text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000 and —
a
except for regulation 4(2), shall come into force on 1st March 2000; and
b
regulation 4(2) shall come into force on 1st March 2001.
2
In these Regulations, “the principal Regulations ” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 .
Amendment of regulation 1(2) of the principal Regulations
2
In the definition of “the relevant Community provisions” in regulation 1(2) of the principal Regulations (interpretation) —
a
in the list of Community provisions, at the end of the entry “Council Directive 75/318/ EEC ” there shall be added “as last amended by Commission Directive 1999/83/ EC ”; and
b
for the words from “as they have” to “into force” there shall be substituted the words “but the amendments to the Annex of Council Directive 75/318/EEC in Commission Directive 1999/82/EC shall only apply as respects new applications for marketing authorizations from 1st July 2000 and as respects all marketing authorizations from 1st March 2001”.
Insertion of regulation 3A into the principal Regulations
3
After regulation 3 of the principal Regulations (marketing authorizations for relevant medicinal products) there shall be inserted the following regulation —
Borderline products
3A
1
Where the licensing authority are of the opinion that a product without a marketing authorization is a relevant medicinal product, they may, by a notice in writing (referred to in this regulation as a “provisional determination notice”) served on any person who has placed or who in the opinion of the licensing authority may place the product on the market —
a
inform him that they are minded to determine that the product is a relevant medicinal product (referred to in this regulation as “the provisional determination”) and of the reasons why they are so minded; and
b
advise him that if he disagrees with the provisional determination, he may request that the licensing authority review their provisional determination, provided that within four weeks of the date on which the provisional determination notice was served on him (referred to in this regulation as “the date of the provisional determination”) he makes that request, and
i
within such period (being not less than six weeks from the date of the provisional determination) as may be specified in the provisional determination notice, he furnishes the licensing authority with written representations explaining why he considers that the product is not a relevant medicinal product, or
ii
within four weeks of the date of the provisional determination, he informs the licensing authority in writing that he wishes to make oral representations to a review panel, appointed by the licensing authority, explaining why he considers that the product is not a relevant medicinal product.
2
Where the licensing authority have been informed, pursuant to paragraph (1)(b)(ii), that a person wishes to make oral representations to a review panel, they shall, after consultation with that person, set a date for the oral hearing (at which the licensing authority may also make oral representations to the panel) and, subject to paragraph (3), that date shall be the date fixed for the oral hearing.
3
Where the licensing authority consider that, because of either exceptional circumstances or the nature and complexity of the issues, additional time is needed —
a
for the preparation of written representations in a case where the licensing authority have not been informed, pursuant to paragraph (1)(b)(ii), that the person on whom the provisional determination notice was served wishes to make oral representations, the licensing authority may alter the period specified in the notice within which written representations are to be furnished to a different period, and then that different period shall be the period within which the written representations are to be furnished;
b
for preparation for the oral hearing, they may alter the date set for the hearing to a different date, and then that different date shall be the date fixed for the oral hearing,
and they shall inform the person on whom the relevant provisional determination notice was served of the alteration and the reasons for it.
4
Where a person on whom a provisional determination notice has been served —
a
has not requested that the licensing authority review their provisional determination within four weeks of the date of the provisional determination; or
b
has made such a request but has not availed himself of the opportunities afforded to him under the procedure set out in this regulation to make representations explaining why he considers that the product in respect of which the provisional determination has been made is not a relevant medicinal product,
the licensing authority shall, after further consideration of the matter, determine whether or not the product is a relevant medicinal product and shall inform that person in writing of their determination and their reasons for it.
5
If a person on whom a provisional determination notice was served —
a
has made written representations to the licensing authority pursuant to paragraph (1)(b)(i), read with paragraph (3)(a), the licensing authority shall —
i
put those written representations before a review panel, appointed by the licensing authority, together with any written representations which the licensing authority may make to the panel on the matter, and
ii
after further consideration of the matter, and in particular after having considered the advice of the review panel arising out of those representations and any other evidence considered by the review panel,
determine whether or not the product is a relevant medicinal product;
b
has made oral representations to a review panel at an oral hearing arranged pursuant to paragraph (2), read with paragraph (3)(b), the licensing authority shall, after further consideration of the matter and in particular after having considered the advice of the review panel arising out of —
i
the oral representations made and any other evidence submitted to the panel at the hearing by that person,
ii
any oral representations made and any other evidence submitted to the panel at the hearing by the licensing authority, and
iii
any other evidence considered by the review panel,
determine whether or not the product is a relevant medicinal product,
and shall inform that person in writing of their determination and their reasons for it, and if the licensing authority make a determination which is contrary to the advice of the review panel, they shall also give their reasons for disagreeing with the advice of the review panel.
6
In respect of any product which the licensing authority determine, in accordance with paragraph (4) or (5), to be a relevant medicinal product, the licensing authority may, by a notice in writing served on any person who has placed or who in the opinion of the licensing authority may place the product on the market, require that he shall —
a
stop marketing the product from a date specified in the notice; or
b
not place the product on the market,
unless or until a marketing authorization is granted in respect of that product.
7
Nothing in this regulation precludes a determination by the licensing authority that a product is a relevant medicinal product otherwise than in accordance with this regulation in appropriate circumstances.
.
Amendment of Schedule 3 to the principal Regulations
4
1
After paragraph 1 of Schedule 3 to the principal Regulations (offences, penalties etc. ) there shall be inserted the following paragraph —
1A
In respect of any product which is a relevant medicinal product, where, following a determination under regulation 3A(4) or (5), the licensing authority serve a notice in respect of that product on any person under regulation 3A(6) requiring him —
a
to stop marketing the product from a date specified in the notice unless or until a marketing authorization is granted in respect of that product, if after the date specified —
i
he places that product on the market, or
ii
in the course of a business carried on by him, he sells, supplies to a member of the public or procures for sale or for supply to a member of the public that product,
without a marketing authorization having been granted in respect of that product, he shall be guilty of an offence;
b
not to place the product on the market unless or until a marketing authorization is granted in respect of that product, if he thereafter places the product on the market without a marketing authorization having been granted in respect of that product, he shall be guilty of an offence.
.
2
In paragraph 6(c) of Schedule 3 to the principal Regulations (offences, penalties etc. — obligations of holders of marketing authorizations), after the words “those Articles” there shall be added the words “or paragraph C.a of Part 2 of the Annex to Council Directive 75/318/EEC ”.
Amendment of Schedule 5 to the principal Regulations
5
In paragraph 5(1) of Schedule 5 to the principal Regulations (labels — relevant medicinal products on a general sale list), in paragraphs (f)(i) and (g)(i), for the word “case”, at each place where it occurs, there shall be substituted the word “event”.
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State
Department of Health
8th February 2000
Bairbre de Brún
Minister of Health, Social Services and Public Safety
3rd February 2000


type: legislation

jurisdiction: UK

text:
1
1
This Order may be cited as the Private Hire Vehicles (London) Act 1998 (Commencement No. 1) Order 2000.
2
In this Order “ the Act ” means the Private Hire Vehicles (London) Act 1998.
2
The following provisions of the Act shall come into force on 22nd January 2001 —
Sections 1, 3, 4(1), (3) and (4), 5(5), 15(1) to (3) and (5), 16(1) and (2), 17 to 20, 21(1) and (3), 22(1) and (4), 23 to 29, 32, 33, 34(1) and (2) and 36 to 38.
3
The following provisions of the Act shall come into force on 22nd October 2001 —
Sections 2, 4(5) and (6), 5(1) to (4), 21(4) and 22(5) and (6).
Signed by authority of the Secretary of State
Keith Hill
Parliamentary Under Secretary of State,
Department of the Environment, Transport and the Regions
28th November 2000


text:
Citation and commencement
1
These Regulations may be cited as the Social Security (Benefits for Widows and Widowers) (Consequential Amendments) Regulations 2000 and shall come into force on 9th April 2001.
Amendment of the Social Security (Hospital In-Patients) Regulations 1975
2
1
The Social Security (Hospital In-Patients) Regulations 1975 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 2(1) (definitions) at the appropriate places in the alphabetical order, insert —
“bereavement allowance” means an allowance referred to in section 39B of the Social Security Contributions and Benefits Act 1992 ; “widowed parent’s allowance” means an allowance referred to in section 39A of the Social Security Contributions and Benefits Act 1992 ;
.
3
In Schedule 2 (personal benefits) after “Widower’s pension under section 69 of the Act”, add —
Bereavement allowance
Widowed parent’s allowance
.
Amendment of the Social Security (Credits) Regulations 1975
3
1
The Social Security (Credits) Regulations 1975 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 2(1) (definitions) at the appropriate places in the alphabetical order, insert —
“bereavement allowance” means an allowance referred to in section 39B of the Contributions and Benefits Act ;
“bereavement benefit” means a benefit referred to in section 20(1)(ea) of the Contributions and Benefits Act;
“widowed parent’s allowance” means an allowance referred to in section 39A of the Contributions and Benefits Act;
.
3
In regulaton 3(1)(a) (which provides that contributions or earnings shall be credited only for the purpose of satisfying the second contribution condition in relation to certain benefits) after “widowed mother’s allowance,”, insert “widowed parent’s allowance, bereavement allowance,”.
4
In regulation 4 in the heading and in paragraph (1) (which provides for the crediting of Class 3 contributions for the purpose of entitlement to certain benefits) after “widowed mother’s allowance”, insert “, a widowed parent’s allowance, a bereavement allowance”.
5
In regulation 7A(1) (credits for invalid care allowance) after —
a
“widow”, insert “or widower”;
b
“widow’s benefit”, insert “, bereavement benefit”.
6
In regulation 7C(1) (which provides for the crediting of earnings equal to the prevailing weekly lower earnings limit in certain cases where working families' tax credit is being paid) after “a widowed mother’s allowance”, insert “, a widowed parent’s allowance, a bereavement allowance”.
7
After regulation 8B (credits for incapacity for work) , insert —
Credits on termination of bereavement benefits
8C
1
This regulation applies for the purpose only of enabling a person who previously received a bereavement benefit (“the recipient”) to satisfy, as the case may be, the condition referred to in —
a
paragraph 2(3)(b) of Schedule 3 to the Contributions and Benefits Act in relation to short-term incapacity benefit; or
b
section 2(1)(b) of the Jobseekers Act 1995 in relation to contribution-based jobseeker’s allowance.
2
For every year up to and including that in which the recipient ceased to be entitled to a bereavement benefit otherwise than by reason of remarriage or living together with a person of the opposite sex as husband and wife, the recipient shall be credited with such earnings as may be required to enable the condition referred to above to be satisfied.
.
Amendment of the Child Benefit and Social Security (Fixing and Adjustment of Rates) Regulations 1976
4
1
The Child Benefit and Social Security (Fixing and Adjustment of Rates) Regulations 1976 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 1(2) (definitions) at the appropriate place in the alphabetical order, insert —
“widowed parent’s allowance” means an allowance referred to in section 39A of the Social Security Contributions and Benefits Act 1992;
.
3
In regulation 2(5)(a)(ii) (which concerns “specified benefits” qualifying for the weekly rate of child benefit) after “widowed mother’s allowance” where those words first occur, insert “, widowed parent’s allowance”.
Amendment of the Social Security (Dependency) Regulations 1977
5
1
The Social Security Benefit (Dependency) Regulations 1977 shall be amended in accordance with the following paragraph of this regulation.
2
For regulation 4B (circumstances in which a person entitled to child benefit is to be treated as if he were not so entitled) , substitute —
Circumstances in which a person entitled to child benefit is to be treated as if he were not so entitled
4B
1
For the purposes of —
a
section 56 (child’s special allowance);
b
section 77 (guardian’s allowance);
c
section 80 (increase in benefit for beneficiary’s dependent children) ;
d
section 82(4) (short-term benefits — increase for adult dependents);
e
section 85(2) (pension increase (person with care of children));
f
section 90 (increase in benefits for beneficiaries under sections 68 and 70),
of the Contributions and Benefits Act, and
g
paragraphs 4(1) (unemployability supplement: increase for beneficiary’s dependent children) and 6(1) (unemployability supplement: increase for dependent adults) of Schedule 7 to,
that Act, a person who is entitled to child benefit in respect of a child shall be treated as if he were not so entitled for the periods referred to in paragraph (2) below.
2
The periods referred to in paragraph (1) above are —
a
any period throughout which —
i
the person referred to in that paragraph, not being a parent of the child, does not fall to be treated as responsible for the child under section 143(1)(a) of the Contributions and Benefits Act, and
ii
a parent of that child falls to be treated as responsible for the child under the said section 143(1)(a); or
b
any period throughout which —
i
that person, not being a parent of that child, falls to be treated as responsible for the child under section 143(1)(a) of the Contributions and Benefits Act, and
ii
a parent of that child also falls to be treated as responsible for the child under the said section 143(1)(a); or
c
any day following the day on which that child died.
3
Sub-paragraph (b) of paragraph (2) shall not apply in the case of a person who is wholly or mainly maintaining the child referred to in that sub-paragraph.
4
For the purposes of —
a
section 37(1) (entitlement to a widowed mother’s allowance);
b
section 39A(2) (entitlement to a widowed parent’s allowance);
c
section 56(1)(b);
d
section 77(1);
e
section 80;
f
section 82(4);
g
section 85(2);
h
section 90;
of the Contributions and Benefits Act, and
i
paragraphs 4(1), 6(1) and 18(1)(a)(ii) of Schedule 7 (industrial death benefit: child of deceased’s family) to,
that Act, a person who is entitled to child benefit in respect of a child shall be treated as if he were not so entitled for any period for which that benefit is not payable by virtue of any of the provisions referred to in paragraph (5) below.
5
The provisions referred to in paragraph (4) above are —
a
regulation 7 (circumstances in which a person who has ceased to receive full-time education is to continue to be treated as a child);
b
regulation 7A (exclusion from benefit of children aged 16 but under the age of 19 who are receiving advanced education);
c
regulation 7B (child receiving training under the youth training scheme); or
d
regulation 7C (child receiving income support),
of the Child Benefit (General) Regulations 1976 or any provision contained in regulations made under section 144(1) of the Contributions and Benefits Act in so far as those regulations provide that child benefit is not to be payable by virtue of section 142(1)(b) of that Act and regulations made thereunder.
.
Amendment of the Social Security (Overlapping Benefits) Regulations 1979
6
1
The Social Security (Overlapping Benefits) Regulations 1979 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 2(1) (definitions) at the appropriate places in the alphabetical order, insert —
“bereavement allowance” means an allowance referred to in section 39B of the Contributions and Benefits Act;
“widowed parent’s allowance” means an allowance referred to in section 39A of the Contributions and Benefits Act;
.
3
In paragraph 3 of Column (1) of Schedule 1 after “Widow’s benefit”, insert “, bereavement allowance, widowed parent’s allowance”.
Amendment of the Social Security (Widow’s Benefit and Retirement Pensions) Regulations 1979
7
1
The Social Security (Widow’s Benefit and Retirement Pensions) Regulations 1979 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 1(2) (definitions) at the appropriate places in the alphabetical order, insert —
“bereavement allowance” means an allowance awarded in accordance with section 39B of the Social Security Contributions and Benefits Act 1992;
“widowed parent’s allowance” means an allowance referred to in section 39A of the Social Security Contributions and Benefits Act 1992;
.
3
In regulation 6 (benefit at reduced rates for those who do not satisfy the contribution conditions in full) in —
a
paragraph (1) after sub-paragraph (a), insert —
aa
widowed parent’s allowance;
ab
bereavement allowance;
;
b
paragraph (2) after sub-paragraph (a), insert —
aa
widowed parent’s allowance;
;
c
paragraph (4)(b) after “widow’s pension”, insert “, bereavement allowance, widowed parent’s allowance”.
4
After regulation 7 (Category B retirement pension for certain widows by virtue of husband’s contributions) , add —
Category B retirement pension for surviving spouses by virtue of deceased spouse’s contributions
7A
1
For the purposes of entitlement of any person (“the pensioner”) to a Category B retirement pension under section 48BB of the Social Security Contributions and Benefits Act 1992 (Category B retirement pension: entitlement by reference to benefit under section 39A or 39B) (“the 1992 Act ”), the pensioner shall be treated as being entitled to a widowed parent’s allowance or a bereavement allowance as the case may be, if he would have been so entitled but for any one or more of the circumstances specifed in paragraph (2) below.
2
The circumstances referred to in paragraph (1) above are —
a
the pensioner’s failure to make, or his delay in making, a claim for that widowed parent’s allowance or bereavement allowance;
b
the operation of section 113 of the 1992 Act (disqualification and suspension) or section 73 of the Social Security Administration Act 1992 (overlapping benefits) or any regulations made under either of those sections, except for the operation of section 113(1)(a) of the 1992 Act (absence from Great Britain);
c
the operation of any provision of the 1992 Act or any regulations made under the 1992 Act, disqualifying the pensioner from receipt of that widowed parent’s allowance or bereavement allowance for any period except for the operation of the said section 113(1)(a);
d
the pensioner’s having attained pensionable age;
e
the pensioner’s having remarried.
3
Where this regulation applies the weekly rate of a Category B pension shall —
a
in the case of a pensioner treated as being entitled to widowed parent’s allowance immediately before attaining pensionable age in consequence of the death of his or her spouse, be that specified in section 48BB(2) of the 1992 Act;
b
in the case of a pensioner treated as being entitled to —
i
widowed parent’s allowance at any time when over the age of 45 but not immediately before attaining pensionable age, or
ii
bereavement allowance at any time prior to obtaining pensionable age,
be that specified in section 48BB(5) and (6) of the 1992 Act as the case may be.
.
5
In regulation 8(1) (which specifies who is entitled to a Category A retirement pension by virtue of the substitution of a former spouse’s contribution record) for sub-paragraph (b), substitute —
b
any man or woman widowed on or after attaining pensionable age, his or her former spouse, as the case may be, being under pensionable age when she or he died; and
.
Amendment of the Social Security (General Benefit) Regulations 1982
8
1
The Social Security (General Benefit) Regulations 1982 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 1(2) (definitions) at the appropriate place in the alphabetical order, insert —
“bereavement benefit” means a benefit referred to in section 20(1)(ea) of the Social Security Contributions and Benefits Act 1992;
.
3
In regulation 2(2) (which provides that a person is not to be disqualified from receiving certain benefits in cases of imprisonment or detention pending criminal proceedings unless a penalty is imposed in respect of such proceedings) after “widow’s benefit,”, insert “bereavement benefit,”.
Amendment of the Social Security (Claims and Payments) Regulations 1987
9
1
The Social Security (Claims and Payments) Regulations 1987 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 2(1) (definitions) —
a
at the appropriate places in the alphabetical order, insert —
“bereavement allowance” means an allowance referred to in section 39B of the Contributions and Benefits Act;
“bereavement benefit” means a benefit referred to in section 20(1)(ea) of the Contributions and Benefits Act;
“Contributions and Benefits Act” means the Social Security Contributions and Benefits Act 1992;
“widowed parent’s allowance” means an allowance referred to in section 39A of the Contributions and Benefits Act;
;
b
in the definition of “long-term benefits” after “a widow’s pension,”, insert “widowed parent’s allowance, bereavement allowance,”.
3
In regulation 3 (claims not required for entitlement to benefit in certain cases) —
a
in paragraph (a) after sub-paragraph (iii), add —
or
iv
bereavement benefit under Part II of the Contributions and Benefits Act;
;
b
in paragraph (d) —
i
in sub-paragraph (i) after “widowed mother’s allowance”, insert “or widowed parent’s allowance”,
ii
in sub-paragraph (ii) after “widow’s pension”, insert “or bereavement allowance”.
4
In regulation 19(3) (which specifies which benefits have to be claimed within the period specified in paragraph (2) of that regulation) after sub-paragraph (g), insert —
ga
bereavement benefit;
.
5
In Schedule 1, Part I (benefit claimed and other benefit which may be treated as if claimed in addition or in the alternative) —
a
in column (1) after “Widow’s benefit” , insert “or bereavement benefit”;
b
in column (2) after “Widow’s benefit”, insert “or bereavement benefit”.
6
In Schedule 6 (days for payment of long-term benefits) —
a
in paragraph 5, for sub-paragraph (b), substitute —
b
where —
i
a woman was entitled to a widow’s benefit, or
ii
a man or a woman was entitled to a bereavement benefit,
immediately before becoming entitled to a retirement pension, that pension shall be payable on Tuesdays;
b
in paragraph 6 after “Widowed mother’s allowance” insert, “, widowed parent’s allowance, bereavement allowance”.
7
In Schedule 7 (manner and time of payment, effective date of change of circumstances and commencement of entitlement in income support cases) —
a
in paragraph 2(c) after “widow’s benefit”, insert “or bereavement benefit”;
b
in paragraph 4 in the definition of “relevant social security benefit” after “retirement pension”, insert “, bereavement benefit”.
Amendment of the Social Security (Payments on account, Overpayments and Recovery) Regulations 1988
10
1
The Social Security (Payments on account, Overpayments and Recovery) Regulations 1988 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 1(2) (definitions) at the appropriate place in the alphabetical order, insert —
“bereavement benefit” means a benefit referred to in section 20(1)(ea) of the Contributions and Benefits Act;
“bereavement payment” means the sum specified in Part II of Schedule 4 to the Contributions and Benefits Act and referred to in section 36 of that Act ;
.
3
In regulation 8(1) (which specifies payments which can be recovered because they were not made on a prescribed date), after sub-paragraph (h) , insert —
i
any bereavement benefit other than a bereavement payment.
.
Signed by authority of the Secretary of State for Social Security.
Angela Eagle
Parliamentary Under-Secretary of State,
Department of Social Security
5th June 2000


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the London Borough of Tower Hamlets (Electoral Changes) Order 2000.
2
This Order shall come into force —
a
for the purpose of proceedings preliminary or relating to any election to be held on 2nd May 2002, on 10th October 2001;
b
for all other purposes, on 2nd May 2002.
3
In this Order —
“borough” means the London borough of Tower Hamlets;
“existing”, in relation to a ward, means the ward as it exists on the date this Order is made; and
any reference to the map is a reference to the map prepared by the Department of the Environment, Transport and the Regions marked “Map of the London Borough of Tower Hamlets (Electoral Changes) Order 2000”, and deposited in accordance with regulation 27 of the Local Government Changes for England Regulations 1994 .
Wards of the London borough of Tower Hamlets
2
1
The existing wards of the borough shall be abolished.
2
The borough shall be divided into seventeen wards which shall bear the names set out in the Schedule.
3
The wards shall comprise the areas designated on the map by reference to the names of the wards and demarcated by red lines; and the number of councillors to be elected for each ward shall be three.
4
Where a boundary is shown on the map as running along a road, railway line, footway, watercourse or similar geographical feature, it shall be treated as running along the centre line of the feature.
Revocation
3
The London Borough of Tower Hamlets (Electoral Arrangements) Order 1978 is hereby revoked.
Signed by authority of the Secretary of State for the Environment, Transport and the Regions
Beverley Hughes
Parliamentary Under Secretary of State,
Department of the Environment, Transport and the Regions
16th March 2000


text:
1
These Regulations may be cited as the Education (Grants) (Dance and Drama) (England) (Amendment) Regulations 2000 and shall come into force on 1st September 2000.
2
1
The Education (Grants) (Dance and Drama) (England) Regulations 2000 shall be amended as follows.
2
In the Table in Schedule 2, in the entry for the London Academy of Music and Dramatic Art for “£5913” in the fifth column there shall be substituted “£5973”.
Tessa Blackstone
Minister of State,
Department for Education and Employment
16th August 2000


text:
Citation and commencement
1
This Order may be cited as the Withernsea and Southern Holderness Rural Achievement Education Action Zone (Amendment) Order 2000 and shall come into force on 15th January 2001.
Amendment of the Withernsea and Southern Holderness Rural Achievement Education Action Zone Order 1999
2
1
The Withernsea and Southern Holderness Rural Achievement Education Action Zone Order 1999 shall be amended in accordance with paragraphs (2) and (3) of this article.
2
For article 5 there shall be substituted the following article —
5
The Forum may at any time appoint additional members as follows —
a
up to three persons who appear to the Forum to represent the interests of business;
b
up to three persons who appear to the Forum to represent the interests of the community in the area served by the zone schools;
c
one person nominated by the Education Joint Consultative Committee of the East Riding of Yorkshire Council, or by any successor body;
d
one person who appears to the Forum to represent the interests of support staff in the zone schools; and
e
up to four persons who appear to the Forum to represent the interests of teachers or organisations of teachers or both.
3
There shall be inserted after article 9 the following article —
Removal from office by Forum
9A
A member of the Forum may be removed from office by the Forum in the following circumstances —
a
in the case of a member who was a governor of a zone school at the time he was appointed to the Forum pursuant to paragraph (a) of article 4, if that person ceases to be a governor at that zone school;
b
in the case of any member appointed either pursuant to paragraph (a) of article 4 or, in the case of the Hedon Nursery school, paragraph (c), if any of the schools referred to in those paragraphs are discontinued;
c
in the case of a member appointed pursuant to paragraph (c) of article 4 (save for the member appointed by the headteacher of Hedon Nursery school), or paragraph (c) of article 5, if the body in question is dissolved or otherwise ceases to exist; and
d
in the case of a member appointed pursuant to paragraphs (a), (b), (d) or (e) of Article 5, if that person no longer appears to the Forum to represent the interests of either business, the community in the area served by the zone schools, the support staff in the zone schools, or teachers or organisation of teachers, as the case may be.
Estelle Morris
Minister of State,
Department for Education and Employment
16th December 2000


text:
Citation and commencement
1
These Regulations may be cited as the In Vitro Diagnostic Medical Devices Regulations 2000 and shall come into force on 7th June 2000.
Interpretation
2
1
In these Regulations, unless the context otherwise requires —
“the 1987 Act ” means the Consumer Protection Act 1987;
“the 1994 Regulations ” means the Medical Devices Regulations 1994 ;
“the 1995 Regulations ” means the Medical Devices Fees Regulations 1995 ;
“accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not —
itself an in vitro diagnostic medical device;
an invasive sampling medical device; or
a medical device which is directly applied to the human body for the purpose of obtaining a specimen;
“authorised representative” means a person established within the Community who, explicitly designated by the manufacturer (in accordance with regulation 13 or otherwise), acts for the manufacturer and may be addressed by authorities and bodies in the Community instead of the manufacturer;
“calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device;
“CE marking” means a conformity marking consisting of the initials “ CE”;
“common technical specification” means a technical specification for a relevant device referred to in a list in Annex II which has been adopted in accordance with the procedure set out in article 7(2) and published in the Official Journal of the European Communities;
“the Community” means the European Community;
“device for performance evaluation” means a product which is intended by its manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analysis or in other appropriate environments outside his own premises;
“device for self-testing” means an in vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment;
“ the Directive ” means Directive 98/79/ EC of the European Parliament and of the Council on in vitro diagnostic medical devices ;
“intended purpose” means the use for which a relevant device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials;
“ in vitro diagnostic medical device” means a medical device which —
is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and
is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information —
concerning a physiological or pathological state,
concerning a congenital abnormality,
to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or
to monitor therapeutic measures,
and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination;
“manufacturer” means —
the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; or
any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient;
“medical device” has the same meaning as the meaning given for “ device” in the 1994 Regulations;
“notified body” means, in relation to any task, a body designated and notified in respect of that task in accordance with article 15 or under regulation 15;
“placing on the market” means, in relation to a relevant device, the first making available in return for payment or free of charge of a new or fully refurbished relevant device with a view to distribution, use, or both, on the Community market;
“putting into service” means, in relation to a relevant device, the first making available of the device in the Community to a final user, including where a device is used in a professional context for the purposes of medical analysis without being marketed;
“relevant device” shall be construed in accordance with regulation 3(1);
“relevant essential requirement” means, in relation to a relevant device, an essential requirement which, for the purposes of regulation 4, applies to it;
“relevant harmonised standard” means a technical specification adopted, on a mandate from the European Commission, by the European Committee for Standardisation or the European Committee for Electrotechnical Standardisation, or by both of those bodies, in accordance with Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations , pursuant to the general guidelines on co-operation between the Commission and the said Committees signed on 13th November 1984;
“relevant national standard” means a standard transposing a relevant harmonised standard, the reference number of which has been published in the Official Journal of the European Communities;
“relevant notified body identification number” means, in relation to a relevant device, the identification number of the notified body responsible for implementation of the procedures set out in Annexes III , IV , VI and VII relating to assessment of that device by a notified body, that number being the identification number assigned to the notified body by the European Commission in accordance with article 15(1);
“specimen receptacle” means a medical device which (whether vacuum-type or not) is specifically intended by its manufacturer to be used for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination;
“supply”, in relation to a device, means the supply of, or offer or agreement to supply, the device, or the exposure or possession for supply of the device;
“ UK notified body” shall be construed in accordance with regulation 15(1).
2
In these Regulations, unless the context otherwise requires, a reference —
a
to a numbered regulation is to the regulation of these Regulations bearing that number;
b
in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter;
c
in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter; and
d
to a numbered article or Annex is to the article or Annex of the Directive bearing that number.
Scope of the Regulations
3
1
Subject to paragraph (3), the requirements of these Regulations in respect of relevant devices apply in respect of in vitro diagnostic medical devices and accessories to such devices, except for products manufactured and used within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity.
2
Subject to paragraph (3), the requirements of these Regulations in respect of devices for performance evaluation do not apply in respect of products manufactured and used only within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity.
3
Restriction notices under regulation 19(4) may be served in respect of any in vitro diagnostic medical device, any accessory to such a device, or any device for performance evaluation.
Essential requirements for relevant devices
4
1
Subject to regulation 8, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it.
2
Subject to regulation 8, no person shall supply a relevant device —
a
if that supply is also a placing on the market or putting into service of that device; or
b
in circumstances where that device has been placed on the market or put into service,
unless that device meets those essential requirements set out in Annex I which apply to it.
3
In determining which of the essential requirements in Annex I apply to a particular relevant device, account shall be taken of the intended purpose of the device.
4
In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English when the device reaches the final user, unless —
a
the Secretary of State, to the extent that the Directive allows him to do so, has authorised the use of another Community language or more than one other Community language; or
b
the relevant device is a device for self-testing, in which case the instructions for use and the label must include a translation into the official language of the member State in which the device reaches its final user.
5
A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant national standard.
6
A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.
CE marking
5
1
Subject to regulation 8, no person shall place on the market, put into service or supply (if that supply is also a placing on the market or putting into service) a relevant device unless, where practical and appropriate, that device bears a CE marking which —
a
meets the requirements set out in Annex X;
b
is in a visible, legible and indelible form; and
c
is accompanied by the relevant notified body identification number, if there is a relevant notified body identification number for that device.
2
Subject to regulation 8, no person shall place on the market, put into service or supply (if that supply is also a placing on the market or putting into service) a relevant device unless a CE marking, meeting the requirements set out in Annex X, appears on —
a
any sales packaging for that device; and
b
the instructions for use for that device,
and that CE marking is accompanied by the relevant notified body identification number, if there is a relevant notified body identification number for that device.
3
Subject to regulation 8, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on —
a
a relevant device;
b
the instructions for use for a relevant device; or
c
any sales packaging for a relevant device,
which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or legibility of the CE marking.
CE marking of relevant devices that come within the scope of more than one Directive
6
Where a relevant device comes both within the scope of the Directive and another directive (“the other directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other directive are satisfied, except where —
a
the other directive includes a provision allowing the manufacturer of the device to choose, during a transitional period, which set of arrangements applies to it;
b
the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and
c
whichever set of arrangements is chosen, the particulars of the other directive, as published in the Official Journal of the European Communities, are given in the documents, notices or instructions accompanying the device.
Relevant devices not ready for use
7
Subject to regulation 8, no person shall —
a
put into service a relevant device;
b
supply a relevant device —
i
if that supply is also a putting into service of that device, or
ii
in circumstances where that device has been placed on the market or put into service,
which is not ready for use.
Exemptions from regulations 4, 5 and 7
8
1
A relevant device being shown at a trade fair, exhibition, scientific gathering or technical gathering is not being placed on the market or put into service if —
a
the device is not used on any specimen taken from the participants; and
b
a visible sign clearly indicates that the device cannot be marketed or put into service until it complies with the requirements of the Directive or these Regulations.
2
Regulations 4, 5 and 7 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking.
Procedure for affixing a CE marking
9
1
A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a CE marking only if its manufacturer or his authorised representative —
a
fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;
b
declares, having taken into account where appropriate the matters referred to in article 9(5), that the device meets the provisions of the Directive which apply to it; and
c
ensures that the device meets the provisions of the Directive which apply to it.
2
A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a CE marking only if its manufacturer or his authorised representative —
a
fulfils the applicable obligations imposed by —
i
Sections 1 to 6 of Annex III,
ii
Annex IV, or
iii
Annex V and either Annex VI or Annex VII;
b
declares, having taken into account where appropriate the matters referred to in article 9(5), that the device meets the provisions of the Directive which apply to it; and
c
ensures that the device meets the provisions of the Directive which apply to it.
3
A relevant device referred to in List A in Annex II may bear a CE marking only if its manufacturer or his authorised representative —
a
fulfils the applicable obligations imposed by —
i
Annex IV, or
ii
Annexes V and VII;
b
declares, having taken into account where appropriate the matters referred to in article 9(5), that the device meets the provisions of the Directive which apply to it; and
c
ensures that the device meets the provisions of the Directive which apply to it.
4
A relevant device referred to in List B in Annex II may bear a CE marking only if its manufacturer or his authorised representative —
a
fulfils the applicable obligations imposed by —
i
Annex IV,
ii
Annexes V and VI, or
iii
Annexes V and VII;
b
declares, having taken into account where appropriate the matters referred to in article 9(5), that the device meets the provisions of the Directive which apply to it; and
c
ensures that the device meets the provisions of the Directive which apply to it.
Supplemental provisions relating to conformity assessment procedures
10
1
Where a conformity assessment procedure set out in the Directive involves the intervention of a notified body, the manufacturer of a relevant device or his authorised representative may apply to any notified body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.
2
Where a manufacturer or his authorised representative has supplied information or data to a notified body in the course of a conformity assessment procedure set out in the Directive, the notified body may, where duly justified, require the manufacturer or his authorised representative to provide any additional information or data which the notified body considers necessary for the purposes of that procedure.
3
The information, data and correspondence that a manufacturer or his authorised representative supplies to a notified body in the course of a conformity assessment procedure set out in the Directive shall, if the notified body is within the United Kingdom, be in English or some other Community language acceptable to the notified body concerned.
4
A manufacturer or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in the Directive in respect of a relevant device, shall observe the manufacturer’s obligations set out in that procedure that apply to him.
5
A manufacturer or, where applicable, his authorised representative shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State —
a
the declaration of conformity for that device;
b
the technical documentation referred to in Annexes III to VIII relating to that device; and
c
the decisions, reports and certificates of notified bodies relating to that device,
for a period ending five years after the manufacture of the last product.
6
A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine .
7
Until the European databank referred to in article 12 has been established, the manufacturer or, where applicable, his authorised representative shall, in respect of any relevant device which the manufacturer has placed on the market in the United Kingdom, provide the Secretary of State with the data referred to in article 12(1)(a), and that data shall be provided in English.
CE marking of a product which is not a relevant device
11
1
No person shall —
a
affix a CE marking for a relevant device to a product which is not a relevant device;
b
place on the market or supply (if that supply is also a placing on the market) a product which has affixed to it a CE marking for a relevant device if that product is not a relevant device.
2
No person shall provide information comprising a CE marking for a relevant device on a product, the instructions for use for a product or the sales packaging of a product if the product is not a relevant device.
Devices for performance evaluation
12
A device for performance evaluation may be made available only if the manufacturer or his authorised representative —
a
has drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;
b
ensures that —
i
the device conforms with the documentation mentioned in the said section 2, and
ii
the relevant requirements of the Directive are complied with as respects that device; and
c
undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.
Designation of authorised representatives for registration purposes
13
A manufacturer without a registered place of business in the Community who, under his own name —
a
places a relevant device on the market; or
b
makes available a device for performance evaluation,
shall designate an authorised representative as the person responsible for performing the functions of an authorised representative referred to in regulation 14.
Registration of manufacturers etc. of devices
14
For the purpose of enabling the Secretary of State to exercise his functions under these Regulations, a manufacturer with a registered place of business in the United Kingdom who places a relevant device on the market or who makes available a device for performance evaluation, under his own name, or an authorised representative designated in accordance with regulation 13, shall give the Secretary of State the following information —
a
the address of his registered place of business in the United Kingdom;
b
in the case of an authorised representative, sufficient evidence that he is the authorised representative of the manufacturer;
c
in relation to a new relevant device, evidence that the device is a new relevant device, and for the purposes of this regulation a device is a “ new relevant device” if —
i
there has been no such device continuously available on the Community market during the previous three years for the relevant analyte or other parameter, or
ii
use of the device involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community market during the previous three years;
d
in relation to a new relevant device, if requested by the Secretary of State (such a request only being permissible within two years from the date on which the Secretary of State was notified that the device was a new relevant device, and on justified grounds), a report relating to the experience gained with the device subsequent to its being placed on the market;
e
if the device wholly or partly consists of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and/or analytes;
f
if the device does not wholly or partly consist or reagents, reagent products or calibration and control materials, the appropriate indications;
g
in relation to devices referred to in a list in Annex II and devices for self-testing —
i
all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I, the outcome of performance evaluation pursuant to Annex VIII, and certificates, and
ii
if requested by the Secretary of State, the labelling and the instructions for use for when the device is placed on the market or put into service within the United Kingdom;
h
in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I,
and shall notify him of any significant change to that information including discontinuation of the placing on the market of the device.
Designation etc. of notified bodies
15
1
The Secretary of State may designate for the purposes of article 15 any corporate or other body as a body which is to carry out any of the tasks of a notified body, and, if he so designates a body (referred to hereafter as a “UK notified body”), he shall designate the tasks which it is to carry out.
2
A body may be designated under paragraph (1) as a body which is to carry out tasks of a notified body only if it is a body in respect of which the criteria for the designation of notified bodies set out in Annex IX are met.
3
The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under the 1995 Regulations in connection with an application for designation.
4
The Secretary of State may vary the tasks that a UK notified body may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.
5
The Secretary of State may place a restriction in relation to or withdraw any designation of a body under paragraph (1) if —
a
the body so requests; or
b
he considers that it is no longer a body in respect of which the criteria set out in Annex IX are met,
and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under the 1995 Regulations.
6
Before —
a
effecting a variation under paragraph (4); or
b
withdrawing designation under paragraph (5),
otherwise than at the notified body’s request, the Secretary of State shall give to the notified body an opportunity to make representations to him in writing and shall take into account any such representations as are made.
7
For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex IX are met as respects the tasks which it wants to carry out or carries out, the Secretary of State may arrange for the inspection of —
a
any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or
b
any premises occupied, or plant or equipment used, by a manufacturer where the body is a notified body undertaking any task in relation to that manufacturer,
and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.
Functions of notified bodies
16
1
A UK notified body to which an application has been made by a manufacturer or his authorised representative to perform the functions of a notified body under a conformity assessment procedure set out in the Directive shall perform those functions, if those functions are within the framework of tasks which the body is designated to carry out.
2
A UK notified body shall lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.
3
Where a UK notified body takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which initially shall be a period of not more than 5 years.
4
Where a UK notified body and a manufacturer or his authorised representative have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of the decision, the body may, on application from and with the agreement of the manufacturer or his authorised representative, extend the period of validity of the decision for further periods of up to 5 years.
5
A UK notified body shall, in carrying out a conformity assessment procedure for affixing the CE marking to a relevant device, take into account where appropriate the matters referred to in article 9(5).
6
A UK notified body which is responsible for carrying out a conformity assessment procedure in connection with a relevant device shall, in doing so, take account of any relevant information relating to the characteristics and performance of that device, including in particular the results of any relevant tests and verification relating to that device already carried out before these Regulations come into force.
7
A UK notified body shall inform all other notified bodies and the Secretary of State of —
a
all certificates suspended or withdrawn; and
b
on request, all certificates issued or refused,
and shall also make available to them, on request, any or all additional relevant information.
8
Where, as respects a relevant device, a UK notified body finds that —
a
the applicable requirements of the Directive have not been met or are no longer met; or
b
a certificate issued by it should not have been issued,
it may (having regard in particular to the principle of proportionality and the ability of the manufacturer to take appropriate corrective measures) suspend or withdraw the certificate issued in respect of that device or place restrictions on it, and in such cases, or in cases where the notified body is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 18 or 19, the notified body shall inform the Secretary of State thereof.
9
The Secretary of State may request that a UK notified body supply to him any or all relevant information and documents, including budgetary documents, necessary to enable him to verify that the body meets the criteria set out in Annex IX, and the body shall supply to him the relevant information and documents so requested.
Fees charged by UK notified bodies
17
1
A UK notified body may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with, performing the functions of a notified body under a conformity assessment procedure set out in the Directive.
2
Except as provided by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.
3
Where the UK notified body charging the fee is a body the activities of which are carried on for profit, the fee for doing anything may include an amount representing a profit which is reasonable in the circumstances, having regard to —
a
the character and extent of the work done or to be done by the notified body; and
b
the commercial rate normally charged in respect of profit for that work or similar work.
4
The UK notified body may require payment of a fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.
Enforcement etc.
18
1
Notwithstanding that they are made partly in exercise of powers other than those conferred by section 11 of the 1987 Act, these Regulations shall be regarded for all purposes relating to enforcement (whether by criminal proceedings or notices or otherwise) and for the purposes of section 38 of that Act (disclosure of information) as safety regulations as defined in that Act and any provision of these Regulations made under those other powers shall be regarded for those purposes as a safety provision as defined in that Act .
2
Except as provided by paragraph (3), each weights and measures authority in Great Britain and each district council in Northern Ireland is relieved of its duty imposed by section 27(1) of the 1987 Act in so far as it is exercisable in relation to relevant devices, and that duty is transferred to the Secretary of State.
3
Paragraph (2) does not relieve an authority or council of its duty in relation to relevant devices which are consumer goods for the purposes of Part II of the 1987 Act , and accordingly but subject to paragraph (4), each weights and measures authority in Great Britain and each district council in Northern Ireland shall, concurrently with the Secretary of State, enforce these Regulations in relation to such devices.
4
The powers of an enforcement authority to serve restriction notices under regulation 19(4) are only exercisable by the Secretary of State.
5
Each authority and council referred to in paragraph (3) on whom a duty is imposed by section 27(1) of the 1987 Act to enforce the provisions of these Regulations shall give immediate notice to the Secretary of State of —
a
any suspension notice served by it under section 14 of the 1987 Act in respect of a device to which paragraph (3) applies;
b
any application made by it under section 16 of the 1987 Act for an order for forfeiture of any such device; and
c
any other thing done by it in respect of such a device for the purposes of, or in connection with the operation of, sections 14 to 17 of the 1987 Act.
6
The powers conferred by section 13 of the 1987 Act to serve prohibition notices and notices to warn are exercisable in relation to non-conforming devices as they are exercisable in relation to relevant goods which the Secretary of State considers are unsafe (as well as being exercisable in relation to such goods), and in relation to non-conforming devices, Schedule 2 to the 1987 Act shall have effect as if references to goods being unsafe or safe were references to relevant devices being or not being non-conforming devices.
7
In paragraph (6), “non-conforming devices” means —
a
relevant devices which, whether or not the Secretary of State considers then unsafe, are devices with or that require a CE marking which he considers to be devices —
i
which do not conform as respects a relevant essential requirement, or
ii
to which a CE marking has or should have been applied following a conformity assessment procedure set out in the Directive, and —
aa
the manufacturer or his authorised representative has failed to comply with his obligations under that procedure, or
bb
they do not conform to the design or type described in any relevant EC design-examination certificate or EC type-examination certificate; or
b
devices for performance evaluation which, whether or not the Secretary of State considers them unsafe, are devices in respect of which there is a failure to comply with these Regulations.
7
The Secretary of State shall perform, as respects the United Kingdom, the functions of a member State under article 11(1) to (3).
Notice procedures
19
1
Except in the case of a device which in the opinion of an enforcement authority is likely to compromise the health or safety of any person, where an enforcement authority has reasonable grounds for suspecting that a relevant device or a device for performance evaluation is a device in respect of which there is a failure to comply with these Regulations, that authority may serve upon the manufacturer or his authorised representative a notice —
a
specifying the description of the device to which the notice relates;
b
stating that the enforcement authority suspects the device is a device in respect of which there is failure to comply with these Regulations and the reasons for that suspicion;
c
specifying the relevant provision of these Regulations;
d
requiring the person on whom the notice is served —
i
to secure that any device to which the notice relates conforms as regards the specified provision within such period as may be specified in the notice, or
ii
to provide evidence within that period to the satisfaction of the enforcement authority that all the provisions of these Regulations have been complied with so far as they relate to that device; and
e
warning the person on whom the notice is served that unless the requirements of sub-paragraph (d) are met, further action may be taken under these Regulations or the 1987 Act in respect of that device or any device of the same type supplied by that person.
2
Where an enforcement authority serves a notice referred to in paragraph (1), section 14, 16 or 17 of the 1987 Act shall not be applied as respects any device to which the notice relates until the period referred to in paragraph (1)(d) has expired and unless, in relation to the alleged failure to comply with these Regulations, at the expiry of that period the person on whom the notice was served has failed to comply with its requirements.
3
The notice referred to in paragraph (1) may include directions as to the measures to be taken by the person on whom the notice is served to secure compliance with the provisions of these Regulations including different ways of securing compliance, and any such directions as are included are requirements of the notice for the purposes of paragraph (2).
4
Where an enforcement authority is of the opinion that it is necessary to restrict the availability of —
a
a particular in vitro diagnostic medical device, a particular accessory to such a device or a particular device for performance evaluation; or
b
in vitro diagnostic medical devices, accessories to such devices or devices for performance evaluation of a particular class or description,
in order to protect the health or safety of any individual or of individuals of any class or description, they may serve on any person a notice (“a restriction notice”) including such directions restricting the availability of that device or those devices as appear to them to be necessary in order to protect the health or safety of that individual or individuals of that class or description.
5
The enforcement authority responsible for serving a restriction notice may, in appropriate circumstances, withdraw the notice.
6
A direction in a restriction notice that has not been withdrawn by an enforcement authority or set aside by an order of a court or a sheriff is a safety provision for the purposes of sections 14 to 17 of the 1987 Act.
7
Where, in the course of or as a result of enforcement action in relation to a suspected contravention of a direction in a restriction notice, an application has been made to a magistrates' court or a sheriff —
a
under section 15 of the 1987 Act (appeals against suspension notices), the court or the sheriff may make an order setting aside the restriction notice and any suspension notice served in respect of the suspected contravention of the direction;
b
under section 16 or 17 of the 1987 Act (which relate to forfeiture of goods), the court or the sheriff may make an order setting aside the restriction notice,
if the court or the sheriff is satisfied that the restriction notice should not have been served or should be withdrawn.
8
In England, Wales or Northern Ireland, for the purposes of the rights of appeal under section 15(5) and 16(5) of the 1987 Act, an order or decision not to make an order —
a
under paragraph 7(a) is an order or decision not to make an order under section 15 of the 1987 Act;
b
under paragraph 7(b) is an order or decision not to make an order under section 16 of the 1987 Act,
and a decision, in Scotland, not to make an order under paragraph 7(b) may, within 21 days of the decision, be appealed to the High Court by Bill of Suspension on the ground of an alleged miscarriage of justice, and the appeal shall be treated in the same way as an appeal under section 17(8) of the 1987 Act.
Transitional provisions
20
1
These Regulations shall not apply before 7th December 2003 in respect of a device placed on the market which is —
a
a relevant device without a CE marking; or
b
a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,
if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 7th December 1998.
2
These Regulations shall not apply before 7th December 2005 in respect of a device put into service which is —
a
a relevant device without a CE marking; or
b
a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,
if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is put into service as in force on 7th December 1998.
Notification of decisions etc.
21
1
Any decision taken by a UK notified body, the Secretary of State or any other enforcement authority pursuant to these Regulations to refuse or restrict the placing on the market or making available of a relevant device, or to withdraw a relevant device from the market, shall be notified to the person proposing to or responsible for placing the device on the market or putting the device into service without delay, and that person shall be informed —
a
of the grounds on which the decision is based;
b
of the legal remedies available to that person and of any time limits which apply to their exercise; and
c
if he was not entitled under the 1987 Act to make representations in respect of the decision, that the decision maker will, on request, review the decision and in the course of so doing will give him or his authorised representative an opportunity to make representations in respect of the decision.
2
Except in cases where urgent action is justified (in particular by public health requirements), if a UK notified body, the Secretary of State or any other enforcement authority is considering making a decision referred to in paragraph (1), they or he shall give the manufacturer or his authorised representative an opportunity to make representations to them or him before the decision is taken.
Amendments to the 1994 Regulations
22
The amendments to the 1994 Regulations set out in Schedule 1 to these Regulations shall have effect.
Amendments to the 1995 Regulations
23
The amendments to the 1995 Regulations set out in Schedule 2 to these Regulations shall have effect.
Hunt
Parliamentary Under Secretary of State,
Department of Health
6th May 2000
We consent,
Clive Betts
Bob Ainsworth
Two of the Lords Commissioners of Her Majesty’s Treasury
11th May 2000


text:
Citation and commencement
1
This Order may be cited as the GLA Roads and Side Roads (Transfer of Property etc.) (Modification) (College Farm, Finchley) Order 2000, and shall come into force on 9th October 2000.
Modification of Order
2
The GLA Roads and Side Roads (Transfer of Property etc.) Order 2000 shall be deemed for all purposes to have come into force with the following inserted at end of paragraph (b) of article 2(2) (property reserved from transfer) —
or
c
all property of the Secretary of State comprised in and relating to College Farm, Fitzalan Road (including 47 and 49 Fitzalan Road), Finchley, London N3 3PG as the same is registered at H.M. Land Registry with title absolute under Title Numbers MX141872 and NGL 244982
.
Signed by authority of the Secretary of State
Keith Hill
Parliamentary Under Secretary of State
Department of the Environment, Transport and the Regions
12th September 2000


text:
Citation and commencement
1
This Order may be cited as the Road Traffic (Permitted Parking Area and Special Parking Area) (Metropolitan Borough of Bolton) Order 2000 and shall come into force on 4th September 2000.
Interpretation
2
In this Order —
“the 1984 Act ” means the Road Traffic Regulation Act 1984 ;
“the 1991 Act ” means the Road Traffic Act 1991; and
“the parking area” means the area designated as a permitted parking area and as a special parking area by article 4 of this Order.
Application
3
This Order applies to the Metropolitan Borough of Bolton with the exception of that section of the A666 trunk road, together with its on and off slip roads, from its junction with the M61 Motorway to its junction with Topway/ St. George’s Road.
Designation of permitted parking area and special parking area
4
The Secretary of State hereby designates the area to which this Order applies as —
a
a permitted parking area; and
b
a special parking area.
Modification and application of Part II of the 1991 Act
5
Sections 66, 69 to 74, 78, 79 and 82 of, and Schedule 6 to, the 1991 Act shall apply in relation to the parking area and as so applied shall have effect subject to the modifications specified in Schedule 1 to this Order.
Modification of other provisions
6
The 1984 Act shall be modified in relation to the parking area as specified in Schedule 2 to this Order.
Signed by authority of the Secretary of State
Keith Hill
Parliamentary Under Secretary of State,
Department of the Environment, Transport and the Regions
8th August 2000


text:
1
This Order may be cited as the Immigration (Passenger Information) Order 2000 and shall come into force on 28th April 2000.
2
1
Subject to paragraph (2), the information listed in the Schedule to this Order is specified for the purposes of paragraph 27B(9) of Schedule 2 to the Immigration Act 1971 (definition of “passenger information”).
2
The information listed in Part II of the Schedule to this Order is so specified only to the extent that it is known to the carrier.
Barbara Roche
Minister of State
Home Office
29th March 2000


text:
Citation, commencement, interpretation and application
1
1
This Order may be cited as the Education (National Curriculum) (Attainment Targets and Programmes of Study in Science) (England) Order 2000 and shall come into force on 1st August 2000.
2
In this Order —
“The Document” means the Document published by the Stationery Office entitled “Attainment Targets and Programmes of Study in Science” .
3
This Order applies only to pupils at:
a
any community, foundation or voluntary school; or
b
any community or foundation special school not established in a hospital,
in England.
Revocation
2
The Education (National Curriculum) (Attainment Targets and Programmes of Study in Science) Order 1995 is hereby revoked.
Specification of attainment targets and programmes of study
3
It is hereby directed that the provisions relating to attainment targets and programmes of study set out in the Document shall have effect for the purposes of specifying attainment targets and programmes of study in relation to Science.
4
The examples [and other passages] printed in grey text within square brackets in the Document (which serve to illustrate the programmes of study described therein [or relate to background information]) do not form part of the provisions made by this Order.
Jacqui Smith
Parliamentary Under-Secretary of State,
Department for Education and Employment
13th June 2000


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the Northern Lincolnshire and Goole Hospitals National Health Service Trust (Establishment) Order 2000 and shall come into force on 31st October 2000.
2
In this Order, unless the context otherwise requires —
“ the Act ” means the National Health Service and Community Care Act 1990;
“community health services” means any services which the Secretary of State may provide under section 3(1)(d) or (e) of or Schedule 1 to the National Health Service Act 1977 and any service which he has a duty to provide under section 5(1) or (1A) of that Act ;
“establishment date” means 31st October 2000;
“operational date” has the meaning assigned to it in paraghraph 3(1)(e) of Schedule 2 to the Act;
“the trust” means the Northern Lincolnshire and Goole Hospitals National Health Service Trust established by article 2 of this Order.
Establishment and name of trust
2
There is hereby established an NHS trust which shall be called the Northern Lincolnshire and Goole Hospitals National Health Service Trust.
Nature and functions of the trust
3
1
The trust is established for the purposes specified in section 5(1) of the Act.
2
The trust’s functions shall be to provide hospital accommodation and services and community health services at or from:
a
Diana Princess of Wales Hospital, Scartho Road, Grimsby DN33 2BA;
b
Goole and District Hospital, Woodland Avenue, Goole;
c
Scunthorpe General Hospital, Cliff Gardens, Scunthorpe;
and at or from any associated hospitals, establishments and facilities.
Directors of trust
4
The trust shall have in addition to the chairman five executive directors and six non-executive directors.
Operational date and accounting date of the trust
5
1
The operational date shall be 1st April 2001.
2
The accounting date of the trust shall be 31st March.
Limited functions before operational date
6
Between its establishment date and its operational date the trust shall have the functions —
a
of entering into NHS contracts;
b
of entering into other contracts including contracts of employment; and
c
of doing such other things as are reasonably necessary to enable it to operate satisfactorily with effect from its operational date.
Assistance by Health Authorities before operational date
7
1
The South Humber Health Authority shall discharge the liabilities of the trust incurred during the period from and including the establishment date until the operational date that are of a description specified in paragraph (2) of this article.
2
The liabilities referred to in the previous paragraph are —
a
liability for the remuneration and travelling or other allowances of the chairman and non-executive directors of the trust;
b
liability for the travelling or other allowances of the members of committees and sub-committees of the trust who are not also directors of the trust;
c
liability for the remuneration of persons employed by the trust; and
d
any other liability which may reasonably be incurred by the trust for the purpose of enabling it to begin to operate satisfactorily with effect from the operational date.
Signed by authority of the Secretary of State for Health
Yvette Cooper
Parliamentary Under Secretary of State for Public Health,
Department of Health
20th October 2000


text:
Citation, commencement and extent
1
1
These Regulations may be cited as the Primary Care Trusts (Functions) (England) Regulations 2000 and shall come into force on 1st April 2000.
2
These Regulations apply only in relation to Health Authorities and Primary Care Trusts established for areas in England.
Interpretation
2
1
In these Regulations, unless the context otherwise requires–
“ the Act ” means the National Health Service Act 1977;
“the 1997 Act ” means the National Health Service (Primary Care) Act 1997 ;
“appropriate Health Authority” means, in relation to a Primary Care Trust, the Health Authority within whose area the trust is established;
“delegable function” is to be construed in accordance with section 17A(2) of the Act;
“the Functions Regulations ” means the National Health Service (Functions of Health Authorities and Administration Arrangements) Regulations 1996 ;
“research ethics committee” means a committee established or recognised by a Health Authority to advise on the ethics of research investigations on human beings;
“PCT order” shall be construed in accordance with section 16A(2) of the Act ;
“population screening programme” means a programme for testing a particular class of persons for the purpose of detecting whether those persons have a particular illness or are at risk of contracting such an illness;
“practice patient” means–
in relation to a medical practitioner who practices otherwise than in partnership, an individual who is on that practitioner’s list of patients (or, if that practitioner and one or more other medical practitioners together have a single list of patients in connection with a pilot scheme under the 1997 Act , an individual who is on that single list);
in relation to a medical practitioner who is one of two or more practitioners who practise in partnership with each other, an individual who is on the list of patients of any of those practitioners (or, if any of those practitioners together have a single list of patients in connection with a pilot scheme under the 1997 Act, an individual who is on that single list);
“the relevant date” means–
1st April 2000;
1st April in the year preceding the year in which the identity of the relevant Health Authority or relevant Primary Care Trust falls to be determined;
in the case of a practitioner providing general medical services and who practices otherwise than in partnership, the date on which he first entered the Health Authority’s medical list;
in the case of a practitioner providing general medical services who is one of two or more practitioners who practise in partnership with each other, the earliest date on which any one of those practitioners entered the Health Authority’s medical list;
in the case of a practitioner performing personal medical services in connection with a pilot scheme under the 1997 Act, the date on which services were first performed under that scheme; or
the date on which the Primary Care Trust in question was established, whichever is the latest;
“relevant Health Authority” means–
in relation to a medical practitioner–
who provides general medical services under Part II of the Act and does not perform personal medical services in connection with a pilot scheme;
whose name is included in the medical list of only one Health Authority; and
who practises on his own or in partnership with others all of whom are medical practitioners who provide general medical services under Part II of the Act and do not perform personal medical services in connection with a pilot scheme and whose names are included only in that Authority’s medical list,
that Authority;
in relation to any other medical practitioner, the Health Authority in whose area, on the relevant date, most of the practitioner’s practice patients at that date were living;
“relevant Primary Care Trust” means, in relation to a medical practitioner, the Primary Care Trust–
which is in the area of the Health Authority which is the practitioner’s relevant Health Authority, and
in whose area, at the relevant date, most of the practitioner’s practice patients living at that date in the area of that authority were living.
2
In Schedule 2, “suspended doctor” means a medical practitioner who is suspended as respects the provision of general medical services by a direction of the Tribunal constituted under section 46 of the Act made pursuant to section 49A(2) or section 49B(1) of the Act (or to any provisions in force in Scotland or Northern Ireland corresponding to those provisions).
3
For the purposes of these Regulations, the persons for whom a Primary Care Trust is responsible in any year are–
a
the practice patients of the medical practitioners providing general medical services under the Act, or performing personal medical services in connection with a pilot scheme under the 1997 Act, in respect of whom the trust is the relevant Primary Care Trust;
b
the persons usually resident in the area for which the trust is established and who are not practice patients of any medical practitioner providing general medical services under the Act or performing personal medical services in connection with a pilot scheme under the 1997 Act.
4
Subject to any directions which the Secretary of State may give as to any particular case or classes of case, if there is doubt as to where a person is usually resident for the purposes of paragraph (3)(b)–
a
he shall be treated as usually resident at the address which he gives, to the person or body providing him with services, as being that at which he usually resides;
b
where he gives no such address, he shall be treated as usually resident at the address which he gives, to the person or body providing him with services, as being his most recent address;
c
where his usual residence cannot be determined under sub-paragraphs (a) and (b) above; he shall be treated as usually resident in the area in which he is present.
Functions to be exercised by Primary Care Trusts
3
1
Subject to regulation 6 and to any prohibitions or restrictions in a PCT order–
a
the functions specified in paragraph (2) are to be exercisable by a Primary Care Trust to the extent specified in paragraphs (3) to (7); and
b
each Health Authority must direct each Primary Care Trust in relation to which they are the appropriate Health Authority to exercise those functions to that extent.
2
The functions referred to in paragraph (1) are–
a
those delegable functions exercisable by virtue of regulation 3(1) of the Functions Regulations and which are conferred on the Secretary of State under or by virtue of the enactments specified in column (1) of Schedule 1 to these Regulations (the subject matter of the relevant functions being indicated in column (2) of that Schedule);
b
those delegable functions exercisable under or by virtue of the enactments specified in column (1) of Schedule 2 to these Regulations (the subject matter of the relevant functions being indicated in column (2) of that Schedule);
c
those delegable functions exercisable under or by virtue of the regulations specified in column (1) of Schedule 3 to these Regulations, to the extent specified in column (2) of that Schedule.
3
Paragraph (1) does not apply to the functions specified in paragraph (2) to the extent that they consist of providing or securing the provision of such facilities or services as the Secretary of State may direct; but, subject to any directions given by the Secretary of State, nothing in this paragraph prevents an appropriate Health Authority from directing a Primary Care Trust to exercise those functions to that extent, in accordance with regulation 5.
4
Subject to paragraph (7), the functions specified in paragraph (2) are to be exercised by a Primary Care Trust–
a
in so far as those functions consist of providing or securing the provision of services to patients, other than the services specified in sub-paragraphs (b) to (e), for the benefit of the persons for whom the trust is responsible;
b
in so far as those functions consist of providing or securing the provision of–
i
accident and emergency services; and
ii
any other services which the Secretary of State may direct,
for the benefit of all persons present in its area;
c
in so far as those functions consist of providing and securing the provision of services under section 117 of the Mental Health Act 1983 (after-care of persons detained under that Act), for the benefit of persons who leave hospital after being detained under the Act and are resident in, or sent on discharge by that hospital to, the trust’s area;
d
in so far as those functions relate to general medical services, in relation to any medical practitioner on the medical list of the appropriate Health Authority and for which the trust is the relevant Primary Care Trust;
e
in so far as those functions relate to pilot schemes under the 1997 Act, for the benefit of persons within the area of the appropriate Health Authority and for whom the trust is responsible;
f
in so far as those functions consist of any other functions, generally as respects its area.
5
The functions under section 45(1) of the Act (consultation of local representative committees) are to be exercisable by a Primary Care Trust only in so far as they relate to any function specified in paragraph (2)(c) relating to general medical services.
6
The functions under the 1997 Act are not to be exercisable by a Primary Care Trust to the extent that they relate to a pilot scheme made before the date on which the trust was established, except with the consent of the persons providing services under that scheme.
7
The functions specified in paragraph (2) are to be exercisable by a Primary Care Trust only to the extent that they do not consist of–
a
providing or securing the provision of emergency ambulance services;
b
ensuring that arrangements for public health surveillance and protection are in place with respect to the area of the appropriate Health Authority, including arrangements for–
i
the surveillance, prevention and control of the spread of, and the collation and provision of information relating to, communicable disease;
ii
the surveillance, prevention and control of the effects on health of exposure to radiation or to substances hazardous to health; and
iii
the collation and provision of information relating to immunisation, vaccination and other public health programmes;
c
preparing plans setting out the arrangements under which health service bodies in the area of the appropriate Health Authority respond to major incidents;
d
establishing or funding research ethics committees;
e
securing the provision of cancer registration services; or
f
preparing and implementing population screening programmes.
8
In this regulation, references to accident and emergency services are references to those services provided at the accident and emergency department, or a minor injuries unit, of a health service hospital, and do not include any subsequent treatment connected with the provision of those services.
Functions not to be exercisable by Primary Care Trusts
4
1
The delegable functions exercisable under or by virtue of the enactments specified in column (1) of Schedule 4 to these Regulations (the subject matter of the relevant functions being indicated in column (2) of that Schedule) are not to be exercisable by a Primary Care Trust.
2
Delegable functions relating to general medical services, other than those functions specified in regulation 3(2), are not to be exercisable by a Primary Care Trust.
3
Any function conferred on a Health Authority with respect to the giving of any directions is not to be exercisable by a Primary Care Trust.
4
A Health Authority may not direct a Primary Care Trust to exercise any of the functions referred to in paragraphs (1) to (3).
Other functions which may be exercisable by a Primary Care Trust
5
Subject to regulation 6, a Health Authority may direct a Primary Care Trust in relation to which they are appropriate Health Authority to exercise–
a
any delegable function which is neither a function which is to be exercised by a Primary Care Trust under regulation 3 nor a function which may not be exercised by a Primary Care Trust under regulation 4; and
b
any functions specified in regulation 3(2) to an extent greater than that specified in regulation 3(3) or (4).
Restriction on the exercise of functions by Primary Care Trusts
6
1
The exercise by a Primary Care Trust of the functions specified in regulations 3(2) or 5 is subject to such limitations as the Secretary of State may direct, and must be in accordance with any directions which are given by the Secretary of State or, subject to any such directions by the appropriate Health Authority.
2
The power under section 2 of the Act (Secretary of State’s general power as to services) is to be exercisable by a Primary Care Trust only to such extent as is necessary for the proper exercise of one or more of its other functions.
3
Where, in the exercise of functions specified in regulation 3(2)(a), arrangements are made by a Primary Care Trust with medical practitioners for the vaccination or immunisation of persons against disease, every medical practitioner providing general medical services in that trust’s area shall, so far as is reasonably practicable, be given an opportunity to participate in the arrangements.
4
Except where the Secretary of State otherwise directs, a Primary Care Trust must not exercise the functions of the Secretary of State under section 51(1) of the Act in so far as those functions are concerned with securing the availability of facilities for clinical teaching.
5
A Primary Care Trust must not exercise the power under section 18A(2) of the Act (provision of goods and services under NHS contracts) so as to arrange for the provision by the trust to another health service body of goods or services which are of the same description as those which the trust has the power to provide only by reason of section 18A(4) (provision of accommodation and services to private patients) and (5) (provision of goods, services etc. for purpose of making more income available for improving the health service).
Signed by authority of the Secretary of State
Gisela Stuart
Parliamentary Under-Secretary of State,
Department of Health
10th March 2000