text:
Citation and commencement
1
These Regulations may be cited as the Motor Cycles Etc. (Single Vehicle Approval) (Fees) Regulations 2003 and shall come into force on 8th August 2003.
Interpretation and application
2
1
In these Regulations —
“ the Act ” means the Road Traffic Act 1988;
“the Approval Regulations ” means the Motor Cycles Etc. (Single Vehicle Approval) Regulations 2003 ;
“approval requirements” has the same meaning as in the Approval Regulations;
“appeal” means an appeal under section 60 of the Act in respect of the determination of an application;
“application” means an application (whether an original application or a further application) under regulation 5 of the Approval Regulations for the issue of a Minister’s approval certificate under section 58 of the Act;
“examination” means an examination for the purposes of an application;
“exceptional circumstances” means an accident, a fire, an epidemic, severe weather, a failure in the supply of essential services or other unexpected happening (excluding a breakdown or mechanical defect in a vehicle or non-delivery of spare parts for that vehicle);
“further application” means an application made in accordance with regulation 5(6) of the Approval Regulations;
“holiday” means any day which is a Saturday, Sunday, Good Friday, Christmas Day or a Bank Holiday (as defined in the Banking and Financial Dealings Act 1971 );
“low power moped” means a vehicle fitted with pedals and an auxiliary engine of a power output not exceeding 1 kilowatt and a maximum speed not exceeding 25 kilometres per hour being a moped within the meaning of the first indent of Article 1(2) of Council Directive 92/61/ EEC relating to the type-approval of two or three wheel motor vehicles as amended by Directive 2000/7/ EC of the European Parliament and of the Council ;
“original application” means an application made in accordance with regulation 5(1) to (3) of the Approval Regulations, not being a further application;
“out of hours period” means —
a holiday; or
any part of a day not being a holiday, other than between —
8.00 am and 5.00 pm on a Monday, Tuesday, Wednesday or Thursday; or
8.00 am and 4.30 pm on a Friday;
“part”, in relation to a vehicle, includes a system, a separate technical unit and a component;
“re-examination” means an examination for the purposes of an appeal; and
“relevant vehicles” means those vehicles to which the Approval Regulations apply.
2
These Regulations apply to relevant vehicles.
Fees for original applications
3
1
Subject to paragraph (2), the fee prescribed for the purposes of regulation 5(3)(b) of the Approval Regulations is —
a
£70 in the case of a vehicle which has two wheels other than a low power moped;
b
£85 in the case of a vehicle which has three or more wheels other than a low power moped; and
c
£45 in the case of a low power moped.
2
Where at the applicant’s request the time appointed for any examination of a vehicle for the purposes of such an application falls within an out of hours period the fee prescribed by paragraph (1) shall be increased by £20 and such amount shall be payable before the examination is carried out.
Fees for further applications
4
1
Subject to paragraph (2), the fee prescribed for the purposes of regulation 5(7)(d) of the Approval Regulations is £15.
2
Any fee which would otherwise be payable by virtue of regulation 5(7)(d) of the Approval Regulations shall not be payable if, by agreement, the vehicle is submitted for examination at the place at which it was previously examined before the end of the fifth day following that previous examination on which the Secretary of State will accept vehicles for examination and the requirements of paragraph (3) are met.
3
The requirements of this paragraph are that the further application must be due to the original application being refused only because —
a
there were instances of failure, not exceeding three in number, to comply with the approval requirements set out or referred to in column 3 of the Table in relation to the items in column 1 of that Table numbered —
i
in the case of a vehicle with two wheels, 14; or
ii
in the case of a vehicle with three or more wheels, 13 or 14;
b
there was a failure to comply with one or more of the approval requirements set out or referred to in column 3 of the Table in relation to the items in column 1 of the Table numbered —
i
1 to 8, 10 to 12, 15 to 17, 21, 22, 26 and 27,
ii
9 (save for the requirement set out in paragraph 3 thereof), and
iii
25 (save for the requirement set out in paragraph 3 thereof in the case of a vehicle with two wheels and save for that requirement and the requirement referred to in paragraph 4 thereof in the case of a vehicle with three or more wheels); or
c
there were no more than three instances of a failure to comply with approval requirements under sub-paragraph (a) and there was a failure to comply with one or more of the approval requirements under sub-paragraph (b).
4
For the purposes of this regulation —
a
a reference to “the Table” means the Table in Schedule 2 to the Approval Regulations; and
b
references to approval requirements set out or referred to in column 3 of the Table in relation to numbered items in column 1 of that Table shall be taken as being subject to any entries in relation to any of those items in column 4 or 5 of the Table.
Repayment of application fees
5
1
If the person who has applied for an examination for the purposes of an original application or a further application fulfils the requirement for repayment to an applicant set out in sub-paragraph (a) or (b) of paragraph (2) the application shall, unless another time therefor is arranged, be treated as one in respect of which no fee is payable and any sum previously paid in respect of that application shall be repaid to that person.
2
The requirement for repayment to an applicant is that he —
a
has before the time appointed for the examination given the Secretary of State three clear days notice (whether in writing or otherwise) at the place appointed for that examination that he does not propose to submit the vehicle for examination at that time; or
b
satisfies the Secretary of State that the vehicle cannot or, as the case may be, could not be submitted for examination at the time appointed because of exceptional circumstances occurring not more than five days before that time and of which the applicant gives notice to the Secretary of State (whether in writing or otherwise) within three days of the occurrence of those circumstances.
Fees for appeals
6
1
Subject to paragraphs (2) and (3), the fee prescribed for the purposes of regulation 8(2) of the Approval Regulations is —
a
£70 in the case of a vehicle which has two wheels other than a low power moped;
b
£85 in the case of a vehicle which has three or more wheels other than a low power moped; and
c
£45 in the case of a low power moped.
2
Where at the appellant’s request the time appointed for any re-examination of a vehicle for the purposes of such an appeal falls within an out of hours period, the fee prescribed by paragraph (1) shall be increased by £20, such additional amount being payable before the re-examination is carried out.
Repayment of appeal fees
7
1
After the completion of a re-examination of a vehicle for the purposes of an appeal the Secretary of State may, as he thinks fit, repay to the appellant either the whole or part of the fee paid on the appeal where it appears to him that there were substantial grounds for contesting the whole or part of the determination against which the appeal was made.
2
If the appellant fulfils the requirement for repayment to an appellant set out in sub-paragraph (a) or (b) of paragraph (3) the re-examination shall, unless another time therefor is arranged, be treated as one in respect of which no fee is payable and any sum previously paid in respect of that appeal shall be repaid to that person.
3
The requirement for repayment to an appellant is that he —
a
has before the time appointed for the re-examination given the Secretary of State two clear days notice (whether in writing or otherwise) at the office at which his appeal was lodged that he does not propose to submit the vehicle for re-examination at that time; or
b
satisfies the Secretary of State that the vehicle cannot or, as the case may be, could not be submitted for re-examination at the time appointed because of exceptional circumstances occurring not more than five days before that time and of which the applicant gives notice to the Secretary of State (whether in writing or otherwise) within three days of the occurrence of those circumstances.
Fees for replacement certificates
8
The fee prescribed for the purposes of regulation 11(2)(b) of the Approval Regulations is £10.
Notices
9
1
A notice under these Regulations may be given by post.
2
For the purpose of calculating the period of any notice given under these Regulations a holiday shall be excluded from the period.
Signed by authority of the Secretary of State for Transport
David Jamieson
Parliamentary Under Secretary of State,
Department for Transport
31st July 2003


type: legislation

jurisdiction: UK

text:
PART I
GENERAL
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Voluntary Adoption Agencies and the Adoption Agencies (Miscellaneous Amendments) Regulations 2003 and shall come into force on 30th April 2003.
2
In these Regulations —
“ the Act ” means the Care Standards Act 2000;
“agency” means an appropriate voluntary organisation ;
“branch manager” shall be construed in accordance with regulation 6(1)(b);
“complaints procedure” shall be construed in accordance with regulation 11(1);
“guardian” has the meaning given to it in section 5 of the Children Act 1989 ;
“manager” shall be construed in accordance with regulation 6(1)(a);
“organisation” means a body corporate other than a public or local authority the activities of which are not carried on for profit;
“registered provider” means, in relation to an agency, a person who is registered under Part II of the Act as the person carrying on the agency ;
“registration authority” means, in relation to an agency, the registration authority which may exercise, in relation to that agency, functions to which section 36A of the Act applies ;
“responsible individual” shall be construed in accordance with regulation 5(2);
“statement of purpose” means the written statement compiled in accordance with regulation 3(1).
3
In these Regulations, references to employing a person include employing a person whether or not for payment, and whether under a contract of service or a contract for services, and allowing a person to work as a volunteer, and references to an employee or to a person being employed shall be construed accordingly.
Application for registration under Part II of the Act
2
No application for registration under Part II of the Act shall be made in respect of a voluntary adoption agency which is an unincorporated body.
Statement of purpose
3
1
The registered provider and the manager shall compile in relation to the agency a written statement (in these Regulations referred to as “the statement of purpose”) which shall consist of a statement as to the matters listed in Schedule 1.
2
The registered provider and the manager shall provide a copy of the statement of purpose to the registration authority and —
a
if the registration authority is the Commission and the agency has a branch in Wales, to the Assembly;
b
if the registration authority is the Assembly and the agency has a branch in England, to the Commission.
3
The registered provider and the manager shall make a copy of the statement of purpose available, upon request, for inspection by —
a
any person working for the purposes of the agency;
b
children who may be adopted, their parents and guardians;
c
persons wishing to adopt a child;
d
adopted persons, their parents, natural parents and former guardians;
e
any local authority.
4
Subject to paragraph (5), the registered provider and the manager shall ensure that the agency is at all times conducted in a manner which is consistent with its statement of purpose.
5
Nothing in paragraph (4) shall require or authorise the registered provider, the manager or the branch manager (if any), to contravene, or not comply with —
a
any other provision of these Regulations;
b
any conditions for the time being in force in relation to the registration of the registered provider under Part II of the Act.
Review of statement of purpose
4
The registered provider and the manager shall —
a
keep under review and, where appropriate, revise the statement of purpose; and
b
notify the registration authority and —
i
if the registration authority is the Commission and the agency has a branch in Wales, the Assembly;
ii
if the registration authority is the Assembly and the agency has a branch in England, the Commission,
of any such revision within 28 days.
PART II
REGISTERED PROVIDERS, RESPONSIBLE INDIVIDUALS AND MANAGERS
Fitness of registered provider
5
1
An organisation shall not carry on an agency unless it is fit to do so.
2
An organisation is not fit to carry on an agency unless —
a
it has given notice to the registration authority of the name, address and position in the organisation of an individual (in these Regulations referred to as “the responsible individual”) who is a director, manager, secretary or other officer of the organisation and is responsible for supervising the management of the agency; and
b
that individual satisfies the requirements set out in paragraph (3).
3
The requirements are that —
a
he is of integrity and good character;
b
he is physically and mentally fit to carry on the agency; and
c
full and satisfactory information is available in relation to him in respect of each of the matters specified in Schedule 2.
Appointment of manager and branch manager
6
1
The registered provider shall appoint —
a
an individual to manage the agency (in these Regulations referred to as “the manager”); and
b
where the agency has a branch, an individual to manage that branch (in these Regulations referred to as “the branch manager”).
2
The registered provider shall forthwith notify the registration authority of —
a
the name of any person appointed in accordance with this regulation; and
b
the date on which the appointment is to take effect.
Fitness of manager and branch manager
7
1
The registered provider shall not allow a person to manage the agency or any branch of the agency unless he is fit to do so.
2
A person is not fit to manage an agency or (as the case may be) branch unless —
a
he is of integrity and good character;
b
having regard to the size of the agency or branch and the agency’s statement of purpose —
i
he has the qualifications, skills and experience necessary for managing the agency or branch; and
ii
he is physically and mentally fit to manage the agency or branch; and
c
full and satisfactory information is available in relation to him in respect of each of the matters listed in Schedule 2.
Registered provider, manager and branch manager — general requirements
8
1
The registered provider, the manager, and the branch manager (if any) shall, having regard to —
a
the size of the agency or (as the case may be) branch and the agency’s statement of purpose; and
b
the need to safeguard and promote the welfare of children who may be, or have been, placed for adoption by the agency,
carry on or manage the agency or (as the case may be) branch, with sufficient care, competence and skill.
2
The registered provider shall ensure that the responsible individual undertakes from time to time such training as is appropriate to ensure that he has the experience and skills necessary for carrying on the agency.
3
The registered provider shall ensure that the manager and branch manager (if any), undertake from time to time such training as is appropriate to ensure that he has the experience and skills necessary for managing the agency or (as the case may be) branch.
Notification of offences
9
Where the registered provider, responsible individual, manager or branch manager (if any) is convicted of any criminal offence, whether in England and Wales or elsewhere, he shall forthwith give notice in writing to the registration authority of —
a
the date and place of the conviction;
b
the offence of which he was convicted; and
c
the penalty imposed on him in respect of the offence.
PART III
CONDUCT OF AGENCIES
Arrangements for the protection of children
10
1
The registered provider and the manager shall prepare and implement a written policy which —
a
is intended to safeguard from abuse or neglect children placed for adoption —
i
by the agency; or
ii
by another adoption agency but with prospective adopters approved by the agency as suitable to be adoptive parents in accordance with the Adoption Agencies Regulations 1983 ; and
b
sets out the procedure to be followed in the event of any allegation of abuse or neglect.
2
The procedure under paragraph (1)(b) shall provide in particular for —
a
liaison and co-operation with any local authority which is, or may be, making child protection enquiries in respect of the child;
b
where the child is placed with prospective adopters, the prompt referral to the local authority in whose area the child is placed of any allegation of abuse or neglect;
c
where the child is not placed with prospective adopters, the prompt referral to the local authority in whose area the principal office of the agency is located of any allegation of abuse or neglect;
d
notification to the registration authority of the instigation and outcome of any child protection enquiries;
e
written records to be kept of any allegation of abuse or neglect and the action taken in response;
f
consideration to be given to the measures that may be necessary to protect children placed with prospective adopters following an allegation of abuse or neglect;
g
arrangements to be made for persons working for the purposes of the agency, prospective adopters and children who have been placed for adoption by the agency, to have access to information that would enable them to contact —
i
the local authority referred to in sub-paragraph (b) or (c) (as the case may be); and
ii
the registration authority,
regarding any concern about child welfare or safety.
3
In this regulation “child protection enquiries” means any enquiries carried out by a local authority in the exercise of any of its functions conferred by or under the Children Act 1989 relating to the protection of children.
Complaints
11
1
The registered provider and the manager shall establish a written procedure for considering complaints (referred to in these Regulations as “the complaints procedure”) made by or on behalf of —
a
children who may be adopted, their parents and guardians;
b
persons wishing to adopt a child;
c
adopted persons, their parents, natural parents and former guardians.
2
The complaints procedure shall, in particular, provide —
a
for an opportunity for informal resolution of a complaint at an early stage;
b
that no person who is the subject of a complaint takes part in its consideration other than, if the registered provider or the manager considers it appropriate, at the informal resolution stage only;
c
for dealing with complaints about the registered provider, the responsible individual, the manager and branch manager (if any); and
d
for complaints to be made by a person acting on behalf of a child.
3
The registered provider and the manager shall provide a copy of the complaints procedure to every person working for the purposes of the agency and shall provide, upon request, a copy of the procedure to any person mentioned in paragraph (1)(a) to (c).
4
The copy of the complaints procedure supplied under paragraph (3) shall include —
a
the name, address and telephone number of the registration authority; and
b
details of the procedure (if any) which has been notified to the registered provider by the registration authority for the making of complaints to the registration authority that relate to the agency.
Complaints — further requirements
12
1
The registered provider and the manager shall ensure that any complaint made under the complaints procedure is fully investigated.
2
The registered provider and the manager shall, so far as is reasonably practicable, within a period of 28 days beginning on the date on which the complaint is received by the agency, inform the complainant of the outcome of the investigation and the action (if any) that is to be taken in consequence.
3
The registered provider and the manager shall ensure that a written record is made of any complaint, including details of the investigation made, the outcome and any action taken in consequence, and for that record to be retained for at least 3 years from the date that it is made.
4
The registered provider and the manager shall take all reasonable steps to ensure that —
a
children are enabled to make a complaint; and
b
no person is subject to any reprisal by the agency for making a complaint.
5
The registered provider shall supply to the registration authority at its request a statement containing a summary of any complaints made in accordance with the complaints procedure during the preceding 12 months and any action taken in consequence.
Staffing of agency
13
The registered provider, the manager and, in relation to any branch, the branch manager, shall ensure that there is, having regard to —
a
the size of the agency or (as the case may be) branch and the agency’s statement of purpose; and
b
the need to safeguard and promote the health and welfare of children placed for adoption —
i
by the agency; or
ii
by another adoption agency but with prospective adopters approved by the agency as suitable to be adoptive parents in accordance with the Adoption Agencies Regulations 1983,
a sufficient number of suitably qualified, competent, and experienced persons working for the purposes of the agency or (as the case may be) branch.
Fitness of workers
14
1
The registered provider, the manager and, in relation to any branch, the branch manager, shall not —
a
employ a person to work for the purposes of the agency unless that person is fit to work for the purposes of an agency; or
b
allow a person to whom paragraph (2) applies, to work for the purposes of the agency unless that person is fit to work for the purposes of an agency.
2
This paragraph applies to any person who is employed by a person other than the registered provider, in a position in which he may in the course of his duties have regular contact with children who may be, or have been, placed for adoption by the agency.
3
For the purposes of paragraph (1), a person is not fit to work for the purposes of an agency unless —
a
he is of integrity and good character;
b
he has the qualifications, skills and experience necessary for the work he is to perform;
c
he is physically and mentally fit for the work he is to perform; and
d
full and satisfactory information is available in relation to him in respect of each of the matters specified in Schedule 2.
4
The registered provider, the manager and, in relation to any branch, the branch manager, shall take reasonable steps to ensure that any person working for the agency who is not employed by the agency and to whom paragraph (2) does not apply is appropriately supervised while carrying out his duties.
Employment of staff
15
1
The registered provider, the manager and, in relation to any branch, the branch manager, shall —
a
ensure that all permanent appointments of staff are subject to the satisfactory completion of a period of probation; and
b
provide all employees with a job description outlining their responsibilities.
2
The registered provider, the manager and, in relation to any branch, the branch manager, shall ensure that all persons employed by the agency —
a
receive appropriate training, supervision and appraisal; and
b
are enabled from time to time to obtain further qualifications appropriate to the work they perform.
Staff disciplinary procedure
16
1
The registered provider and the manager shall operate a disciplinary procedure which, in particular —
a
provides for the suspension of an employee where necessary in the interests of the safety or welfare of children placed for adoption by the agency;
b
provides that the failure on the part of an employee to report, to an appropriate person, an incident of abuse, or suspected abuse of a child placed for adoption by the agency is a ground on which disciplinary proceedings may be instituted.
2
For the purposes of paragraph (1)(b), an appropriate person is —
a
the registered provider, the manager, or in relation to any person working at any branch of the agency, the branch manager;
b
an officer of the registration authority;
c
a police officer;
d
an officer of the National Society for the Prevention of Cruelty to Children;
e
an officer of a local authority in whose area the agency or (as the case may be) branch is situated; or
f
an officer of a local authority in whose area the child is placed for adoption.
Records with respect to staff
17
1
The registered provider, the manager and, in relation to any person working at any branch of the agency, the branch manager, shall maintain and keep up to date the records specified in Schedule 3.
2
The records referred to in paragraph (1) shall be retained for at least 15 years from the date of the last entry.
Fitness of premises
18
1
The registered provider shall not use premises for the purposes of the agency unless the premises are suitable for the purpose of achieving the aims and objectives set out in the statement of purpose.
2
The registered provider, the manager and, in relation to any branch, the branch manager, shall ensure —
a
that there are adequate security arrangements at the premises, in particular that there are secure facilities for the storage of records; and
b
that any records which are, for any reason, not on the premises are nevertheless kept in conditions of appropriate security.
PART IV
MISCELLANEOUS — AGENCIES
Notifiable events
19
1
If, in relation to an agency, any of the events listed in column 1 of the table in Schedule 4 takes place, the registered provider and the manager shall without delay notify the person indicated in respect of the event in column 2 of that table.
2
Any notification made in accordance with this regulation which is given orally shall be confirmed in writing within 14 days.
3
In the table —
“approved by the agency” means approved by the agency as suitable to be an adoptive parent in accordance with the Adoption Agencies Regulations 1983;
“area authority” means the local authority in whose area the child is placed for adoption;
“placing agency” means the adoption agency that placed the child for adoption with the prospective adopter;
“Primary Care Trust” means the Primary Care Trust in whose area the child is placed for adoption by the agency; and
“Local Health Board” means the Local Health Board in whose area the child is placed for adoption by the agency.
Financial position
20
1
The registered provider shall carry on the agency in such a manner as is likely to ensure that it will be financially viable for the purpose of achieving the aims and objectives set out in its statement of purpose.
2
The registered provider shall, if the registration authority so requests, provide the authority with such information and documents as it may require for the purpose of considering the financial viability of the agency, including —
a
the annual accounts of the agency certified by an accountant; and
b
a certificate of insurance for the registered provider in respect of liability which may be incurred by him in relation to the agency in respect of death, injury, public liability, damage or other loss.
Notice of absence
21
1
Where —
a
the manager proposes to be absent from the agency; or
b
the branch manager proposes to be absent from the branch of the agency,
for a continuous period of 28 days or more, the registered provider and the manager shall give notice in writing to the registration authority of the proposed absence.
2
Except in the case of an emergency, the notice referred to in paragraph (1) shall be given no later than one month before the proposed absence is to start, or within such shorter period as may be agreed with the registration authority, and the notice shall specify —
a
the length or expected length of the proposed absence;
b
the reason for the proposed absence;
c
the arrangements which have been made for the running of the agency or (as the case may be) branch during that absence;
d
the name, address and qualifications of the person who will be responsible for the management of the agency or (as the case may be) branch during the absence; and
e
the arrangements that have been made or are proposed to be made for appointing another person to manage the agency or (as the case may be) branch during the absence, including the proposed date by which the appointment is to start.
3
Where the absence arises as a result of an emergency, the registered provider and the manager shall give notice of the absence within one week of its occurrence, specifying the matters mentioned in paragraph (2)(a) to (e).
4
Where the manager or branch manager has been absent from the agency or (as the case may be) branch for a continuous period of 28 days or more, and the registration authority has not been given notice of the absence, the registered provider and the manager shall without delay give notice in writing to the authority specifying the matters mentioned in paragraph (2)(a) to (e).
5
The registered provider and the manager shall notify the registration authority of the return to duty of the manager or branch manager not later than 7 days after the date of his return.
Notice of changes
22
1
The registered provider and the manager shall give notice in writing to the registration authority as soon as it is practicable to do so if any of the following events takes place or is proposed to take place —
a
a person other than the registered provider carries on the agency;
b
a person ceases to manage the agency;
c
the name or address of the registered provider is changed;
d
there is any change of trustee, or director, manager, secretary, or other similar officer, of the registered provider;
e
there is to be any change in the identity of the responsible individual;
f
a receiver, manager, liquidator or provisional liquidator is appointed in respect of the registered provider; or
g
the agency intends to cease to act or exist as such.
2
The registered provider shall notify the registration authority in writing and without delay of the death of the responsible individual, the manager or branch manager (if any).
Appointment of liquidators etc.
23
1
Any person to whom paragraph (2) applies shall —
a
forthwith notify the registration authority of his appointment indicating the reasons for it;
b
appoint a manager to take full-time day to day control of the agency in any case where there is no manager; and
c
not more than 28 days after his appointment notify the registration authority of his intentions regarding the future operation of the agency.
2
This paragraph applies to any person appointed as —
a
the receiver or manager of the property of a registered provider;
b
the liquidator or provisional liquidator of a registered provider.
Compliance with regulations
24
Where anything is required under these Regulations to be done by more than one person, it shall, if done by one of those persons, not be required to be done by the other person or, as the case may be, persons.
PART V
MISCELLANEOUS
Amendments to the Adoption Agencies Regulations 1983
25
1
The Adoption Agencies Regulations 1983 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 1(3) (interpretation) —
a
at the appropriate place there shall be inserted the following definition —
“the 2000 Act ” means the Care Standards Act 2000;
;
b
in the definition of “adoption agency” for the words “an approved adoption society” there shall be substituted the words “an appropriate voluntary organisation” ; and
c
at the appropriate place there shall be inserted the following definition —
“registration authority” means, in relation to an agency, the registration authority which may exercise, in relation to that agency, functions to which section 36A of the Act applies;
.
3
Regulations 2 and 3 shall be omitted.
4
In regulation 6 (adoption agency arrangements for adoption work) —
a
in paragraph (1) for the words “reviewed by the agency not less than once every three years” there shall be substituted the words “kept under review and, where appropriate, revised by the agency”; and
b
paragraph (3) shall be omitted.
5
In regulation 15 (access to case records and disclosure of information) in paragraph (1) after sub-paragraph (b) there shall be inserted the following sub-paragraph —
bb
the registration authority,
.
6
In regulation 16 (transfer of case records) —
a
for paragraph (2) there shall be substituted the following paragraph —
2
An appropriate voluntary organisation which intends to cease to act or exist as such shall forthwith either transfer its case records to another adoption agency having first obtained the registration authority’s approval for such transfer, or transfer its case records —
a
to the local authority in whose area the organisation’s principal office is situated; or
b
in the case of an organisation that amalgamates with another approved voluntary organisation to form a new approved voluntary organisation, to the new organisation.
; and
b
in paragraph (3) for the words “Secretary of State” there shall be substituted the words “registration authority”.
Signed by the authority of the Secretary of State for Health
Jacqui Smith
Minister of State,
Department of Health
Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998
Daffyd Elis-Thomas
Presiding Officer, National Assembly for Wales


text:
Citation and commencement
1
These Regulations may be cited as the Social Security Contributions and Benefits Act 1992 (Modifications for Her Majesty’s Forces and Incapacity Benefit) Regulations 2003 and shall come into force for the purposes of this regulation and regulation 3 on 6 th April 2003 and for all other purposes on 5th May 2003.
Modification of section 30A of the Social Security Contributions and Benefits Act 1992
2
Section 30A of the Social Security Contributions and Benefits Act 1992 (entitlement to incapacity benefit) shall be modified, in respect of persons who have been members of Her Majesty’s forces, as if —
a
at the beginning of subsection (3), there were inserted “Subject to subsection (3A),”, and
b
after subsection (3), there were inserted —
3A
Subsection (3) does not apply to a person —
a
who is discharged from Her Majesty’s forces, and
b
for whom days of sickness absence from duty, which are recorded by the Secretary of State for Defence, are included in calculating the number of days for which the person has been entitled to short-term incapacity benefit.
.
Modification of section 30D of the Social Security Contributions and Benefits Act 1992
3
Section 30D of the Social Security Contributions and Benefits Act 1992 (calculating days of entitlement to incapacity benefit) shall be modified, in respect of persons who have been members of Her Majesty’s forces, as if, after subsection (3), there were inserted —
3A
In respect of a person who is discharged from Her Majesty’s forces after 3rd May 2003, there shall also be included such days as may be prescribed .
.
Modification of paragraph 2(6) of Schedule 3 to the Social Security Contributions and Benefits Act 1992
4
Paragraph 2(6) of Schedule 3 to the Social Security Contributions and Benefits Act 1992 (contribution conditions for entitlement to incapacity benefit) shall be modified, in respect of persons who have been members of Her Majesty’s forces, as if —
a
after “is” in paragraph (b) (meaning of “the relevant benefit year”) , there were inserted “, subject to paragraph (c),”, and
b
at the end, there were added —
c
in the case of a person who is discharged from Her Majesty’s forces, and for whom days of sickness absence from duty recorded by the Secretary of State for Defence are included in calculating the number of days for which the person has been entitled to short-term incapacity benefit, “the relevant benefit year” is the benefit year in which there falls the beginning of the period to which the claim for incapacity benefit relates.
.
Jim Fitzpatrick
John Heppell
Two of the Lords Commissioners of Her Majesty’s Treasury
14 th March 2003
The Secretary of State hereby concurs.
Signed by authority of the Secretary of State.
Nicholas Brown
Parliamentary Under Secretary of State,
Department for Work and Pensions
12th March 2003


text:
This Order may be cited as the Health Professions Council (Health Committee) (Procedure) Rules Order of Council 2003 and shall come into force on 9th July 2003.
A. K. Galloway
Clerk of the Privy Council


text:
Citation, commencement and effect
1
These Regulations may be cited as the General Insurance Reserves (Tax) (Amendment) Regulations 2003, shall come into force on 5th December 2003 and shall have effect for periods of account ending on or after that date.
Interpretation
2
In these Regulations “the principal Regulations ” means the General Insurance Reserves (Tax) Regulations 2001 .
Amendment of the principal Regulations
3
The principal Regulations shall be amended as follows.
4
1
Amend regulation 2 (interpretation) as follows.
2
In paragraph (1) after the definition of “controlled foreign company” insert —
“corporate general insurer” means a general insurer which is a company;
.
3
At the end add —
3
In these Regulations a reference to a numbered Rule is a reference to the Rule in regulation 3 bearing that number.
.
5
1
Amend regulation 3 (recalculation of technical provisions for the purposes of section 107) as follows.
2
In paragraph (2), after the definition of “the recalculation date” insert —
“relevant transaction” means any disposal or acquisition (in whole or in part) of the rights or liabilities of —
a corporate general insurer under a contract of insurance; or
a reinsurer under a contract of reinsurance;
.
3
In paragraph (3) —
a
omit sub-paragraph (b) and the word “and” preceding it;
b
in Rule 2.1 —
i
for paragraph (a) substitute —
a
where the earlier period of account is the general insurer’s first period of account which began on or after 1st January 2000, were provisions made and taken into account for that period, and; and
ii
in paragraph (b) for “was provision” substitute “were provisions”;
c
in Rule 3.1 for “or qualifying contract” substitute “, qualifying contract or relevant transaction”;
d
for Rule 4.1 substitute —
4.1
This Rule applies where either Rule 4.1A or 4.1B is satisfied.
4.1A
This Rule is satisfied if —
a
on or after 1st January 2004 a corporate general insurer enters into a qualifying contract, other than a reinsurance to close contract, with another person (“ the reinsurer ”) and —
i
the corporate general insurer and the reinsurer are connected companies; or
ii
the qualifying contract is, or forms part of, a transaction, as a result of which a company connected with the corporate general insurer (“ the connected company ”) directly or indirectly agrees to meet a liability of the corporate general insurer or any further liability representing that liability, through any number of such agreements (“ the replacement agreements ”); and
b
Rule 4.1C applies.
4.1B
This Rule is satisfied if —
a
on or after 1st January 2004, as a result of —
i
a relevant transaction between a corporate general insurer and a company with which it is connected (“ a connected company ”), or
ii
a series of transactions having the same effect as a relevant transaction between a corporate general insurer and a connected company,
the connected company directly or indirectly replaces the corporate general insurer as a party to a contract of insurance including by way of novation; and
b
Rule 4.1C applies.
4.1C
This Rule applies if the person assuming the liabilities —
a
is not within the charge to corporation tax in respect of income arising from the qualifying contract or the relevant replacement agreement, assuming there were such income; and
b
is not a controlled foreign company in relation to which —
i
an apportionment under section 747(3) falls to be made regarding, or
ii
section 748(1)(a) applies to,
the accounting period in which the qualifying contract is made.
This is subject to the following qualification.
This Rule applies only to the extent that the qualifying contract reinsures liabilities represented in technical provisions which the corporate general insurer has previously taken into account.
In this Rule “the person assuming the liabilities” means, as the case requires, the reinsurer referred to in Rule 4.1A(a) or the connected company referred to in Rule 4.1A(a)(ii).
;
e
in Rule 4.2 —
i
after “qualifying contract” insert “or the relevant transaction”; and
ii
in paragraph (a) after “under that contract” insert “or that transaction”;
f
in Rule 5.4 for “where a foreign currency discount rate is to apply (see regulation 5)” substitute “where the calculations under these Regulations are carried out in Australian dollars, Canadian dollars, euro, Japanese yen, Swiss francs or United States dollars (“ the relevant foreign currency ”)”;
g
in Rule 8.1 —
i
in paragraph (b) after “in relation to” insert “the same earlier period of account”; and omit sub-paragraphs (i) and (ii);
ii
in the words following paragraph (b) after “the adjustment is a deficiency, that is” add “subject to Rule 8A”,
h
after Rule 8 insert —
8A.1
This Rule applies if, in respect of the provisions made for the earlier period of account —
a
an election has been made under section 107(4) for the earlier period of account in question, and
b
the result of applying Rule 8 is a deficiency.
8A.2
Where Rule 8A.1 applies, apply Rules 6 to 8 but, in carrying out the calculation made at the end of the later period of account, add to the amount of the original provisions —
a
the amount of any losses set off, under section 393 of the Taxes Act (losses other than terminal losses of a trade) against the trading income of the company’s general insurance business for the period of account for which an election under section 107(4) was made in respect of the provisions for the earlier period of account; and
b
any amount which remains to be set off against the profits of the company’s general insurance business for the period of account for which an election under section 107(4) was made in respect of the provisions for the earlier period of account under —
i
section 393A of the Taxes Act (trading losses: set off against the profits of the same or an earlier accounting period) ;
ii
Chapter 4 of Part 10 of the Taxes Act (group relief);
iii
section 83 of, and Schedule 8 to the Finance Act 1996 (non-trading deficit on loan relationships) ;
iv
paragraph 35 of Schedule 29 to the Finance Act 2002 (non-trading losses on intangible fixed assets); and
v
other charges on the income of the company;
after treating any other profits of the general insurer for the earlier period as being reduced in priority to the profits of its general insurance business.
This is subject to the following qualifications.
8A.3
The qualifications referred to in Rule 8A.2 are that —
a
the total amount added in accordance with it to the provisions for all earlier periods of account taken together shall not exceed the sum of the amounts found under paragraphs (a) and (b) of that Rule; and
b
the adjustment made under that Rule shall not exceed the amount of the technical provisions for the earlier period of account.
8A.4
Compare the result of applying Rule 8A.2 with that found before applying it.
If both the amounts are deficiencies, for the purposes only of Rule 9 the smaller deficiency is the amount referred to in section 107(3).
If the result of applying Rule 8A.2 is an excess —
it is disregarded for the purposes of section 107(2); and
the deficiency produced by Rule 8 is disregarded for the purposes of section 107(3).
8A.5
If any amount mentioned in Rule 8A.2 is amended in accordance with any provision of the Taxes Act, the adjustment made under that Rule shall be amended accordingly.
;
i
in Rule 9.1 —
i
for “at the rate specified” substitute “at the rate or rates specified in respect of the period mentioned below”;
ii
for “therefrom” substitute “from the amount of such interest”; and
iii
for the words from “until” to “as if they were accounting periods” substitute “until the stop date”;
j
after Rule 9.1 insert —
9.1A
Interest shall be calculated on the amount of the result of Rule 8 or 8A (as the case requires) in respect of the period —
a
beginning with the stop date, and
b
ending with the date when corporation tax for the later period of account becomes due and payable at the rate specified in regulation 3ZA(1) of the Taxes (Interest Rate) Regulations 1989 ,
but as if there were deducted from the amount of such interest corporation tax at the rate fixed for companies generally (within the meaning of section 13(1) of the Taxes Act) for the later period of account.
9.1B
In Rules 9.1 and 9.1A the “stop date” is the earlier of —
a
the date when corporation tax for the later period of account becomes due and payable; and
b
the tenth anniversary of the date on which corporation tax for the earlier period of account became due and payable.
Subsection (1) of section 59D of the Taxes Management Act 1970 (day when corporation tax due and payable) applies for the purposes of this Rule and Rules 9.1 and 9.1A as it applies for the purposes of that section but as if the references in that subsection to an accounting period were to a period of account.
; and
k
in Rule 9.3 for “sections 92 to 94” substitute “92 to 93A ”.
6
1
Amend regulation 4 (provisions supplementing regulation 3) as follows.
2
In paragraph (1) for sub-paragraph (b) substitute —
ab
a scheme which would be an insurance business transfer scheme but for section 105(1)(b) of the Financial Services and Markets Act 2000;
b
a transfer in accordance with an authorisation granted outside the United Kingdom for the purposes of Article 12 of Council Directive 92/49/ EC on the co-ordination of the laws, regulations and administrative provisions relating to direct insurance other than life assurance and amending Directives 73/329/ EEC and 88/357/EEC ,
.
3
After paragraph (1) insert —
1A
Paragraph (2) also applies where, as a result of —
a
a relevant transaction effected after 5th December 2003 between a corporate general insurer and another company —
i
with which it is connected, and
ii
which is within the charge to corporation tax in respect of that transaction, or
b
a series of transactions having the same effect as a relevant transaction effected after 5th December 2003 between two companies which —
i
have been connected with each other at any time in the course of that series of transactions, and
ii
are within the charge to corporation tax in respect of the relevant transaction,
one of those companies directly or indirectly replaces the other as the insurer under a contract of insurance, or as the reinsurer under a contract of reinsurance, including (in either case) by way of novation.
.
4
In paragraph (2) —
a
at the end of sub-paragraph (a) omit “and”;
b
after sub-paragraph (a) insert —
ab
an election made under section 107(4) by the transferor had been made by the transferee; and.
5
After paragraph (2) insert —
2A
In paragraph (2)(a) “technical provisions made and taken into account by the transferor” means, in relation to a period of account in which a transfer of business occurs, the technical provisions which would have been made and taken into account had the transferor’s period of account ended immediately before the transfer.
The time at which the technical provisions are treated as made and taken into account by this paragraph shall be treated as the end of a period of account for the purposes of regulation 3(3) (and an election under section 107(4) may accordingly be made in respect of that period).
.
6
In paragraph (3) —
a
for “paragraph (c) of Rule 4.1” substitute “Rule 4.1C”;
b
for “paragraph (b)(i) of Rule 4.1” substitute “Rule 4.1A(a)(i)”;
c
for “paragraph (b)(ii) thereof” substitute “Rule 4.1A(a)(ii)”;
d
for “the general insurer (as defined in that Rule)” substitute “the corporate general insurer”;
e
in sub-paragraphs (a) and (c) before “general insurer” insert “corporate”; and
f
in sub-paragraph (c) for “Rules 1 to 9” substitute “Rules 1 to 10”.
7
1
For regulation 5 (currency elections) substitute —
Accounting in foreign currencies and relevant discount rates
5
1
In respect of that part of a general insurer’s business to which subsection (1) of section 747A of the Taxes Act applies, any calculation required under these Regulations shall be made in the same currency as that required to be used, for the purposes of Chapter 4 of Part 17 of the Taxes Act, by subsection (2) of that section.
2
In respect of that part of a general insurer’s business to which section 93A of the Finance Act 1993 applies, so much of any calculation required under these Regulations as relates to business in respect of which financial statements and records are prepared in the relevant foreign currency (within the meaning of that section) shall be made in that currency.
3
In respect of that part of a general insurer’s business to which section 93 of the Finance Act 1993 applies —
a
any calculation required under these Regulations shall be made in the relevant foreign currency (within the meaning of that section); and
b
the exchange rate to be used for determining the sterling equivalent of the amount of the receipt or expense found under Rule 9.3 is the London closing exchange rate.
4
In respect of so much of general insurer’s business as does not fall within the previous provisions of this regulation section 94AA of the Finance Act 1993 shall apply to the calculation of an excess or deficiency under regulation 3 as it applies to a computation under section 92(1) of that Act.
5
If the foreign currency used in the calculations under paragraphs (1) to (3) is one of the currencies mentioned in paragraph (b) of Rule 5.4, the discount rate to be applied to those calculations shall be found in accordance with the formula in that paragraph, and in any other case shall be found in accordance with the formula in paragraph (a) of Rule 5.4.
.
This substitution is subject to the qualification in paragraph (2).
2
Notwithstanding the substitution made by paragraph (1) —
a
an election may be made before 31st December 2003 under regulation 5(1) as it stood immediately before the substitution; and
b
if such an election is made (whether before or after the coming into force of these Regulations) the currency chosen under regulation 5(5) of the principal Regulations as it stood before the substitution may continue to be used as it might have been had the substitution not occurred.
8
1
Amend regulation 6 (excluded descriptions of general insurer) as follows.
2
Renumber the existing regulation 6 as paragraph (1) of that regulation.
3
In paragraph (1) so created —
a
in sub-paragraph (a) for “has gone into” substitute “is in”;
b
in sub-paragraph (c) for “has been” substitute “is”;
c
in sub-paragraph (d) for “has taken effect” substitute “is in force”; and
d
at the end add —
This is subject to the following qualification.
.
4
After paragraph (1) add —
2
A general insurer is not excluded from the operation of section 107 by virtue of paragraph (1)(c) or (d) unless —
a
it is insolvent at the time the provisional liquidator is appointed or the relevant arrangement or compromise comes into force; or
b
in a case falling within paragraph (1)(d), it would be insolvent but for the relevant arrangement or compromise coming into force.
.
9
1
Amend regulation 7 (“technical provisions” in relation to an underwriting member) as follows.
2
In paragraph (2) —
a
in sub-paragraph (a) for “(6)” substitute “(5)”; and
b
in sub-paragraph (b) omit “, (6)”.
3
In paragraph (4)(b), within the paragraph (b) substituted for Rule 2.1(b), for “was provision” substitute “were provisions”.
4
Omit paragraph (6).
5
In paragraph (10) for “regulation 4(2)(a) and (b)” substitute “sub-paragraphs (a), (ab) and (b) of regulation 4(2)”.
10
1
Amend regulation 8 (elections under section 107(4) of the Finance Act 2000 or paragraph 4(2) of Schedule 24 to the Taxes Act) as follows.
2
For paragraph (1) substitute —
1
An election by a general insurer for the purposes of section 107(4) or for the purposes of paragraph 4(2) of Schedule 24 to the Taxes Act may be made or withdrawn at any time up to whichever is the last of the following dates —
a
the first anniversary of the filing date for the company tax return of the company making the election for the period of account in respect of which the election is made;
b
if notice of enquiry is given into that return, 30 days after the enquiry is completed;
c
if, after such an enquiry, the Board amend the return under paragraph 34(2) of Schedule 18 to the Finance Act 1998, 30 days after the notice of the amendment is issued; and
d
if an appeal is brought against such an amendment, 30 days after the date on which the appeal is finally determined.
1A
Paragraph (1) applies to an underwriting member other than a body corporate with the substitution for paragraphs (a) to (c) of —
a
the first anniversary of 31st January next following the end of the year of assessment in which falls the end of the period of account in respect of which the election is made;
b
if notice of enquiry is given into the underwriting member’s tax return for that year of assessment, 30 days after the enquiry is completed;
c
if after such an enquiry the Board amend the return under section 28A of the Taxes Management Act 1970 , 30 days after the amendment of the return;
.
3
In paragraph (2) for “paragraph (1)” substitute “paragraph (1)(a)”.
4
At the end add —
4
An election under section 107(4) by a controlled foreign company may be communicated, on its behalf, by the person or persons resident in the United Kingdom by whom it is controlled to the Board.
5
An election under section 107(4) shall be made in writing and shall specify —
a
the period of account in respect of which the election is made;
b
the earlier period or periods of account to which the technical provisions in question relate;
c
the amount of technical provisions being disclaimed in respect of each such period; and
d
the currency in which the technical provisions being disclaimed are expressed.
.
11
After regulation 9 add —
Modification: companies subject to these Regulations on or after 5th December 2003
10
1
Paragraph (2) applies to a company if any of the following Cases applies.
Case 1
The company is one to which these Regulations first apply on or after 5th December 2003 by reason of its becoming —
a controlled foreign company on or after that date; or
subject to corporation tax for the first time on of after that date.
Case 2
The company, already being subject to corporation tax in respect of its general insurance business, is charged to tax under Case I of Schedule D in respect of that business for the first time for a period of account beginning on or after 5th December 2003.
Case 3
The company is a controlled foreign company and the first period of account in respect of which —
an apportionment falls to be made under section 747(3), or
section 748(1)(a) applies,
is a period of account ending on or after 5th December 2003.
Case 4
The company is one to which these Regulations apply on 5th December 2003 by reason only of the amendments made by regulation 8 of the General Insurance Reserves (Tax) (Amendment) Regulations 2003 to regulation 6 of these Regulations.
2
In the case of a company to which this paragraph applies, regulations 2 to 9 of these Regulations shall apply as if references to the first earlier period of account were to the period of account preceding that during which the company first becomes subject to these Regulations and references to original technical provisions shall be construed accordingly.
3
If paragraph (2) applies, an election may be made under section 107(4) in respect of the original technical provisions of the period of account preceding that during which the company in question first becomes subject to these Regulations.
.
Nick Montagu
Dave Hartnett
Two of the Commissioners of Inland Revenue
10th November 2003


text:
1
This Order may be cited as the Reciprocal Enforcement of Foreign Judgments (Israel) (Amendment) Order 2003 and shall come into force on 6th November 2003.
2
In this Order an Article referred to by number alone means the Article so numbered in the Reciprocal Enforcement of Foreign Judgments (Israel) Order 1971 .
3
In Article 3 —
a
for “superior courts” substitute “recognised courts”; and
b
after “The District Courts;” insert “The Magistrates' Courts;”.
4
In each of Articles 4, 5, 6 and 7 for “superior court” substitute “recognised court”.
A. K. Galloway
Clerk of the Privy Council


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2003 and shall come into force —
a
except for the purposes of regulation 4(2), (3) and (5)(b), on 1st April 2003; and
b
for the purposes of regulation 4(2), (3) and (5)(b), on 1st July 2003.
2
In these Regulations —
“the Devices Regulations ” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 ;
“the General Fees Regulations ” means the Medicines (Products for Human Use — Fees) Regulations 1995 ; and
“the Homoeopathic Products Regulations ” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 .
Amendment of the Homoeopathic Products Regulations
2
1
The Homoeopathic Products Regulations are amended as follows.
2
In regulation 14 (fees for variations of certificates) —
a
in paragraph (1)(a), for “£103” substitute “£110”;
b
in paragraph (1)(b)(i), for “£103” substitute “£110”;
c
in paragraph (1)(b)(ii), for “£51.50” substitute “£55”;
d
in paragraph (2)(a), for “£200” substitute “£216”;
e
in paragraph (2)(b)(i), for “£200” substitute “£216”;
f
in paragraph (2)(b)(ii), for “£200” substitute “£216”;
g
in paragraph (2)(b)(iii), for “£100” substitute “£108”; and
h
in paragraph (2)(b)(iv), for “£50” substitute “£54”.
3
In regulation 15(1) (fees payable by holders of certificates), for “£13” substitute “£14”.
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 “£122” substitute “£132”,
ii
for “£368” substitute “£397”, and
iii
for “£607” substitute “£656”; and
b
in column (3) (fees for other applications) —
i
for “£302” substitute “£326”,
ii
for “£542” substitute “£585”, and
iii
for “£795” substitute “£859”.
Amendment of regulation 3 of the Devices Regulations
3
In regulation 3 of the Devices Regulations (fees) —
a
in paragraph (1)(a), for “£3,271” substitute “£3,533”;
b
in paragraph (1)(b), for “£7,264” substitute “£8,234”;
c
in paragraph (2)(a), for “£647” substitute “£699”;
d
in paragraph (2)(b), for “£1,810” substitute “£1,955”;
e
in paragraph (3)(a), for “£3,271” substitute “£3,533”;
f
in paragraph (3)(b), for “£7,264” substitute “£8,234”;
g
in paragraph (4)(a), for “£647” substitute “£699”;
h
in paragraph (4)(b), for “£1,810” substitute “£1,955”;
i
in paragraph (5)(a), for “£33,450” substitute “£36,126”; and
j
in paragraph (5)(b), for “£8,305” substitute “£8,969”.
Amendment of the General Fees Regulations
4
1
The General Fees Regulations are amended as follows.
2
In regulation 2(1), in the definition of “marketing authorization” after “means” insert “, except in regulation 3A”.
3
After Part I of the General Fees Regulations (general) insert the following Part —
PART IA
CAPITAL FEES FOR PRE-APPLICATION MEETINGS
3A
In this Part —
“clinical development” means the conduct of studies of a medicinal product in human subjects in order to —
discover or verify the effects of such a product,
identify any adverse reaction to such a product, or
study absorption, distribution, metabolism and excretion of such a product,
with the object of ascertaining the safety or efficacy of that product, in accordance with Part 4 of Annex I to the 2001 Directive ;
“ EC marketing authorization” means —
a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations,
a marketing authorization granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive, or
a Community marketing authorization;
“quality development” means the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a relevant medicinal product, in accordance with Part 2 of Annex I to the 2001 Directive;
“scientific advice” means advice in connection with the quality, safety or clinical development for a relevant medicinal product;
“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply ;
“safety development” means the toxicological and pharmacological testing necessary to demonstrate the safety of a relevant medicinal product, in accordance with Part 3 of Annex I to the 2001 Directive.
3B
Subject to regulation 19, where the licensing authority holds a meeting with a person for the purpose of providing scientific advice to that person with a view to him making an application for an EC marketing authorization, there shall be payable by that person —
a
if the advice provided at that meeting consists of advice in connection with —
i
quality development only, or
ii
safety development only,
a fee of £1,000;
b
if the advice provided at that meeting consists of advice in connection with —
i
quality and safety development, or
ii
clinical development only,
a fee of £1,330;
c
if the advice provided at that meeting consists of advice in connection with —
i
quality and clinical development, or
ii
safety and clinical development,
a fee of £1,670; and
d
if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development, a fee of £2,000.
3C
Subject to regulation 19, all sums payable by way of fees under regulation 3B shall become payable within 14 days following written notice from the licensing authority requiring payment of those fees.
.
4
After Part III of the General Fees Regulations (capital fees for applications for variations of authorizations, licences or certificates and for associated inspections) insert the following Part —
PART IIIA
CAPITAL FEES FOR ASSESSMENT OF LABELS AND LEAFLETS
9A
For the purposes of this Part and Part IIIA of Schedule 1, a “set of proposed changes” means a number of proposed changes to the labelling or package leaflet of a medicinal product, where —
a
if there is more than one version of the labelling or package leaflet for that product, those changes all relate to the same version; and
b
those changes are submitted to the licensing authority at the same time.
9B
1
Subject to paragraph (2) and regulation 19, where —
a
a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a United Kingdom marketing authorization (other than a parallel import licence) is submitted to the licensing authority in accordance with Article 61(3) of the 2001 Directive, or
b
a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a parallel import licence is submitted to the licensing authority,
there shall be payable by the holder of that authorization or licence the fee prescribed in Part IIIA of Schedule 1 in connection with that change.
2
Paragraph (1) shall not apply where a change to the labelling or package leaflet of a medicinal product is proposed in connection with an application for the variation of the marketing authorization for that product.
9C
Subject to regulation 19, all sums payable by way of fees under regulation 9B(1) shall be payable at the time when the proposed changes are submitted to the licensing authority.
.
5
In regulation 16 (time for payment of capital fees in connection with applications or inspections), in paragraph (1) —
a
after “6C” insert “or 9C”; and
b
after “regulation” insert “3C,”.
6
After Part III of Schedule 1 (capital fees for applications for variations of authorizations, licences and certificates) insert the following Part —
PART IIIA
CAPITAL FEES FOR ASSESSMENT OF LABELS AND LEAFLETS
1
In this Part, “clinical particulars”, in relation to a medicinal product, means the clinical particulars contained in the Summary of Product Characteristics for that product as specified in paragraph 5 of Article 11 of the 2001 Directive.
2
Subject to paragraph 3, the fee payable under regulation 9B(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product shall be —
a
in respect of a product which is the subject of a United Kingdom marketing authorization other than a parallel import licence, £350; and
b
in respect of a product which is the subject of a parallel import licence, £270.
3
1
This paragraph applies where more than one set of proposed changes falling within regulation 9B(1) is submitted by the same marketing authorization holder at the same time and where —
a
the sets of proposed changes consist of identical changes to the labelling or package leaflets of products with the same active ingredient or combination of ingredients, dosage form and clinical particulars; or
b
the sets of proposed changes consist of identical changes to different versions of the labelling or package leaflet of the same product.
2
Where this paragraph applies, the fee payable under regulation 9B(1) shall be —
a
in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 2; and
b
in connection with each of the other sets of proposed changes, 50 per cent of that amount.
.
7
In Schedule 2 (fees for inspections) —
a
in paragraph 1 (interpretation), in sub-paragraph (1) —
i
before the definition of “major inspection” 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
ii
after the definition of “minor inspection” insert the following definitions —
“new premises or facilities”, in relation to an inspection at a site, means premises or facilities —
which have not been specified in any application for the grant, variation or renewal of a manufacturer’s licence, other than an application to which the inspection relates, or
which have been so specified, provided that —
no manufacturing or assembly operations have been carried out at those premises or facilities, or
no inspection has been made of those premises or facilities on or after the date on which manufacturing or assembly operations were first carried out at those premises or facilities;
“non-routine inspection” means an inspection at a site in connection with the grant, variation or renewal of a manufacturer’s licence or during the currency of such a licence which —
relates to new premises or facilities on that site, or plans for such premises or facilities,
relates to a material alteration of any existing premises or facilities at that site, or plans for such an alteration, provided that if the alteration has been made prior to the inspection —
no manufacturing or assembly operations have been carried out at those premises or facilities since the alteration, or
no inspection has been made of those premises or facilities on or after the date on which manufacturing or assembly operations were first carried out following that alteration, or
is made to ascertain whether the holder of the licence is able to demonstrate compliance with —
any principle or guideline of good manufacturing practice (but not all those principles and guidelines), or any individual requirement of such a principle or guideline; or
the “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products” published by the European Commission in Volume 3 of its publication “The Rules Governing Medicinal Products in the European Union”;
“principle or guideline of good manufacturing practice” means one of the principles and guidelines of good manufacturing practice set out in Chapter II of Commission Directive 91/356/ EEC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use;
;
b
in paragraph 2 —
i
at the beginning of sub-paragraph (b) insert “except in the case of an inspection falling within sub-paragraph (cc)”,
ii
in sub-paragraph (c), for “(b) or (d)” substitute “(b), (cc) or (d)”,
iii
after sub-paragraph (c), insert the following paragraph —
cc
except in the case of an inspection falling within sub-paragraph (d), where the inspection is a non-routine inspection —
i
if the time taken to make the inspection is not more than one day, £1,500,
ii
if the time taken to make the inspection is more than one day but not more than 3 days, £4,000,
iii
if the time taken to make the inspection is more than 3 days, £7,500; and
; and
c
in paragraph 3, in sub-paragraph (1), after “any inspection at a site” insert “(other than a non-routine inspection)”;
d
in paragraph 4 —
i
in sub-paragraph (1), for “sub-paragraph (2)” substitute “sub-paragraphs (2) and (3)”, and
ii
after sub-paragraph (2), insert the following sub-paragraph —
3
This paragraph shall not apply in respect of a non-routine inspection.
;
e
in paragraph 5 —
i
in sub-paragraph (1), at the beginning insert “Subject to paragraph (3),”, and
ii
after sub-paragraph (2), insert the following sub-paragraph —
3
In the case of an inspection of a site in connection with the variation or renewal of a wholesale dealer’s licence which relates to exempt imported products or during the currency of such a licence, the fee payable shall be the fee specified in the entry in column 2 of the following Table corresponding to the number of such products imported under that licence in the period of 12 months before the inspection specified in column 1 of that Table —
Column 1 Column 2 Number of exempt imported products imported in previous 12 months Fee payable
None £1,011 1 to 4 £1,211 5 to 20 £2,011 21 to 100 £4,011 101 to 500 £9,011 More than 500 £16,011
; and
f
after paragraph 5, insert the following paragraph —
5A
The fee payable in respect of an inspection at a site during the currency of a marketing authorization for the purposes of ascertaining whether the holder of that authorization has complied with the obligations relating to pharmacovigilance imposed on him by virtue of regulation 7(1) and (2) of the 1994 Regulations shall be —
a
if the holder of the marketing authorization holds less than 5 such authorizations, £3,500;
b
if the holder of the marketing authorization holds 5 or more such authorizations, but less than 50, £5,000; and
c
if the holder of the marketing authorization holds 50 or more such authorizations, £10,000.
.
8
In Schedule 5 (waiver, reduction or refund of capital fees) —
a
paragraph 2 is renumbered as sub-paragraph (1) of that paragraph and after that sub-paragraph insert the following sub-paragraph —
2
Where, at the specific request of the licensing authority, a proposed change is submitted to the licensing authority as a consequence of new information having a bearing on the safe use of the product, the fee payable under regulation 9B(1) shall be refunded or, if it has not yet been paid, shall be waived.
; and
b
after paragraph 5, insert the following paragraph —
5A
Where the inspection of a site is a non-routine inspection within the meaning of Schedule 2 and the time taken to make that inspection is not more than 2 hours, the fee otherwise payable under these Regulations in respect of that inspection shall be waived.
.
9
In each provision of the General 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.
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State,
Department of Health
11th March 2003
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
D. C. Gowdy
Permanent Secretary,
Department of Health, Social Services and Public Safety
4th March 2003
Sealed with the Official Seal of the Department of Agriculture and Rural Development
P. J. Small
Permanent Secretary,
Department of Agriculture and Rural Development
7th March 2003
We consent,
Nick Ainger
Philip Woolas
Two of the Lords Commissioners of Her Majesty’s Treasury
10th March 2003


text:
Citation, commencement and application
1
1
These Regulations may be cited as the National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2003 and shall come into force on 22nd August 2003.
2
These Regulations extend to England and Wales but paragraphs 1 and 5 of the Schedule apply to England only.
Consequential amendments
2
The enactments specified in the Schedule are amended as there specified.
Signed by authority of the Secretary of State
Stephen Ladyman
Parliamentary Under Secretary of State,
Department of Health
22nd July 2003