text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 and shall come into force on 30th October 2005.
2
In these Regulations —
“ the Act ” means the Medicines Act 1968 ;
“the 1994 Regulations ” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 ;
“the Applications Regulations ” means the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971 ;
“the Standard Provisions Regulations ” means the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 ;
“ BCG ” means the bacillus of Calmette and Guerin;
“BCG vaccine” means a vaccine that is a preparation of the bacteria in a living pure culture of a strain of the bacillus of Calmette and Guerin;
“biological medicinal product” means a medicinal product, the active substance of which is a biological substance;
“biological substance” means a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control;
“blood” means whole human blood;
“blood component” means a therapeutic constituent of blood (red cells, white cells, platelets and plasma);
“blood product” means any industrially prepared medicinal product for human use derived from human blood or human plasma and includes but is not limited to albumin, coagulation factors and immunoglobulins of human origin, but does not include blood or blood components;
“ Commission Directive 2003/94/EC ” means Commission Directive 2003/94/ EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and for investigational medicinal products for human use;
“ the 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 of 27 January 2003 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 on the Community code relating to medicinal products for human use ,
Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and
Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use ;
“ EEA State ” means a member State, Norway, Iceland or Liechtenstein;
“exempt relevant medicinal product” means a relevant medicinal product to which paragraph 1 of Schedule 1 to the 1994 Regulations or any equivalent legislation in any EEA State other than the United Kingdom applies;
“the guidelines on good distribution practice” means the Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C63/03) published by the European Commission pursuant to Article 84 of the Directive ;
“intermediate product” means a substance, other than a starting material, which —
has been manufactured for use in the manufacture of medicinal products, and
is intended for further processing by a manufacturer of such products;
“marketing authorization” means —
a marketing authorization granted by the licensing authority under the 1994 Regulations;
a marketing authorization issued by the competent authority of an EEA state, other than the United Kingdom, in accordance with the Directive;
a marketing authorization granted by the European Commission under Council Regulation ( EEC ) No. 2309/93 or Regulation (EC) No. 726/2004 ;
a traditional herbal registration granted by the licensing authority under the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 ; or
a certificate of registration granted by the licensing authority under the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994 ;
“the principles and guidelines of good manufacturing practice” means the principles and guidelines of good manufacturing practice set out in Commission Directive 2003/94/EC ;
“qualified person” means —
a person whose qualifications and experience satisfy the requirements of Article 49 or 50 of the Directive, or
insofar as the activities of the qualified person are limited to traditional herbal medicinal products, a person who, without satisfying the requirements referred to in paragraph (a) —
has been engaged in activities equivalent to those to be performed in accordance with Article 51 of the Directive in respect of traditional herbal medicinal products on or before 30th April 2011; and
has, whilst they continue to be engaged in activities equivalent to those to be performed in accordance with Article 51 of the Directive, been named as a qualified person in an application for a manufacturer’s licence which is made in accordance with the requirements of the Applications Regulations and before 30th April 2013;
“relevant medicinal product” means a medicinal product for human use to which the provisions of the Directive apply;
“serum” means a fluid fraction of coagulated blood;
“smallpox vaccine” means a vaccine that is a preparation of an infective vaccinia virus;
“toxins” means substances used in the diagnosis, prevention or treatment of disease consisting wholly or partly of poisonous substances derived from specific micro-organisms, plants or animals;
“traditional herbal medicinal product” has the meaning given by Article 1(29) of the Directive;
“vaccines” means antigenic substances which consist wholly or partly of —
any micro-organisms, viruses or other organisms in any state,
any toxins of microbial origin which have been detoxified (toxoids), or
any extracts or derivatives of any micro-organisms or of any viruses,
being substances which, when administered to human beings are used for the treatment of specific diseases.
3
Expressions used in these Regulations which are used in any provision of the Act have the meaning which they bear in the Act.
Requirement that manufacturer’s licence holders comply with certain obligations in relation to the manufacture and assembly of relevant medicinal products
2
1
In relation to the manufacture and assembly of relevant medicinal products, a manufacturer’s licence holder shall —
a
comply with the principles and guidelines of good manufacturing practice;
b
comply with the requirements of paragraph (3); and
c
subject to paragraph (2), use active substances as starting materials only where those active substances have been manufactured or assembled in accordance with the principles and guidelines of good manufacturing practice applicable to starting materials;
2
A manufacturer’s licence holder shall not be required to comply with the requirement of paragraph (1)(c) in relation to the manufacture or assembly of relevant medicinal products pursuant to his manufacturer’s licence, insofar as such activity is limited to the manufacture or assembly of exempt relevant medicinal products.
3
The requirements of this paragraph are that the manufacturer’s licence holder shall —
a
maintain such staff, premises, equipment and facilities as are necessary for such stages of the manufacture and assembly of relevant medicinal products as are undertaken by him in accordance with the requirements of —
i
his licence, and
ii
the marketing authorizations of the relevant medicinal products in question;
b
maintain such staff, premises, equipment and facilities for the handling, control, storage and distribution of the relevant medicinal products which he handles, stores and distributes under his licence, as are necessary to maintain the quality of those medicinal products;
c
ensure that any arrangements he makes with any person for the control, storage and distribution of the relevant medicinal products are adequate to maintain the quality of those products;
d
not carry out any manufacture or assembly of relevant medicinal products other than —
i
the manufacture or assembly of those classes of relevant medicinal product specified in his licence, and
ii
at the premises specified in his licence;
e
not use any premises for the handling, control, storage or distribution of relevant medicinal products other than those specified in his licence as approved by the licensing authority for that purpose, or approved by the licensing authority for that purpose from time to time;
f
inform the licensing authority before making any material alteration to the premises or facilities used under his licence, or in the operations for which they are used;
g
inform the licensing authority of any change that he proposes to make to any personnel named in his licence as responsible for quality control of the medicinal products being manufactured or assembled by him, including the person named as the qualified person for the purposes of regulation 4;
h
for the purpose of enabling the licensing authority to ascertain whether there are any grounds —
i
for suspending, revoking or varying any licence granted under Part II of the Act; or
ii
suspending or terminating any licence in accordance with the provisions of Part II of the Act,
permit, and provide all necessary facilities to enable, any person duly authorised in writing by the licensing authority, on production if required of his credentials, to carry out such inspection or to take such samples or copies, in relation to things belonging to, or any business carried on by, the holder of the licence, as such person would have the right to carry out or take under the Act for the purpose of verifying any statement contained in an application for a licence ;
i
ensure that any blood or blood component imported into the United Kingdom and used by him as a starting material or raw material in the manufacture of a relevant medicinal product shall meet equivalent standards of quality and safety to those laid down in Commission Directive 2004/33/EC , implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components; and
j
shall, where he distributes by way of wholesale dealing, any relevant medicinal product manufactured or assembled pursuant to his licence, comply with the requirements of regulations 8(1)(a) and (b) and (2), and 9 (2) and (3), as if he was the holder of a wholesale dealer’s licence.
Requirement that manufacturer’s licence holders comply with certain obligations in relation to the import from a third country of relevant medicinal products
3
In relation to the import from a third country of any relevant medicinal product, a manufacturer’s licence holder shall —
a
comply with the principles and guidelines of good manufacturing practice insofar as they are relevant to the import of relevant medicinal products;
b
comply with the guidelines on good distribution practice;
c
ensure that any relevant medicinal products (other than exempt relevant medicinal products) imported by him from a third country use active substances as starting materials only where those active substances have been manufactured in accordance with the principles and guidelines of good manufacturing practice applicable to starting materials;
d
maintain such staff, premises, equipment and facilities for the handling, control, storage and distribution of the relevant medicinal products which he handles, stores and distributes under his licence, as are necessary to maintain the quality of those medicinal products;
e
ensure that any arrangements he makes with any person for the storage and distribution of the medicinal products are adequate to maintain the quality of those products;
f
not use any premises for the handling, control, storage or distribution of relevant medicinal products other than those specified in his licence as approved by the licensing authority for that purpose, or approved by the licensing authority for that purpose from time to time;
g
inform the licensing authority before making any material alteration in the premises or facilities used under his licence, or in the operations for which they are used;
h
inform the licensing authority of any change that he proposes to make to any personnel named in his licence as responsible for quality control of the medicinal products being imported by him including the person named as the qualified person for the purposes of regulation 4;
i
for the purpose of enabling the licensing authority to ascertain whether there are any grounds —
i
for suspending, revoking or varying any licence granted under Part II of the Act; or
ii
suspending or terminating any licence in accordance with the provisions of Part II of the Act,
permit, and provide all necessary facilities to enable, any person duly authorised in writing by the licensing authority, on production if required of his credentials, to carry out such inspection or to take such samples or copies, in relation to things belonging to, or any business carried on by, the holder of the licence, as such person would have the right to carry out or take under the Act for the purpose of verifying any statement contained in an application for a licence ; and
j
where he distributes by way of wholesale dealing, any relevant medicinal product manufactured or assembled pursuant to his licence, comply with the requirements of regulations 8(1)(a) and (b) and (2), and 9 (2) and (3), as if he was the holder of a wholesale dealer’s licence.
Requirements as to qualified persons
4
1
Subject to paragraphs (7) and (8), where a manufacturer’s licence relates to the manufacture, assembly or importation of relevant medicinal products, a manufacturer’s licence holder shall ensure that he has at all times at his disposal the services of at least one qualified person who is responsible for carrying out, in relation to those products, the duties specified in Article 51 of the Directive in respect of relevant medicinal products manufactured, assembled or imported by him.
2
If a licence holder satisfies the requirements as to qualifications and experience specified in the definition of “qualified person” in regulation 1(2), he may act as the qualified person in accordance with paragraph (1) for the purposes of that licence.
3
For the purposes of this paragraph, but without prejudice to paragraph (4) below, the licence holder may regard a person as satisfying the provisions of Article 49 or 50 of the Directive as respects formal qualifications if he produces evidence that —
a
he is a member of —
i
the Institute of Biology,
ii
the Pharmaceutical Society,
iii
the Royal Society of Chemistry, or
iv
such other body as may appear to the licensing authority to be an appropriate body for the purpose of this paragraph; and
b
he is regarded by the body of which he is a member as so satisfying those provisions.
4
The licence holder —
a
shall notify the licensing authority of the name and address and degrees, diplomas or qualifications and experience of the person who will carry out the functions of qualified person;
b
shall notify the licensing authority of any change to the qualified person; and
c
shall not permit any person to act as qualified person other than the person named in his licence as qualified person or, subject to paragraph (5), any other such person whose name is notified to the licensing authority.
5
Where, after giving the licence holder and the person acting as a qualified person the opportunity of making representations to them (orally or in writing), the licensing authority is of the opinion that —
a
the person so acting does not satisfy —
i
the provisions of Articles 49 and 50 of the Directive as respects qualifications and experience, or
ii
the requirements as to qualifications and experience specified in paragraph (b) of the definition of “qualified person” in regulation 1(2); or
b
he is failing to carry out the duties referred to in paragraph (1) adequately or at all,
and has notified the licence holder accordingly in writing, the licence holder shall not permit that person to act as a qualified person.
6
Subject to paragraph (7), the licence holder shall at all times provide and maintain such staff, premises, equipment and facilities as will enable the qualified person who is at his disposal pursuant to paragraph (1), to carry out the duties referred to in that subsection.
7
A licence holder shall not be required to meet the requirements of this regulation in relation to any activity carried out pursuant to his licence which consists of the manufacture, assembly or import from a third country of relevant medicinal products pursuant to a manufacturer’s licence insofar as such activity is limited to the manufacture, assembly or importation of —
a
exempt relevant medicinal products; or
b
products which may be placed on the market in any EEA State without a marketing authorization by virtue of legislation adopted by that State under Article 5(2) of the Directive.
8
Where the conditions specified in paragraph 2 of Article 51 of the Directive are satisfied, a qualified person shall not be required to meet the requirements of point (b) of the first sub-paragraph of paragraph 1 of Article 51 of the Directive in respect of the import of any relevant medicinal product from a third country.
Offence relating to the sale and supply of starting materials for use in the manufacture of relevant medicinal products
5
1
Any person who, in the course of a business carried on by him, sells or supplies any active substance in circumstances where the active substance —
a
has not been manufactured in accordance with the principles of good manufacturing practice applicable to starting materials; and
b
is intended to be used by the person to whom it is sold or supplied in the manufacture of a relevant medicinal product other than an exempt relevant medicinal product,
shall be guilty of an offence.
2
It shall be a defence to an offence under paragraph (1) for the person who sells or supplies the relevant medicinal product in question to show that he could not, by reasonable diligence have discovered that it was not manufactured in accordance with the principles of good manufacturing practice applicable to starting materials.
3
A person guilty of an offence under paragraph (1) shall be liable —
a
on summary conviction to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or to both; or
b
on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or to both.
Standard provisions for manufacturer’s licences
6
The standard provisions, for the purposes of Part II of the Act, for manufacturer’s licences, insofar as those licences relate to relevant medicinal products shall be —
a
those provisions set out in Schedule 1, insofar as those licences relate to the manufacture and assembly of relevant medicinal products; and
b
those provisions set out in Schedule 2, insofar as those licences relate to the import from a third country of relevant medicinal products.
Additional standard provisions for manufacturers licences which relate to vaccines, toxins and sera
7
1
In addition to the standard provisions for manufacturer’s licences set out in Schedules 1 and 2, there shall be the following additional standard provisions for manufacturer’s licences, insofar as those licences relate to relevant medicinal products which are vaccines for human use —
a
for all vaccines, including smallpox and BCG vaccines, those provisions set out in Part 1 of Schedule 3;
b
for smallpox vaccine, those provisions set out in Part 2 of Schedule 3; and
c
for BCG vaccine, those provisions set out in Part 3 of Schedule 3.
2
In addition to the standard provisions for manufacturer’s licences set out in Schedules 1 and 2, there shall be the following additional standard provisions for manufacturers licences relating to relevant medicinal products which are toxins and sera for human use —
a
for toxins, those provisions set out in Part 4 of Schedule 3; and
b
for sera, those provisions set out in Part 5 of Schedule 3.
Requirement that holders of wholesale dealer’s licences comply with certain obligations
8
1
The holder of a wholesale dealer’s licence, insofar as that licence relates to relevant medicinal products, shall —
a
comply with the guidelines on good distribution practice;
b
ensure, within the limits of his responsibility as a distributor of relevant medicinal products, the appropriate and continued supply of such relevant medicinal products to pharmacies and persons who may lawfully sell such products by retail or who may lawfully supply them in circumstances corresponding to retail sale so that the needs of patients in the United Kingdom are covered;
c
provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the relevant medicinal products which he handles, stores or distributes under his licence as are necessary to maintain the quality of, and ensure proper distribution of the medicinal products which he handles, stores or distributes pursuant to his licence;
d
inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or premises which have been approved from time to time by the licensing authority.
2
Subject to paragraph (3), the holder of a wholesale dealer’s licence shall not sell or offer for sale or supply any relevant medicinal product unless —
a
there is a marketing authorization for the time being in force in respect of that product; and
b
the sale or offer for sale is in conformity with the provisions of that authorisation.
3
The restriction in paragraph (2) shall not apply to —
a
the sale or offer for sale of any exempt relevant medicinal product; and
b
the export to an EEA State, or supply for the purposes of such export, of a relevant medicinal product which may be placed on the market in that State without a marketing authorization by virtue of legislation adopted by that State under Article 5(2) of the Directive.
4
The holder of a wholesale dealer’s licence shall —
a
keep such documents relating to the sale of medicinal products to which his licence relates as will facilitate the withdrawal or recall from sale of relevant medicinal products in accordance with paragraph (b);
b
have in place an emergency plan which will ensure effective implementation of the recall from the market of any relevant medicinal products where such recall is —
i
ordered by the licensing authority or by the competent authority of any other EEA State; or
ii
carried out in co-operation with the manufacturer of, or the holder of the marketing authorization for, the product in question;
c
keep such records, which may be in the form of purchase and sales invoices, or on a computer or in any other form, which give, as a minimum, where any relevant medicinal products are received or dispatched, the following information —
i
the date of receipt or, as the case may be, dispatch,
ii
the name of the relevant medicinal product,
iii
the quantity of relevant medicinal product received or, as the case may be, dispatched, and
iv
the name and address of, as may be applicable in each case, the person from whom the products are received or to whom they are sold or supplied.
5
Where the holder of a wholesale dealer’s licence imports from another EEA State any relevant medicinal product in respect of which he is not either —
a
the marketing authorization holder in respect of that product; or
b
acting on behalf of the marketing authorization holder in importing that product,
he shall notify the marketing authorization holder and the licensing authority of his intention to import it.
6
The licence holder, for the purpose of enabling the licensing authority to ascertain whether there are any grounds —
a
for suspending, revoking or varying any licence granted under Part II of the Act; or
b
suspending or terminating any licence in accordance with the provisions of Part II of the Act,
shall permit, and provide all necessary facilities to enable, any person duly authorised in writing by the licensing authority, on production if required of his credentials, to carry out such inspection or to take such samples or copies, in relation to things belonging to, or any business carried on by, the holder of the licence, as such person would have the right to carry out or take under the Act for the purpose of verifying any statement contained in an application for a licence.
Requirement that wholesale dealers deal only with specified persons
9
1
The holder of a wholesale dealer’s licence shall obtain supplies of relevant medicinal products only from either —
a
a manufacturer’s licence holder or wholesale dealer’s licence holder in respect of such products; or
b
a person who holds an authorisation granted by another EEA State authorizing the manufacture of such products or their distribution by way of wholesale dealing.
2
The holder of a wholesale dealer’s licence shall distribute relevant medicinal products by way of wholesale dealing only to —
a
a holder of a wholesale dealer’s licence relating to those products;
b
a holder of an authorization granted by the competent authority of another EEA State authorising the supply of those products by way of wholesale dealing;
c
any person who may lawfully sell those products by retail or who may lawfully supply them in circumstances corresponding to retail sale; or
d
any person who may lawfully administer those products.
3
Where any relevant medicinal product is supplied to any person pursuant to paragraph (2)(c), the licence holder shall enclose with the product a document which makes it possible to ascertain —
a
the date on which the supply took place;
b
the name and pharmaceutical form of the product supplied;
c
the quantity of product supplied; and
d
the names and addresses of the person or persons from whom the products were supplied to the licence holder.
4
The licence holder shall —
a
keep a record of the information supplied pursuant to paragraph (3) for a minimum period of five years after the date on which it is supplied; and
b
ensure, during that period, that that record is available to the licensing authority for inspection.
Requirement as to responsible persons
10
1
Where a wholesale dealer’s licence relates to relevant medicinal products, the wholesale dealer’s licence holder shall at all times have at his disposal the services of a person (referred to in this regulation as “a responsible person”) who, in the opinion of the licensing authority —
a
has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate for performing the functions of responsible person; and
b
has experience in those procedures and activities which is adequate for those purposes.
2
The functions of the responsible person shall be to ensure, in relation to relevant medicinal products, that —
a
the conditions under which the licence has been granted have been, and are being, complied with; and
b
the quality of relevant medicinal products which are being handled by the wholesale dealer’s licence holder are being maintained in accordance with the requirements of the marketing authorizations applicable to those products.
3
The licence holder shall —
a
notify the licensing authority of the name and address and degrees, diplomas or qualifications and experience of the person who will carry out the functions of responsible person;
b
notify the licensing authority of any change to the responsible person; and
c
not permit any person to act as responsible person other than the person named in his licence as responsible person or, subject to paragraph (4) any other such person whose name is notified to the licensing authority.
4
Where, after giving the licence holder and the person acting as a responsible person the opportunity of making representations to them (orally or in writing), the licensing authority are of the opinion that —
a
the person so acting does not satisfy the provisions of paragraph (1) as respects qualifications and experience, or
b
he is failing to carry out the duties referred to in paragraph (2) adequately or at all,
and have notified the licence holder accordingly in writing, the licence holder shall not permit that person to act as a responsible person.
Standard provisions for wholesale dealer’s licences
11
The standard provisions, for the purposes of Part II of the Act, for wholesale dealer’s licences, insofar as those licences relate to relevant medicinal products, shall be those provisions set out in Schedule 4 to these Regulations.
Application of these Regulations to manufacturer’s and wholesale dealer’s licences
12
1
Regulations 2, 3 and 4 shall have effect as though they were made under section 8(2D) of the Act .
2
Regulations 7, 8, 9 and 10 shall have effect as they were made under section 8(3D) of the Act .
Consequential and other amendments to enactments
13
The provisions of the enactments specified in Schedule 5 are amended as there specified.
Revocations
14
1
The Standard Provisions Regulations are revoked insofar as they relate to —
a
manufacturer’s licences, and
b
wholesale dealer’s licences,
insofar as such licences relate to relevant medicinal products.
2
The Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 are revoked insofar as they relate to —
a
manufacturer’s licences, and
b
wholesale dealer’s licences,
insofar as such licences relate to relevant medicinal products.
Transitional provisions
15
The transitional provisions set out in Schedule 6 shall have effect.
Signed by authority of the Secretary of State for Health
Warner
Minister of State,
Department of Health
5th October 2005
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
A.McCormick
Permanent Secretary,
Department of Health, Social Services and Public Safety
10th October 2005
Sealed with the OfficialSealof the Department of Agriculture and Rural Development
Pat Toal
Permanent Secretary,
Department of Agriculture and Rural Development
7th October 2005


type: legislation

jurisdiction: UK

text:
Citation and commencement
1
1
This Order may be cited as the County of Cambridgeshire (Electoral Changes) Order 2005.
2
This Order shall come into force –
a
for the purpose of proceedings preliminary or relating to any election to be held on the ordinary day of election of councillors in 2005, on the day after that on which it is made;
b
for all other purposes, on the ordinary day of election of councillors in 2005.
Interpretation
2
In this Order –
“county” means the county of Cambridgeshire;
“existing”, in relation to an electoral division or ward, means the electoral division or ward as it exists on the date this Order is made;
references to wards, unless the context otherwise requires, are references to district and city wards in the county ; and
any reference to the map is a reference to the map marked “Map referred to in the County of Cambridgeshire (Electoral Changes) Order 2005”, of which prints are available for inspection at –
the principal office of the Electoral Commission; and
the offices of Cambridgeshire County Council.
Electoral divisions of the county of Cambridgeshire
3
1
The existing electoral divisions of the county shall be abolished.
2
The county shall be divided into sixty electoral divisions which shall bear the names set out in column (1) of the Schedule.
3
The electoral divisions shall comprise the areas described in column (2) of the Schedule by reference to wards, parishes, or parish wards or, where an area is not so described, the area designated on the map by reference to the name of the electoral division and demarcated by red lines; and the number of councillors to be elected for each electoral division shall be the number specified in respect of the electoral division in column (3) of the Schedule.
4
Where a boundary is shown on the map as running along a road, railway line, footway, watercourse or similar geographical feature, it shall be treated as running along the centre line of the feature.
Maps
4
Cambridgeshire County Council shall make a print of the map marked “Map referred to in the County of Cambridgeshire (Electoral Changes) Order 2005” available for inspection at its offices by any member of the public at any reasonable time.
Electoral registers
5
The Electoral Registration Officer for each district or city in the county shall make such rearrangement of, or adaptation of, the register of local government electors as may be necessary for the purposes of, and in consequence of, this Order.
Revocation
6
The County of Cambridgeshire (Electoral Arrangements) Order 1984 is revoked, save for article 5.
Sealed with the seal of the Electoral Commission on the 1st day of February 2005
Sam Younger
Chairman of the Commission
1st February 2005
Peter Wardle
Chief Executive to the Commission
1st February 2005


text:
1
This Order may be cited as the Family Proceedings Fees (Amendment) Order 2005 and shall come into force on 6th April 2005.
2
In article 3(2)(b) of the Family Proceedings Fees Order 2004 , for “£14,600” substitute “£15,050”.
Falconer of Thoroton, C
21st February 2005
We consent
Nick Ainger
Joan Ryan
Two of the Lords Commissioners of Her Majesty’s Treasury
2nd March 2005


text:
Citation, commencement and application
1
1
These Regulations may be cited as the Water Fluoridation (Consultation)(England) Regulations 2005, and shall come into force on 1st April 2005.
2
These Regulations apply in respect of fluoridation arrangements relating to water supplied to premises within an area which is wholly in England other than in a case to which subsection (5)(a) of section 89 of the Act applies.
Interpretation
2
1
In these Regulations —
“the Act” means the Water Industry Act 1991;
“fluoridation arrangements” means arrangements under section 87(1) of the Act ;
“local authority” means a county council, a district council, the Greater London Authority, a London borough council or the Common Council of the City of London;
“house” means any building or part of a building which is occupied as a dwelling-house, whether or not a private dwelling-house, or which, if unoccupied, is likely to be so occupied, and
“Strategic Health Authority” means a Strategic Health Authority established under section 8 of the National Health Service Act 1977 .
2
References to individuals who would be affected by a step concerning fluoridation arrangements are to those individuals who live in the area to which the arrangements relate, or work in that area on a regular basis.
Consultation
3
1
In order to consult and ascertain opinion before taking any step concerning fluoridation arrangements that falls within section 89(2) of the Act, a Strategic Health Authority shall —
a
publish details of the step they propose to take, and the manner in which individuals who would be affected by it and bodies with an interest can make representations regarding the proposal —
i
in one or more newspapers circulating within the area to which the arrangements relate and
ii
in such other media accessible within that area as the Authority consider appropriate for the purpose of bringing the proposal to the attention of individuals affected and bodies with an interest;
b
give notice of the proposal to every local authority whose area falls wholly or partly within the area to which the arrangements relate.
2
The details published under paragraph (1)(a) shall include —
a
the nature of the step the Authority propose to take;
b
the reasons for the proposal;
c
the area affected by the proposal, and
d
the period, being a period of not less than 3 months from the date on which the details are first published, within which representations can be made to the Authority.
Particular circumstances in which consultation is required
4
1
Requesting a water undertaker to vary fluoridation arrangements is a step falling within section 89(2) of the Act if —
a
the variation concerns the boundary of the area to which the arrangements relate, and
b
the number of houses that would be affected by the variation, either by being brought within the area or by being excluded from it, exceeds 20% of the number of houses within the area at the time that the request is made.
2
Maintaining fluoridation arrangements is a step falling within section 89(2) of the Act if it involves the upgrading or replacement of fluoridation plant, otherwise than for the purpose of meeting operational or health and safety standards.
Outcome of consultation
5
A Strategic Health Authority shall not proceed with any step regarding fluoridation arrangements that falls within section 89(2) of the Act unless, having regard to the extent of support for the proposal and the cogency of the arguments advanced, the Authority are satisfied that the health arguments in favour of proceeding with the proposal outweigh all arguments against proceeding.
Signed by authority of the Secretary of State for Health
Melanie Johnson
Parliamentary Under Secretary of State,
Department of Health
24th March 2005


text:
Citation
1
This Order may be cited as the Tax Information Exchange Agreement (Taxes on Income) (Isle of Man) Order 2005.
Declaration about exchange of information
2
1
It is declared that the arrangements specified in the Agreement set out in Part I of the Schedule to this Order, and the Exchange of Notes constituting an Agreement set out in Part II of that Schedule have been made with the Government of the Isle of Man with a view to the exchange of information foreseeably relevant to the administration or enforcement of —
a
the domestic laws of the United Kingdom concerning income tax, capital gains tax and corporation tax; and
b
the laws of the Isle of Man concerning taxes imposed by the Isle of Man which are of a similar character to any of those taxes.
2
It is further declared that it is expedient that the arrangements referred to in paragraph (1) should have effect.
A. K. Galloway
Clerk of the Privy Council


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the General and Specialist Medical Practice (Education, Training and Qualifications) Transitional Provisions Order 2005 and shall come into force on 30th September 2005.
2
In this Order —
“ the Order ” means the General and Specialist Medical Practice (Education, Training and Qualifications) Order 2003;
“performers list” means a medical performers list, a primary medical services performers list or a primary medical services performers list (Scotland); and
“primary care organisation” means —
in England, a Primary Care Trust;
in Wales, a Local Health Board
in Scotland, a Health Board; and
in Northern Ireland, a Health and Social Services Board.
Article 16 of the Order
2
1
Until the coming into force of article 16 of the Order (decisions on inclusion in the Registers) in relation to general practitioners, paragraphs (2) and (3) shall apply in respect of decisions made by the Board under article 11(3) of the Order (general practitioners eligible for entry in the General Practitioner Register).
2
The Board shall, within the time specified in paragraph (3), notify a person who has made an application to the Board under article 11(3) of the Order of the Board’s decision as to whether it is satisfied that the person is an eligible general practitioner.
3
The specified time for the purposes of paragraph (2) is —
a
the period of three months beginning with the date on which the Board receives the application with full supporting documentation; or
b
any additional time which is permitted by article 15 of the Directive.
The General Practitioner Register
3
1
Where a general practitioner is included in the performers list of a primary care organisation at any time between the coming into force of this Order and 1st April 2006, the GMC may include his name in the General Practitioner Register from 1st April 2006 if the GMC is satisfied that —
a
by virtue of information it has requested of, and received from, the primary care organisation in whose performers list that general practitioner is included, the general practitioner is eligible to be included in the General Practitioner Register by virtue of article 10(2) of the Order; and
b
he is a registered medical practitioner,
unless the general practitioner has, prior to 1st April 2006, notified the GMC in writing that he does not wish his name to be so included.
2
Paragraph (1) shall only apply in relation to a general practitioner whom the GMC proposes to include in the General Practitioner Register pursuant to that paragraph if the GMC has sent a written request to him to confirm that the information it has obtained by virtue of paragraph (1)(a) in respect of that practitioner is accurate.
3
Where a primary care organisation receives a request for information from the GMC in relation to general practitioners included in its performers list for the purpose of paragraph (1), it shall, unless it has good reason for not doing so, supply the information requested.
Caroline Flint
Parliamentary Under Secretary of State,
Department of Health
24th August 2005


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Occupational Pension Schemes (Employer Debt etc.) (Amendment) Regulations 2005.
2
These Regulations come into force on 2nd September 2005.
3
Regulation 2(1), (2)(c), (3) and (5) does not apply if the employment-cessation event occurs before that date.
4
Regulation 4(2) does not apply if the applicable time is before that date.
5
In these Regulations —
“the 2004 Act ” means the Pensions Act 2004;
“the 2005 Regulations ” means the Occupational Pension Schemes (Employer Debt) Regulations 2005 ;
“the applicable time” has the meaning given in regulation 2(1) of the 2005 Regulations (interpretation);
“employment-cessation event” has the meaning given in regulation 6(4) of the 2005 Regulations (multi-employer schemes: general).
Multi-employer schemes: employment-cessation events and withdrawal arrangements etc.
2
1
At the end of regulation 2(1) of the 2005 Regulations (interpretation) add —
“withdrawal arrangement” and “approved withdrawal arrangement” are to be read in accordance with paragraph 1(1) of Schedule 1A to these Regulations.
.
2
In regulation 5 of the 2005 Regulations (calculation of the value of scheme liabilities and assets: defined benefit schemes) —
a
in paragraph (1)(c) after “paragraphs (2), (3),” insert “(3A),”;
b
after paragraph (3) insert —
3A
If the modification specified in regulation 7(3) has applied in the case of an employment-cessation event that occurred in relation to an employer before the applicable time —
a
the liabilities of the scheme that are attributable to employment with that employer, and
b
the debts treated as due under section 75(4) of the 1995 Act in accordance with that modification,
are not to be taken into account under paragraph (1).
;
c
in paragraph (8) for “valuations for employment cessation events” substitute “employment-cessation events and withdrawal arrangements”.
3
For regulation 7 of the 2005 Regulations (multi-employer schemes: valuations for employment cessation events) substitute —
Multi-employer schemes: employment-cessation events and withdrawal arrangements
7
1
This regulation applies where —
a
section 75 of the 1995 Act applies to a trust scheme with the modifications referred to in regulation 6 (multi-employer schemes: general); and
b
as a result of the occurrence of an employment-cessation event in relation to an employer, a debt (“the cessation debt”) calculated on the basis of assets and liabilities valued in accordance with regulation 5 is treated as due from the employer (“the cessation employer”) under section 75(4) of that Act.
2
If the cessation employer notifies the Authority in writing that he proposes to enter into a withdrawal arrangement —
a
the Authority may issue a direction that the cessation debt is to be unenforceable for such period as the Authority may specify in the direction, and where such a direction has been issued the debt is unenforceable for that period; and
b
the Authority may issue a direction that if an approved withdrawal arrangement has come into force within that period, section 75 of the 1995 Act is to apply in the case of the employment-cessation event with the modification specified in paragraph (3) instead of the modification referred to in regulation 6(1)(e)(ii), and where such a direction has been issued and such an arrangement has so come into force, that modification so applies.
3
The modification is that section 75 of the 1995 Act has effect as if the reference in section 75(4) to an amount equal to the difference being treated as a debt due from the employer were a reference to —
a
amount A being treated as a debt due from the employer; and
b
unless and until the Authority issue a direction that it is not to be so treated, amount B being treated as a debt due from the guarantors at the guarantee time for which (if there is more than one guarantor) they are jointly or, if the approved withdrawal arrangement so provides, jointly and severally liable,
where amount A is calculated in accordance with regulation 7A and amount B is calculated in accordance with regulation 7B.
4
In this regulation —
“the guarantee time” means the earliest time when an event specified in paragraph 1(3) of Schedule 1A to these Regulations occurs; and
“the guarantors” means such one or more of the parties to the approved withdrawal arrangement as are specified in the arrangement as the persons who are the guarantors for the purposes of this regulation.
5
The Authority may issue a direction extending the period mentioned in paragraph (2)(a) by such further period as they may specify (so that the debt is unenforceable for the extended period).
6
The Authority may only issue a direction under paragraph (3)(b) —
a
before the guarantee time, and
b
if the Authority consider that the approved withdrawal arrangement is no longer required.
7
Schedule 1A to these Regulations applies for the purpose of making further provision in cases where this regulation applies; and in that Schedule and regulations 7A and 7B “the cessation employer” has the same meaning as in this regulation.
Calculation of amounts due from cessation employer by virtue of regulation 7
7A
1
For the purposes of regulation 7(3), amount A depends on whether or not a debt (a “scheme funding basis debt”) would have been treated as due from the cessation employer under section 75(4) of the 1995 Act if —
a
regulation 5 had applied with the modifications specified in paragraph (4); and
b
section 75(4) had applied in accordance with regulation 6(1)(d) and (e) but subject to the modifications of regulation 6 specified in paragraph (5) (instead of in accordance with the modification specified in regulation 7(3)).
2
If a debt would have been so treated, amount A is the sum of the scheme funding basis debt and the cessation expenses attributable to the employer.
3
If a debt would not have been so treated, amount A is equal to the amount of the cessation expenses attributable to the employer.
4
The modifications of regulation 5 are that —
a
paragraphs (1)(a) and (2) and the references to those provisions in paragraph (1)(b), (c) and (d) (by virtue of which liabilities for pensions and other benefits are to be valued on the assumption that they will be discharged by the purchase of annuities) are omitted;
b
paragraph (3) and the references to that paragraph in paragraph (1)(c) and (d) (by virtue of which winding up expenses are to be taken into account) are omitted; and
c
in paragraph (5) for the words “for the purposes of section 75(2) and (4) of the 1995 Act” there are substituted the words “for the purposes of section 75(2) of the 1995 Act and for the purposes of section 75(4) of the 1995 Act where no approved withdrawal arrangement has been entered into by the employer”.
5
The modifications of regulation 6 are that —
a
for paragraph (ii) of paragraph (1)(e) there is substituted —
ii
in a case where the difference is ascertained immediately before an employment-cessation event occurs in relation to the employer, a reference to an amount equal to the employer’s share of the difference, less the relevant transferred liabilities deduction, being treated as a debt due from the employer;
;
b
after paragraph (5) there is added —
6
In this regulation “the relevant transferred liabilities deduction” means the amount of any relevant transferred liabilities, less the value of the corresponding assets.
7
For the purposes of paragraph (6) —
a
“corresponding assets”, in relation to relevant transferred liabilities, means the assets transferred from the scheme in connection with the transfer from the scheme of those liabilities; and
b
the value of the corresponding assets is to be determined —
i
in the case of corresponding assets that are assets of the scheme at the applicable time, as at that time; and
ii
in the case of corresponding assets that are not assets of the scheme at that time, as at the date of the transfer of the assets.
8
For the purposes of paragraph (6) —
a
“relevant transferred liabilities” means liabilities in respect of members —
i
which are transferred from the scheme in circumstances where the conditions set out in paragraphs (2)(a) or (b) and (3) of regulation 12 of the Occupational Pension Schemes (Preservation of Benefit) Regulations 1991 (transfer without consent) are met;
ii
which are so transferred during the period beginning with the applicable time and ending with the date on which the approved withdrawal arrangement is approved (“the relevant period”);
iii
the transfer of which reduces the amount of the scheme’s liabilities attributable to employment with the employer in relation to whom the employment-cessation event has occurred; and
iv
in connection with the transfer of which there is a transfer of corresponding assets during the relevant period; and
b
the amount of the relevant transferred liabilities is to be calculated in accordance with regulation 5 as modified by regulation 7A(4).
.
6
The value of the assets and the amount of the liabilities of a scheme which are to be taken into account for the purposes of determining whether a scheme funding basis debt would have been treated as due as mentioned in paragraph (1) must be certified by the actuary in the form set out in Schedule 1B to these Regulations, but —
a
if the actuary is of the opinion that the value of the assets of the scheme was not less than the amount of the liabilities of the scheme —
i
substituting in the first sentence of the comparison of value of scheme assets with amount of scheme liabilities for the words “was less” the words “was not less”; and
ii
omitting the last sentence of that comparison; and
b
if the scheme is being wound up on the date as at which the valuation is made, omitting from the Note the words from “if the scheme” onwards.
7
In this regulation “the cessation expenses attributable to the employer” has the meaning given by regulation 6(5).
Calculation of amounts due from guarantors by virtue of regulation 7
7B
1
For the purposes of regulation 7(3), amount B depends on whether the approved withdrawal arrangement provides for amount B to be the amount provided for under paragraph (2).
2
If the approved withdrawal arrangement so provides, amount B is equal to the amount (if any) that would be the amount of the debt due from the cessation employer under section 75(4) of the 1995 Act if —
a
the employment-cessation event had occurred at the guarantee time;
b
the cessation employer had not entered into an approved withdrawal arrangement; and
c
there were no cessation expenses attributable to the employer.
3
If the approved withdrawal arrangement does not provide for amount B to be the amount provided for under paragraph (2), amount B is equal to the amount that would be the amount treated as due from the cessation employer under section 75(4) of the 1995 Act if the cessation employer had not entered into an approved withdrawal arrangement, less the sum of —
a
the amount that is amount A for the purposes of regulation 7(3);
b
if the amount that the approved withdrawal arrangement provides for the cessation employer to pay exceeds that amount, an amount equal to the excess; and
c
the relevant transferred liabilities deduction.
4
The value of the assets and the amount of the liabilities of a scheme which are to be taken into account for the purposes of determining the amount (if any) that would be the amount of the debt due from the cessation employer under section 75(4) of the 1995 Act in the case mentioned in paragraph (2) must be certified by the actuary in the form set out in Schedule 1 to these Regulations, but —
a
substituting for the reference to regulation 5 a reference to paragraph (2) of this regulation;
b
if the actuary is of the opinion that the value of the assets of the scheme was not less than the amount of the liabilities of the scheme —
i
substituting in the first sentence of the comparison of value of scheme assets with amount of scheme liabilities for the words “was less” the words “was not less”; and
ii
omitting the last sentence of that comparison; and
c
if the scheme is being wound up on the date as at which the valuation is made, omitting from the Note the words from “if the scheme” onwards.
5
In this regulation —
“the cessation expenses attributable to the employer” has the meaning given by regulation 6(5); and
“the relevant transferred liabilities deduction” has the meaning given by regulation 6(6), as inserted by the modification of regulation 6 made by regulation 7A(5)(b), except that for the purposes of this regulation the amount of the relevant transferred liabilities is to be calculated in accordance with regulation 5 without the modifications made by regulation 7A(4).
.
4
In regulation 9 of the 2005 Regulations (former employers) —
a
in paragraph (2)(b)(ii) for “condition A, B” substitute “condition A, B, BB”;
b
after paragraph (4) insert —
4A
Condition BB is that such a debt was treated as becoming due from him, the modification in regulation 7(3) applied, and the amount treated as becoming due from him under regulation 7(3)(a) has been paid before the applicable time.
.
5
The Schedules set out in the Schedule to these Regulations are inserted after Schedule 1 to the 2005 Regulations.
The Pensions Regulator’s functions under the 2005 Regulations
3
1
The following functions under the 2005 Regulations are regulatory functions for the purposes of Part 1 of the 2004 Act —
a
the power to issue directions under regulation 7;
b
the power to issue a notice under paragraph 1(3)(c) of Schedule 1A; and
c
the power to issue a notice under paragraph 2 of Schedule 1A.
2
The Pensions Regulator may, if it thinks fit, delegate the functions specified in paragraph (1) to the Determinations Panel established under section 9 of the 2004 Act (the Determinations Panel).
Minor amendments of the 2005 Regulations
4
1
In regulation 4(1) of the 2005 Regulations (schemes to which section 75 of the 1995 Act does not apply) omit sub-paragraph (l) (the scheme established by the Salvation Army Act 1963 ).
2
In regulation 10 of the 2005 Regulations (money purchase schemes: fraud and levy deficiencies etc.), as it applies by virtue of regulation 12 of those Regulations (multi-employer money purchase schemes), in paragraph (1A)(a) (under which, unless the scheme makes contrary provision, an employer’s share of the levy deficit or the criminal deficit is such proportion of the total deficit as, in the opinion of the actuary, the amount of the scheme’s liabilities attributable to employment with that employer bears to the total amount of the scheme’s liabilities attributable to employment with the employers) for “the actuary” substitute “the trustees or managers”.
3
In paragraph 2 of Schedule 2 to the 2005 Regulations (consequential amendment of the Occupational Pension Schemes (Winding Up) Regulations 1996 ) for “the Occupational Pension Schemes Winding Up Regulations 1996” substitute “the Occupational Pension Schemes (Winding Up) Regulations 1996”.
Consequential amendments of the Pensions Regulator (Financial Support Directions etc.) Regulations 2005
5
In regulation 15(2) of the Pensions Regulator (Financial Support Directions etc.) Regulations 2005 (former employers) —
a
for “condition A, B” substitute “condition A, AA, B”; and
b
after sub-paragraph (a) insert —
aa
condition AA is that —
i
such a debt became due;
ii
the modification in regulation 7(3) of the Occupational Pension Schemes (Employer Debt) Regulations 2005 (multi-employer schemes: employment-cessation events and withdrawal arrangements) applied, and
iii
the amount treated as becoming due from him under regulation 7(3)(a) of those Regulations has been paid;
.
Amendment of the Occupational Pension Schemes (Minimum Funding Requirement and Actuarial Valuations) Regulations 1996
6
In regulation 6(1)(b) of the Occupational Pension Schemes (Minimum Funding Requirement and Actuarial Valuations) Regulations 1996 (excluded assets) for “60(5) or 75(1)” substitute “or 60(5) or under section 75(1), as it has effect before 6th April 2005, or under section 75(2) or (4), as it has effect on or after that date”.
Amendment of the Pension Protection Fund (Entry Rules) Regulations 2005
7
In regulation 16(1)(a)(ii) of the Pension Protection Fund (Entry Rules) Regulations 2005 (restrictions on winding up, discharge of liabilities etc.) for “section 94(1)(a)” substitute “section 94(1)(aa)” .
David Blunkett
Secretary of State for Work and Pensions
9th August 2005


text:
Title, commencement and application
1
1
These Regulations may be cited as the Common Agricultural Policy Single Payment and Support Schemes Regulations 2005, shall come onto force on 1 st March 2005 and, subject to paragraph (2), shall apply to England only.
2
Regulations 12(3) and 15(1), (2), (6), (7) and, in so far as it relates to paragraph (6) of regulation 15, (8) shall apply to the United Kingdom.
Interpretation
2
1
In these Regulations —
“ Commission Regulation 795/2004 ” means Commission Regulation ( EC ) No. 795/2004 laying down detailed rules for the implementation of the single payment scheme provided for in Council Regulation (EC) No. 1782/2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers ;
“ Commission Regulation 796/2004 ” means Commission Regulation (EC) No. 796/2004 laying down detailed rules for the implementation of cross-compliance, modulation and the integrated administration and control system provided for in the Council Regulation ;
“ Commission Regulation 1973/2004 ” means Commission Regulation (EC) No. 1973/2004 laying down detailed rules for the application of Council Regulation (EC) No. 1782/2003 as regards the support schemes provided for in Titles IV and IVa of that Regulation and the use of land set aside for the production of raw materials ;
“Council Regulation” means Council Regulation (EC) No. 1782/2003 establishing common rules for direct support under the common agricultural policy and establishing certain support schemes for farmers ;
“direct payment” has the meaning given to it in Article 2(d) of the Council Regulation;
“farmer” has the meaning given to it in Article 2(a) of the Council Regulation;
“holding” has the meaning given to it in Article 2(b) of the Council Regulation;
“ IACS Regulations ” means the Common Agricultural Policy Single Payment and Support Schemes (Integrated Administration and Control System) Regulations 2005 ;
“moorland” means all the land that is both —
in the severely disadvantaged area, and
shown coloured pink in the three volumes of maps entitled “Moorland Map of England 1992” each volume being marked with the number of the volume, dated 20th February 2001, signed on behalf of the Minister of Agriculture, Fisheries and Food and deposited at the offices of the Department for Environment, Food and Rural Affairs at Ergon House, Horseferry Road, London SW1P 2AL;
“relevant competent authority” has the meaning given to it in regulation 5 of the IACS Regulations;
“single application” has the meaning given to it in Article 2(11) of Commission Regulation 796/2004;
“single payment scheme” means the support scheme established under Title III of the Council Regulation;
“the severely disadvantaged area” means all the land, excluding the Isles of Scilly, shown coloured pink in the three volumes of maps entitled “Volume of maps of less- favoured areas in England”, each volume being marked with the number of the volume, dated 20th May 1991, signed and sealed by the Minister of Agriculture, Fisheries and Food and deposited at the offices of the Department for Environment, Food and Rural Affairs at Ergon House, Horseferry Road, London SW1P 2AL.
2
Other expressions used in these Regulations shall be construed in accordance with the Council Regulation, Commission Regulation 795/2004, Commission Regulation 796/2004 and Commission Regulation 1973/2004.
3
Any reference in these Regulations to a Community instrument is a reference to that instrument as amended on the date these Regulations are made.
Regions
3
In accordance with Article 58 of the Council Regulation, there shall be three regions in England and they shall be —
a
moorland;
b
the severely disadvantaged area, excluding moorland; and
c
all other land.
Applications
4
The Secretary of State is the competent authority for the purposes of Article 34(1) of the Council Regulation (which requires the competent authority to send application forms to farmers).
Minimum size of holding
5
For the purposes of Article 12(6) of Commission Regulation 795/2004, the minimum size of a holding for which the establishment of payment entitlements may be requested shall be 0.3 hectares.
10 month period
6
For the purposes of Article 24(2) of Commission Regulation 795/2004, a farmer shall choose a date for the beginning of the 10 month period referred to in Article 44(3) of the Council Regulation within a period beginning on 1st October of the calendar year of the year preceding the year of submitting an application under the single payment scheme and ending on 30th April of the year of application.
Dairy premium and additional payments
7
In accordance with Article 62 of the Council Regulation the amounts resulting from dairy premium and additional payments, provided for in Articles 95 and 96 of the Council Regulation, shall be included at a regional level, in full, in the single payment scheme starting in 2005.
Progressive modifications of entitlements
8
1
For the purposes of Article 63(3) of the Council Regulation entitlements established in accordance with Article 59(3) of that Regulation shall be subject to progressive modifications in accordance with this regulation and Schedule 1.
2
Subject to the provisions of Article 41 of the Council Regulation (which relates to the national ceiling for reference amounts), the unit value of the farmer’s entitlement, in each year specified in column 1 of Schedule 1, is the sum of the relevant proportions in column 2 and column 3 of Schedule 1 where —
a
column 2 is the proportion of the farmer’s entitlement consisting of the regional unit value of the entitlement calculated in accordance with Article 59(3) first sub-paragraph of the Council Regulation; and
b
column 3 is the proportion of the farmer’s entitlement consisting of the farmer’s reference amounts where he is entitled to receive entitlements calculated in accordance with Article 59(3) second sub-paragraph of the Council Regulation.
Horticulture
9
1
Subject to paragraph (2), in accordance with Article 51(b) second paragraph of the Council Regulation, secondary crops may be cultivated on the eligible hectares during a period of not more than three months beginning each year on 15 th August.
2
Paragraph (1) shall not apply to the year beginning on 1 st January 2005.
Transfers
10
For the purposes of Article 25(3) of Commission Regulation 795/2004, a transferor of a payment entitlement shall communicate the transfer to the relevant competent authority responsible for determining the particular single application in question and shall do so —
a
no later than six weeks before the transfer is to take place; and
b
no later than six weeks before the last day for submission of the single application.
Additional modulation
11
1
For the purposes of calculating the total amount of direct payments to be paid to a farmer for any year, the Secretary of State shall deduct a sum equal to the specified proportion of the relevant amount and shall apply the sum so deducted by way of funds for one or more of the relevant purposes .
2
In this regulation —
“the relevant amount” means the amount which would have been granted to the farmer in respect of the year concerned but for the application of Article 10(1) of the Council Regulation;
“the relevant purposes” means the purposes of any payment made pursuant to any measure which implements any provision of Articles 10 to 12 inclusive (early retirement), 13 to 21 inclusive (less-favoured areas and areas with environmental restrictions), 21a to 21d inclusive (meeting standards), 22 to 24 inclusive (agri-environment and animal welfare), 24a to 24d inclusive (food quality) and 31 (afforestation) of Council Regulation (EC) No. 1257/1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund ;
“the specified proportion” means —
in respect of 2005, 2%, and
in respect of 2006, 6%.
Aid for energy crops
12
1
Regulations 13 and 14 apply where an applicant uses areas covered by the aid provided for in Article 88 of the Council Regulation for the growing of agricultural raw materials under Article 24 of Commission Regulation 1973/2004 and references to raw materials shall be construed accordingly.
2
Subject to paragraph (3), the Secretary of State is the competent authority for the purposes of Chapter 8 of Commission Regulation 1973/2004 (Aid for energy crops).
3
In the case of an applicant the competent authority shall be the relevant competent authority responsible for determining the particular single application in question.
4
In this regulation “applicant” has the meaning given to it in Article 23 of Commission Regulation 1973/2004.
Provisions relating to raw material
13
1
For the purposes of Article 43(2) of Commission Regulation 1973/2004, the minimum cultivated area for any raw material referred to in Article 24 of that Regulation shall be 0.1 hectares.
2
Where the Secretary of State excludes any agricultural raw material from aid for energy crops in accordance with Article 43(1) of Commission Regulation 1973/2004, the Secretary of State must notify the farmers concerned stating, with reasons, the details and duration of the exclusion.
3
Raw materials to which Article 25(2)(b) of Commission Regulation 1973/2004 applies shall be weighed by an operator of public weighing equipment holding a certificate issued under section 18 of the Weights and Measures Act 1985 .
4
For the purposes of Article 25(4) of Commission Regulation 1973/2004, cereals, oilseeds and oil produced by processing oilseeds, to which that paragraph applies, shall be denatured by dying them with a brightly coloured dye.
5
For the purposes of Article 34(1) of Commission Regulation 1973/2004, the last day on which a contract to which that paragraph applies may be deposited with the Secretary of State shall be the last day for submission of the relevant single application.
6
For the purposes of Article 34(3) of Commission Regulation 1973/2004, the last day on which a first processor to whom that paragraph applies may provide the Secretary of State with the information specified in that paragraph shall be the 9 th February of the year following the year in which the relevant single application is made.
7
In this regulation —
a
“relevant single application” means the single application in which aid for energy crops is being claimed on the areas used for the growing of agricultural raw materials to which the contract referred to in paragraph (5), or the information referred to in paragraph (6), relates (as the case may be); and
b
“first processor” has the meaning given to it in Article 23 of Commission Regulation 1973/2004.
Keeping and retention of records
14
1
For the purposes of Article 39 of Commission Regulation 1973/2004 on any day during which a processor purchases, processes, destroys, sells or otherwise disposes of any raw materials he shall make a record showing (as the case may be) —
a
the quantities of the different raw materials purchased by him for processing;
b
the quantities of raw materials processed by him together with the quantities and types of end products, co-products and by-products obtained from the processing;
c
the quantities of wastage of raw materials during the processing;
d
the quantities of raw materials destroyed together with the reason for such destruction;
e
the quantities and types of products sold or otherwise disposed of by him and the price obtained; and
f
the names and addresses of any subsequent buyers or processors to whom he sells such raw materials or products of processing.
2
A processor shall retain the records referred to in paragraph (1) for four years from —
a
where the records relate to the purchasing, processing, wastage, destruction, sale or other disposal of raw materials, the date on which he purchases, processes, wastes, destroys, sells or otherwise disposes of the raw materials, as the case may be; and
b
where the records relate to the sale or other disposal of products obtained from the processing of raw materials, the date on which such products were sold or otherwise disposed of, as the case may be.
Revocations and savings
15
1
Subject to paragraph (2), the Common Agricultural Policy Support Schemes (Modulation) Regulations 2000 , regulation 7(16) of the Intervention Board for Agricultural Produce (Abolition) Regulations 2001 and the Common Agricultural Policy Support Schemes (Modulation) (Amendment) Regulations 2004 are revoked.
2
The Common Agricultural Policy Support Schemes (Modulation) Regulations 2000 shall continue to apply to direct payments in respect of scheme years which began before 2005.
3
Subject to paragraphs (4) and (5), the Regulations specified in Schedule 2, so far as they apply to England, are revoked to the extent there specified.
4
Regulation 12 of the Arable Area Payments Regulations 1996 (delivery notifications for non-food raw materials) shall continue to apply in respect of farmers, collectors and first processors who make the declaration or provide the information mentioned in that regulation (as the case may be) after the coming into force of these Regulations.
5
Paragraphs (1), (4) and (5) of regulation 14 of the Arable Area Payments Regulations 1996 (keeping and retention of records by a collector and a processor) shall continue to apply in respect of processors who purchased, after the coming into force of these Regulations, Annex I raw materials.
6
Subject to paragraph (8), the Regulations specified in Schedule 3 are revoked to the extent there specified, in so far as the Secretary of State is the relevant competent authority in relation to the holding for the purposes of the IACS Regulations.
7
In this regulation “Annex I raw materials”, “farmer” and “processor” have the meanings given to them in the Arable Area Payments Regulations 1996.
8
The Regulations revoked by paragraphs (3) and (6) shall continue to apply in respect of applications for direct payments in respect of calendar years preceding 2005.
Whitty
Parliamentary Under Secretary of State
Department for Environment, Food and Rural Affairs
1st February 2005


text:
Citation, commencement, application and interpretation
1
1
These Regulations may be cited as the Transfer of Employment (Pension Protection) Regulations 2005 and shall come into force on 6th April 2005.
2
These Regulations apply in the case of a person (“the employee”) in relation to whom section 257 of the Act (conditions for pension protection) applies, that is to say a person who, in the circumstances described in subsection (1) of that section, ceases to be employed by the transferor of an undertaking or part of an undertaking and becomes employed by the transferee.
3
In these Regulations “the Act” means the Pensions Act 2004.
Requirements concerning a transferee’s pension scheme
2
1
In a case where these Regulations apply, and the transferee is the employer in relation to a pension scheme which is not a money purchase scheme, that scheme complies with section 258(2)(c)(ii) of the Act (alternative standard for a scheme which is not a money purchase scheme) if it provides either —
a
for members to be entitled to benefits the value of which equals or exceeds 6 per cent. of pensionable pay for each year of employment together with the total amount of any contributions made by them, and, where members are required to make contributions to the scheme, for them to contribute at a rate which does not exceed 6 per cent. of their pensionable pay; or
b
for the transferee to make relevant contributions to the scheme on behalf of each employee of his who is an active member of it.
2
In this regulation —
“pensionable pay” means that part of the remuneration payable to a member of a scheme by reference to which the amount of contributions and benefits are determined under the rules of the scheme.
Requirements concerning a transferee’s pension contributions
3
1
In a case where these Regulations apply, the transferee’s pension contributions are relevant contributions for the purposes of section 258(2)(b) of the Act in the case of a money purchase scheme, section 258(3) to (5) of the Act in the case of a stakeholder pension scheme, and regulation 2(1)(b) above in the case of a scheme which is not a money purchase scheme, if —
a
the contributions are made in respect of each period for which the employee is paid remuneration, provided that the employee also contributes to the scheme in respect of that period, and
b
the amount contributed in respect of each such period is —
i
in a case where the employee’s contribution in respect of that period is less than 6 per cent. of the remuneration paid to him, an amount at least equal to the amount of the employee’s contribution;
ii
in a case where the employee’s contribution in respect of that period equals or exceeds 6 per cent. of the remuneration paid to him, an amount at least equal to 6 per cent. of that remuneration.
2
In calculating the amount of an employee’s remuneration for the purposes of paragraph (1) —
a
only payments made in respect of basic pay shall be taken into account, and bonus, commission, overtime and similar payments shall be disregarded, and
b
no account shall be taken of any deductions which are made in respect of tax, national insurance or pension contributions.
3
In calculating the amount of a transferee’s pension contributions for the purposes of paragraph (1) in the case of a scheme which is contracted-out by virtue of section 9 of the Pension Schemes Act 1993 , minimum payments within the meaning of that Act shall be disregarded.
Signed by authority of the Secretary of State for Work and Pensions.
Malcolm Wicks
Minister of State,
Department for Work and Pensions
10th March 2005