text:
PART 1
GENERAL
Citation, commencement and application
1
1
These Regulations may be cited as the National Health Service (Personal Dental Services Agreements) Regulations 2005 and shall come into force on 1st January 2006.
2
These Regulations apply in relation to England only .
Interpretation
2
1
In these Regulations —
“ the Act ” means the National Health Service Act 1977;
“the 1990 Act ” means the National Health Service and Community Care Act 1990;
“additional services” means one or more of —
advanced mandatory services;
dental public health services;
domiciliary services;
orthodontic services; and
sedation services;
“adjudicator” means the Secretary of State or a person or persons appointed by the Secretary of State under section 4(5) of the 1990 Act ( NHS contracts) or paragraph 55(4) of Schedule 3 (NHS dispute resolution procedure);
“advanced mandatory services” means any primary dental service that would fall within the services described in regulation 14 of the GDS Contracts Regulations , but by virtue of the high level of facilities, experience or expertise required in respect of a particular patient, is provided as a referral service;
“agreement” means, except where the context otherwise requires, an agreement for primary dental services made under section 28C of the Act;
“Band 1 course of treatment” means a course of treatment, including a course of treatment consisting of urgent treatment, provided to a patient in respect of which a Band 1 NHS Charge is payable pursuant to the NHS Charges Regulations , or would be payable if the patient was not an exempt person;
“Band 2 course of treatment” means a course of treatment provided to a patient in respect of which a Band 2 NHS Charge is payable pursuant to the NHS Charges Regulations, or would be payable if the patient was not an exempt person;
“Band 3 course of treatment” means a course of treatment provided to a patient in respect of which a Band 3 NHS Charge is payable pursuant to the NHS Charges Regulations, or would be payable if the patient was not an exempt person;
“banded course of treatment” means a Band 1, Band 2 or Band 3 course of treatment;
“bank holiday” means any day that is specified or proclaimed as a bank holiday in England pursuant to section 1 of the Banking and Financial Dealings Act 1971 ;
“bridge” means a fixed or removable bridge which takes the place of any teeth;
“case assessment”, in respect of an orthodontic course of treatment, means a clinical examination of the patient, including the taking of such radiographs, colour photographs and models as are required in order to determine what orthodontic treatment (if any) is to be provided to the patient;
“charge exempt course of treatment” means a course of treatment that involves the examination and assessment of a patient leading to —
the issue of a prescription;
the repair of a dental appliance;
the arrest of bleeding; or
the removal of sutures,
which, by virtue of regulation 3(2)(d) or (e) of the NHS Charges Regulations, is provided free of charge to the patient;
“charity trustee” means one of the persons having the general control and management of the administration of a charity;
“child” means a person who has not attained the age of 16 years;
“complete”, in relation to —
a course of treatment, means that —
where no treatment plan has to be provided in respect of a course of treatment pursuant to paragraph 8(5) of Schedule 3 (treatment plans), all the treatment recommended to, and agreed with, the patient by the contractor at the initial examination and assessment of that patient has been provided to the patient; or
where a treatment plan has to be provided to the patient pursuant to paragraph 8(1) of Schedule 3, all the treatment specified on that plan by the contractor (or that plan as revised in accordance with paragraph 8(3) of that Schedule) has been provided to the patient; and
an orthodontic course of treatment, means that —
where the contractor determines in accordance with paragraph 4 of Schedule 1 (patients to whom orthodontic treatment may be provided) that no orthodontic treatment should be provided following the case assessment, the completion of the case assessment; or
where the contractor has determined that orthodontic treatment should be provided following the case assessment, all of the orthodontic treatment specified on the orthodontic treatment plan by the contractor pursuant to paragraph 6 of Schedule 1 (orthodontic treatment plans) (or that plan as revised in accordance with paragraph 6(3) of that Schedule) has been provided to the patient,
and “completed” shall be construed accordingly;
“contractor” means, except where the context otherwise requires —
where a Primary Care Trust is not providing services under the agreement, a person or persons other than a Primary Care Trust, who is a party, or are parties, to the agreement; or
where a Primary Care Trust is providing services under the agreement, that Primary Care Trust and any other person or persons (other than a Strategic Health Authority) who is a party, or are parties, to the agreement;
“course of treatment” means —
an examination of a patient, an assessment of his oral health, and the planning of any treatment to be provided to that patient as a result of that examination and assessment; and
the provision of any planned treatment (including any treatment planned at a time other than the time of the initial examination) to that patient,
provided by, except where expressly provided otherwise, one or more providers of primary dental services, but it does not include the provision of any orthodontic services or dental public health services;
“dental appliance” means a denture or bridge and for the purposes of this definition, a denture includes an obturator;
“dental care professional” means a person whose name is included in the register of dental care professionals or on the appropriate roll for dental auxiliaries established in accordance with Part II of the Dental Auxiliaries Regulations 1986 ;
“dental performers list” means a list of dental practitioners prepared in accordance with regulations made under section 28X of the Act (persons performing primary medical and dental services);
“dental public health services” means services provided by the contractor by virtue of section 16CB(4)(c) of the Act (dental public health);
“ Dentists Act ” means the Dentists Act 1984 ;
“ Dentists Act Order ” means the Dentists Act 1984 (Amendment) Order 2005 ;
“Dentists Register” means the register maintained by the General Dental Council pursuant to section 14 of the Dentists Act (the dentists register and the registrar);
“domiciliary services” means a course of treatment, or part of a course of treatment, provided at a location other than —
the practice premises of any provider of primary dental services;
a mobile surgery of any provider of primary dental services; or
a prison;
“exempt person” means a person who is, by virtue of either Schedule 12ZA to the Act (dental charging: exemptions) or the NHS Charges Regulations, exempt from the need to pay an NHS Charge in respect of the services he has received under the agreement;
“family member” means —
a spouse;
a civil partner;
a person whose relationship with the registered patient has the characteristics of the relationship between husband and wife, or civil partners;
a parent or step-parent;
a son;
a daughter;
a child of whom the person is —
the guardian; or
the carer duly authorised by the local authority to whose care the child has been committed under the Children Act 1989 ; or
a grandparent;
“ FHSAA ” means the Family Health Services Appeal Authority constituted under section 49S of the Act (the Family Health Services Appeal Authority);
“financial year” means the period of 12 months ending with 31st March in any year;
“GDS Contracts Regulations” means the National Health Service (General Dental Services Contracts) Regulations 2005 ;
“health care professional” has the same meaning as in section 28M of the Act (persons eligible to enter into GDS contracts) and “health care profession” shall be construed accordingly;
“health service body” has, unless the context otherwise requires, the meaning given to it in section 4(2) of the 1990 Act (NHS contracts);
“licensing body” means any body that licenses or regulates any profession;
“listed”, in relation to drugs, medicines or appliances, means such drugs, medicines or appliances as are included in a list for the time being approved by the Secretary of State for the purposes of section 41(1)(c) of the Act (arrangements for pharmaceutical services);
“mandatory services” means the services described in regulation 14 of the GDS Contracts Regulations;
“mobile surgery”, except where expressly provided otherwise in these Regulations, means any vehicle in which services under the agreement are to be provided;
“national disqualification” means —
a decision made by the FHSAA under section 49N or under regulations corresponding to that section made under section 28X(4) of the Act (national disqualifications);
a decision under provisions in force in Scotland or Northern Ireland corresponding to section 49N of the Act; or
a decision by the NHS Tribunal which is treated as a national disqualification by the FHSAA by virtue of regulation 6(4)(b) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2001 or regulation 6(4)(b) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002 ;
“NHS Charge” means a charge made to the patient for provision of services pursuant to the NHS Charges Regulations;
“NHS Charges Regulations” means the National Health Service (Dental Charges) Regulations 2005 ;
“NHS contract” has the meaning assigned to it in section 4 of the 1990 Act;
“NHS dispute resolution procedure” means the procedure for disputes specified in paragraphs 55 and 56 of Schedule 3;
“NHS Tribunal” means the Tribunal constituted under section 46 of the Act for England and Wales, and which, except for prescribed cases, had effect in relation to England only until 14th December 2001 and in relation to Wales only until 26th August 2002 ;
“normal surgery hours” means the times at which the contractor has agreed with the Relevant Body (and specified in the agreement) that the surgery will be open to patients for the provision of services;
“ NPSA ” means the National Patient Safety Agency established as a Special Health Authority by the National Patient Safety Agency (Establishment and Constitution) Order 2001 ;
“orthodontic appliance” means a device used in the mouth to move or immobilise the teeth in order to correct or prevent malocclusion;
“orthodontic course of treatment” means —
a case assessment of a patient; and
the provision of any orthodontic treatment that the contractor determines should be provided to the patient in accordance with Part 2 of Schedule 1 (orthodontic services);
“orthodontic services” means the provision of orthodontic courses of treatment or the services referred to in paragraph 5(2) of Schedule 1 (repairs);
“orthodontic treatment” means treatment of, or treatment to prevent, malocclusion of the teeth and jaws, and irregularities of the teeth;
“parent”, in relation to any child, means a parent or other person who has parental responsibility for that child;
“patient” means, unless the context otherwise requires, a person to whom the contractor is providing services under the agreement;
“patient record” means a form supplied by a Relevant Body for the purpose of maintaining a record of treatment, and may include an electronic form;
“practice premises”, except where expressly provided otherwise in these Regulations, means an address specified in the agreement as one at which services are to be provided under the agreement but does not include a mobile surgery;
“prescriber” means a dental practitioner who is either engaged or employed by the contractor or is a party to the agreement;
“primary care list” means —
a list of persons performing primary medical or dental services under section 28X of the Act ;
a list of persons undertaking to provide general ophthalmic services or, as the case may be, pharmaceutical services prepared in accordance with regulations made under section 39, 42 or 43 of the Act ;
a list of persons approved for the purposes of assisting in the provision of any services mentioned in paragraph (b) or (d) prepared in accordance with regulations made under section 43D of the Act ;
a list of persons who undertook to provide general medical services or general dental services prepared in accordance with regulations made under sections 29 or 35 of the Act ;
a services list which fell within the meaning of section 8ZA of the National Health Service (Primary Care) Act 1997 ;
a list corresponding to a services list prepared by virtue of regulations made under section 41 of the Health and Social Care Act 2001 ; or
a list corresponding to any of the above lists in Scotland or Northern Ireland;
“Primary Care Trust” means, except where the context otherwise requires, the Primary Care Trust which is a party, or prospective party, to an agreement;
“prison” includes a young offender institution but not a secure training centre or a naval, military or air force prison, and for the purposes of this definition —
“secure training centre” means a place in which offenders subject to detention and training orders under section 100 of the Powers of Criminal Courts (Sentencing) Act 2000 (offenders under 18: detention and training orders) may be detained and given training and education and prepared for their release; and
“young offender institution” means a place for the detention of offenders sentenced to detention in a young offender institution or to detention in a young offender institution as part of a longer custodial sentence, including custody for life;
“private”, in the context of services or treatment, means otherwise than under the agreement or Part 1 of the Act, and “privately” shall be construed accordingly;
“professional registration number” means the number against a dental practitioner’s name in the Dentists Register;
“referral notice” means the notice referred to in paragraph 10(2)(a) of Schedule 3 (referral to another contractor, a hospital or other relevant service provider for advanced mandatory, domiciliary or sedation services);
“referral service” means one or more of advanced mandatory services, domiciliary services or sedation services provided by the contractor to a patient who has, during a course of treatment, been referred to the contractor by —
another contractor; or
another provider of primary dental services under Part 1 of the Act,
for the provision of one or more of those services as part of that course of treatment;
“referral treatment plan” means a treatment plan provided pursuant to paragraph 2(1) of Schedule 1 or that plan as varied in accordance with paragraph 2(2) of that Schedule;
“register of dental care professionals” means the register maintained by the General Dental Council under section 36B of the Dentists Act (the dental care professionals register);
“Relevant Body” means —
in a case where a contractor is a party to an agreement with a Primary Care Trust, that Primary Care Trust; and
in a case where a contractor is a party to an agreement with a Strategic Health Authority, that Strategic Health Authority;
“relevant Strategic Health Authority” means the Strategic Health Authority established for an area which includes the area for which the Primary Care Trust is established;
“sedation services” means a course of treatment provided to a patient during which the contractor administers one or more drugs to a patient, which produce a state of depression of the central nervous system to enable treatment to be carried out, and during and in respect of that period of sedation —
the drugs and techniques used to provide the sedation are deployed by the contractor in a manner that ensures loss of consciousness is rendered unlikely; and
verbal contact with the patient is maintained in so far as is reasonably possible;
“trauma” means damage to teeth, gingival tissues or alveoli caused by a force arising outside the mouth, resulting in mobility, luxation, subluxation or fracture of the hard tissues or injury to the soft tissues;
“unit of dental activity” means the unit of activity which is in the agreement used to —
express the amount of; and
measure in accordance with Part 1 of Schedule 2 the provision of,
mandatory services and advanced mandatory services provided under the agreement;
“unit of orthodontic activity” means the unit of activity which is in the agreement used to —
express the amount of; and
measure in accordance with Part 2 of Schedule 2 the provision of,
orthodontic services provided under the agreement;
“urgent treatment” means a course of treatment that consists of one or more of the treatments listed in Schedule 4 to the NHS Charges Regulations (urgent treatment under Band 1 charge) that are provided to a person in circumstances where —
a prompt course of treatment is provided because, in the opinion of the contractor, that person’s oral health is likely to deteriorate significantly, or the person is in severe pain by reason of his oral condition; and
treatment is provided only to the extent that is necessary to prevent that significant deterioration or address that severe pain; and
“working day” means any day apart from Saturday, Sunday, Christmas Day, Good Friday or a bank holiday.
2
In these Regulations —
a
the use of the term it in relation to the contractor shall be deemed to include a reference to a contractor that is an individual dental practitioner or two or more persons contracting together to provide services under an agreement and related expressions shall be construed accordingly; and
b
references to forms supplied by the Primary Care Trust to contractors includes electronic forms and forms which are generated electronically, but does not include prescription forms.
PART 2
CONTRACTORS
Conditions: introductory
3
A Relevant Body may only enter into an agreement if the conditions set out in —
a
regulation 4; and
b
in the case of an agreement to be entered into with a qualifying body , on or after the coming into force for all purposes of article 39 of the Dentists Act Order (substitution of sections 43 and 44), regulation 5,
are met.
General conditions relating to all agreements
4
1
A Relevant Body may make an agreement with an individual falling within section 28D(1)(b) to (d) if that individual does not fall within paragraph (3).
2
A Relevant Body may make an agreement with a qualifying body only if —
a
the qualifying body; or
b
any director, chief executive or secretary of the qualifying body,
does not fall within paragraph (3).
3
A person falls within this paragraph if —
a
he or it (in the case of a qualifying body) is the subject of a national disqualification;
b
subject to paragraph (4), he or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world;
c
within the period of five years prior to the date the agreement is to be commenced or, if earlier, the date on which the agreement is to be signed —
i
he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body, unless he has subsequently been employed by that health service body or another health service body and paragraph (5) applies to him or that dismissal was the subject of a finding of unfair dismissal by any competent tribunal or court; or
ii
he or it has been removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act respectively) unless his or its name has subsequently been included in such a list;
d
he has been convicted in the United Kingdom of —
i
murder; or
ii
a criminal offence other than murder, committed on or after 14th December 2001, and has been sentenced to a term of imprisonment of over six months;
e
subject to paragraph (6), he has been convicted outside the United Kingdom of an offence —
i
which would, if committed in England and Wales, constitute murder; or
ii
committed on or after 14th December 2001, which would if committed in England and Wales, constitute a criminal offence other than murder, and been sentenced to a term of imprisonment of over six months;
f
he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of this Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply) committed on or after 1st April 2006;
g
he or it has —
i
been adjudged bankrupt or had sequestration of his estate awarded unless (in either case) he has been discharged or the bankruptcy order has been annulled;
ii
been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986 unless that order has ceased to have effect or has been annulled; or
iii
made a composition or arrangement with, or granted a trust deed for, his or its creditors unless he or it has been discharged in respect of it;
h
an administrator, administrative receiver or receiver is appointed in respect of it;
i
he has within the period of five years prior to the date the agreement is to be commenced or, if earlier, the date on which the agreement is to be signed —
i
been removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated;
ii
been removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (powers of the Court of Session to deal with management of charities), from being concerned in the management or control of any body; or
iii
been subject to a disqualification order under the Company Directors Disqualification Act 1986 , the Companies (Northern Ireland) Order 1986 or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order).
4
A person shall not fall within paragraph (3)(b) where the Relevant Body is satisfied that the disqualification or suspension from practising is imposed by a licensing body outside the United Kingdom and it does not make the person unsuitable to be —
a
a party to an agreement; or
b
in the case of an agreement with a qualifying body, a director, chief executive or secretary of the qualifying body,
as the case may be.
5
Where a person has been employed as a member of a health care profession any subsequent employment must also be as a member of that profession.
6
A person shall not fall within paragraph (3)(e) where the Relevant Body is satisfied that the conviction does not make the person unsuitable to be —
a
a party to an agreement; or
b
in the case of an agreement with a qualifying body, a member, director, chief executive or secretary of the qualifying body.
Additional conditions relating to agreements with qualifying bodies
5
1
Subject to paragraph (2), it is a condition in the case of an agreement to be entered into with a qualifying body on or after the date of the coming into force of article 39 of the Dentists Act Order, that no —
a
offence has been or is being committed under section 43 of the Dentists Act; or
b
financial penalty has been imposed under section 43B or 44 of the Dentists Act.
2
Paragraph (1) shall not apply if the Relevant Body is satisfied that any offence under section 43 or penalty imposed under section 43B or 44 of the Dentists Act does not make the qualifying body unsuitable to be a contractor, whether by virtue of the time that has elapsed since any conviction or penalty was imposed, or otherwise.
Reasons
6
1
Where a Relevant Body is of the view that the conditions in regulation 4 or 5 for entering into an agreement are not met it shall notify in writing the person or persons intending to enter into the agreement of its view and its reasons for that view and of his, its, or their right of appeal under regulation 7.
2
The Relevant Body shall also notify in writing of its view and its reasons for that view, any director, chief executive or secretary of a qualifying body that is notified under paragraph (1) where its reasons for the decision relate to that person or those persons.
Appeal
7
A person who has been served with a notice under regulation 6(1) may appeal to the FHSAA against the decision of the Relevant Body that the conditions in regulation 4 or 5 are not met by giving notice in writing to the FHSAA within the period of 28 days beginning on the day that the Relevant Body served its notice.
PART 3
PRE-AGREEMENT DISPUTE RESOLUTION
Pre-agreement disputes
8
1
Subject to paragraphs (2) and (3), if in the course of negotiations intending to lead to an agreement the prospective parties to that agreement are unable to agree on a particular term of the agreement, either party may, subject to paragraph (2), refer the dispute to the Secretary of State to consider and determine the matter.
2
Both parties to the prospective agreement must make every reasonable effort to communicate and co-operate with each other with a view to resolving a dispute arising during the course of negotiations, before referring the dispute for determination under paragraph (1).
3
Disputes referred to the Secretary of State in accordance with paragraph (1), or section 4(4) of the 1990 Act, shall be considered and determined in accordance with the provisions of paragraphs 55(4) to 55(13) and 56(1) of Schedule 3, and paragraph (4) (where it applies) of this regulation.
4
In the case of a dispute referred to the Secretary of State under paragraph (1), the determination —
a
may specify terms to be included in the proposed agreement;
b
may require the Relevant Body to proceed with the proposed agreement, but may not require the proposed contractor to proceed with the proposed agreement; and
c
shall be binding upon the prospective parties to the agreement.
PART 4
HEALTH SERVICE BODY STATUS
Health service body status
9
1
A contractor shall be regarded as a health service body for the purposes of section 4 of the 1990 Act from the date it makes an agreement unless —
a
in the case of an agreement with a single individual or qualifying body, that individual or body; or
b
in the case of any other agreement, the proposed parties to the agreement (other than the Relevant Body),
object in a written notice served on the Relevant Body at any time prior to the agreement being made.
2
Where a contractor is to be regarded as a health service body for the purposes of section 4 of the 1990 Act pursuant to paragraph (1), any change in the parties comprising the contractor shall not affect the health service body status of the contractor.
3
If, pursuant to paragraph (1) or (4), a contractor is to be regarded as a health service body, that fact shall not affect the nature of, or any rights or liabilities arising under, any other agreement or contract with a health service body entered into by that contractor before the date on which the contractor is to be so regarded.
4
A contractor may at any time request a variation of the agreement to include or remove provision from the agreement that the agreement is an NHS contract, and if it does so —
a
the Relevant Body shall agree to the variation; and
b
the procedure in paragraph 60(1) of Schedule 3 (variation of a contract: general) shall apply.
5
Where, pursuant to paragraph (4), the Relevant Body agrees to a variation of the agreement, the contractor shall —
a
be regarded; or
b
subject to paragraph (7), cease to be regarded,
as a health service body for the purposes of section 4 of the 1990 Act from the date that variation takes effect pursuant to paragraph 60(1) of Schedule 3.
6
Subject to paragraph (7), a party or parties who were to be regarded as a health service body pursuant to paragraphs (1) or (4), as the case may be, shall cease to be a health service body for the purposes of section 4 of the 1990 Act if the agreement is terminated.
7
Where a contractor ceases to be a health service body pursuant to —
a
paragraph (5) or (6), it shall continue to be regarded as a health service body for the purposes of being a party to any other NHS contract entered into after it became a health service body but before the date on which the contractor ceased to be a health service body (for which purposes it ceases to be such a body on the termination of that NHS contract);
b
paragraph (5), it shall, if it or the Relevant Body has referred any matter to the NHS dispute resolution procedure before it ceases to be a health service body, be bound by the determination of the adjudicator as if the dispute had been referred pursuant to paragraph 54 of Schedule 3 (dispute resolution: non-NHS contracts);
c
paragraph (6), it shall continue to be regarded as a health service body for the purposes of the NHS dispute resolution procedure where that procedure has been commenced —
i
before the termination of the agreement; or
ii
after the termination of the agreement, whether in connection with, or arising out of, the termination of the agreement or otherwise,
for which purposes it ceases to be such a body on the conclusion of that procedure.
PART 5
AGREEMENTS: REQUIRED TERMS
NHS contracts
10
If the contractor is to be regarded as a health service body, the agreement must state that it is an NHS contract.
Additional services
11
If the agreement includes the provision of additional services, it must contain in relation to each such service as is included in the agreement, terms that have the same effect as those specified in Schedule 1 in so far as they are relevant to that service.
Agreements: general
12
1
An agreement must specify —
a
the services to be provided by the contractor;
b
the duration of the agreement;
c
to whom such services are to be provided; and
d
the postal address of each of the premises to be used by the contractor or any sub-contractor for the provision of such services, or, if the contractor is to provide services from a mobile surgery, that fact.
2
The premises referred to in paragraph (1)(d) do not include any place in which a patient is residing.
Units of dental activity
13
1
Where an agreement includes the provision of mandatory or advanced mandatory services, the agreement must specify the number of units of dental activity to be provided by the contractor —
a
where the agreement begins on 1st April, in each financial year or, by virtue of the duration of the agreement, part financial year; or
b
where the agreement begins on a date other than 1st April, in the remainder of the financial year in which the agreement begins, and in each financial year thereafter.
2
An agreement must contain terms which have the effect of those specified in Part 1 of Schedule 2 in relation to the calculation of the number of units of dental activity that the contractor has provided under the agreement.
Units of orthodontic activity
14
1
Where an agreement includes the provision of orthodontic services, the agreement must specify the number of units of orthodontic activity to be provided by the contractor —
a
where the agreement begins on 1st April, in each financial year or, by virtue of the duration of the agreement, part financial year; or
b
where the agreement begins on a date other than 1st April, in the remainder of the financial year in which the agreement begins, and in each financial year or part financial year thereafter.
2
Where paragraph (1) applies, the agreement must also contain terms which have the effect of those specified in Part 2 of Schedule 2 in relation to the calculation of how many units of orthodontic activity a contractor has provided under the agreement.
Under-provision of units of dental activity or units of orthodontic activity
15
1
The agreement shall provide that the Relevant Body shall not, pursuant to Part 9 of Schedule 3 (variation and termination of agreements), be entitled to take any action for breach of a term of the agreement giving effect to regulation 13 or 14 (including termination of the agreement) where paragraph (2) applies.
2
Subject to paragraph (4), this paragraph applies where the contractor has failed to provide —
a
the number of units of dental activity; or
b
the number of units of orthodontic activity,
it is contracted to provide pursuant to a term of the agreement giving effect to regulation 13 or 14 where —
i
that failure amounts to 4 per cent or less of the total number of units of dental activity or units of orthodontic activity that ought to have been provided; and
ii
the contractor agrees to provide and does so provide the units it has failed to provide within such period as the Relevant Body specifies in writing, such period to consist of not less than 60 days.
3
Paragraphs (1) and (2) shall not prevent the Relevant Body from taking action under Part 9 of Schedule 3 for breach of contract (including terminating the agreement) on other grounds.
4
In the case of an agreement with a duration period of less than 12 months, the period of 60 days in paragraph (2)(ii) may not apply if the Relevant Body considers it not appropriate or considers that another period of less than 60 days should apply.
Domiciliary services and sedation services
16
Where an agreement includes the provision of domiciliary services or sedation services, the agreement must specify the number of courses of treatment that the contractor is —
a
to provide; or
b
to contribute to where provided as a referral service,
that involve the provision of domiciliary services or sedation services —
i
where the contract begins on 1st April, in each financial year; or
ii
where the contract begins on a date other than 1st April, in the remainder of the financial year in which the contract begins, and in each financial year thereafter for which the contract continues.
Finance
17
1
The agreement must contain a term which has the effect of requiring —
a
the Relevant Body to make payments to the contractor under the agreement promptly and in accordance with both the terms of the agreement and any other conditions relating to the payment contained in directions given by the Secretary of State under section 28E(3A) of the Act (personal medical or dental services: regulations);
b
the contractor to make payments promptly to the Relevant Body and in accordance with both the terms of the agreement and any other conditions relating to the payment contained in directions given by the Secretary of State under section 17 (Secretary of State’s directions: exercise of functions) or 28E(3A) of the Act.
2
The obligation referred to in paragraph (1) is subject to any right the Relevant Body has to set off against an amount payable to the contractor an amount that —
a
is owed by the contractor to the Relevant Body under the agreement;
b
has been paid to the contractor owing to an error or in circumstances when it was not due; or
c
the Relevant Body may withhold from the contractor in accordance with the terms of the agreement or any other applicable provisions contained in directions given by the Secretary of State under section 28E(3A).
3
The agreement must contain a term to the effect that where, pursuant to directions under section 17 or 28E(3A) of the Act, a Relevant Body is required to make a payment to a contractor under an agreement but subject to conditions, those conditions are to be a term of the agreement.
Fees, charges and financial interests of the contractor
18
1
The agreement must contain terms relating to fees, charges and financial interests which have the same effect as those set out in paragraphs (2) to (4).
2
The contractor shall not, either itself or through any other person, demand or accept a fee or other remuneration for its own or another’s benefit from —
a
any patient of its for the provision of any treatment under the agreement, except as otherwise provided in the NHS Charges Regulations; or
b
any person who has requested services under the agreement for himself or a family member, as a prerequisite to providing services under the agreement to that person or his family member.
3
The agreement must contain a term that —
a
only permits the contractor to collect from any patient of its any charge that that patient is required to pay by virtue of the NHS Charges Regulations, in accordance with the requirements of those Regulations; and
b
provides for obligations imposed on the contractor by virtue of the NHS Charges Regulations to be terms of the agreement.
4
The agreement must contain a term that requires the contractor in making a decision —
a
as to what services to recommend or provide to a patient who has sought services under the agreement; or
b
to refer a patient for other services by another contractor, hospital or other relevant service provider under Part 1 of the Act,
to do so without regard to its own financial interests.
5
The term “patient” in paragraph (3) shall have the same meaning as in regulation 2(1) of the NHS Charges Regulations.
Arrangements on termination
19
An agreement shall make suitable provision for arrangements on termination of an agreement including the consequences (whether financial or otherwise) of the agreement ending.
Other contractual terms
20
1
An agreement must, unless it is of a type or nature to which a particular provision does not apply, contain other terms which have the same effect as those specified in Schedule 3 except paragraphs 55(4) to 55(13) and 56 and Schedule 5.
2
The paragraphs specified in paragraph (1) shall have effect in relation to the matters set out in those paragraphs.
3
Where an agreement does not commence on 1st April in any financial year or the duration of an agreement is less than 12 months, there must be a contractual term —
a
specifying the date and periods for the purposes of a mid-year review of the services provided; and
b
which, other than as to the date and periods, have similar effect as those specified in paragraphs 58(3) to (8) and 59 of Schedule 3 in respect of the requirement and procedure for carrying out mid-year reviews.
PART 6
RIGHT TO A GENERAL DENTAL SERVICES CONTRACT
Right to a general dental services contract
21
1
A contractor which is providing mandatory services and which wishes a general dental services contract to be entered into pursuant to this regulation shall notify the Relevant Body in writing at least three months before the date on which it wishes the general dental services contract to be entered into.
2
A notice under paragraph (1) shall —
a
state that the contractor wishes to terminate the agreement and the date on which the contractor wishes the agreement to terminate which must be at least three months after the date of service of the notice;
b
subject to paragraph (3), give the name or names of the person or persons whom the contractor wishes the Relevant Body to enter into a general dental services contract with; and
c
confirm that the person or persons so named meet the conditions set out in section 28M of the Act (persons eligible to enter into GDS contracts) and regulations 4 and 5 (where applicable) of the GDS Contracts Regulations or, where the contractor is not able so to confirm, the reason why it is not able to do so and confirmation that the person or persons immediately prior to entering into the general dental services contract will meet those conditions.
3
A person’s name may only be given in a notice referred to in paragraph (1) if that person is a party to the agreement.
4
The Relevant Body shall acknowledge receipt of the notice served under paragraph (1) within the period of seven days beginning on the day that it received the notice.
5
Provided that the conditions set out in section 28M of the Act and regulations 4 and 5 (where applicable) of the GDS Contracts Regulations are met, the Relevant Body shall enter into a general dental services contract with the person or persons named in the notice served under paragraph (1).
6
In addition to the terms required by the Act and the GDS Contracts Regulations, a general dental services contract entered into pursuant to this regulation shall provide for —
a
the general dental services contract to commence immediately after the termination of the agreement;
b
the same services to be provided under the general dental services contract as were provided under the agreement immediately before it was terminated unless the parties otherwise agree;
c
the contractor to complete any course of treatment or orthodontic course of treatment that were not complete immediately before the agreement was terminated —
i
in accordance with the terms of the general dental services contract in so far as those terms correspond with the terms of the agreement immediately before it was terminated, and
ii
subject to such terms of the general dental services contract that permits the termination of a course of treatment or orthodontic course of treatment; and
d
unless the parties otherwise agree —
i
subject to paragraph (ii), the same number of units of dental activity or units of orthodontic activity (as the case may be) specified in the agreement in a term giving effect to regulation 13 or 14 to be provided under the general dental services contract;
ii
where the general dental services contract is to begin on a day other than 1st April, the contractor to provide under that contract during the remainder of that financial year any units of dental activity or units of orthodontic activity that the contractor would have been obliged to provide in that financial year under the agreement but had not yet provided immediately before the general dental services contract begins;
e
unless the parties otherwise agree —
i
subject to paragraph (ii), the same number of courses of treatment involving the provision of sedation services or domiciliary services specified in the agreement in a term giving effect to regulation 16 to be provided under the general dental services contract;
ii
where the general dental services contract is to begin on a day other than 1st April, the contractor under that contract to provide or contribute to during the remainder of that financial year any courses of treatment involving the provision of sedation services or domiciliary services that the contractor would have been obliged to provide or contribute to in that financial year under the agreement but had not yet provided or contributed to immediately before the general dental services contract begins;
f
in respect of a course of treatment or orthodontic course of treatment falling within sub-paragraph (c), the contractor to ensure that a patient who is not an exempt person only pays one NHS Charge in respect of that course of treatment or orthodontic course of treatment; and
g
the contractor to comply with the term of the general dental services contract giving effect to paragraph 12 of Schedule 3 to the GDS Contracts Regulations (repair or replacement of restorations) in respect of any patients to whom it provided treatment under its agreement, in addition to patients to whom it provides treatment under the general dental services contract.
7
An agreement shall terminate on the date stated in the notice given by the contractor under paragraph (1) unless a different date is agreed by the contractor and the Relevant Body or no general dental services contract is entered into by the Relevant Body pursuant to this regulation.
8
Where there is a dispute as to whether or not a person satisfies the conditions set out in section 28M of the Act or regulation 4 or 5 of the GDS Contracts Regulations, the contractor may appeal to the FHSAA and the Relevant Body shall be the respondent.
9
Any other dispute relating to this regulation shall be determined by the Secretary of State in accordance with regulation 8(3) and (4) of the GDS Contracts Regulations (pre-contract disputes).
10
The parties to a dispute referred to the Secretary of State in accordance with paragraph (9) shall be the contractor and the Relevant Body.
PART 7
TRANSITIONAL PROVISION
Commencement of agreement
22
The agreement shall provide for services to be provided under it from any date after 31st March 2006.
Signed by authority of the Secretary of State for Health
Rosie Winterton
Minister of State,
Department of Health
7th December 2005


type: legislation

jurisdiction: UK

text:
Citation, commencement and interpretation
1
1
This Order may be cited as the Chelsea and Westminster Healthcare National Health Service Trust (Transfer of Trust Property) Order 2005 and shall come into force on 1 st October 2005.
2
In this Order —
“the NHS Trust” means the Chelsea and Westminster Healthcare National Health Service Trust ;
“the new trustees” means the trustees for the Chelsea and Westminster Healthcare National Health Service Trust ; and
“the trust property” means the property specified in the schedule of trust property prepared and agreed by the NHS Trust and the new trustees and signed on behalf of the NHS Trust and the new trustees on 1 st August 2005.
Transfer of trust property
2
1
On the date that this Order comes into force the trust property, and any rights and liabilities arising from that property, shall be transferred from the NHS Trust to the new trustees.
2
In any instrument relating to the trust property, any reference to the name by which the trustees of the trust property are to be known shall be construed as a reference to the new trustees and any reference to the NHS Trust in the name by which the charitable trust governing the trust property is to be known shall be construed as a reference to the new trustees.
Signed by authority of the Secretary of State for Health
Jane Kennedy
Minister of State,
Department of Health
31st August 2005


text:
Citation and commencement
1
These Regulations may be cited as the Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 and shall come into force —
a
except for the purposes of the provisions specified in paragraph (b), on 30th October; and
b
for the purposes of paragraphs (2)(a)(ii) and (vi) and (c), (9)(a), (11)(a) and (14)(e), (f)(i), (iii) to (v) of regulation 2, and paragraphs 3 to 5, 6(b)(iii), 7 to 9, 11, 12 and 17(b) of the Schedule, on 20th November 2005.
Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
2
1
The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 are amended as follows.
2
In regulation 1 (citation, commencement and interpretation) —
a
in paragraph (2) —
i
after the definition of “the Act” insert the following definition —
“certificate of registration” means a certificate of registration granted by the licensing authority under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 ;
,
ii
in the definition of “Community marketing authorization”, after “2309/93” insert “or Regulation ( EC ) No. 726/2004 ”,
iii
in the definition of “the 2001 Directive ” —
aa
after “as amended by Commission Directive 2003/63/EC ” insert “, Directive 2004/24/EC ” , and
bb
omit “Article 1(21), (44), (45) and (54) of ”,
iv
after the definition of “the 2001 Directive” insert the following definition —
“Directive 2004/24/EC ” means 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 ;
,
v
for the definition of “ EEA State” substitute the following definition —
“EEA State” means a Member State, Norway, Iceland or Liechtenstein;
vi
in the definition of “the relevant Community provisions” —
aa
omit “Regulation ( EEC ) No. 2309/93 ;”, and
bb
omit “Title IV of”,
vii
for the definition of “relevant medicinal product” substitute the following definition —
“relevant medicinal product” means, except in regulation 3A and paragraph 1A of Schedule 3, a medicinal product for human use to which the provisions of the 2001 Directive apply other than —
a traditional herbal medicinal product, or
a homoeopathic medicinal product that fulfils the conditions laid down in Article 14(1) of the 2001 Directive;
, and
viii
after the definition of “supplementary prescriber” insert the following definition —
“traditional herbal registration” means a traditional herbal registration granted by the licensing authority under the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 ;
;
b
omit paragraph (3); and
c
omit paragraph (5A).
3
In regulation 3 (marketing authorizations for relevant medicinal products) in paragraph (1) for “paragraphs 1 and 3” substitute “paragraphs 1 and 3 to 5A”.
4
In regulation 3A (borderline products) —
a
in paragraph (1), after “marketing authorization” insert “, traditional herbal registration or certificate of registration”;
b
in paragraph (6), after “marketing authorization” insert “, traditional herbal registration or certificate of registration”; and
c
after paragraph (7) insert the following paragraph —
8
In this regulation, “relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply.
.
5
After regulation 3A (borderline products) insert the following regulation —
Immunity from liability for consequences arising from the use in certain cases of an unauthorised medicinal product or the use of a medicinal product for an unauthorised indication
3B
1
This regulation applies where, in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation which may cause harm to humans, the licensing authority recommend or require the use of —
a
a medicinal product which is not the subject of a Community marketing authorization or a United Kingdom marketing authorization; or
b
a medicinal product which is the subject of such an authorization, for a therapeutic indication which is not included in the summary of product characteristics under that authorization.
2
Subject to paragraph (3) —
a
the holder of a marketing authorization for the product the use of which is recommended or required by the licensing authority;
b
a manufacturer of that product;
c
an officer, servant, employee or agent of a person referred to in sub-paragraph (a) or (b); and
d
a health professional,
shall not be subject to any civil liability for any loss or damage resulting from the use of the product in accordance with the recommendation or requirement.
3
Paragraph (2) shall not apply in relation to liability under section 2 of the Consumer Protection Act 1987 .
4
In this regulation, “health professional” means —
a
a doctor,
b
a dentist,
c
a registered nurse ,
d
a pharmacist,
e
a person registered in a register of optometrists maintained under section 7 of the Opticians Act 1989 ,
f
a person registered in a register established and maintained under article 5 of the Health Professions Order 2001 ,
g
a registered osteopath as defined by section 41 of the Osteopaths Act 1993 , or
e
a registered chiropractor as defined by section 43 of the Chiropractors Act 1994 .
.
6
In regulation 4 (applications for the grant, renewal or variation of a United Kingdom marketing authorization) —
a
for paragraphs (3) and (4), substitute the following paragraph —
3
One copy of the application and of any accompanying material shall be supplied to the licensing authority in the English language and where the application or any accompanying material has been translated from another language, one copy of the application or the accompanying material, as the case may be, shall also be supplied in the original language.
;
b
for paragraph (6), substitute the following paragraph —
6
For the purposes of Article 10(1) of the 2001 Directive, the period of 8 years (period during which reference medicinal products must have been authorized) there mentioned shall not apply if the application for the authorization of the reference medicinal product was submitted before 30th October 2005.
;
c
after paragraph (6), insert the following paragraphs —
6A
Where, by reason of paragraph (6) the period of 8 years does not apply, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which has been authorized in an EEA State for not less than 10 years.
6B
The fourth sub-paragraph of Article 10(1) of the 2001 Directive shall not apply if the application for the initial authorization of the reference medicinal product was submitted before 30th October 2005.
; and
d
in paragraph (9), for “3” substitute “6”.
7
In regulation 5 (consideration, and grant or refusal, of an application for, or renewal or variation of, a United Kingdom marketing authorization) —
a
for paragraph (4) substitute the following —
4
A parallel import licence shall, unless previously renewed or revoked, be valid for the period specified in it, but where an application to renew it is made in accordance with regulation 4(9) it shall remain in force pending the decision of the licensing authority on that application.
; and
b
after paragraph (4), insert the following paragraphs —
5
An authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive shall, unless previously revoked, be valid for the period specified in it.
6
Subject to paragraph (8), a United Kingdom marketing authorization, other than a parallel import licence shall, unless previously revoked, be valid for an unlimited period unless —
a
it has not been renewed on the basis of a re-evaluation by the licensing authority of the risk-benefit balance in accordance with, and on the basis of the data set out in, Article 24(2) of the 2001 Directive; or
b
it has been so renewed, but the licensing authority considers on justified grounds relating to pharmacovigilance that it should be subject to one additional renewal five years after the date of the first renewal, and it has not yet been subject to that additional renewal.
7
Subject to paragraph (8), where, by reason of paragraph (6), a United Kingdom marketing authorization is not valid for an unlimited period, it shall, unless previously revoked, be valid for a period of five years beginning with the date on which it is granted or was renewed, whichever is the later, but where an application for its renewal is made in accordance with Article 24 of the 2001 Directive the marketing authorization shall remain in force pending the decision of the licensing authority on that application.
8
Subject to paragraph (9), a United Kingdom marketing authorization (other than a parallel import licence) shall cease to be valid if at any time after it is granted the medicinal product to which it relates is not placed on the market in the United Kingdom for a period of three consecutive years, unless an exemption is granted in accordance with Article 24(6) of the 2001 Directive.
9
For the purposes of calculating the period of three consecutive years referred to in paragraph (8), no account shall be taken of any period before 30th October 2005.
.
8
In regulation 5A (classification of medicinal products), after paragraph (1) insert the following paragraph —
1A
For the purposes of paragraph (1), “marketing authorization” includes an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive.
.
9
In regulation 6 (revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products) —
a
in paragraph (5), for “Council Regulation (EEC) No. 2309/93 ” substitute “Regulation (EC) No. 726/2004 ”; and
b
after paragraph (7), insert the following paragraph —
7A
For the purposes of this regulation, “marketing authorization” includes an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive.
.
10
In regulation 6A (urgent safety restrictions) —
a
in paragraph (1), after “marketing authorization” insert “or an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive”; and
b
in paragraph (2), omit “marketing”.
11
In regulation 7 (obligations of holders of marketing authorizations, and offences by holders of marketing authorizations and other persons) —
a
in paragraph (1), for “Regulation (EEC) No. 2309/93 ” substitute “Regulation (EC) No. 726/2004 ”;
b
after paragraph (3), insert the following paragraph —
3A
Where a person is authorised by the licensing authority to place a product on the market in accordance with Article 126a of the 2001 Directive, he shall comply with all obligations under Titles V, VI , VIII , IX and XI of that Directive which would apply to him by virtue of those provisions and these Regulations if he were the holder of a United Kingdom marketing authorization for that product.
; and
c
after paragraph (6), insert the following paragraph —
7
For the purposes of paragraphs (2), (3), (4) and (6), “marketing authorization” includes an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive.
.
12
In regulation 9 (consequential and other amendments of the Act and the Medicines Act 1971), after paragraph (14), insert the following paragraphs —
15
Subject to paragraph (16), for the purposes of this regulation, “marketing authorization” includes an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive.
16
Paragraph (15) shall not apply in relation to paragraph (10).
.
13
In Schedule 1 (exemptions and exceptions from the provisions of regulation 3) —
a
in paragraph 1, after “responsibility” insert “, in order to fulfil the special needs of those patients”;
b
in paragraph 2, for sub-paragraph (e) substitute the following sub-paragraph —
e
if the relevant medicinal product is manufactured or assembled in the United Kingdom, or imported into the United Kingdom from a third country, the product —
i
is manufactured, assembled or imported by the holder of a manufacturer’s licence which relates specifically to the manufacture, assembly or import of relevant medicinal products to which paragraph 1 applies; or
ii
has been manufactured, assembled or imported as an investigational medicinal product by the holder of a manufacturing authorization granted by the licensing authority for the purposes of regulation 36 of the Medicines for Human Use (Clinical Trials) Regulations 2004 ; and
; and
c
after paragraph 5 insert the following paragraph —
5A
Regulation 3(1) shall not apply to a medicinal product for which there is in force an authorization to place the product on the market granted by the licensing authority in accordance with Article 126a of the 2001 Directive.
.
14
In Schedule 3 (offences, penalties etc ) —
a
paragraph 1A is amended as follows —
i
paragraph 1A shall be renumbered as sub-paragraph (1) of that paragraph,
ii
in paragraph (a) of sub-paragraph (1), after “marketing authorization”, in both places those words appear, insert “, traditional herbal registration or certificate of registration”,
iii
in paragraph (b) of sub-paragraph (1), after “marketing authorization”, in both places those words appear, insert “, traditional herbal registration or certificate of registration”, and
iv
after sub-paragraph (1), insert the following sub-paragraph —
2
In this paragraph, “relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply.
.
b
after paragraph 1A insert the following paragraph —
1AA
Any person who places a generic medicinal product on the market before the period of —
a
in a case where during the first eight years after the grant of the initial marketing authorization of the reference medicinal product the holder of that authorization is granted an authorization for a new therapeutic indication of significant clinical benefit as set out in the fourth sub-paragraph 4 of Article 10(1) of the 2001 Directive, eleven years; and
b
in any other case, ten years
has elapsed from the date of that initial authorization, shall be guilty of an offence.
;
c
in paragraph 2, after “paragraph 1” insert “or paragraph 1AA”;
d
after paragraph 2, insert the following paragraph —
2A
Any person who distributes a relevant medicinal product by way of wholesale dealing contrary to regulation 3(1)(b) shall be guilty of an offence.
;
e
in paragraphs 4, 7, 8, 9 and 10 for “Council Regulation (EEC) No. 2309/93 ” substitute “Regulation (EC) No. 726/2004 ”;
f
in paragraph 6 —
i
in sub-paragraph (b), for “Article 15.1 of Council Regulation (EEC) No 2309/93 ” substitute “Article 16.1 of Regulation (EC) No. 726/2004 ”,
ii
in sub-paragraph (cc), after “Article 23” insert “or the first paragraph of Article 23a”,
iii
in sub-paragraph (d), for “Article 15.2 of Council Regulation (EEC) No 2309/93 ” substitute “Article 16.2 of Regulation (EC) No. 726/2004 ” and, after the semi-colon, omit “or”,
iv
after sub-paragraph (d), insert the following sub-paragraph —
dd
provide information to the EMEA as required by the first or second paragraphs of Article 13(4) of Regulation No. 726/2004; or
, and
v
in sub-paragraph (e), for “Article 15.3 of Council Regulation (EEC) No 2309/93 ” substitute “Article 16.3 of Regulation (EC) No. 726/2004 ”;
g
in paragraph 6A, after “Article 23”, insert “or of Article 23a”;
h
after paragraph 6A, insert the following paragraphs —
6B
Subject to paragraph 17, any person who is the holder of a United Kingdom marketing authorization who fails, not less than two months before an interruption in the placing on the market of the product to which the authorization relates, to notify the licensing authority that the product is to cease to be placed on the market, shall be guilty of an offence.
6C
Subject to paragraph 17, any person who is the holder of a Community or United Kingdom marketing authorization who fails to ensure appropriate and continued supplies pursuant to the second paragraph of Article 81 of the 2001 Directive shall be guilty of an offence.
6D
Any person who is the holder of a Community marketing authorization who fails to provide the EMEA with any data requested pursuant to the final paragraph of Article 13(4) or the final paragraph of Article 26 of Regulation (EC) No. 726/2004 —
a
within the time specified in the request, if a time within which to provide the data to the EMEA is so specified; or
b
promptly, if no such time is specified,
shall be guilty of an offence.
6E
Any person who is the holder of a Community or United Kingdom marketing authorization who communicates to the general public information —
a
relating to pharmacovigilance concerns about the product to which the authorization relates;
b
without having previously communicated, or without simultaneously communicating, such information to the EMEA, in the case of a product for which there is a Community marketing authorization, or otherwise the licensing authority,
shall be guilty of an offence.
6F
Any person —
a
who is the holder of a Community or United Kingdom marketing authorization; and
b
who fails to ensure that the information which he communicates to the general public, the licensing authority or the EMEA relating to pharmacovigilance concerns about the product to which his authorization relates is presented objectively and is not misleading,
shall be guilty of an offence.
;
i
in paragraph 17, after “paragraph” insert “6B, 6C,”; and
j
after paragraph 17, insert the following paragraphs —
Definitions
18
For the purposes of paragraphs 1, 3, 3A, 4, 5, 6E, 6F, 11, 12 and 16, “marketing authorization” includes an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive.
19
For the purposes of paragraphs 7, 8 , 9 and 10 the Directive requirements referred to in those paragraphs are deemed to apply in relation to the holder of an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive as they apply to the holder of a marketing authorization.
.
15
In Schedule 6 (transitional provisions), after paragraph 4A insert the following paragraph —
4B
Until 30th October 2010, these Regulations shall apply, in so far as they relate to the labelling of medicinal products in respect of which a marketing authorization was granted before 30th October 2005, as if the 2001 Directive had not been amended by Article 1(40), (41) and (42) of Directive 2004/27/EC .
.
Amendments of the Patents Act 1977
3
In section 60 of the Patents Act 1977 (meaning of infringement) —
a
in subsection (5), after paragraph (h), insert the following —
i
it consists of —
i
an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC , or
ii
any other act which is required for the purpose of the application of those paragraphs.
, and
b
in subsection (7), at the end insert the following —
“Directive 2001/82/EC ” means Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products as amended by Directive 2004/28 of the European Parliament and of the Council ;
“Directive 2001/83/EC ” 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, by Commission Directive 2003/63/EC and by Directives 2004/24/EC and 2004/27/EC of the European Parliament and of the Council
.
Consequential amendments to enactments
4
The provisions of the enactments specified in the Schedule shall be amended as there specified.
Signed by authority of the Secretary of State for Health
Warner
Minister of State
Department
6th October 2005


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2005 and shall come into force on 7 th April 2005.
2
In these Regulations, “the principal Regulations ” means the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 .
Amendment of regulation 1 of the principal Regulations
2
In regulation 1 of the principal Regulations (citation, commencement and interpretation), in paragraph (2), in sub-paragraph (a) —
a
in the definition of “relevant register” —
i
in paragraph (a), omit “and”;
ii
in paragraph (b), after “the Pharmacy (Northern Ireland) Order 1976 ;” insert “and”; and
iii
after paragraph (b), insert —
c
in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to —
i
chiropodists and podiatrists;
ii
physiotherapists; or
iii
radiographers: diagnostic or therapeutic,
that register
;
b
in the definition of “supplementary prescriber” —
i
in paragraph (b), omit “or”;
ii
in paragraph (c), after “a registered midwife;”, insert “or”;
iii
after paragraph (c), insert —
d
a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to —
i
chiropodists and podiatrist;
ii
physiotherapists; or
iii
radiographers: diagnostic or therapeutic, or,
and
iv
after “an annotation” insert “or entry”.
Amendment of regulation 5 of the principal Regulations
3
In regulation 5 of the principal Regulations (restrictions on persons to be supplied with certain medicinal products), in paragraph (2), in sub-paragraph (c), omit “eye ointment containing Oxyphenbutazone and”; “Framycetin sulphate”, and “Thymoxamine hydrochloride”.
Amendment of regulation 8 of the principal Regulations
4
In regulation 8 of the principal Regulations (pack size on retail sale or supply of certain medicinal products on a general sale list), in paragraph (2A) , for “20 tablets” substitute “50 tablets”.
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State,
Department of Health
16th March 2005
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
Deirdre Kenny
A Senior Officer of the
Department of Health, Social Services and Public Safety
15th March 2005
Sealed with the Official Seal of the Department of Agriculture and Rural Development
Gerald Lavery
A Senior Officer of the
Department of Agriculture and Rural Development
15th March 2005


text:
Citation and commencement
1
These Regulations may be cited as the Terrorism (United Nations Measures) Order 2001 (Amendment) Regulations 2005 and come into force on 29th June 2005.
Amendment to the Terrorism (United Nations Measures) Order 2001
2
For the definition of “Council Decision” in article 2(1) of the Terrorism (United Nations Measures) Order 2001 substitute —
“Council Decision” means Council Decision 2005/221/ CFSP of 14th March 2005 implementing Article 2(3) of Regulation ( EC ) No 2580/2001 and repealing Council Decision 2004/306/EC of 2nd April 2004 ;
.
Revocation
3
The Terrorism (United Nations Measures) Order 2001 (Amendment) Regulations 2004 are revoked.
Gillian Merron
Joan Ryan
Two of the Lords Commissioners of Her Majesty’s Treasury
7th June 2005


text:
Citation
1
This Order may be cited as the Courts Act 2003 (Commencement No. 12 and Transitional Provision) Order 2005.
Commencement of provisions of the Courts Act 2003
2
Subject to article 3, the following provisions of the Courts Act 2003 shall come into force on 10th January 2006 —
a
in Schedule 8 (minor and consequential amendments), paragraphs 242 and 254 (Magistrates' Courts Act 1980);
b
in Schedule 10 (repeals), the repeal of sections 137 and 138 of, and Schedule 6 to, the Magistrates' Courts Act 1980 ; and
c
section 109(1) and (3) to the extent necessary for those amendments and repeals.
3
The following provisions of the Courts Act 2003 shall come into force on 6th April 2006 —
a
subsection (1)(a), (b), and (c) and subsection (3)(a) and (b) of section 98 (register of judgments and orders etc );
b
paragraph 16 of Schedule 9 (transitional provisions and savings);
c
in Schedule 10 (repeals), the repeal of sections 73 and 73A of the County Courts Act 1984 ; and
d
section 109(2) and (3) to the extent necessary for the purposes of paragraphs (b) and (c).
Transitional provision
4
Sections 137(1) and 138 of, and Part 1 of Schedule 6 to, the Magistrates' Courts Act 1980 are to continue to have effect for the purposes of an application under the following sections of the Adoption Act 1976 —
a
section 20 (revocation of a section 18 order);
b
section 27(1) or (2) (restriction on removal of child where adoption pending or application made under section 18); and
c
section 29 (return of child taken away in breach of section 27).
Falconer of Thoroton, C
Date 16th December 2005


text:
Citation
1
This Order may be cited as the Tax Information Exchange Agreement (Taxes on Income) (Netherlands Antilles) Order 2005.
Declaration about exchange of information
2
1
It is declared that the arrangements specified in the Convention 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 Kingdom of the Netherlands in respect of the Netherlands Antilles 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 or corporation tax; and
b
the laws of the Netherlands Antilles concerning taxes imposed by the law of the Netherlands Antilles 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 application
1
These Regulations may be cited as the Environmental Stewardship (England) Regulations 2005, shall come into force on 2nd April 2005 and shall apply to England only.
Interpretation
2
In these Regulations —
“agreement land” means land which is the subject of an environmental stewardship agreement;
“agreement year” means a period of 12 months commencing with the date of, or the anniversary of the date of, the coming into effect of an environmental stewardship agreement;
“beneficiary” means a person who has entered into an environmental stewardship agreement with the Secretary of State;
“carry out”, in relation to an obligation under an environmental stewardship agreement or a feasibility study agreement, includes ensuring that the obligation is carried out;
“Compendium of UK Organic Standards” means the Compendium of UK Organic Standards, May 2004 Edition, published by the Department for Environment, Food and Rural Affairs ;
“conventional land” means agreement land which is not organic land;
“conversion grant” means a grant for converting land to production in accordance with organic standards;
“Council Regulation” means Council Regulation ( EEC ) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs as last amended by Commission Regulation ( EC ) No 2254/2004 ;
“date of application” means the date on which an application to enter into an environmental stewardship agreement is received by the Secretary of State;
“ ELS element” means obligations relating to ELS options;
“ELS options” means the options set out in column 1 of Part 2 of Schedule 2 for which a points value per unit is specified in column 2 of that Part of that Schedule;
“ELS points score” means the points score for conventional land calculated in accordance with paragraph 2 of Schedule 3;
“ELS points target” means the points target for conventional land calculated in accordance with paragraph 1 of Schedule 3;
“environmental stewardship agreement” has the meaning given to it in regulation 3(2);
“ HLS capital works items” means the capital works items set out in column 1 of Parts 4 and 5 of Schedule 2;
“HLS element” means obligations relating to —
HLS options; or
HLS capital works items;
“HLS options” means the options set out in —
column 1 of Part 2 of Schedule 2 for which a maximum payment rate per agreement year is specified in column 4 of that Part of that Schedule; and
column 1 of Part 3 of Schedule 2.
“improved land” means land which has been ploughed or has received artificial fertilizer during the period of 20 years immediately before the date of application and which is not —
top fruit orchard; or
planted with mature trees or shrubs or planted to woodland or coppice, unless such land is used for grazing or keeping livestock;
“interest”, in relation to land, means —
a freehold interest;
a leasehold interest;
a licence to occupy; or
in relation to common land, a right to graze or to represent a person with such a right;
“less favoured area” means all the land shown coloured blue and pink in the three volumes of maps numbered 1 to 3, each volume being marked “Volume of maps of less-favoured farming areas in England”, 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, 2 Horseferry Road, London SW1 2AL;
“ OELS element” means obligations relating to OELS options;
“OELS options” means the options set out in column 1 of Part 2 of Schedule 2 for which a points value per unit is specified in column 3 of that Part of that Schedule;
“OELS points score” means the points score for organic land calculated in accordance with paragraph 5 of Schedule 3;
“OELS points target” means the points target for organic land calculated in accordance with paragraph 4 of Schedule 3;
“organic land” means agreement land which —
is registered with a private inspection body either as being in conversion to organic farming or as being fully organic; and
if it is situated within the less favoured area, comprises of, or is situated within, a parcel with an area of less than 15 hectares;
“organic standards” means the standards for organic production set out in the Council Regulation, as read with any additional provisions set out in the Compendium of UK Organic Standards;
“parcel” has the same meaning as “reference parcel” in Article 2(26) of 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 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 ;
“private inspection body” means a private inspection body approved by the Secretary of State for the purposes of Article 9(4) of the Council Regulation ;
“special project activity” has the meaning given to it by regulation 5(9)(a);
“special project element” means obligations relating to a special project activity;
“specified purposes” means —
the conservation or enhancement of the natural beauty or amenity of the countryside (including its flora and fauna and geological and physiographical features) or of any features of archaeological interest there,
the promotion of the enjoyment of the countryside by the public, or
the upkeep of the landscape and historical features on agricultural land;
“top fruit” means apples (excluding cider apple varieties), cherries, pears and plums.
Power to make grants
3
1
The Secretary of State may make a grant in accordance with these Regulations to a person who undertakes to do anything in relation to land in which that person has an interest which in the Secretary of State’s opinion is conducive to any of the specified purposes.
2
Such a grant shall be made subject to the condition that the beneficiary complies with the conditions set out in an agreement (“an environmental stewardship agreement”) made between that person and the Secretary of State.
3
The Secretary of State may vary the conditions of an environmental stewardship agreement —
a
by agreement with the beneficiary; or
b
by notice served on the beneficiary if the variation is, in the opinion of the Secretary of State, necessary to prevent a breach of a provision of, or made under, the Community Treaties .
4
The amount of the grant shall be calculated in accordance with regulations 6 and 7(4).
Applications for grant
4
1
An application for a grant shall —
a
include an application to enter into an environmental stewardship agreement with the Secretary of State; and
b
be made at such times, in such form and be accompanied by such information, as the Secretary of State requires.
2
An application to enter into an environmental stewardship agreement containing an HLS element must be accompanied by a plan (“a farm environment plan”), in such form as the Secretary of State requires, identifying the features of environmental significance on the relevant land.
3
Subject to paragraph (4), in paragraph (2) and Schedule 1 relevant land means land —
a
which —
i
is farmed by the applicant as a single farming business; or
ii
would have been farmed as a single farming business but is instead farmed by the applicant as two or more farming businesses in order to comply with the requirement of the second paragraph of Part A of Annex III of the Council Regulation (which provides that production in accordance with organic standards must be clearly separated from production which is not in accordance with such standards);
and which includes the land which is the subject of the application to enter into an environmental stewardship agreement with an HLS element; and
b
which is registered on the Rural Land Register held by the Rural Payments Agency, an executive agency of the Department for Environment, Food and Rural Affairs; and
c
in relation to which the applicant, either —
i
alone, or
ii
with a person who countersigns the application,
has, on the date of the application, the right, for at least five years from that date, to carry out activities of the type required by HLS options.
4
In paragraph (2), where the land which is the subject of the application forms all or part of a common, the relevant land is the land comprising the entire common.
5
The Secretary of State shall make a grant (“a farm environment plan grant”) to an applicant in respect of a farm environment plan if the plan and the associated application to enter into an environmental stewardship agreement are in such form as the Secretary of State requires.
6
The amount of a farm environment plan grant shall be calculated in accordance with Schedule 1.
Conditions of environmental stewardship agreements
5
1
An environmental stewardship agreement must contain one (and may contain more than one) of the following elements —
a
an ELS element;
b
an OELS element;
c
an HLS element;
d
a special project element.
2
An environmental stewardship agreement which contains an ELS element must include an undertaking by the beneficiary to carry out on the conventional land, for the duration of the agreement, sufficient ELS options to obtain an ELS points score equal to or greater than the ELS points target in relation to that land.
3
An environmental stewardship agreement which contains an OELS element must include an undertaking by the beneficiary to carry out on the organic land, for the duration of the agreement, sufficient OELS options to obtain an OELS points score equal to or greater than the OELS points target in relation to that land.
4
An environmental stewardship agreement which contains an HLS element must include an undertaking by the beneficiary to carry out on the agreement land, for the duration of the agreement, at least one HLS option.
5
An environmental stewardship agreement which contains an HLS element must also specify —
a
the payment rate for each HLS option included in the agreement;
b
the payment rate for each HLS capital works item listed in column 1 of Part 4 of Schedule 2 included in the agreement; and
c
the percentage of the cost payable for each HLS capital works item listed in column 1 of Part 5 of Schedule 2 included in the agreement.
6
The payment rate referred to in paragraph (5)(a) must not exceed the maximum payment rate per agreement year specified for that HLS option in column 4 of Part 2, or column 2 of Part 3, of Schedule 2 (as the case may be).
7
The payment rate referred to in paragraph (5)(b) must not exceed the maximum payment rate specified for that HLS capital works item in column 2 of Part 4 of Schedule 2.
8
The percentage referred to in paragraph (5)(c) must not exceed the maximum percentage of cost specified for that HLS capital works item in column 2 of Part 5 of Schedule 2.
9
An environmental stewardship agreement which contains a special project element must —
a
include an undertaking by the beneficiary to carry out on the agreement land any activity (“a special project activity”) which, in the Secretary of State’s opinion, would better, or more fully achieve, the specified purposes than an ELS option, an OELS option, an HLS option or an HLS capital works item (or more than one such option or capital works item);
b
specify the payment rate or the amount of grant for each special project activity included in such agreement.
10
The payment rate or the amount of grant referred to in paragraph (9)(b) must not exceed 120% of the sum of —
a
the loss of income suffered, and
b
the additional costs incurred
as a result of carrying out such activity.
Amount of grants
6
The amount of a grant payable by the Secretary of State pursuant to regulation 3 shall be determined in relation to —
a
an ELS element of an environmental stewardship agreement, in accordance with paragraph 3 of Schedule 3;
b
an OELS element of an environmental stewardship agreement, in accordance with paragraph 6 of Schedule 3;
c
an HLS element of an environmental stewardship agreement, in accordance with paragraph 7 of Schedule 3; and
d
a special project element of an environmental stewardship agreement, in accordance with paragraph 8 of Schedule 3.
Conversion grants for organic land
7
1
The Secretary of State may only make a grant which is a conversion grant —
a
in respect of eligible land; and
b
where the beneficiary agrees to comply with the conditions set out in an environmental stewardship agreement which contains an OELS element.
2
In paragraph (1), eligible land means land which meets the conditions specified in paragraph (3) and is —
a
improved land; or
b
top fruit orchard which —
i
has a total area of least 0.5 hectares; and
ii
is planted with at least 80 top fruit trees per hectare.
3
The conditions mentioned in paragraph (2) are that the land must —
a
on the date of application, be registered with a private inspection body as being in its first year of conversion to organic production; and
b
at no time during the period beginning on 10th August 1993 and ending immediately before the date of the agreement, have been registered with a private inspection body as being in conversion to organic production or fully organic (or both).
4
The amount of a conversion grant shall be calculated in accordance with Schedule 4.
Feasibility study agreements
8
1
The Secretary of State may make a grant (“a feasibility study grant”) to a person who undertakes to carry out a detailed study of land in which that person has an interest which, in the Secretary of State’s opinion, is conducive to any of the specified purposes.
2
A feasibility study grant shall be made subject to the condition that the beneficiary complies with the conditions set out in an agreement (“a feasibility study agreement”) made between that person and the Secretary of State.
3
An application to enter into a feasibility study agreement shall be made at such times, in such form and be accompanied by such information, as the Secretary of State requires.
4
The amount of a feasibility study grant shall not exceed the sum of —
a
the loss of income suffered, and
b
the additional costs incurred
as a result of complying with the conditions of the feasibility study agreement to which such grant relates.
Amendment of the England Rural Development Programme (Enforcement) Regulations
9
The England Rural Development Programme (Enforcement) Regulations 2000 shall be amended by adding to Part I of the Schedule, after the words “The Environmentally Sensitive Areas (Stage IV ) Order 2000”, the following —
The Environmental Stewardship (England) Regulations 2005
.
Revocation
10
1
Subject to paragraph (2), the Organic Farming (England Rural Development Programme) Regulations 2003 (“the 2003 Regulations ”) are hereby revoked.
2
The 2003 Regulations shall continue to apply in relation to any application for a grant under those Regulations which was received before the date on which these Regulations come into force.
Elliot Morley
Minister of State
Department for Environment, Food and Rural Affairs
27th February 2005
We consent,
Nick Ainger
Gillian Merron
Two of the Lords Commissioners of Her Majesty’s Treasury
8th March 2005


text:
Citation and commencement
1
These Regulations may be cited as the Misuse of Drugs (Amendment) Regulations 2005 and shall come into force on 14th March 2005.
Amendment of the Misuse of Drugs Regulations 2001
2
1
The Misuse of Drugs Regulations 2001 shall be amended as follows.
2
In regulation 2(1) —
a
after the definition of “authorised as a member of a group”, insert ““clinical management plan” has the same meaning as in the Prescription Only Medicines (Human Use) Order 1997 ;”;
b
in the definition of “prescription”, after “prescriber for the medical treatment of a single individual”, insert “by a supplementary prescriber for the medical treatment of a single individual;”;
c
after the definition of “state registered paramedic”, insert ““supplementary prescriber” has the same meaning as in the Prescription Only Medicines (Human Use) Order 1997 ;”;
3
In regulation 6(2), after “registered nurse”, insert “, a supplementary prescriber”.
4
In regulation 6A(2), after “treatment services” insert —
d
a supplementary prescriber acting under and in accordance with the terms of a clinical management plan
.
5
In regulation 7, after paragraph (5) insert —
6
Notwithstanding the provisions of paragraph (3), a supplementary prescriber acting under and in accordance with the terms of a clinical management plan may administer to a patient, without the directions of a doctor or dentist, any drug specified in Schedule 2, 3 or 4.
7
Notwithstanding the provisions of paragraph (3), any person may administer to a patient, in accordance with the directions of a supplementary prescriber acting under and in accordance with the terms of a clinical management plan, any drug specified in Schedule 2, 3 or 4.
6
In regulation 8(2), after paragraph (j) insert —
k
a supplementary prescriber acting under and in accordance with the terms of a clinical management plan,
.
7
In regulation 9(2), after paragraph (h) insert —
i
a supplementary prescriber acting under and in accordance with the terms of a clinical management plan,
.
8
In regulation 10 —
a
In paragraph (1)(a), “(k)” shall be substituted for “(j)”;
b
In paragraph (1)(b), “(i)” shall be substituted for “(h)”;
c
In paragraph (2) after “practitioner”, insert “, a supplementary prescriber acting under and in accordance with the terms of a clinical management plan”;
d
In paragraph (2) after “doctor”, insert “, a supplementary prescriber”;
e
In paragraph (2)(a) after the first “doctor”, insert “, another supplementary prescriber”;
f
In paragraph (2)(a) after the second “doctor”, insert “, supplementary prescriber”.
9
In regulation 14(4) after paragraph (f), insert —
g
a supplementary prescriber
.
10
In regulation 18(2)(d) after “practitioner”, insert “or supplementary prescriber”.
11
In regulation 26(2) after paragraph (h), insert —
i
a supplementary prescriber
.
Caroline Flint
Parliamentary Under Secretary of State
Home Office
9th February 2005


text:
Citation, commencement and application
1
1
These Regulations may be cited as the Council Tax (Civil Partners) (England) Regulations 2005 and shall come into force on 10th December 2005.
2
These Regulations apply to billing authorities in England only.
3
The amendments made by —
a
paragraph (2), and sub-paragraph (a) of paragraph (3), of regulation 2;
b
regulation 3; and
c
regulation 4;
apply in relation to financial years beginning on or after 1st April 2006.
Amendment of the Council Tax (Administration and Enforcement) Regulations 1992
2
1
The Council Tax (Administration and Enforcement) Regulations 1992 are amended in accordance with paragraphs (2) and (3).
2
In regulation 32 (interpretation and application of Part VI), in paragraph (1), in the definition of “net earnings” at sub-paragraph (c)(ii), after “widows” insert “widowers, surviving civil partners ”.
3
In regulation 58 (outstanding liabilities on death) —
a
in sub-paragraph (b) of paragraph (1), after “spouse” insert “or civil partner;” and
b
in sub-paragraph (a) of paragraph (5), after “regulation 34(7)(b) or (8)” insert “, 36A(5)(b) ,”.
Amendment of the Council Tax (Additional Provisions for Discount Disregards) Regulations 1992
3
1
The Council Tax (Additional Provisions for Discount Disregards) Regulations 1992 are amended in accordance with paragraphs (2) and (3).
2
In regulation 3 (persons of other descriptions), in paragraph (a) of Class E, after “spouse” insert “or civil partner”.
3
After paragraph (a) of sub-paragraph (1) of paragraph 4 of the Schedule insert —
aa
he is the civil partner of the other or they live together as if they were civil partners;
Amendment of the Council Tax (Prescribed Classes of Dwellings) (England) Regulations 2003
4
1
The Council Tax (Prescribed Classes of Dwellings) (England) Regulations 2003 are amended in accordance with paragraphs (2) to (4).
2
In paragraph 1 of the Schedule for the words “by reason of the spouse's” substitute “or civil partner by reason of that person's”.
3
In sub-paragraphs (1), (2) and (3) of paragraph 2 of the Schedule and in paragraph 2A of the Schedule, after “spouse” insert “or civil partner”.
4
In paragraph 3 of the Schedule add at the end —
; and
references to the civil partner of a person shall be taken to include references to a person of the same sex who is living with the other as if he were that person’s civil partner.
.
Phil Woolas
Minister of State Office of the Deputy Prime Minister
11th October 2005


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the Medicines for Human Use (Prescribing) (Miscellaneous Amendments) (No. 2) Order 2005 and shall come into force on 6 th January 2006.
2
In this Order —
“the POM Order ” means the Prescription Only Medicines (Human Use) Order 1997 ;
“the Pharmacy and General Sale Order” means the Medicines (Pharmacy and General Sale — Exemption) Order 1980 .
Amendment of Schedule 3A to the POM Order
2
In the table in Schedule 3A to the POM Order (substances which may be prescribed, administered or directed for administration by extended formulary nurse prescribers and conditions for such prescription or administration), in column 1, insert, at the appropriate place in the alphabetical order of the entries as they appear in that column, the entries set out in column 1 below, and in column 2, insert, against those entries, the corresponding entries in column 2 below —
Column 1 Column 2
Buprenorphine Transdermal administration in palliative care Chlordiazepoxide hydrochloride Oral Diamorphine hydrochloride Oral and parenteral Fentanyl Transdermal administration in palliative care Morphine sulphate Oral, parenteral and rectal Morphine hydrochloride Rectal Oxycodone hydrochloride Oral and parenteral administration in palliative care
Amendment of Schedule 5 to the POM Order
3
In the table in Part I of Schedule 5 to the POM Order (exemption from restrictions on sale or supply), in paragraph 6A, column 2, insert, at the appropriate place in the alphabetical order of the entries as they appear in that column, “Pilocarpine nitrate”.
Amendment of Schedule 1 to the Pharmacy and General Sale Order
4
In the table in Part I of Schedule 1 to the Pharmacy and General Sale Order, in paragraph 2A, in column 2, insert, at the appropriate place in the alphabetical order of the entries as they appear in that paragraph, “Pilocarpine nitrate”.
Signed by authority of the Secretary of State for Health
Jane Kennedy
Minister of State,
Department of Health
27th November 2005
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
Andrew McCormick
Permanent Secretary,
Department of Health, Social Services and Public Safety
2nd December 2005


text:
Establishment of fees
1
The fees appearing in the Tables of the Schedule to this Order are established and are substituted for the fees appearing in the Tables of the Schedule to the Ecclesiastical Judges, Legal Officers and Others (Fees) Order 2004 . The Tables of the Schedule to this Order contain particulars of the fees which are to be received, after the commencement of this Article —
1
by the ecclesiastical judges and legal officers named in that Schedule in respect of carrying out by them of the duties of their offices specified in that Schedule; and
2
by diocesan boards of finance in respect of the matters specified in Part II of Table I of that Schedule.
Revocation of 2004 Order
2
The Ecclesiastical Judges, Legal Officer and Others (Fees) Order 2004 is hereby revoked.
Supplementary annual fee
3
1
Subject to the provisions of this paragraph nothing in this Order shall preclude a diocesan board of finance from agreeing to pay an additional fee to a diocesan registrar by way of annual fee or retainer (hereinafter called a “supplementary annual fee”) which is in addition to the annual fee or fees prescribed by Order made under the Ecclesiastical Fees Measure 1986.
2
An agreement made under sub-paragraph (1) above shall be expressed to be an agreement for a payment by way of supplementary annual fee.
3
An agreement made under sub-paragraph (1) above shall be in writing. The period for which the agreement is to run shall be stated in the agreement. In the absence of any such statement the agreement shall remain binding until determined by not less that three months' notice on either side.
4
The body responsible for paying a supplementary annual fee shall be the diocesan board of finance.
Travel, subsistence, accommodation and court hearings
4
A fee specified in the Schedule to this Order (other than a fee specified in Part II of Table I of that Schedule) shall be increased by a sum for reasonable expenses of travel, subsistence, accommodation and the holding of court hearings.
Value Added Tax
5
Where Value Added Tax is chargeable in respect of the provision of any service for which a fee is prescribed in this Order there shall be payable in addition to that fee the amount of the Value Added Tax.
Citation and commencement
6
1
This Order may be cited as the Ecclesiastical Judges, Legal Officers and Others (Fees) Order 2005.
2
This Order shall come into operation on the first day of January 2006.
Approved by the General Synod on 8th July 2005
J Laws
G F Tattersall
H M Morgan
M A Chamberlain
A Whittam Smith
T E Allen
David Williams
Clerk to the Synod


text:
Citation and commencement
1
These Regulations may be cited as the Railways (Accident Investigation and Reporting) (Amendment) Regulations 2005 and shall come into force on 11th January 2006.
Amendment of the Railways (Accident Investigation and Reporting) Regulations 2005
2
1
The Railways (Accident Investigation and Reporting) Regulations 2005 shall be amended as follows.
2
In regulation 2(1), after the definition of “Safety Directive” insert —
“working days” shall be taken to exclude Saturdays, Sundays, Christmas Day, Good Friday and, in relation to an accident or incident that occurs in England and Wales, any day which, under the Banking and Financial Dealings Act 1971 , is a bank holiday in England and Wales, in relation to an accident or incident that occurs in Scotland, any other day which, under that Act, is a bank holiday in Scotland and, in relation to an accident or incident that occurs in Northern Ireland, any day which, under that Act, is a bank holiday in Northern Ireland.”
3
In regulation 12(4), before “determine” insert “reasonably”.
Alistair Darling
Secretary of State
Department for Transport
Date 23rd November 2005