment firm” substitute “a MiFID investment firm”.
3
In section 467 (companies excluded from being treated as medium-sized), in subsection (2)(d), for “an ISD investment firm” substitute “a MiFID investment firm”.
4
In section 474 (minor definitions relating to Part 15), in subsection (1) —
a
omit the definition of “ISD investment firm”;
b
at the appropriate place insert —
“MiFID investment firm” means an investment firm within the meaning of Article 4.1.1 of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments, other than —
a company to which that Directive does not apply by virtue of Article 2 of that Directive,
a company which is an exempt investment firm within the meaning of regulation 4A(3) of the Financial Services and Markets Act 2000 (Markets in Financial Instruments) Regulations 2007, and
any other company which fulfils all the requirements set out in regulation 4C(3) of those Regulations;
.
5
In section 478 (companies excluded from small companies exemption), in paragraph (b)(i), for “an ISD investment firm” substitute “a MiFID investment firm”.
6
In section 481 (companies excluded from dormant companies exemption), in paragraph (a), for “an ISD investment firm” substitute “a MiFID investment firm”.
7
In section 539 (minor definitions relating to Part 16) —
a
omit the definition of “ISD investment firm”;
b
at the appropriate place insert —
“MiFID investment firm” means an investment firm within the meaning of Article 4.1.1 of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments, other than —
a company to which that Directive does not apply by virtue of Article 2 of that Directive,
a company which is an exempt investment firm within the meaning of regulation 4A(3) of the Financial Services and Markets Act 2000 (Markets in Financial Instruments) Regulations 2007, and
any other company which fulfils all the requirements set out in regulation 4C(3) of those Regulations;
.
8
In Schedule 8 (index of defined expressions) —
a
omit the entry for “ISD investment firm”;
b
at the appropriate place insert —
“MiFID investment firm — in Part 15 section 474(1). — in Part 16 section 539
.
Amendments to the Companies (Northern Ireland) Order 1986
4
1
The Companies (Northern Ireland) Order 1986 is amended as follows.
2
In Article 255A (cases in which special provisions for small and medium-sized companies do not apply) —
a
in paragraph (1B)(b), for “an ISD investment firm” substitute “a MiFID investment firm”;
b
in paragraph (2)(ba), for “an ISD investment firm” substitute “a MiFID investment firm”.
3
In Article 256 (exemption for small and medium-sized groups), in paragraph (2)(ba) , for “an ISD investment firm” substitute “a MiFID investment firm”.
4
In Article 257AA (dormant companies), in paragraph (3)(a) , for “an ISD investment firm” substitute “a MiFID investment firm”.
5
In Article 257B (cases where exemptions not available), in paragraph (1)(b) , for “an ISD investment firm” substitute “a MiFID investment firm”.
6
In Article 270 (minor definitions relating to Part 8) —
a
omit the definition of “ISD investment firm”;
b
at the appropriate place insert —
“MiFID investment firm” means an investment firm within the meaning of Article 4.1.1 of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments, other than —
a company to which that Directive does not apply by virtue of Article 2 of that Directive,
a company which is an exempt investment firm within the meaning of regulation 4A(3) of the Financial Services and Markets Act 2000 (Markets in Financial Instruments) Regulations 2007, and
any other company which fulfils all the requirements set out in regulation 4C(3) of those Regulations;
.
7
In Article 270A (index of defined expressions) —
a
omit the entry for “ISD investment firm”;
b
at the appropriate place insert —
MiFID investment firm Article 270
.
Amendment to the Limited Liability Partnerships Regulations 2001
5
In Schedule 1 to the Limited Liability Partnerships Regulations 2001 (modifications to provisions of Part 7 of the Companies Act 1985 applied by those Regulations), in the entry relating to subsection (3) of section 249AA (dormant companies), for “an ISD investment firm” substitute “a MiFID investment firm”.
Amendment to the Financial Services and Markets Act 2000 (Gibraltar) Order 2001
6
In article 2 of the Financial Services and Markets Act 2000 (Gibraltar) Order 2001 , in paragraph (1A), for “investment services directive” substitute “markets in financial instruments directive”.
Amendment to the Limited Liability Partnerships Regulations (Northern Ireland) 2004
7
In Schedule 1 to the Limited Liability Partnerships Regulations (Northern Ireland) 2004 (modifications to provisions of Part 8 of the 1986 Order applied by those Regulations), in the entry relating to paragraph (3) of Article 257AA (dormant companies), for “an ISD investment firm” substitute “a MiFID investment firm”.
Transitional provision: accounting and audit requirements
8
1
This regulation has effect for a financial year (“the transitional financial year”) beginning before, but ending on or after, 1st November 2007.
2
In the enactments amended by regulations 2, 4, 5 and 7 the references to a “MiFID investment firm” do not include a person who satisfies conditions A and B.
3
Condition A is satisfied if, at any time that is within the transitional financial year and is before 1st November 2007, the person would have been a MiFID investment firm if Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments had had effect at that time.
4
In paragraph (3), “MiFID investment firm” has the same meaning as in section 262 of the Companies Act 1985 (as it has effect on 1st November 2007, disregarding this regulation).
5
Condition B is satisfied if the person —
a
was not, at any time that is within the transitional financial year and is before 1st November 2007, an ISD investment firm within the meaning of section 262 of the Companies Act 1985 (as it had effect at that time), and
b
would not, at any time that is within the transitional financial year and is on or after 1st November 2007, have been such a firm if that section and Council Directive 93/22/EC of 10 May 1993 on investment services in the securities field had had effect at that time as they had effect immediately before 1st November 2007.
Dave Watts
Frank Roy
Two of the Lords Commissioners of Her Majesty’s Treasury
9th October 2007


type: legislation

jurisdiction: UK

text:
Citation and extent
1
1
This Order may be cited as the Police Act 1997 (Commencement No. 10) Order 2007.
2
The Order extends to Northern Ireland.
Commencement on 3rd December 2007
2
The following provisions of the Police Act 1997 shall come into force on 3rd December 2007 —
a
section 120;
b
section 120ZA;
c
section 120A;
d
section 120AA;
e
section 120AB;
f
section 122;
g
section 122A;
h
section 123;
i
section 124;
j
section 124A;
k
section 125;
l
section 126; and
m
section 127.
Paul Goggins
Minister of State
Northern Ireland Office
26th November 2007


text:
Citation and commencement
1
These Regulations may be cited as the Road Vehicles (Registration and Licensing) (Amendment) (No. 3) Regulations 2007 and shall come into force on 1st October 2007.
Amendment of regulations
2
Schedule 2 (reduced pollution certificates and the reduced pollution requirements) to the Road Vehicles (Registration and Licensing) Regulations 2002 shall be amended in accordance with the following regulations.
3
In paragraph 1 (interpretation of Schedule) in sub-paragraph (1) —
a
after the definition of “authorised examiner” there shall be inserted —
“diesel engine” has the same meaning as that expression bears in section 2.1 of Annex I to Directive 2005/55/ EC ;
;
b
after the definition of “Directive 1999/96” there shall be inserted —
“Directive 2005/55/EC ” means Directive 2005/55/EC of the European Parliament and of the Council of 28th September 2005 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive-ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles ;
“Directive 2005/78/EC ” means Commission Directive 2005/78/EC of 14th November 2005 of the European Parliament and of the Council on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression ignition engines for use in vehicles and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles and amending Annexes I, II , III , IV and VI thereto ;
;
c
after the definition of “eligible vehicle” there shall be inserted —
“gas engine” has the same meaning as that expression bears in section 2.1 of Annex I to Directive 2005/55/EC ;
“limit value” has the same meaning as in Directive 2005/55/EC ;
; and
d
for the definition of “prescribed adaptation” there shall be substituted —
“prescribed adaptation” means an adaptation of a description specified in paragraph 4(2) or 4A(b)(ii)
.
4
In paragraph 3 (reduced pollution examinations) —
a
in sub-paragraph (2) after paragraph (c) there shall be inserted —
cc
a reduced pollution certificate has previously been issued in respect of the vehicle and the last such certificate issued is not surrendered;
; and
b
in sub-paragraph (3) paragraph (f) for “the prescribed adaptation” there shall be substituted “any prescribed adaptation”.
5
After paragraph 3 there shall be inserted —
The reduced pollution requirements
3A
An eligible vehicle satisfies the reduced pollution requirements for the purposes of the 1994 Act at any time if paragraph 4 or 4A applies to it.
.
6
In paragraph 4 (the reduced pollution requirements) —
a
the heading shall be omitted; and
b
for sub-paragraph (1) there shall be substituted —
1
This paragraph applies to an eligible vehicle where, as a result of an adaptation of a description specified in paragraph (2) having been made to it after 17th March 1998, it satisfies the reduced pollution requirements in accordance with sub-paragraph (3) or (4).
; and
c
in sub-paragraph (2) for “A prescribed adaptation is — ” there shall be substituted “The adaptation referred to in sub-paragraph (1) is — ”.
7
After paragraph 4 there shall be inserted —
4A
This paragraph applies to an eligible vehicle which —
a
is registered before 1st October 2009; and
b
complies with the requirements of paragraph 4B as a result of —
i
its design, construction or equipment as manufactured; or
ii
an adaptation made to the vehicle after 30 th September 2006 which —
aa
affects the durability or in-service conformity of the engine control system,
bb
affects or introduces an on-board diagnostic system,
cc
affects or introduces a sensor for the detection of oxides of nitrogen, or
dd
otherwise concerns the system for controlling or managing the emissions of the vehicle.
4B
The requirements of this paragraph, in relation to an eligible vehicle, are that —
a
the vehicle complies with the limit values in section 6.2.1 of Annex I to Directive 2005/55/EC in accordance with that Directive and as set out —
i
in the case of a vehicle propelled by a diesel engine, in row B2 of table 1 and row B2 of table 2 of the Directive; and
ii
in the case of a vehicle propelled by a gas engine, in row B2 of table 2 of the Directive;
b
an on-board diagnostic system as described in Article 4(2) of Directive 2005/55/EC is fitted to the vehicle in accordance with the requirements of Annex IV to Directive 2005/78/EC ; and
c
the vehicle meets the requirements of section 6.5 of Annex 1 to Directive 2005/55/EC .
.
8
In paragraph 6 (contents of a reduced pollution certificate) —
a
in sub-paragraph (e) for “the prescribed adaptation” there shall be substituted “any prescribed adaptation”; and
b
for sub-paragraph (f) there shall be substituted —
f
the emission standard with which the vehicle complies;
.
Signed by authority of the Secretary of State
Rosie Winterton
Minister of State
Department for Transport
1st September 2007


text:
Citation and commencement
1
These Regulations may be cited as the Social Security Contributions (Consequential Provisions) Regulations 2007 and shall come into force on 6th April 2007.
Application of Paragraph 3 of Schedule 1 to the Social Security Contributions and Benefits Act 1992 (and corresponding provision for Northern Ireland)
2
1
Paragraph 3 of Schedule 1 to the Social Security Contributions and Benefits Act 1992 shall apply (to the extent that it does not otherwise) where an amount is retrospectively treated as earnings by regulations made by virtue of section 4B(2) of that Act.
2
Paragraph 3 of Schedule 1 to the Social Security Contributions and Benefits (Northern Ireland) Act 1992 shall apply (to the extent that it does not otherwise) where an amount is retrospectively treated as earnings by regulations made by virtue of section 4B(2) of that Act.
Amendment of the Social Security (Contributions) Regulations 2001
3
The Social Security (Contributions) Regulations 2001 are amended as follows.
4
In regulation 1(2) (interpretation) —
a
insert the following definitions at the appropriate places —
“retrospective contributions regulations” means regulations made by virtue of section 4B(2) of the Act and, in relation to an amount of retrospective earnings, “the relevant retrospective contributions regulations” means the regulations which treat that amount as earnings;
;
“retrospective earnings” means an amount retrospectively treated as earnings by retrospective contributions regulations;
;
“retrospective contributions”, in relation to an amount of retrospective earnings, means the amount of earnings-related contributions based on those earnings which the employee is liable to pay under section 6(4)(a) of the Act (primary contributions);
;
b
omit the definition of “normal rate” and insert it immediately after the definition of “non-contracted out rate”.
5
In regulation 60 (treatment for purpose of contributory benefit of unpaid primary Class 1 contributions) add at the end —
3
Where —
a
an amount is retrospectively treated as earnings by retrospective contributions regulations, and
b
the primary Class 1 contribution payable in respect of those earnings is not paid, and the failure to pay that contribution is shown to the satisfaction of an officer of the Board not to have been with the consent or connivance of, or attributable to any negligence on the part of the primary contributor,
that contribution shall be treated in accordance with paragraph (1)(a) and (b).
.
6
In regulation 90H (mandatory electronic payment) at the end add —
4
This regulation does not apply to a payment of contributions, whether primary or secondary, in respect of retrospective earnings where those earnings relate to a tax year which is closed (see paragraph 1(2) of Schedule 4) at the time the relevant retrospective contributions regulations come into force
.
7
In regulation 90N (mandatory use of electronic communications) at the end add —
4
This regulation does not apply to a return in respect of retrospective earnings where those earnings relate to a tax year which is closed (see paragraph 1(2) of Schedule 4) at the time the relevant retrospective contributions regulations come into force
.
8
1
Schedule 4 is amended as follows.
2
In paragraph 1(2) (interpretation) insert the following definitions at the appropriate places —
“closed tax year” means any year preceding the current year and cognate expressions shall be construed accordingly;
and
“ HMRC ” means Her Majesty’s Revenue and Customs;
.
3
In paragraph 6 after sub-paragraph (1) insert —
1A
Where a liability to pay retrospective contributions has arisen in respect of an employee, an employer shall amend the relevant deductions working sheet or where necessary prepare one in respect of that employee.
.
4
In paragraph 7 —
a
after sub-paragraph (3) insert —
3A
Where an amount has been treated as retrospective earnings paid to or for the benefit of an employee, the employer may deduct the retrospective contributions based on those earnings from any payment of general earnings made by him to that employee —
a
after the relevant retrospective contributions regulations come into force, and
b
during the same and the following year.
This sub-paragraph is subject to sub-paragraph (5).
.
b
sub-paragraph (5) —
i
after “(3),” insert “(3A),”;
ii
in paragraph (b), after “any of those sub-paragraphs” insert “except sub-paragraph (3A)”.
5
In paragraph 10 —
a
in sub-paragraph (1) after “Subject to” insert “sub-paragraph (1A) and”;
b
after sub-paragraph (1) insert —
1A
This paragraph does not apply in respect of amounts of retrospective earnings.
.
6
In paragraph 11 —
a
in sub-paragraph (1) after “Subject to” insert “sub-paragraph (1A) and”;
b
after sub-paragraph (1) insert —
1A
This paragraph does not apply in respect of amounts of retrospective earnings.
;
c
in sub-paragraph (4) —
i
in the definition of “N”, after paragraph (a) insert —
aa
any amount payable in respect of retrospective earnings;
;
ii
for the definition of “P” substitute —
“P” is the amount which would be payable to HMRC under regulation 68 of the PAYE Regulations but disregarding any amount payable in respect of retrospective employment income (within the meaning of regulation 2 of those Regulations);
;
7
After paragraph 11 insert —
Payments of earnings-related contributions in respect of retrospective earnings
11A
1
This paragraph applies where there are retrospective earnings in respect of which contributions (whether primary or secondary contributions) are payable.
2
The employer shall pay the contributions referred to in sub-paragraph (1) to HMRC within 14 days or, if payment is made in respect of the current year by an approved method of electronic communications, 17 days of the end of the tax month immediately following the tax month in which the relevant retrospective contributions regulations came into force.
.
8
In paragraph 12, for “10 or 11” wherever it appears substitute “10, 11 or 11A”.
9
In paragraph 17 —
a
in sub-paragraph (1) after “Subject to” insert “sub-paragraph (4A) and”.
b
in sub-paragraph (3)(b) after paragraph (ii) add —
iii
a contribution payable in respect of retrospective earnings relating to a tax year which is closed at the time that the relevant retrospective contributions regulations come into force, the 14th day after the end of the tax month immediately following the tax month in which those regulations came into force.
;
c
after sub-paragraph (4) insert —
4A
Where an employer has not paid contributions in respect of retrospective earnings relating to a closed tax year by the date set out in paragraph 11A, any contribution not so paid shall carry interest at the rate applicable under paragraph 6(3) of Schedule 1 to the Act from the reckonable date until payment.
.
10
In paragraph 19 after “shall be repaid to him” insert “if”.
11
In paragraph 22 for “the Inland Revenue”, in each place where it occurs, substitute “HMRC”.
12
After paragraph 22(2) insert —
2A
Where a liability arises to pay contributions in respect of retrospective earnings relating to a closed tax year, the employer shall render a replacement return, or where necessary prepare one, in respect of the employee for that closed tax year before 20th May following the end of the year in which the relevant retrospective contributions regulations came into force, in accordance with paragraphs (a) to (c) of sub-paragraph (1), setting out the revised earnings and earnings-related contributions.
2B
The return required by sub-paragraph (2A) shall include a statement and declaration in a form prescribed by HMRC containing a list of all deductions working sheets in accordance with paragraph 6(1A) of this Schedule in respect of that year, and shall also include a certificate showing —
a
the total amount of earnings-related contributions originally payable (in accordance with sub-paragraph (2)(a)) in respect of each employee to whom sub-paragraph (2A) applies;
b
the total amount of earnings-related contributions originally payable (in accordance with sub-paragraph (2)(b)) in respect of all employees to whom sub-paragraph (2A) applies;
c
the total amount of revised earnings-related contributions payable in respect of each of those employees;
d
the total amount of revised earnings-related contributions payable in respect of all those employees,
e
the difference between the amount certified in paragraph (b) and paragraph (d) of this sub-paragraph in respect of all of those employees;
f
in relation to any contracted-out employment the number notified by HMRC on the relevant contracting-out certificate as the employer’s number.
.
13
In paragraph 22(4) —
a
for “the declaration” substitute “the declarations”;
b
for “the certificate” substitute “the certificates”; and
c
for “sub-paragraph (2)” substitute “sub-paragraphs (2) and (2B)”.
14
In paragraph 22(6) —
a
for “the return referred to in sub-paragraph (1)” substitute “the returns referred to in sub-paragraphs (1) and (2A)”; and
b
in paragraph (b) for “the return” substitute “the returns”.
15
In paragraph 22(7) at the end add “and (2A)”.
16
In paragraph 31 —
a
for “the Inland Revenue”, wherever it occurs, substitute “HMRC”; and
b
after sub-paragraph (7) insert —
7A
Where a liability arises to pay contributions in respect of retrospective earnings relating to a closed tax year, the employer shall render a replacement return for the closed tax year before 20th May following the end of the year in which the relevant retrospective contributions regulations came into force in accordance with sub-paragraph (7), setting out the revised earnings and earnings-related contributions.
7B
Where sub-paragraph (7A) applies, the employer shall amend the relevant deductions working sheet or where necessary prepare one in accordance with sub-paragraph (2)
.
c
in sub-paragraph (8), for “(6) and (7)” substitute “(6), (7) and (7A)”.
Claire Ward
Dave Watts
Two of the Lords Commissioners of Her Majesty’s Treasury
29th March 2007
The Secretary of State concurs.
James Purnell
Minister of State,
Department for Work and Pensions
29th March 2007
The Department for Social Development concurs.
Sealed with the Official Seal of the Department for Social Development on the 28th day of March 2007.
John O’Neill
Senior Officer of the Department for Social Development


text:
Citation and commencement
1
This Order may be cited as the Bus Lane Contraventions (Approved Local Authorities) (England) (Amendment) (No. 2) Order 2007 and shall come into force on 3rd April 2007.
Specification of approved local authorities
2
The Isle of Wight Council is specified as an approved local authority for the purposes of section 144 of the Transport Act 2000 (civil penalties for bus lane contraventions) .
Amendment to the Bus Lane Contraventions (Approved Local Authorities) (England) Order 2005
3
1
The Schedule to the Bus Lane Contraventions (Approved Local Authorities) (England) Order 2005 shall be amended as set out in paragraph (2).
2
After the row in the table relating to Hertfordshire County Council, insert the following row —
Isle of Wight Council S.I. 2007/648
Signed by authority of the Secretary of State
G Merron
Parliamentary Under Secretary of State
Department for Transport
1st March 2007


text:
Citation and commencement
1
1
These Regulations may be cited as the Social Fund Cold Weather Payments (General) Amendment Regulations 2007 and shall come into force on 1st November 2007.
2
In these Regulations “the principal Regulations ” means the Social Fund Cold Weather Payments (General) Regulations 1988 .
Amendment of the principal Regulations
2
The principal Regulations are amended in accordance with regulations 3 and 4.
Substitution of Schedule 1 to the principal Regulations
3
For Schedule 1 to the principal Regulations (identification of stations and postcode districts), substitute the Schedule set out in Schedule 1 to these Regulations.
Substitution of Schedule 2 to the principal Regulations
4
For Schedule 2 to the principal Regulations (specified alternative stations), substitute the Schedule set out in Schedule 2 to these Regulations.
Signed by authority of the Secretary of State for Work and Pensions
James Plaskitt
Parliamentary Under-Secretary of State,
Department for Work and Pensions
8th October 2007


text:
Citation and commencement
1
1
These Regulations may be cited as the Childcare Providers (Information, Advice and Training) Regulations 2007 and come into force on 1st October 2007.
Interpretation
2
In these Regulations —
“ the Act ” means the Childcare Act 2006;
“the equality enactments” means the Sex Discrimination Act 1975 , the Race Relations Act 1976 , the Disability Discrimination Act 1995 , Part 2 of the Equality Act 2006 and regulations under Part 3 of that Act, the Employment Equality (Sexual Orientation) Regulations 2003 and the Employment Equality (Religion or Belief) Regulations 2003 ; and
“Early Years Foundation Stage” has the meaning in section 39 of the Act.
Childcare providers and employees
3
1
An English local authority must secure the provision of information, advice and training on the matters mentioned in regulation 4(1) to persons falling within section 13(1)(a) to (d) of the Act.
2
An English local authority must secure the provision of information, advice and training on matters mentioned in regulation 4(1)(d) to (i) to any person falling within section 13(1)(e) of the Act.
Information, advice and training
4
1
The matters referred to in regulation 3(1) are —
a
registration procedures under Chapters 2, 3 and 4 of Part 3 (regulation and provision of childcare in England) of the Act and the prescribed requirements for registration ;
b
information on the significance of registration under Chapter 4 (voluntary registration) of Part 3 of the Act;
c
business planning, financial management and marketing;
d
meeting the requirements of the Early Years Foundation Stage;
e
meeting the requirements of regulations under sections 59(2) and 67(2) of the Act (regulations governing activities of providers of childcare);
f
meeting the requirements of the equality enactments;
g
meeting the needs of persons described in paragraph (2) in relation to the provision of suitable childcare;
h
effective safeguarding and promotion of children’s welfare and compliance with statutory requirements, guidance and procedures for the protection of children; and
i
the use of the Common Assessment Framework .
2
The persons referred to in paragraph (1)(g) are —
a
disabled children;
b
children with special educational needs;
c
looked after children within the meaning given in section 22(1) of the Children Act 1989 ;
d
those using, or intending to use, childcare in respect of which the child care element of the working tax credit is payable; and
e
other children who are at risk of social exclusion by virtue of unemployment, poverty, homelessness, geographical remoteness, ill health, family breakdown or other economic, cultural or social factors.
3
In this regulation —
a
“child care element”, in relation to working tax credit, is to be read in accordance with section 12 of the Tax Credits Act 2002 ;
b
“disabled child” means a child who has a disability for the purposes of the Disability Discrimination Act 1995; and
c
“special educational needs” has the meaning in section 312(1) of the Education Act 1996 .
Additional support
5
1
An English local authority must secure the provision of information, advice and training to any person falling within section 13(1)(a) to (d) of the Act —
a
if the childcare provided by such person falls below an adequate standard, as assessed by Her Majesty’s Chief Inspector of Education, Children’s Services and Skills ; or
b
in respect of whom an exemption has been granted for a specified period of time by a direction under regulations made under section 46(1) of the Act for the purposes of developing childcare provision to meet the learning and development requirements of the Early Years Foundation Stage.
2
An English local authority shall not be required to secure information, advice and training under paragraph (1)(b) following the expiry of an exemption described in that paragraph.
Beverley Hughes
Minister of State
Department for Education and Skills
21st June 2007


text:
1
1
This Order may be cited as the A66 Trunk Road (South Stockton Link Slip Roads) (Trunking) Order 2007 and shall come into force on 25th May 2007.
2
In this Order, all measurements of distance are measured along the route of the relevant highway.
2
The lengths of highways described in the Schedule to this Order shall become trunk roads from the date when this Order comes into force.
3
The centre line of each of the new trunk roads is indicated by a heavy black line on the plan numbered HA 10/ TD /023, marked “The A66 Trunk Road (South Stockton Link Slip Roads) (Trunking) Order 2007”, signed by authority of the Secretary of State for Transport and deposited at the ODPM-DfT Records Management Branch, Floor 13 (IMD), Ashdown House, St Leonards on Sea, Hastings, East Sussex TN37 7GA.
Signed by authority of the Secretary of State for Transport
A.W. Ashburner
A Divisional Director Highways Agency
2nd March 2007


text:
Citation and commencement
1
These Regulations may be cited as the Tax and Civil Partnership Regulations 2007 and shall come into force on the day after that on which they are made.
Amendments to the Finance Act 2004
2
1
Schedule 28 to the Finance Act 2004 (registered pension schemes: authorised pensions –supplementary) is amended as follows.
2
After paragraphs 2(6)(a) and 3(2)(a) insert —
aa
entering into a civil partnership,
.
3
In paragraphs 17(1)(d) and (e), after the words “marrying” insert “, entering into a civil partnership”.
Amendments to the Pensions Schemes (Application of UK Provisions to Relevant Non-UK Schemes) Regulations 2006
3
1
Regulation 13 of the Pension Schemes (Application of UK Provisions to Relevant Non‑UK Schemes) Regulations 2006 (modification of section 279 of the Finance Act 2004) is amended as follows.
2
In paragraph (2) —
a
in the definition of “applicable pension scheme” for “or ex-spouse” substitute “, ex-spouse, civil partner or former civil partner”; and
b
after the definition of “ex-spouse” add —
“former civil partner” in relation to a member means the other party to a civil partnership with the member that has been dissolved or annulled.
.
3
In paragraph (3)(a) for “ or ex-spouse” substitute “, ex-spouse, civil partner or former civil partner”.
4
In paragraph (4) —
a
for “or ex-spouse” substitute “, ex-spouse, civil partner or former civil partner”; and
b
after the words “annulment of the marriage” insert “or civil partnership”.
Frank Roy
Dave Watts
Two of the Lords Commissioners of Her Majesty’s Treasury
21st February 2007


text:
Citation, interpretation and extent
1
1
These Regulations may be cited as the Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007.
2
In these Regulations —
a
“the 1973 Regulations ” means the Misuse of Drugs (Safe Custody) Regulations 1973 ; and
b
“the 2001 Regulations ” means the Misuse of Drugs Regulations 2001 .
3
These Regulations extend to England, Wales and Scotland.
Commencement
2
1
Subject to paragraphs (2), (3) and (4), these Regulations shall come into force on 16th August 2007.
2
Regulation 4(11)(b) shall come into force on 1st September 2007.
3
The following regulations shall come into force on 1st January 2008 —
a
regulation 3(4);
b
regulation 4(6)(e);
c
regulation 4(8);
d
regulation 4(11)(a);
e
regulation 4(13) to (14).
4
The following regulations shall come into force on 1st February 2008 —
a
regulation 4(9) to (10);
b
regulation 4(15).
Amendments to the Misuse of Drugs (Safe Custody) Regulations 1973
3
1
The 1973 Regulations shall be amended as follows.
2
In regulation 2 —
a
after the definition of “the Act” insert —
“care home” in relation to —
a
England and Wales has the same meaning as in the Care Standards Act 2000 ; and
b
Scotland means the accommodation provided by a care home service;
“care home service” has the same meaning as in the Regulation of Care (Scotland) Act 2001 ;
;
b
omit paragraphs (2) and (3).
3
For regulation 3(1), substitute —
This regulation applies to the following premises —
a
those occupied by a retail dealer for the purposes of his business;
b
a care home.
.
4
In paragraph 3 of Schedule 1, after “Methyprylone” insert “(ha) Midazolam”.
Amendments to the Misuse of Drugs Regulations 2001
4
1
The 2001 Regulations shall be amended as follows.
2
In regulation 2(1) (interpretation) —
a
after the definition of “the Act”, insert —
“accountable officer” has the same meaning as in the Health Act 2006 ;
;
b
after the definition of “authorised as a member of a group”, insert —
“care home” in relation to —
a
England and Wales has the same meaning as in the Care Standards Act 2000; and
b
Scotland means the accommodation provided by a care home service;
“care home service” has the same meaning as in the Regulation of Care (Scotland) Act 2001;
;
c
after the definition of “officer of customs and excise”, insert —
“operating department practitioner” means a person who is registered under the Health Professions Order 2001 as an operating department practitioner;
;
d
after the definition of “register” insert —
“registered chiropodist” has the same meaning as in the Prescription Only Medicines (Human Use) Order 1997 ;
;
e
for the definition of “registered ophthalmic optician”, substitute —
“registered optometrist” has the same meaning as in the Prescription Only Medicines (Human Use) Order 1997 ;
“registered orthoptist” has the same meaning as in the Prescription Only Medicines (Human Use) Order 1997 ;
;
f
after the definition of “registered orthotist and prosthetist” insert —
“registered paramedic” has the same meaning as in the Prescription Only Medicines (Human Use) Order 1997 ;
;
g
after the definition of “registered pharmacy” insert —
registered physiotherapist” has the same meaning as in the Prescription Only Medicines (Human Use) Order 1997 ;
“registered radiographer” has the same meaning as in the Prescription Only Medicines (Human Use) Order 1997 ;
;
h
omit the definitions of “sister or acting sister”, “state registered chiropodist” and “state registered paramedic”.
3
For “nursing home”, in each place those words appear in the following regulations, substitute “care home” —
a
regulation 8(2) (production and supply of drugs in Schedules 2 and 5);
b
regulation 9(3) (production and supply of drugs in Schedules 3 and 4);
c
regulation 14(4) , 14(5) and 14(6) (documents to be obtained by supplier of controlled drugs);
d
regulation 15(3) (form of prescriptions);
e
regulation 19(3) (record-keeping requirements in respect of drugs in Schedules 1 and 2);
f
regulation 24(3) (preservation of records relating to drugs in Schedules 3 and 5); and
g
regulation 26(2) (furnishing of information with respect to controlled drugs).
4
For “sister or acting sister”, in each place those words appear in the following regulations, substitute “senior registered nurse or acting senior registered nurse” —
a
regulation 8(2) (production and supply of drugs in Schedules 2 and 5);
b
regulation 9(3) (production and supply of drugs in Schedules 3 and 4);
c
regulation 14(6) (documents to be obtained by supplier of controlled drugs);
d
regulation 19(3) (record-keeping requirements).
5
In regulation 8 (production and supply of drugs in Schedules 2 and 5) —
a
after paragraph (2)(e), insert —
ea
in the case of such a drug supplied to him by a person responsible for the dispensing and supply of medicines at a hospital, an operating department practitioner practising in that hospital;
;
b
at the end of paragraph (2)(i), omit “or”;
c
in paragraph (2)(ii) for “doctor or dentist.” substitute “doctor, dentist, supplementary prescriber acting under and in accordance with the terms of a clinical management plan or, subject to paragraph (2A), a nurse independent prescriber; or”;
d
after paragraph (2)(ii), insert —
iii
an operating department practitioner to supply any drug otherwise than for administration to a patient in a ward, theatre or other department in accordance with the directions of a doctor, dentist, supplementary prescriber acting under and in accordance with the terms of a clinical management plan or, subject to paragraph (2A), a nurse independent prescriber.
;
e
after paragraph (2), insert —
2A
The directions given by a nurse independent prescriber referred to in paragraph (2)(ii) and (iii) shall relate only to a controlled drug which she may prescribe under regulation 6B and a purpose for which it may be prescribed under that regulation.
.
6
In regulation 9 (production and supply of drugs in Schedules 3 and 4) —
a
after paragraph (3)(c), insert —
d
in the case of such a drug supplied to him by a person responsible for the dispensing and supply of medicines at a hospital, an operating department practitioner practising in that hospital;
;
b
in paragraph (3)(ii) for “doctor or dentist.” substitute “doctor, dentist, supplementary prescriber acting under and in accordance with the terms of a clinical management plan or, subject to paragraph (3A), a nurse independent prescriber; or”;
c
after paragraph (3)(ii), insert —
iii
an operating department practitioner to supply any drug otherwise than for administration to a patient in a ward, theatre or other department in accordance with the directions of a doctor, dentist, supplementary prescriber acting under and in accordance with the terms of a clinical management plan or, subject to paragraph (3A), a nurse independent prescriber.
;
d
after paragraph (3), insert —
3A
The directions given by a nurse independent prescriber referred to in paragraph (3)(ii) and (iii) shall relate only to a controlled drug which she may prescribe under regulation 6B and a purpose for which it may be prescribed under that regulation.
;
e
in paragraph (8), after “any drug specified in Schedule 4” insert “or Midazolam”.
7
In regulation 10 (possession of drugs in Schedules 2, 3 and 4) —
a
in paragraphs (1)(c) and (d), for “regulation 9(3)(b) or (c)” substitute “regulation 9(3)(b) to (d)”;
b
in paragraph (1)(i), after “sub-paragraph (e)” insert “or (ea)”;
c
in paragraph (1)(ii), after “sub-paragraph (c)” insert “or (d)”.
8
In regulation 14 (documents to be obtained by supplier of controlled drugs) —
a
in paragraph (2), for “paragraph” where this first occurs substitute “regulation”;
b
after paragraph (5) insert —
5A
Subject to paragraph (5B), on receipt of a requisition (other than a veterinary requisition) mentioned in paragraph (2), the supplier shall —
a
mark on the requisition in ink or otherwise indelibly his name and address; and
b
send the requisition to the relevant National Health Service agency in accordance with arrangements specified by that agency.
5B
Paragraph (5A) shall not apply where the supplier is —
a
a wholesale dealer; or
b
a person responsible for the dispensing and supply of medicines at a hospital or care home.
;
c
after paragraph (7) insert —
8
In this regulation, “veterinary requisition” means a requisition which states, in accordance with paragraph (2)(ii), that the recipient is a veterinary surgeon or veterinary practitioner.
.
9
In regulation 19 (record-keeping requirements) —
a
in paragraph (1)(a) for “in the form specified in Part I or II of Schedule 6, as the case may require,” substitute “subject to subparagraph (f), using the headings specified in subparagraphs (d) and (e),”;
b
after paragraph (1)(c) insert —
d
The headings in respect of entries made for drugs obtained are —
i
Date supply received;
ii
Name and address from whom received;
iii
Quantity received.
e
The headings in respect of entries made for drugs supplied are —
i
Date supplied;
ii
Name/Address of person or firm supplied;
iii
Details of authority to possess – prescriber or licence holder’s details;
iv
Quantity supplied;
v
Person collecting Schedule 2 controlled drug (patient/ patient’s rep/ healthcare professional) and if healthcare professional, name and address;
vi
Was proof of identity requested of patient/ patient’s rep (Yes/No);
vii
Was proof of identity of person collecting provided (Yes/No).
f
The headings at subparagraph (e)(v) to (vii) apply only in respect of drugs specified in Schedule 2.
;
c
for paragraph (2), substitute —
2
Entries made in respect of drugs obtained and drugs supplied may be made on the same page or on separate pages in the register.
;
d
in paragraph (2A), for “paragraphs (1) and (2)” substitute “paragraph (1)”.
10
In regulation 20 (requirements as to registers), for paragraph (a) substitute “in the separate register or separate part of the register used for each class of drug, a separate page shall be used in respect of each strength and form of that drug and the head of each such page shall specify the class of the drug, its strength and form;”.
11
In regulation 23 (preservation of registers, books and other documents) —
a
in paragraph (3) —
i
omit “requisition, order and”; and
ii
for “regulations” substitute “Regulations”;
b
in paragraph (4) for “, or a copy of such prescription, must” insert “shall”.
12
In regulation 27 (destruction of controlled drugs) —
a
in paragraph (1), after “the Secretary of State” insert “or, subject to paragraph (1A), an accountable officer”;
b
after paragraph (1), insert —
1A
An accountable officer shall not be an authorised person.
.
13
In paragraph 1 of Part 1 of Schedule 4 (controlled drugs subject to the requirements of regulations 22, 23, 26 and 27), omit “Midazolam”.
14
In paragraph 1(a) of Schedule 3 (controlled drugs subject to the requirements of regulations 14 to16, 18, 22 to 24, 26 and 27), after “Methyprylone” insert “Midazolam”.
15
Omit Schedule 6 (form of register).
16
In paragraph (1) of Schedule 8 —
a
in sub-paragraph (a), after “who is a” omit “state”;
b
for sub-paragraphs (d) to (h) substitute —
d
a registered optometrist;
e
a registered chiropodist;
f
a registered orthoptist;
g
a registered physiotherapist;
h
a registered radiographer;
.
Amendments to the Misuse of Drugs (Amendment No. 2) Regulations 2006
5
1
The Misuse of Drugs (Amendment No. 2) Regulations 2006 shall be amended as follows.
2
In regulation 2 (commencement) —
a
for “paragraphs (2) and (3)” substitute “paragraph (3)”;
b
omit paragraph (2).
3
Omit regulations 7(1) and 10.
Amendment to the Misuse of Drugs (Amendment No. 3) Regulations 2006
6
Omit regulation 7 of the Misuse of Drugs (Amendment No. 3) Regulations 2006 (Amendment to the Misuse of Drugs (Amendment No. 2) Regulations 2006).
Vernon Coaker
Parliamentary Under Secretary of State
Home Office
23rd July 2007


text:
Citation and commencement
1
These Regulations may be cited as the Wireless Telegraphy (Radio Frequency Identification Equipment) (Exemption) (Amendment) Regulations 2007 and shall come into force on 14th May 2007.
Amendment of the Wireless Telegraphy (Radio Frequency Identification Equipment) (Exemption) Regulations 2005
2
1
The Wireless Telegraphy (Radio Frequency Identification Equipment) (Exemption) Regulations 2005 are amended in accordance with the following provisions of this regulation.
2
In regulation 2 —
a
omit paragraph (a);
b
omit paragraph (b);
c
omit paragraph (e).
3
In regulation 3 for “section 1(1) of the Wireless Telegraphy Act 1949” substitute “section 8(1) of the Wireless Telegraphy Act 2006 ”.
4
In regulation 4 omit paragraph (2) in its entirety.
Ed Richards
Chief Executive of the Office of Communications
For and by the authority of the Office of Communications
20th April 2007


text:
Title, commencement and application
1
These Regulations may be cited as the Miscellaneous Food Additives and the Sweeteners in Food (Amendment) (England) Regulations 2007, come into force on 25th July 2007 and apply in relation to England only.
Amendments to the Miscellaneous Food Additives Regulations 1995
2
The Miscellaneous Food Additives Regulations 1995 (“the Additives Regulations”) are amended in accordance with regulations 3 to 13 below.
3
In paragraph (1) of regulation 2 (interpretation) —
a
In the definition of “carrier” and “carrier solvent”, after “miscellaneous additive,” insert “flavouring,” ;
b
in the definition of “Directive 95/2/EC ” for the expression “and European Parliament and Council Directive 2003/114/EC ” substitute “, European Parliament and Council Directive 2003/114/EC and European Parliament and Council Directive 2006/52/EC ;”;
c
in the definition of “Directive 96/77/EC ”, for the expression “and Commission Directive 2004/45/EC ” substitute “, Commission Directive 2004/45/EC and Commission Directive 2006/129/EC ;”; and
d
after the definition of “food additive” insert the following definition —
”food supplement” means a foodstuff the purpose of which is to supplement the normal diet and which is a concentrated source of vitamins or minerals or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop-dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities;
.
4
In regulation 11 (transitional provision and exemptions), after paragraph (1F), insert the following paragraph —
1G
In any proceedings for an offence under these Regulations in respect of any food additive or food, it shall be a defence to prove that —
a
the food additive or food concerned was put on the market or labelled before 15th August 2008; and
b
the matter constituting the offence would not have constituted an offence under these Regulations if the amendments made by regulation 5(a), 6(a), 6(b) and (d), or 8 of the Miscellaneous Food Additives and the Sweeteners in Food (Amendment) (England) Regulations 2007 had not been made when the food additive or food was placed on the market or labelled.
.
5
In Schedule 1 (miscellaneous additives generally permitted for use in foods not referred to in Schedule 6, 7 or 8) —
a
as Note (5) add the following —
5
The substances E400, E401, E402, E403, E404, E406, E407, E407a, E410, E412, E413, E414, E415, E417, E418 and E440 may not be used in jelly cups, defined for the purpose of these Regulations as jelly confectionery of a firm consistency, contained in semi-rigid mini-cups or mini-capsules, intended to be ingested in a single bite by exerting pressure on the mini-cup or mini-capsule so as to project the confectionery into the mouth.
;
b
after the entry relating to E461 insert the following —
E 462 Ethyl cellulose
6
In Schedule 2 (conditionally permitted preservatives and antioxidants) part A (sorbates, benzoates and p-hydroxybenzoates) —
a
omit the entries for E 216 Propyl p-hydroxybenzoate and E 217 Sodium propyl p-hydroxybenzoate in the first table;
b
omit the entries for “Shrimps, cooked” and “Crayfish tails, cooked and pre-packed marinated cooked molluscs” in the second table;
c
in the first column (entitled “Food”) of the second table, for the words “Dietetic foods intended for special medical purposes” substitute “Dietary foods for special medical purposes as defined in Directive 1999/21/EC ”;
d
add the following entries to the second table at the end:
Crustaceans and molluscs, cooked 1000 2000 Food supplements supplied in liquid form 2000
7
In Schedule 2 Part B (sulphur dioxide and sulphites), in the second table —
a
for the entries relating to crustaceans and cephalopods substitute the following —
Crustaceans and cephalopods: fresh, frozen and deep frozen 150* crustaceans, Panaeidae, Solenoceridae, Aristaeidae family: — ≤ 80 units 150* — > 80 units but ≤ 120 units 200* — > 120 units 300* cooked 50* cooked crustaceans, Panaeidae, Solenoceridae, Aristaeidae family: — ≤ 80 units 135* — > 80 units but ≤ 120 units 180* — > 120 units 270* * In edible parts
b
for the expression “Starches (excluding starches for weaning foods, follow-on formulae and infant formulae)” substitute “Starches (excluding starches in infant formulae, follow-on formulae and processed cereal-based foods and baby foods)”;
c
at the end of the table add the following entries —
Salsicha fresca 450 Table grapes 10 Fresh lychees 10 (measured on edible parts)
8
In Schedule 2 Part C (other preservatives) the table relating to E 249, E 250, E 251 and E 252 is replaced by the table set out in Schedule 1 to these Regulations.
9
In Schedule 2 Part D (other antioxidants) the table is replaced by the table set out in Schedule 2 to these Regulations.
10
In Schedule 3 (other permitted miscellaneous additives) —
a
in the entry relating to E385 in the third and fourth columns (entitled respectively “Food” and “Maximum level”) add the following entries —
Libamáj, egézben és tömbben 250 mg/ kg
b
after the entry relating to E 967 insert the following —
E 968 Erythritol Food in general (except drinks and those foods referred to in Article 2(3) of Directive 95/2/EC quantum satis Frozen and deep-frozen unprocessed fish, crustaceans, molluscs and cephalopods quantum satis Liqueurs quantum satis For purposes other than sweetening
c
after the entry relating to E 425 insert the following —
E 426 Soybean hemicellulose Dairy-based drinks intended for retail sale 5 g/l Food supplements 1.5 g/l Emulsified sauces 30 g/l Pre-packaged fine bakery wares intended for retail sale 10 g/kg Pre-packaged ready-to-eat oriental noodles intended for retail sale 10 g/kg Pre-packaged ready-to-eat rice intended for retail sale 10 g/kg Pre-packaged processed potato and rice products (including frozen, deep-frozen, chilled and dried processed products) intended for retail sale 10 g/kg Dehydrated, concentrated, frozen and deep-frozen egg products 10 g/kg Jelly confectionery, except jelly mini-cups 10 g/kg
d
in the third column of the entry relating to E 468, for the expression “Solid dietary supplements” substitute “Food supplements supplied in solid form”;
e
in the third column of the entry relating to E 338 to E 452, for the expression “Dietary supplements” substitute “Food supplements”;
f
in the third column of the entries relating to E 405, E 416, E 432 to E 436, E 473 and E 474, E 475, E 491 to E 495, E 551 to E 559 and E 901 to E 904, for the expression “Dietary food supplements” substitute “food supplements”;
g
in the third column of the entries relating to E 1201 and E 1202, for the expression “Dietary food supplements in tablet and coated form” substitute “Food supplements in tablet and coated form”;
h
in the third column of the entries relating to E 405, E 432 to E 436, E 473 and E 474, E 475, E 477, E 481 and E 482, and E 491 to E 495, for the expression “Dietetic foods intended for special medical purposes” substitute “Dietary foods for special medical purposes as defined in Directive 1999/21/EC ”;
i
in the fourth column of the entries relating to E 1505 to E 1520, after the expression “In the case of beverages,” insert the expression “with the exception of cream liqueurs,”;
j
at the end of the table add the following entries —
E 1204 Pullulan Food supplements in capsule and tablet form quantum satis Breath-freshening micro-sweets in the form of films quantum satis E 1452 Starch Aluminium Octenyl Succinate Encapsulated vitamin preparations in food supplements 35 g/kg in food supplement
11
In Schedule 4 (permitted carriers and carrier solvents) —
a
after the entry relating to E 967, in the first column insert “E 968” and in the second column opposite insert “Erythritol”;
b
after the entry relating to E 461, in the first column insert “E 462” and in the second column opposite insert “Ethyl cellulose”;
c
in the third column of the entry related to E 551 and E 552, add the expression “For E 551: in E 171 titanium dioxide and E 172 iron oxides and hydroxides (max. 90% relative to the pigment).”.
12
In Schedule 7 (foods in which a limited number of miscellaneous additives listed in Schedule 1 may be used) —
a
for the entry relating to ripened cheese, substitute the following —
Ripened cheese E 170 Calcium carbonate quantum satis E 504 Magnesium carbonates E 509 Calcium chloride E 575 Glucono-delta-lactone E 500ii Sodium hydrogen carbonate quantum satis (only for sour milk cheese)
b
in the entry relating to “ pain courant français ”, in the first column add the expression “ Friss búzankenyér, fehér és félbarna kenyerek ”;
c
in the entry relating to “ foie gras, foie gras entier, blocs de foie gras ”, in the first column add the expression “ Libamáj, libamáj egézben, libamáj tömbben ”.
13
In Schedule 8 (miscellaneous additives permitted in foods for infants and young children) —
a
in paragraphs 1, 1A and 1B of the introductory notes, for the expression “weaning foods” substitute in each case the expression “processed cereal-based foods and baby foods”;
b
in Part 3 (miscellaneous additives permitted in weaning foods for infants and young children in good health) —
i
where it appears in the title and in the third column of the entries relating to E 170 to E 526, E 500 to E 503, E 338, E 410 to E 440, E 1404 to E 1450, and E 1451, for the expression “weaning foods” substitute “processed cereal-based foods and baby foods”; and
ii
after the entry relating to E 472c insert the following entry —
E 473 Sucrose esters of fatty acids Products containing hydrolysed proteins, peptides and amino acids 120 mg/kg
Amendments to the Sweeteners in Food Regulations 1995
14
1
The Sweeteners in Food Regulations 1995 are amended in accordance with paragraphs (2) and (3).
2
In regulation 2 (interpretation) —
a
in the definition of “Directive 94/35/EC ”, for the expression “and by Directive 2003/115/EC ” substitute “ and by European Parliament and Council Directives 2003/115/EC and 2006/52/EC .”;
b
in the definition of “Directive 95/31/EC ”, for the expression “and by Directive 2004/46/EC ” substitute “and by Directives 2004/46/EC and 2006/128/EC .”.
3
In Schedule 1 (permitted sweeteners and the foods in or on which they may be used) —
a
in column 1 after “E 967” add “E 968”; and
b
in column 2 after “Xylitol” add “Erythritol”.
Signed by authority of the Secretary of State for Health
Caroline Flint
Minister of State
Department of Health
20th June 2007


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007 and shall come into force on 1st April 2007.
2
In these Regulations, “the Medicines Fees Regulations ” means the Medicines (Products for Human Use — Fees) Regulations 1995 .
Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
2
1
The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 are amended as follows.
2
In regulation 14 (fees for variations of certificates) —
a
in paragraph (2)(a), for “£226” substitute “£237”;
b
in paragraph (2)(b)(i), for “£226” substitute “£237”;
c
in paragraph (2)(b)(ii), for “£226” substitute “£237”;
d
in paragraph (2)(b)(iii), for “£114” substitute “£120”; and
e
in paragraph (2)(b)(iv), for “£57” substitute “£60”.
3
In regulation 15 (fees payable by holders of certificates), in paragraph (1), for “£15” substitute “£19”.
4
In the table in Schedule 2 (fees for applications for the grant of certificates of registration) —
a
in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks) —
i
for “£148” substitute “£155”,
ii
for “£444” substitute “£466”,
iii
in paragraph 3, for “£465” substitute “£488”, and
iv
for “£734” substitute “£770”; and
b
in column (3) (fees for other applications) —
i
for “£365” substitute “£383”,
ii
for “£654” substitute “£686”,
iii
in paragraph 3, for “£608” substitute “£622”, and
iv
for “£960” substitute “£1,007”.
5
In Schedule 2A (fees for assistance in obtaining certificates of registration in other EEA States) , in paragraph 2 —
a
in sub-paragraph (a), for “£266” substitute “£279”; and
b
in sub-paragraph (b), for “£348” substitute “£365”.
Amendment of Part I of the Medicines Fees Regulations
3
In Part I of the Medicines Fees Regulation (general), in regulation 2 (interpretation) —
a
for the definition of “the 2001 Directive ” substitute the following definition —
“the 2001 Directive” means Directive 2001/83/ EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use , as amended by —
Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components ,
Commission Directive 2003/63/EC amending Directive 2001/83/EC ,
Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC ,
Directive 2004/27/EC of the European Parliament and of the Council also amending Directive 2001/83/EC , and
Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92 , Directive 2001/20/EC , Directive 2001/83/EC and Regulation (EC) No 726/2004 ;
;
b
after the definition of “EEA State” insert the following definition —
“exempt imported product” means a medicinal product, as defined in Article 1(2) of the 2001 Directive, to which paragraph 1 of Schedule 1 to the 1994 Regulations applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;
; and
c
after the definition of “relevant fee period” substitute the following definition —
“special import notice” means a written notice given to the licensing authority in accordance with paragraph 7(2) of Schedule 2 to, or paragraph 3(2) of Schedule 4 to, the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 ;
.
Amendment of Part IA of the Medicines Fees Regulations
4
1
Part IA of the Medicines Fees Regulations (capital fees for pre-application meetings) shall be amended as follows.
2
In regulation 3A, in the definition of “pharmacovigilance advice” —
a
in paragraph (a) —
i
at the end of sub-paragraph (i), omit “or”, and
ii
after sub-paragraph (i) insert the following sub-paragraph —
ia
the pharmacovigilance and risk-management systems that the applicant would be required to introduce in accordance with Article 8(3)(ia) of the 2001 Directive;
; and
b
in paragraph (b) —
i
at the end of sub-paragraph (i), omit “or”, and
ii
after sub-paragraph (i) insert the following sub-paragraph —
ia
the pharmacovigilance and risk-management systems that he has introduced in accordance with Article 8(3)(ia) of the 2001 Directive;
.
3
In regulation 3B, for paragraph (b) substitute the following paragraphs —
b
if the advice provided at that meeting consists of advice in connection with clinical development only, a fee of £2,648;
bb
if the advice provided at that meeting consists of advice in connection with quality and safety development only, a fee of £2,934;
.
4
After regulation 3BD, insert the following regulation —
3BE
1
Where the licensing authority holds a meeting with a person who —
a
is or is to be a sponsor of a clinical trial;
b
manufactures medicinal products;
c
is or is to be responsible for placing such products on the market; or
d
acts on behalf of, or provides advice or assistance to, a person referred to in sub-paragraphs (a) to (c),
for the purpose of providing the advice specified in paragraph (2), there shall be payable by that person a fee of £4,335.
2
The advice referred to in paragraph (1) is advice in relation to —
a
scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product;
b
the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product;
c
the management of risks in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed in the European Community; or
d
other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EC marketing authorization has been granted for that product or a product of that type.
3
This regulation does not apply to a meeting for the purpose of providing only any advice specified in regulations 3B to 3BD.
4
In this regulation —
a
“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/ EEC ;
b
“Directive 93/42/EEC ” means Council Directive 93/42/EEC concerning medical devices as amended by Directive 200/70/EC of the European Parliament and of the Council amending Council Diretcove 93/42/EEC as regards medical devices incorporating stable derivatives of human blood or human plasma ;
c
“medicinal product” includes a substance incorporated in a medical device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;
d
“regulatory issues” means issues relating to the application of any Community instrument relating to EC marketing authorizations or to medical devices, or any enactment which implements such an instrument;
e
“risks” means any risk relating to the quality, safety or efficacy of a medicinal product as regards patients’ health or public health, or any risk of undesirable effects on the environment;
f
“sponsor” shall be construed in accordance with regulation 3 of the Medicines for Human Use (Clinical Trials) Regulations 2004 ; and
g
a reference to the development of a medicinal product or a type of medicinal product is a reference to development for the purposes of —
i
obtaining an EC marketing authorization, or making a variation to an EC marketing authorization, for that product or a product of that type; or
ii
obtaining an EC design-examination certificate within the meaning of paragraph 4.3 of Annex II to Directive 93/42/EEC or an EC type-examination certificate within the meaning of paragraph 5 of Annex III to that Directive, for a medical device incorporating that product or a product of that type.
.
5
In regulation 3C, for “regulation 3B” substitute “regulations 3B to 3BE”.
Amendment of Part VI of the Medicines Fees Regulations
5
In Part VI of the Medicines Fees Regulations (periodic fees for marketing authorizations and licences), in regulation 14A (periodic fees for clinical trial authorisations) —
a
in paragraph (1), for “paragraphs (3) to (5)” substitute “paragraphs (4) and (5)”; and
b
omit paragraph (3).
Amendment of Part VII of the Medicines Fees Regulations
6
In Part VII of the Medicines Fees Regulations (administration), in regulation 15 (payment of fees to Ministers), omit the words from “specified in section 1(1)(a)” to the end.
Amendment of Schedule 1 to the Medicines Fees Regulations
7
1
Schedule 1 to the Medicines Fees Regulations (capital fees for applications for, and variations to, marketing authorizations, licences and certificates) is amended as follows.
2
In Part I (interpretation), in paragraph 1 —
a
in the definition of “complex application” —
i
for “sub-paragraphs (a) to (o)” substitute “sub-paragraphs (a) to (r)”, and
ii
after paragraph (o) insert —
p
an application where the sole or primary evidence for the safety and efficacy of the medicinal product consists of published scientific literature;
q
the application is —
i
for an extension of an existing marketing authorization which fulfils the conditions set out in Annex II to Commission Regulation (EC) No. 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State , and
ii
includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;
r
the application —
i
is not an application in accordance with Article 10, 10a or 10c of the 2001 Directive, and
ii
includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;
;
b
after the definition of “EC marketing authorization”, insert the following definition —
“eCTD format” means the electronic format of the Common Technical Document referred to in the guidance published by the European Commission in Volume 2B of “The Rules Governing Medicinal Products in the European Union”, referred to in paragraph (1) of the Introduction to Annex I to the 2001 Directive ;
; and
c
after the definition of “major application”, insert the following definition —
“the MHRA portal” means the internet-based hosted platform which enables persons to carry out business with the Medicines and Healthcare products Regulatory Agency of the Department of Health electronically, known as the “the MHRA Portal” ;
.
3
In Part II (capital fees for applications for authorizations, licences and certificates), in paragraph 1, for sub-paragraph (1) substitute —
1
Subject to paragraphs 1A, 2, 3, 4 and 4A, the fee payable under regulation 4(a) in connection with an application for a marketing authorization of a kind described in column 1 of the following table shall be —
a
if —
i
the application is made using the MHRA portal, and
ii
the particulars and documents accompanying the application are presented in eCTD format,
the fee specified in the corresponding entry in column 2 of that table; or
b
in any other case, the fee specified in the corresponding entry in column 3 of that table.
Fees for marketing authorization applications
Column 1
Kind of application
Column 2
Fee payable if application is in eCTD format
Column 3
Fee payable in other cases
1 Major application (a) in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies £28,494 £29,890 (b) which is a mutual recognition procedure incoming application £61,959 £64,995 (c) which is a European reference product application £61,959 £64,995 (d) which is a decentralised procedure application where the United Kingdom is a concerned Member State £88,993 £93,249 (e) which is a decentralised procedure application where the United Kingdom is a reference Member State £126,982 £133,204 (f) in any other case £88,893 £93,249 2 Complex application (a) which is a mutual recognition procedure incoming application £17,202 £18,045 (b) which is a European reference product application £17,202 £18,045 (c) which is a decentralised procedure application where the United Kingdom is a concerned Member State £24,576 £25,780 (d) which is a decentralised procedure application where the United Kingdom is a reference Member State £34,353 £36,036 (e) in any other case £24,576 £25,780 3 Standard application (a) which is a mutual recognition procedure incoming application £6,304 £6,613 (b) which is a European reference product application £6,304 £6,613 (c) which is a decentralised procedure application where the United Kingdom is a concerned Member State £9,011 £9,453 (d) which is a decentralised procedure application where the United Kingdom is a reference Member State £12,921 £13,554 (e) in any other case £9,011 £9,453 4 Simple application (a) which is a decentralised procedure application where the United Kingdom is a concerned Member State £2,457 £2,577 (b) in any other case £2,457 £2,577 5 Application for a parallel import licence Not applicable £1,718 6 Change of ownership application Not applicable £424
4
In Part III (capital fees for applications for variations of authorizations, licences and certificates) —
a
for paragraph 2 substitute the following paragraph —
2
Subject to paragraphs 4 to 6 and 13 to 15, the fee payable under regulation 7(1) in connection with an application for a variation of a marketing authorization of a kind described in column 1 of the following table shall be —
a
if —
i
the application is made using the MHRA portal, and
ii
the particulars and documents accompanying the application are presented in eCTD format,
the fee specified in the corresponding entry in column 2 of that table; or
b
in any other case, the fee specified in the corresponding entry in column 3 of that table.
Fees for applications for variations of marketing authorizations
Column 1
Kind of application
Column 2
Fee payable if application is in eCTD format
Column 3
Fee payable in other cases
1 Application where, for the purposes of Commission Regulation (EC) No. 1084/2003 , the United Kingdom is the reference Member State as defined in Article 3.4 of that Regulation (a) Type IA Application £264 £276 (b) Type IB Application £526 £552 (c) Type II Application £852 £894 (d) Type II Complex Variation Application £13,808 £14,484 (e) Extended Type II Complex Variation Application £34,353 £36,036 2 Other variation applications (a) Type IA Application £170 £178 (b) Type IB Application £266 £280 (c) Type II Application £704 £738 (d) Type II Complex Variation Application £7,964 £8,354 (e) Extended Type II Complex Variation Application £24,576 £25,780 (f) reclassification variation application £8,206 £8,206
; and
b
omit paragraph 3.
Amendment of Schedule 2 to the Medicines Fees Regulations
8
In Schedule 2 to the Medicines Fees Regulations (fees for inspections) —
a
in paragraph 1, in sub-paragraph (1), omit the definition of “exempt imported product”;
b
in paragraph 2, omit sub-paragraph (f); and
c
in paragraph 5 —
i
in sub-paragraph (1), omit “sub-paragraph (3) and”, and
ii
omit sub-paragraph (3).
Amendment of Schedule 3 to the Medicines Fees Regulations
9
1
Part III of Schedule 3 to the Medicines Fees Regulations (periodic fees for marketing authorizations and licences) is amended as follows.
2
In the table in paragraph 1 —
a
in column (1), at the end insert the following entry —
h
Homoeopathic or anthroposophic product which is the subject of a licence of right
;
b
in column (2), at the end insert the following entry —
2(h) £68
.
3
In paragraph 7, after sub-paragraph (2), insert the following sub-paragraph —
3
The fee payable under regulation 14(3) in connection with the holding of a manufacturer’s licence which relates to the import of exempt imported products from a third country shall be the fee payable in accordance with sub-paragraph (1) and an additional amount calculated in accordance with paragraph 9B.
.
4
In paragraph 8, in sub-paragraph (1), for “paragraph 9” substitute “paragraphs 9 and 9A”
5
After paragraph 9, insert the following paragraphs —
9A
The fee payable under regulation 14(3) in connection with the holding of a wholesale dealer’s licence which relates to exempt imported products shall be the fee payable in accordance with paragraphs 8 and 9 and an additional amount calculated in accordance with paragraph 9B.
Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products
9B
1
The additional amount referred to in paragraphs 7(3) and 9A in relation to any fee period shall be the fee specified in the entry in column 2 of the following table corresponding to the estimated number of special import notices for that fee period specified in column 1.
Column 1
Number of special import notices
Column 2
Additional amount
1 to 100 £100 101 to 1,000 £500 1,001 to 10,000 £5,000 10,001 to 25,000 £17,000 25,001 to 50,000 £37,000 50,001 to 100,000 £75,000 100,001 to 150,000 £125, 000 150,001 to 200,000 £175,000 200,001 or more £250,000
2
For the purposes of this paragraph, the estimated number of special import notices for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.
.
Amendment of Schedule 6 to the Medicines Fees Regulations
10
In Schedule 6 to the Medicines Fees Regulations (adjustment, reduction or refund of periodic fees), after paragraph 1 insert the following paragraph —
1A
1
This paragraph applies to periodic fees payable in connection with a manufacturer’s licence or a wholesale dealer’s licence which relates to exempt imported products.
2
If during a fee period the number of special import notices given by a licence holder is greater than the estimated number notified by the licensing authority in accordance with paragraph 9B of Part III of Schedule 3, the periodic fee payable in relation to that period shall be increased by the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.
3
If during a fee period the number of special import notices given by a licence holder is less than the estimated number notified by the licensing authority in accordance with paragraph 9B of Part III of Schedule 3, the licensing authority shall refund the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.
.
Increase in fee amounts prescribed by the Medicines Fees Regulations
11
In each provision of the Medicines Fees Regulations specified in the entries in column (1) of the Schedule to these Regulations (the content of which is described in column (2) of that Schedule), for the amount specified opposite that provision in column (3) of that Schedule substitute the amount specified opposite that provision in column (4) of that Schedule.
Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995
12
1
The Medical Devices (Consultation Requirements) (Fees) Regulations 1995 are amended as follows.
2
In regulation 1 (citation, commencement and interpretation), in paragraph (2) —
a
for the definitions of “Annex II” and “Annex III” substitute the following definitions —
“Annex I”, “Annex II” and “Annex III” mean respectively Annex I, Annex II and Annex III to the Directive;
;
b
in the definition of “competent body”, for the words from “Directive 2001/83/EC ” to the end substitute “the 2001 Directive”;
c
after the definition of “the Directive” insert the following definition —
“the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended by —
Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components,
Commission Directive 2003/63/EC amending Directive 2001/83/EC ,
Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC ,
Directive 2004/27/EC of the European Parliament and of the Council also amending Directive 2001/83/EC , and
Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92 , Directive 2001/20/EC , Directive 2001/83/EC and Regulation (EC) No 726/2004 ;
;
d
omit the definition of “fee”;
e
in the definition of “manufacturing authorisation”, for the words from “Directive 2001/83/EC ” to the end substitute “the 2001 Directive”; and
f
in the definition of “medicinal substance”, for the words from “Directive 2001/83/EC ” to the end substitute “the 2001 Directive”.
3
In regulation 2 (circumstances in which a fee is payable), in paragraph (1), after “pay a fee” insert “specified by, or determined under, regulation 3”.
4
In regulation 3 (fees) —
a
in paragraph (1) —
i
in sub-paragraph (a), for “£3,948” substitute “£4,141”, and
ii
in sub-paragraph (b), for “£9,202” substitute “£9,653”;
b
in paragraph (2) —
i
in sub-paragraph (a), for “£781” substitute “£819”, and
ii
in sub-paragraph (b), for “£2,184” substitute “£2,291”;
c
in paragraph (3) —
i
in sub-paragraph (a), for “£3,948” substitute “£4,141”, and
ii
in sub-paragraph (b), for “£9,262” substitute “£9,653”;
d
in paragraph (4) —
i
in sub-paragraph (a), for “£781” substitute “£819”, and
ii
in sub-paragraph (b), for “£2,184” substitute “£2,291”; and
e
in paragraph (5) —
i
in sub-paragraph (a), for “£40,374” substitute “£42,352”, and
ii
in sub-paragraph (b), for “£10,024” substitute “£10,515”.
5
After regulation 3 insert the following regulation —
Fees for pre-consultation meetings
3A
1
Where the Department of Health holds a meeting —
a
with a person other than a notified body for the purpose of providing scientific advice to that person with a view to him making an application for an EC examination certificate in relation to a medical device incorporating a medicinal substance, or
b
with a notified body for the purpose of providing scientific advice to that body with a view to that body consulting the Department in relation to an application for an EC examination certificate in relation to a medical device incorporating a medicinal substance,
that person or notified body shall pay the fee specified in paragraph (2).
2
The fee payable shall be —
a
if the advice provided at that meeting consists of advice in connection with —
i
quality development only, or
i
safety development only,
£750;
b
if the advice provided at that meeting consists of advice in connection with —
i
quality and safety development only, or
i
clinical development only,
£950;
c
if the advice provided at that meeting consists of advice in connection with —
i
quality and clinical development only, or
i
safety and clinical development only,
£1,300;
a
if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development, £1,650.
3
In this regulation —
“clinical development” means the conduct of studies of a medicinal substance in human subjects in order to —
discover or verify the effects of such a substance,
identify any adverse reaction to such a substance, or
study absorption, distribution, metabolism and excretion of such a substance,
with the object of ascertaining the safety or efficacy of that substance, as required to verify the safety and usefulness of the substance in accordance with paragraph 7.4 of Annex I;
“quality development” means the chemical, pharmaceutical and biological testing required in order to verify the quality of a medicinal substance in accordance with paragraph 7.4 of Annex I;
“safety development” means the toxicological and pharmacological testing required in order to verify the safety of a medicinal substance in accordance with paragraph 7.4 of Annex I; and
“scientific advice” means advice in connection with the quality, safety or clinical development for a medicinal substance incorporated, or to be incorporated, in a medical device.
.
6
For regulation 4 (payment and recovery of fees) substitute the following regulation —
Payment and recovery of fees
4
1
Any fee payable in accordance with regulations 2 and 3 shall be paid to the Secretary of State not later than the day on which a notified body consults the competent body.
2
Any fee payable in accordance with regulation 3A shall become payable within 14 days following written notice from the Department of Health requiring payment of that fee.
3
All unpaid sums due on account of any fee payable under these Regulations shall be recoverable as debts due to the Crown.
.
Amendment of the Medical Devices Regulations 2002
13
1
The Medical Devices Regulations 2002 shall be amended as follows.
2
In regulation 54 (fees payable in connection with the designation etc of UK notified bodies) —
a
in paragraph (1) —
i
in sub-paragraph (a), for “£650” substitute “£850”, and
ii
in sub-paragraph (b), for “£2,600” substitute “£3,400”;
b
in paragraph (2), for “£1,300” substitute “£1,700”;
c
in paragraph (3), for sub-paragraphs (a) to (c) substitute the following sub-paragraphs —
a
in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of £4,200 plus the amounts specified in paragraph (3A);
b
in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection —
i
if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in all three of the Annexes referred to in this paragraph are met, a fee of £6,800,
ii
if the inspection is for the purpose of deciding whether or not the body is one in respect of which the criteria set out in only two of the three Annexes referred to in this paragraph are met, a fee of £5,100, or
iii
if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in only one of the Annexes referred to in this paragraph are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, a fee of £3,400,
plus the amounts specified in paragraph (3A); and
c
in respect of an inspection pursuant to regulation 45(7)(b), a fee of £3,400 plus the amounts specified in paragraph (3A).
; and
d
after paragraph (3), insert the following paragraphs —
3A
Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be —
a
an amount for time spent by a member of staff undertaking a site visit at a rate —
i
for the time spent on site, of £240 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and
ii
for the time spent travelling to and from the site, of £67.10 per hour;
b
the actual costs of travel, accommodation and subsistence; and
c
out of pocket expenses.
3B
Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a) —
a
the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and
b
the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).
.
3
In regulation 55 (fees payable in connection with the designation etc of EC conformity assessment bodies) —
a
in paragraph (1) —
i
in sub-paragraph (a), for “£650” substitute “£850”, and
ii
in sub-paragraph (b), for “£2,600” substitute “£3,400”;
b
in paragraph (2), for “£1,300” substitute “£1,700”;
c
in paragraph (3) —
i
at the beginning insert “Subject to paragraphs (3A) to (3C)”, and
ii
for paragraphs (a) to (c) substitute the following sub-paragraphs —
a
in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of £4,200 plus the amounts specified in paragraph (3D);
b
in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of £3,400 plus the amounts specified in paragraph (3D);
c
in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of £1,700;
d
in respect of an inspection pursuant to regulation 48(7)(b), a fee of £3,400 plus the amounts specified in paragraph (3D).
; and
d
after paragraph (3), insert the following paragraphs —
3A
Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be £4,200 plus —
a
£1,700 for each additional inspection; and
b
the amounts specified in paragraph (3D).
3B
Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be £3,400 plus —
a
£1,700 for each additional inspection; and
b
the amounts specified in paragraph (3D)
3C
Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be £1,700 for each inspection.
3D
The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be —
a
an amount for time spent by a member of staff undertaking a site visit at a rate —
i
for the time spent on site, of £240 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and
ii
for the time spent travelling to and from the site, of £67.10 per hour;
b
the actual costs of travel, accommodation and subsistence, and
c
out of pocket expenses.
.
4
In regulation 56 (fees payable in relation to clinical investigations), in paragraph (1) —
a
in sub-paragraph (a) —
i
in sub-paragraph (i), for “£1,600” substitute “£1,800”, and
ii
in sub-paragraph (ii), for “£2,100” substitute “£2,400”; and
b
in sub-paragraph (b) —
i
in sub-paragraph (i), for “£2,200” substitute “£2,700”, and
ii
in sub-paragraph (ii), for “£3,000” substitute “£3,800”; and
Signed by authority of the Secretary of State
Hunt
Minister of State
Department of Health
28th February 2007
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
Andrew McCormick
Permanent Secretary
Department of Health, Social Services and Public Safety
1st March 2007
We consent,
Claire Ward
Frank Roy
Two of the Lords Commissioners of Her Majesty’s Treasury
28th February 2007