text:
Citation, commencement and application
1
These Regulations —
a
may be cited as the Welfare of Farmed Animals (England) Regulations 2007;
b
come into force on 1st October 2007; and
c
apply in England only.
Definitions and interpretation
2
1
In these Regulations —
“calf” means a bovine animal up to six months old;
“laying hen” means a hen of the species Gallus gallus which has reached laying maturity and is kept for the production of eggs not intended for hatching;
“litter” means, in relation to laying hens, any friable material enabling the hens to satisfy their ethological needs;
“nest” means a separate space for egg laying, the floor component of which may not include wire mesh that can come into contact with the birds, for an individual hen or for a group of hens;
“person responsible” for an animal has the same meaning as in section 3 of the Animal Welfare Act 2006;
“pig” means an animal of the porcine species of any age, kept for breeding or fattening;
“usable area” means an area, other than that taken up by a nest, used by laying hens which is at least 30cm wide with a floor slope not exceeding 14% and with headroom of at least 45cm.
2
Expressions used in these Regulations that are not defined in these Regulations and are used in the following Directives, have the meaning they bear in those Directives —
a
in relation to pigs, Directive 91/630/ EEC , 2001/88/ EC and 2001/93/EC ;
b
in relation to laying hens, Directive 99/74/EC ; and
c
in relation to calves, Directive 91/629/EEC , 97/2/EC and 97/182/EC .
3
An expression used in regulation 4 or Schedule 1, which is not defined in these Regulations and which appears in Directive 98/58/EC , has the same meaning as it has for the purposes of that Directive.
Animals to which these Regulations apply
3
1
These Regulations apply to farmed animals only.
2
In these Regulations, a “farmed animal” means an animal bred or kept for the production of food, wool or skin or other farming purposes, but not including —
a
a fish, reptile or amphibian;
b
an animal whilst at, or solely intended for use in, a competition, show or cultural or sporting event or activity;
c
an experimental or laboratory animal; or
d
an animal living in the wild.
Duties on persons responsible for farmed animals
4
1
A person responsible for a farmed animal must take all reasonable steps to ensure that the conditions under which it is bred or kept comply with Schedule 1.
2
In complying with the duty in paragraph (1), a person responsible for a farmed animal must have regard to its —
a
species;
b
degree of development;
c
adaptation and domestication; and
d
physiological and ethological needs in accordance with good practice and scientific knowledge.
Additional duties on persons responsible for poultry, laying hens, calves, cattle, pigs or rabbits
5
1
A person responsible for —
a
poultry (other than those kept in the systems referred to in Schedules 2 to 4) kept in a building must ensure they are kept on, or have access at all times to, well-maintained litter or a well-drained area for resting;
b
laying hens kept in establishments with 350 or more laying hens must comply with Schedules 2, 3, 4 and 5, as applicable;
c
calves confined for rearing and fattening must comply with Schedule 6;
d
cattle must comply with Schedule 7;
e
pigs must, subject to paragraph (2), comply with Part 2 of Schedule 8 and, where applicable, the requirements of Parts 3, 4, 5 and 6 of Schedule 8; or
f
rabbits must comply with Schedule 9.
2
Paragraphs 12, 28, 29 and 30 of Schedule 8 apply to all holdings newly built, rebuilt or brought into use for the first time on or after 1st January 2003, but in the case of all other holdings, those paragraphs do not apply until 1st January 2013.
3
Part 1 of Schedule 8 has effect.
Codes of Practice
6
1
A person responsible for a farmed animal —
a
must not attend to the animal unless he is acquainted with any relevant code of practice and has access to the code while attending to the animal; and
b
must take all reasonable steps to ensure that a person employed or engaged by him does not attend to the animal unless that other person —
i
is acquainted with any relevant code of practice;
ii
has access to the code while attending to the animal; and
iii
has received instruction and guidance on the code.
2
In this section, a “relevant code of practice” means a code of practice issued under section 14 of the Animal Welfare Act 2006 or a statutory welfare code issued under section 3 of the Agriculture (Miscellaneous Provisions) Act 1968 relating to the particular species of farmed animal to which a person is attending.
Offences
7
A person commits an offence if, without lawful authority or excuse, he —
a
contravenes, or does not comply with a duty in, regulation 4, 5 or 6;
b
makes an entry in a record, or gives any information for the purposes of these Regulations which he knows to be false in any material particular or, for those purposes, recklessly makes a statement or gives any information which is false in any material particular; or
c
causes or permits any of the above.
Prosecutions
8
1
A local authority may prosecute proceedings for an offence under these Regulations.
2
The Secretary of State may direct that he, and not the local authority, prosecutes proceedings for an offence under these Regulations in relation to cases of a particular description or any particular case.
Penalties
9
1
A person guilty of an offence under regulation 7 is liable on summary conviction to —
a
imprisonment for a term not exceeding 51 weeks;
b
a fine not exceeding level 4 on the standard scale; or
c
both the term of imprisonment referred to sub-paragraph (a) and the fine referred to in sub-paragraph (b).
2
In relation to an offence committed before the commencement of section 281(5) of the Criminal Justice Act 2003 , the reference in paragraph (1)(a) to 51 weeks must be taken as a reference to 6 months.
Jeff Rooker
Minister of State
Department for Environment, Food and Rural Affairs
19th July 2007


type: legislation

jurisdiction: UK

text:
Citation and commencement
1
These Regulations may be cited as the Social Security (National Insurance Credits) Amendment Regulations 2007 and shall come into force on 1st October 2007.
Amendment of the Social Security (Credits) Regulations 1975
2
After regulation 8C of the Social Security (Credits) Regulations 1975 , insert —
Credits for the purposes of entitlement to incapacity benefit following official error
8D
1
This regulation applies for the purpose only of enabling a person who was previously entitled to incapacity benefit to satisfy the condition referred to in paragraph 2(3)(a) of Schedule 3 to the Contributions and Benefits Act in respect of a subsequent claim for incapacity benefit where his period of incapacity for work is, together with a previous period of incapacity for work, to be treated as one period of incapacity for work under section 30C of that Act.
2
Where —
a
a person was previously entitled to incapacity benefit;
b
the award of incapacity benefit was as a result of satisfying the condition referred to in paragraph (1) by virtue of being credited with earnings for incapacity for work or approved training in the tax years from 1993-94 to 2007-08;
c
some or all of those credits were credited by virtue of official error derived from the failure to transpose correctly information relating to those credits from the Department for Work and Pensions’ Pension Strategy Computer System to Her Majesty’s Revenue and Customs’ computer system ( NIRS2 ) or from related clerical procedures;
d
that person makes a further claim for incapacity benefit; and
e
his period of incapacity for work is, together with the period of incapacity for work to which his previous entitlement referred to in sub-paragraph (a) related, to be treated as one period of incapacity for work under section 30C of the Contributions and Benefits Act,
that person shall be credited with such earnings as may be required to enable the condition referred to in paragraph (1) to be satisfied.
3
In this regulation and in regulations 8E and 8F, “official error” means an error made by —
a
an officer of the Department for Work and Pensions or an officer of Revenue and Customs acting as such which no person outside the Department or Her Majesty’s Revenue and Customs caused or to which no person outside the Department for Work and Pensions or Her Majesty’s Revenue and Customs materially contributed; or
b
a person employed by a service provider and to which no person who was not so employed materially contributed,
but excludes any error of law which is shown to have been an error by virtue of a subsequent decision of a Commissioner or the court.
4
In paragraph (3) —
“Commissioner” means the Chief Social Security Commissioner or any other Social Security Commissioner and includes a tribunal of three or more Commissioners constituted under section 16(7) of the Social Security Act 1998;
“service provider” means a person providing services to the Secretary of State for Work and Pensions or to Her Majesty’s Revenue and Customs.
Credits for the purposes of entitlement to retirement pension following official error
8E
1
This regulation applies for the purpose only of enabling the condition referred to in paragraph 5(3)(a) of Schedule 3 to the Contributions and Benefits Act to be satisfied in respect of a claim for retirement pension made by a person (“the claimant”) —
a
who would attain pensionable age no later than 31st May 2008;
b
not falling within sub-paragraph (a) but based on the satisfaction of that condition by another person —
i
who would attain, or would have attained, pensionable age no later than 31st May 2008; or
ii
in respect of whose death the claimant received a bereavement benefit.
2
Where —
a
a person claims retirement pension;
b
the satisfaction of the condition referred to in paragraph (1) would be based on earnings credited for incapacity for work or approved training in the tax years from 1993-94 to 2007-08; and
c
some or all of those credits were credited by virtue of official error derived from the failure to transpose correctly information relating to those credits from the Department for Work and Pensions’ Pension Strategy Computer System to Her Majesty’s Revenue and Customs’ computer system (NIRS2) or from related clerical procedures,
those earnings shall be credited.
3
In this regulation, “bereavement benefit” means a bereavement allowance, a widowed mother’s allowance, a widowed parent’s allowance or a widow’s pension.
Credits for the purposes of entitlement to contribution-based jobseeker’s allowance following official error
8F
1
This regulation applies for the purpose only of enabling a person to satisfy the condition referred to in section 2(1)(b) of the Jobseekers Act 1995 .
2
Where —
a
a person claims a jobseeker’s allowance;
b
the satisfaction of the condition referred to in paragraph (1) would be based on earnings credited for incapacity for work or approved training in the tax years from 1993-94 to 2007-08; and
c
some or all of those credits were credited by virtue of official error derived from the failure to transpose correctly information relating to those credits from the Department for Work and Pensions’ Pension Strategy Computer System to Her Majesty’s Revenue and Customs’ computer system (NIRS2) or from related clerical procedures,
that person shall be credited with those earnings.
.
Amendment of the Social Security and Child Support (Decisions and Appeals) Regulations 1999
3
1
Regulation 3 of the Social Security and Child Support (Decisions and Appeals) Regulations 1999 (revision of decisions) is amended in accordance with the following paragraphs.
2
At the beginning of paragraph (5)(a) insert “except where paragraph (5ZA) applies”.
3
After paragraph (5) insert —
5ZA
This paragraph applies where —
a
the decision which would otherwise fall to be revised is a decision to award a benefit specified in paragraph (5ZB), whether or not the award has already been put in payment;
b
that award was based on the satisfaction by a person of the contribution conditions, in whole or in part, by virtue of credits of earnings for incapacity for work or approved training in the tax years from 1993-94 to 2007-08;
c
the official error derives from the failure to transpose correctly information relating to those credits from the Department for Work and Pensions’ Pension Strategy Computer System to Her Majesty’s Revenue and Customs’ computer system (NIRS2) or from related clerical procedures; and
d
that error has resulted in an award to the claimant which is more advantageous to him than if the error had not been made.
5ZB
The specified benefits are —
a
bereavement allowance;
b
contribution-based jobseeker’s allowance;
c
incapacity benefit;
d
retirement pension;
e
widowed mother’s allowance;
f
widowed parent’s allowance; and
g
widow’s pension.
5ZC
In paragraph (5ZA)(b), “tax year” has the meaning ascribed to it by section 122(1) of the Contributions and Benefits Act.
.
Amendment of the Social Security (Crediting and Treatment of Contributions, and National Insurance Numbers) Regulations 2001
4
1
The Social Security (Crediting and Treatment of Contributions, and National Insurance Numbers) Regulations 2001 is amended in accordance with the following paragraphs.
2
After regulation 1(2) (interpretation), insert —
3
In these Regulations, “official error” means an error made by —
a
an officer of the Department for Work and Pensions or an officer of Revenue and Customs acting as such which no person outside the Department or Her Majesty’s Revenue and Customs caused or to which no person outside the Department or Her Majesty’s Revenue and Customs materially contributed; or
b
a person employed by a service provider and to which no person who was not so employed materially contributed,
but excludes any error of law which is shown to have been an error by virtue of a subsequent decision of a Commissioner or the court.
4
In paragraph (3) —
“Commissioner” means the Chief Social Security Commissioner or any other Social Security Commissioner and includes a tribunal of three or more Commissioners constituted under section 16(7) of the Social Security Act 1998;
“service provider” means a person providing services to the Secretary of State for Work and Pensions or to Her Majesty’s Revenue and Customs.
.
3
In regulation 4 (treatment for the purpose of any contributory benefit of late paid contributions) —
a
in paragraph (1), for “6A” substitute “6B”;
b
after paragraph (1) insert —
1A
Any relevant contribution which is paid —
a
by virtue of an official error; and
b
more than six years after the end of the year in which the contributor was first advised of that error,
shall be treated as not paid.
.
4
After regulation 6A insert —
Treatment for the purpose of any contributory benefit of certain Class 2 or Class 3 contributions
6B
For the purpose of entitlement to any contributory benefit, a Class 2 or a Class 3 contribution paid after the due date —
a
which would otherwise under regulation 4 (apart from paragraph (1A) of that regulation) —
i
have been treated as paid on a day other than the day on which it was actually paid; or
ii
have been treated as not paid; and
b
which was paid after the due date by virtue of an official error,
shall be treated as paid on the day on which it is paid.
.
Signed by authority of the Secretary of State for Work and Pensions.
Mike O’Brien
Minister of State,
Department for Work and Pensions.
1st September 2007
The Commissioners for Her Majesty’s Revenue and Customs hereby concur in relation to regulation 4.
Mike Eland
Paul Gray
Two of the Commissioners for Her Majesty’s Revenue and Customs.
4th September 2007


text:
1
This Order may be cited as the Finance (No.2) Act 2005, Section 2(7), (Appointed Day) Order 2007.
2
The appointed day for the purposes of section 2(7) of the Finance ( No. 2) Act 2005 is 22nd March 2007.
Frank Roy
Alan Campbell
Two of the Lords Commissioners of Her Majesty’s Treasury
21st March 2007


text:
Citation and commencement
1
These Regulations may be cited as the Non-Domestic Rating Contributions (England) (Amendment) Regulations 2007 and shall come into force on 31st December 2007.
Amendment of the Non-Domestic Rating Contributions (England) Regulations 1992
2
The Non-Domestic Rating Contributions (England) Regulations 1992 are amended as follows in relation to financial years beginning on or after 1st April 2008.
Rules for the calculation of non-domestic rating contributions
3
In Schedule 1 —
a
in paragraph 1(4), for “2007” substitute “2008”;
b
in paragraph 4(4), for “2007” substitute “2008”; and
c
for Part II substitute —
PART II COST FACTORS
Name or description of authority Cost factor
The councils of the districts of Bracknell Forest, Crawley, Elmbridge, Epsom and Ewell, Guildford, Mole Valley, Reigate and Banstead, Runnymede, Slough, Spelthorne, Surrey Heath, Tandridge, Waverley, Windsor and Maidenhead and Woking 1.1274 The councils of the districts of Broxbourne, Chiltern, Dacorum, East Hertfordshire, Hertsmere, St Albans, South Buckinghamshire, Three Rivers, Watford and Welwyn Hatfield 1.1016 The councils of the districts of Reading, West Berkshire and Wokingham 1.1119 The councils of the districts of Basildon, Brentwood, Epping Forest, Harlow, Dartford, Sevenoaks and Thurrock 1.081 The councils of the districts of Aylesbury Vale, Milton Keynes and Wycombe 1.0808 The council of a district which falls within the county of Oxfordshire 1.0643 The councils of the districts of Luton, Mid Bedfordshire, North Hertfordshire, South Bedfordshire, Stevenage and Bedford 1.0421 The councils of the districts of Cambridge, East Cambridgeshire, Fenland, Huntingdonshire, Peterborough and South Cambridgeshire 1.0454 The councils of the districts of Basingstoke and Deane, East Hampshire, Eastleigh, Fareham, Gosport, Hart, Havant, New Forest, Portsmouth, Rushmoor, Southampton, Test Valley and Winchester 1.0415 The council of a district which falls within the county of Warwickshire 1.0224 The councils of the districts of Kennet, North Wiltshire, Salisbury, Swindon and West Wiltshire 1.0308 The councils of the districts of Bath and North East Somerset, Bristol, North Somerset and South Gloucestershire 1.0349 The council of a district which falls within the county of Northamptonshire 1.0185 The councils of the districts of Ashford, Canterbury, Dover, Gravesham, Maidstone, Medway, Shepway, Swale, Thanet, Tonbridge and Malling and Tunbridge Wells 1.0161 The council of a district which falls within the county of Gloucestershire 1.0189 The council of a district which falls within the West Midlands metropolitan county 1.0154 The councils of the districts of Chester, Congleton, Crewe and Nantwich, Ellesmere Port and Neston, Halton, Macclesfield, Vale Royal and Warrington 1.0109 The council of a district which falls within the Greater Manchester metropolitan county 1.0223 The councils of the districts of Braintree, Castle Point, Chelmsford, Colchester, Maldon, Rochford, Southend-on-Sea, Tendring and Uttlesford 1.02 The councils of the districts of Brighton & Hove, Eastbourne, Hastings, Lewes, Rother and Wealden 1.0156 The council of a district which falls within the West Yorkshire metropolitan county 1.0126 The councils of the districts of Blaby, Charnwood, Harborough, Hinckley and Bosworth, Leicester, Melton, North West Leicestershire, Oadby and Wigston and Rutland 1.0135 The councils of the districts of Ashfield, Bassetlaw, Broxtowe, Gedling, Mansfield, Newark and Sherwood, Nottingham and Rushcliffe 1.0075 The council of a district which falls within the Merseyside metropolitan county 1.0076 The council of a district other than a district named, or falling within a description given, above 1 The council of an inner London borough 1.2358 The councils of the boroughs of Barnet, Brent, Ealing, Harrow, Hillingdon, Hounslow, Kingston upon Thames, Merton, Richmond upon Thames and Sutton 1.1278 The councils of the boroughs of Barking and Dagenham, Bexley, Bromley, Croydon, Enfield, Haringey, Havering, Newham, Redbridge and Waltham Forest 1.0845 The Common Council of the City of London 1.4329 The Council of the Isles of Scilly 1.5 The Isle of Wight Council 1.0415
.
Assumptions relating to provisional amounts
4
In Schedule 2 —
a
in paragraph 2(12), for “0.991” substitute “0.990”; and
b
for the table in paragraph 8(1) substitute —
Name or description of authority Percentage
The council of a metropolitan district 0.9 The council of a non-metropolitan district which has the functions of a county council 0.7 The council of a non-metropolitan district which does not have the functions of a county council 0.5 The council of an inner London borough and the Common Council of the City of London 0.8 The council of an outer London borough 1.2 The Council of the Isles of Scilly and the Isle of Wight Council 0.7
.
Signed by authority of the Secretary of State for Communities and Local Government
John Healey
Minister of State
Department for Communities and Local Government
30th November 2007


text:
PART 1 Introduction
Title and commencement
1
These Regulations may be cited as the Transfrontier Shipment of Waste Regulations 2007 and come into force on 12th July 2007.
Application
2
1
For the purposes of these Regulations, the following (“the marine area”) shall be considered as part of the United Kingdom —
a
the territorial sea adjacent to the United Kingdom;
b
the area on the landward side of the baselines that is submerged at mean high water springs, including, so far as the tide flows at mean high water springs, an estuary or arm of the sea and the waters of any channel, creek, bay or river;
c
the seabed and subsoil situated within the areas designated by Order in Council under section 1(7) of the Continental Shelf Act 1964 ; and
d
the waters superjacent to the seabed and the seabed and its subsoil situated within the areas designated by Order in Council under section 84(4) of the Energy Act 2004 .
2
In this regulation, “baselines” means the baselines from which the breadth of the territorial sea is measured for the purposes of the Territorial Sea Act 1987 .
Scope of the Regulations
3
These Regulations do not apply to the transit of waste occurring only through the marine area.
Interpretation
4
1
In these Regulations —
“Annex VII document” means the document set out in Annex VII to the Community Regulation;
“authorised person” means a person authorised by a competent authority in accordance with regulation 50(2) ;
“the Community Regulation” means Regulation (EC) No 1013/2006 of the European Parliament and of the Council on shipments of waste;
“the marine area” has the meaning given by regulation 2(1) ;
“notifiable waste” means waste that is subject to the prior written notification and consent procedures of Title II of the Community Regulation, by virtue of any provision of that Regulation;
“waste vessel” means any vessel or any part of any vessel that is in itself waste within the meaning of the Community Regulation.
2
Expressions used in these Regulations that are also used in the Community Regulation have the same meaning in these Regulations as they have in the Community Regulation.
3
Any reference in these Regulations to —
a
an Article is, save where the context otherwise requires, a reference to an Article of the Community Regulation;
b
the Community Regulation is a reference to that Regulation as amended from time to time.
Meaning of transport and person who transports waste
5
1
Any reference in these Regulations to transport includes consigning for transport.
2
Any reference in these Regulations to a person who transports waste includes the following persons —
a
the notifier;
b
any transporter of waste, by land or otherwise —
i
into or in the United Kingdom; or
ii
from the United Kingdom;
c
any freight-forwarder; or
d
any other person involved in the shipment of waste.
Competent authorities of destination and dispatch
6
1
The competent authorities of destination and dispatch for the purposes of the Community Regulation are —
a
in England and Wales, the Environment Agency;
b
in Scotland, the Scottish Environment Protection Agency;
c
in Northern Ireland, the Department of the Environment,
excluding in each case, subject to paragraph (2) , the marine area.
2
The Secretary of State is the competent authority of destination and dispatch for the marine area, except in the case of waste vessels in the area specified in regulation 2(1)(b) , where the competent authority is the body in paragraph (1) .
Competent authority of transit
7
The Secretary of State is the competent authority of transit for the United Kingdom for the purposes of the Community Regulation.
Correspondent
8
The Secretary of State is the correspondent for the United Kingdom for the purposes of Article 54.
Notices
9
1
Any notice under these Regulations must be in writing.
2
A notice may be subject to conditions and may be amended, suspended or revoked by notice in writing at any time.
3
A notice may be served on a person by —
a
delivering it to him in person;
b
leaving it at his proper address; or
c
sending it by post or electronic means to him at his proper address.
4
Any such notice may —
a
in the case of a body corporate, be served on the secretary or clerk of that body;
b
in the case of a partnership, be served on a partner or a person having the control or management of the partnership business.
5
If the person to be served with any such notice has specified an address in the United Kingdom other than his proper address as the one at which he or someone on his behalf will accept notices of the same description as those notices, that address is also to be treated for the purposes of this regulation as his proper address.
6
For the purposes of this regulation, “proper address” means a person’s last known address, which for the purposes of paragraph (3)(c) includes an e-mail address, except that —
a
in the case of a body corporate or its secretary or clerk it is the address of the registered or principal office of that body;
b
in the case of a partnership, partner or person having the control or management of the partnership business, it is the principal office of the partnership,
and for the purposes of this paragraph, the principal office of a company registered outside the United Kingdom or of a partnership carrying on business outside the United Kingdom is its principal office within the United Kingdom.
Transitional provisions
10
Schedule 1 (transitional provisions for shipments to Latvia, Poland, Slovakia, Bulgaria or Romania) has effect.
PART 2 Waste management plan
Waste management plan
11
The Secretary of State must prepare a waste management plan in accordance with Article 7 of Directive 2006/12/ EC of the European Parliament and of the Council on waste containing his policies on the bringing into, or dispatch from, the United Kingdom of waste for disposal.
Public participation procedures
12
1
As soon as reasonably practicable after preparing proposals for a waste management plan, the Secretary of State must —
a
take such steps as he considers appropriate to bring the proposals to the attention of the persons who in his opinion are affected or likely to be affected by, or have an interest in, the plan (in this Part, referred to as “public consultees”);
b
inform public consultees of the address from which a copy of the proposals may be obtained;
c
invite public consultees to express their opinions on the proposals, specifying the address to which, and the period within which, opinions must be sent.
2
The period referred to in paragraph (1)(c) must be sufficient to ensure that public consultees are given an effective opportunity to express their opinions on the proposals.
3
The Secretary of State must keep a copy of the proposals for inspection by the public at all reasonable times free of charge.
4
The Secretary of State may make a reasonable charge for copies provided under paragraph (1)(b) .
Procedures following public participation
13
1
Before decisions on a waste management plan are made, the Secretary of State must take account of any opinions expressed by public consultees in accordance with regulation 12 .
2
As soon as reasonably practicable after making decisions on a waste management plan, the Secretary of State must —
a
inform public consultees of the matters referred to in paragraph (3);
b
take such steps as he considers appropriate to bring those matters to the attention of the public;
c
if he has adopted the waste management plan, make a copy of it available for inspection at all reasonable times free of charge.
3
The matters are —
a
the decisions made by the Secretary of State on the waste management plan;
b
the reasons and considerations upon which those decisions are based; and
c
information about the public participation procedure.
Provision of the plan to competent authorities
14
The Secretary of State must send a copy of the waste management plan to —
a
the Environment Agency;
b
the Scottish Environment Protection Agency; and
c
the Department of the Environment in Northern Ireland.
Objections to shipments of waste
15
For the purpose of preventing shipments of waste that are not in accordance with the waste management plan —
a
a competent authority of destination must object to any shipment notified in accordance with the Community Regulation which that plan indicates should not be brought into the United Kingdom; and
b
a competent authority of dispatch must object to any shipment notified in accordance with the Community Regulation which that plan indicates should not be dispatched from the United Kingdom.
Waste Management Licensing Regulations 1994 etc.
16
Paragraph 4(1)(b) of Schedule 4 to the Waste Management Licensing Regulations 1994 and paragraph 4(1)(b) of Part 1 of Schedule 3 to the Waste Management Licensing Regulations (Northern Ireland) 2003 have effect as if the references in those paragraphs to any plan made under the plan-making provisions include references to a waste management plan made under this Part.
PART 3 General requirements for shipment of waste
Protection of the environment
17
A person commits an offence if he fails to comply with Article 49(1) (the management of shipments of waste in an environmentally sound manner and without endangering human health).
Compliance with notification etc.
18
A person commits an offence if he transports waste other than in accordance with —
a
the notification document or movement document, in the case of notifiable waste; or
b
the Annex VII document, in the case of waste subject to the procedural requirements of Article 18(1).
PART 4 Shipment of waste within the Community
Requirements for shipments of notifiable waste
19
1
This regulation applies to waste specified in Article 3(1)(a) or (b) that originates in the Community and is either brought into the United Kingdom or destined for another member State, whether or not that waste passes through a third country.
2
A person who transports such waste commits an offence if he does so without —
a
the competent authority of dispatch having been notified in accordance with Article 4;
b
a contract having been entered into or a declaration having been made in accordance with Article 5;
c
a financial guarantee or equivalent insurance being in place and approved by the competent authority in accordance with Article 6;
d
a consent issued by the competent authority of dispatch and destination in accordance with Article 9 and a consent issued by the competent authority of transit, unless there is tacit consent to the transit in accordance with Article 9(1);
e
the movement document having been —
i
completed in accordance with Article 16, first paragraph and Article 16(a); or
ii
sent to the competent authorities concerned and the consignee in accordance with Article 16(b);
f
the waste being accompanied by the movement document and notification document in accordance with Article 16(c); or
g
the competent authorities and consignee having been notified of any change in the details or conditions of the shipment in accordance with Article 17 and, in such a case, a new notification having been submitted in accordance with that Article.
3
He commits an offence if —
a
he does so in breach of any condition imposed under Article 10;
b
in the case of a shipment covered by a general notification, he does so without the competent authorities concerned having been notified of a change in route in accordance with Article 13(2);
c
in the case of a shipment of waste destined for an interim recovery or disposal operation, he does so without the notification document having been completed in accordance with Article 15(a); or
d
he fails to comply with Article 19.
Requirements for shipment of waste specified in Article 3(2) and (4)
20
1
This regulation applies to waste specified in Article 3(2) or (4) that originates in the Community and is either brought into the United Kingdom or is destined for another member State, whether or not that waste passes through a third country.
2
A person who transports such waste commits an offence if —
a
he does so without the waste being accompanied by a completed Annex VII document in accordance with Article 18(1)(a), that is signed in accordance with Article 18(1)(b);
b
in the case of waste specified in Article 3(2), he does so without a contract as referred to in Article 18(2) having been entered into; or
c
he fails to comply with Article 19.
PART 5 Export of waste to third countries
Prohibition on export of waste for disposal other than to EFTA countries
21
A person commits an offence if he transports waste destined for disposal in a third country in breach of Article 34 (prohibition on export except, in certain circumstances, to EFTA countries Parties to the Basel Convention).
Requirements for export of waste for disposal to EFTA countries
22
1
This regulation applies to waste destined for disposal in any EFTA country Party to the Basel Convention.
2
A person who transports such waste commits an offence if he does so —
a
without the provisions of Article 35(1) having been complied with (procedural requirements for export to EFTA countries); or
b
in breach of Article 35(5) (requirement for consignment only to facilities operating or authorised to operate under the applicable national law of the country of destination).
Prohibition on export of certain waste for recovery to non-OECD Decision countries
23
A person commits an offence if, in breach of Article 36(1), he transports waste specified in that Article that is destined for recovery in a country to which the OECD Decision does not apply.
Requirements for export of waste for recovery to OECD Decision countries
24
1
This regulation applies to waste specified in Article 38(1) destined for recovery in any country to which the OECD Decision applies (with or without transit through any country to which that Decision applies).
2
A person who transports such waste commits an offence if he does so —
a
without the provisions of Article 38(1) having been complied with (procedural requirements for the export of waste listed in Annexes III , IIIA, IIIB, IV and IVA); or
b
in breach of Article 38(6) (requirement for consignment only to facilities operating or authorised to operate under the applicable national law of the country of destination).
Miscellaneous prohibitions on export of waste
25
A person commits an offence if —
a
he transports waste to the Antarctic;
b
he transports waste destined for disposal in an overseas country or territory in breach of Article 40(1);
c
he transports waste destined for recovery in an overseas country or territory in breach of Article 40(2)(prohibition on the export of certain waste); or
d
he transports waste specified in Article 40(3) destined for recovery in an overseas country or territory without the provisions of that Article having been complied with (procedural requirements for exports to overseas countries or territories).
PART 6 Import of waste from third countries
Prohibition on the import of waste for disposal
26
A person commits an offence if, in breach of Article 41(1), he transports waste destined for disposal that has come from a third country or area other than those specified in that Article.
Procedure for import of waste for disposal from a country Party to the Basel Convention
27
1
This regulation applies to waste destined for disposal that has come from a country Party to the Basel Convention.
2
A person who transports such waste commits an offence if he does so without the provisions of Article 42(1) having been complied with (procedural requirements for the import of waste destined for disposal from countries Parties to the Basel Convention).
Prohibition on import of waste for recovery
28
A person commits an offence if, in breach of Article 43(1), he transports waste destined for recovery that has come from a third country or area other than specified in that Article.
Requirements for import of waste for recovery from or through an OECD Decision country
29
1
This regulation applies to waste destined for recovery that has come from or through a country to which the OECD Decision applies.
2
A person who transports such waste commits an offence if he does so without the provisions of Article 44(1) having been complied with (procedural requirements for imports of waste destined for recovery from, or through, an OECD Decision country).
Requirements for import of waste for recovery from a non-OECD Decision country Party to the Basel Convention
30
1
This regulation applies to waste destined for recovery that has come —
a
from a country to which the OECD Decision does not apply; or
b
through a country to which the OECD Decision does not apply and that is Party to the Basel Convention.
2
A person who transports such waste commits an offence if he does so without the provisions of Article 45 having been complied with (procedural requirements for imports from a non-OECD Decision country Party to the Basel Convention).
Requirements for import of waste from overseas countries or territories
31
A person who transports waste that has come from any overseas country or territory commits an offence if he does so without the provisions of Article 46(1) having been complied with (procedural requirements for the import of waste from overseas countries or territories).
PART 7 Transit of waste
Requirements for transit of waste for disposal
32
1
This regulation applies to waste destined for disposal that —
a
originates from, and is destined for, a third country; and
b
is transported through the United Kingdom.
2
A person who transports such waste commits an offence if he does so without the provisions of Article 47 having been complied with (procedural requirements for shipments of waste destined for disposal from and to a third country).
Requirements for transit of waste for recovery: non-OECD Decision countries
33
1
This regulation applies to waste destined for recovery that —
a
originates from, and is destined for, a country to which the OECD Decision does not apply; and
b
is transported through the United Kingdom.
2
A person who transports such waste commits an offence if he does so without the provisions of Article 48(1) having been complied with (procedural requirements for shipments of waste destined for recovery from and to a country to which the OECD Decision does not apply).
Requirements for transit of waste for recovery: OECD Decision countries
34
1
This regulation applies to waste destined for recovery that —
a
originates from, and is destined for, a country to which the OECD Decision applies; and
b
is transported through the United Kingdom.
2
A person who transports such waste commits an offence if he does so without the provisions of Article 48(2) having been complied with (procedural requirements for shipments of waste destined for recovery from and to a country to which the OECD Decision applies).
Requirements for transit of waste between OECD Decision countries and non-OECD Decision countries
35
1
This regulation applies to waste destined for recovery that —
a
originates from a country to which the OECD Decision does not apply and is destined for a country to which the OECD Decision does apply; or
b
originates from a country to which the OECD Decision applies and is destined for a country to which the OECD Decision does not apply,
and is transported through the United Kingdom.
2
A person who transports such waste commits an offence if he does so without the provisions of Article 48(3) having been complied with (procedural requirements for shipments of waste destined for recovery between OECD Decision and non-OECD Decision countries).
PART 8 Additional duties
Illegal shipments of waste brought to a facility
36
If the operator of a facility knows or has reasonable grounds to suspect that waste brought to that facility is an illegal shipment of waste, he must notify the competent authority immediately and comply with their instructions and failure to do so is an offence.
Duties on operators of facilities in respect of notifiable waste
37
1
This regulation applies to the operator of a facility that receives notifiable waste.
2
He commits an offence if he fails to —
a
ensure that the recovery or disposal of such waste is completed within the time period in Article 9(7);
b
comply with any condition of a consent imposed on him by the competent authority of destination in accordance with Article 10(1);
c
comply with any condition, imposed by the competent authority of destination in accordance with Article 10(5), requiring him to keep records specified in that Article and send them to that competent authority in accordance with that Article;
d
retain the movement document in accordance with Article 16(c);
e
provide, in accordance with Article 16(d), confirmation that waste has been received;
f
certify, in accordance with Article 16(e), that non-interim recovery or disposal has been completed;
g
keep any document sent to or by the competent authorities in relation to a notified shipment in accordance with Article 20(1); or
h
inform the competent authority of destination in accordance with Article 22(1) if a shipment of waste is rejected.
Interim recovery or disposal operations
38
1
This regulation applies to the operator of a facility that carries out interim recovery or disposal operations.
2
He commits an offence if he fails to —
a
provide confirmation to the notifier or competent authorities concerned of the receipt of waste for interim recovery or disposal operations in accordance with Article 15(c); or
b
certify, in accordance with Article 15(d), that interim recovery or disposal has been completed.
3
He commits an offence if, in the case of waste sent to another facility for subsequent interim or non-interim recovery or disposal operation, he fails to —
a
obtain from that facility, in accordance with Article 15(e), first paragraph, a certificate that such operation has been completed; or
b
transmit that certificate to the notifier and competent authorities concerned in accordance with Article 15(e), second paragraph.
4
He commits an offence if he delivers waste for subsequent interim or non-interim recovery or disposal operations in accordance with Article 15(f), without complying with the notification requirements of that Article.
Duties on operators of facilities in respect of waste subject to general information requirements
39
1
This regulation applies to the operator of a recovery facility that receives waste subject to the procedural requirements of Article 18(1).
2
He commits an offence if he fails to —
a
sign the Annex VII document, in accordance with Article 18(1)(b); or
b
keep the information given pursuant to Article 18(1), in accordance with Article 20(2).
Duties on consignees in respect of notifiable waste
40
1
This regulation applies to a consignee of notifiable waste.
2
He commits an offence if he fails to keep any document sent to or by the competent authorities in relation to a notified shipment in accordance with Article 20(1).
Duties on consignees in respect of waste subject to general information requirements
41
1
This regulation applies to a consignee of waste subject to the procedural requirements of Article 18(1).
2
He commits an offence if he fails to —
a
sign the Annex VII document, in accordance with Article 18(1)(b);
b
provide a copy of the contract referred to in Article 18(2), second paragraph, to the competent authority upon request, in accordance with that Article; or
c
keep information given pursuant to Article 18(1), in accordance with Article 20(2).
Duties on laboratories
42
1
This regulation applies to the operator of a laboratory that receives waste subject to the procedural requirements of Article 18(1).
2
He commits an offence if he fails to —
a
sign the Annex VII document, in accordance with Article 18(1)(b); or
b
keep the Annex VII document for three years from the date the shipment started.
Notifier’s duty to keep documents
43
A notifier commits an offence if he fails to keep —
a
a copy of the movement document in accordance with Article 16(c); or
b
any document sent to or by the competent authorities in relation to a notified shipment in accordance with Article 20(1).
Duties on persons who arrange the shipment of waste
44
1
This regulation applies to a person who arranges the shipment of waste subject to the procedural requirements of Article 18(1).
2
He commits an offence if he fails to —
a
provide the competent authority with a copy of the contract referred to in Article 18(2) upon request, in accordance with the second paragraph of that Article; or
b
keep the information given pursuant to Article 18(1), in accordance with Article 20(2).
Annex VII document
45
1
This regulation applies in Scotland and Northern Ireland only.
2
A person who arranges the shipment of waste subject to the procedural requirements of Article 18(1) must ensure that a copy of the Annex VII document that he has signed in accordance with Article 18(1)(b) is received by the competent authority before the shipment takes place and failure to do so is an offence.
PART 9 Miscellaneous
Fees
46
1
Section 41(1) of the Environment Act 1995 (power to make schemes imposing charges) is amended as follows —
a
omit the word “and” at the end of paragraph (b);
b
after paragraph (c), insert —
and
d
as a means of recovering costs incurred by it in performing functions conferred by Regulation (EC) No 1013/2006 of the European Parliament and of the Council on shipments of waste, as amended from time to time, each of the new Agencies may require the payment to it of such charges as may from time to time be prescribed;
.
2
In order to meet any administrative costs incurred by them in implementing the notification and supervision procedures of the Community Regulation and of any costs of any analyses or inspections undertaken for the purpose of carrying out their functions under that Regulation —
a
the Environment Agency and the Scottish Environment Protection Agency may charge the fees in Schedule 2 until a charging scheme under section 41 of the Environment Act 1995 to recover such costs takes effect or until 1st April 2011, whichever is earlier; and
b
the Department of the Environment in Northern Ireland may charge the fees in Schedule 3.
3
Fees must be paid by the notifier when he submits a notification and the competent authorities may refuse to proceed with a notification unless the required fee is submitted.
Costs of take-back etc.
47
A competent authority may charge fees to meet any costs arising from —
a
the return of waste from a shipment that cannot be completed (including costs of transport, recovery, disposal and storage) in accordance with Article 23; and
b
the take-back, recovery or disposal of waste from an illegal shipment (including costs of transport and storage) in accordance with Article 25.
Approval of a financial guarantee
48
Schedule 4 (application for approval of a financial guarantee) has effect.
Supply of the financial guarantee
49
For the purposes of Article 4(5), third paragraph, the notifier must supply —
a
the financial guarantee or equivalent insurance; or
b
evidence of that guarantee or insurance or a declaration certifying its existence,
as part of the notification document at the time of notification or, with the consent of the competent authority, at any other time before the waste is shipped.
Enforcement bodies
50
1
These Regulations must be enforced by the competent authorities in regulation 6(1) and (2).
2
The competent authorities may authorise in writing persons to act for the purposes of these Regulations.
3
An authorisation under —
a
section 108 of the Environment Act 1995; or
b
Article 72 of the Waste and Contaminated Land (Northern Ireland) Order 1997 ,
is an authorisation for the purposes of these Regulations.
Enforcement powers
51
Schedule 5 (enforcement powers) has effect.
Compliance with notices
52
1
A person on whom a notice is served under these Regulations commits an offence if he fails to comply with the provisions of that notice.
2
Such a notice must be complied with at the expense of the person on whom it is served and, if it is not complied with, the competent authority may arrange for it to be complied with at the expense of that person.
3
A competent authority may enforce compliance with a notice by way of an injunction or, in Scotland, by way of an order under section 45(b) of the Court of Session Act 1988 .
Obstruction
53
A person commits an offence if he —
a
intentionally obstructs any person acting in the execution of these Regulations;
b
gives any information which he knows to be false or misleading to any person acting in the execution of these Regulations; or
c
fails, without reasonable excuse —
i
to give any assistance or information that any person acting in the execution of these Regulations may require him to give; or
ii
to produce any record that any person acting in the execution of these Regulations may require him to produce,
for the performance of that person’s functions under these Regulations.
Falsely obtaining consent etc.
54
A person commits an offence if, for the purpose of obtaining consent to a shipment or approval of a financial guarantee or equivalent insurance, he —
a
makes any statement or declaration that he knows to be false or misleading; or
b
endeavours to obtain such consent or approval by deception.
Offences by bodies corporate
55
1
If an offence under these Regulations committed by a body corporate is shown —
a
to have been committed with the consent or connivance of an officer; or
b
to be attributable to any neglect on his part,
the officer as well as the body corporate is guilty of the offence and is liable to be proceeded against and punished accordingly.
2
If the affairs of a body corporate are managed by its members, paragraph (1) applies in relation to the acts and defaults of a member in connection with his functions of management as if he were a director of the body.
3
“Officer”, in relation to a body corporate, means a director, member of the committee of management, chief executive, manager, secretary or other similar officer of the body, or a person purporting to act in any such capacity.
Offences by Scottish partnerships
56
Where a Scottish partnership commits an offence under these Regulations, and that offence is proved to have been committed with the consent or connivance of, or to have been attributable to any neglect on the part of —
a
any of the partners; or
b
any person who was purporting to act in such capacity,
he, as well as the partnership, is guilty of the offence and is liable to be proceeded against and punished accordingly.
Acts of third parties
57
Where the commission by any person of an offence under these Regulations is due to the act or default of some other person, that other person is guilty of the offence and a person may be charged with and convicted of an offence by virtue of this regulation whether or not proceedings are taken against the first-mentioned person.
Penalties
58
A person guilty of an offence under these Regulations is liable —
a
on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment not exceeding three months or to both;
b
on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.
Fixed penalties
59
1
If an authorised person has reason to believe that a person has committed an offence under these Regulations, he may give that person a notice (a “fixed penalty notice”) offering him the opportunity of discharging any liability to conviction for that offence by payment of a fixed penalty.
2
Where a person is given a fixed penalty notice in respect of an offence —
a
no proceedings may be instituted for that offence before the expiry of 28 days following the date of the notice; and
b
he may not be convicted of that offence if he pays the fixed penalty before the expiry of that period.
3
A fixed penalty notice must —
a
be in the form set out in Schedule 6;
b
give such particulars of the circumstances alleged to constitute the offence as are necessary for giving reasonable information of the offence; and
c
state —
i
the period during which, by virtue of paragraph (2) , proceedings will not be taken for the offence;
ii
the amount of the fixed penalty; and
iii
the name of the person to whom and the address at which the fixed penalty may be paid.
4
Payment of the fixed penalty may be made by pre-paying and posting to that person at that address a letter containing the amount of penalty.
5
Where a letter is sent in accordance with paragraph (4) , payment is deemed to be made at the time at which that letter would be delivered in the ordinary course of post.
6
The amount of fixed penalty payable in pursuance of a notice under this regulation is £300 which is to be paid —
a
to the Secretary of State; or
b
in the case of a notice served by an authorised person from the Department of the Environment in Northern Ireland, to that Department.
7
In any proceedings, a certificate which —
a
purports to be signed by or on behalf of the chief finance officer, or in Northern Ireland an authorised person; and
b
states that payment of a fixed penalty was or was not received by a date specified in the certificate,
is evidence of the facts stated.
Revocations
60
1
The following are revoked —
a
the Transfrontier Shipment of Waste Regulations 1994 ;
b
the Transfrontier Shipment of Waste (Amendment) Regulations 2005 ; and
c
the Transfrontier Shipment of Waste (Fee) Regulations (Northern Ireland) 2005 .
2
Notwithstanding the revocation of the Transfrontier Shipment of Waste Regulations 1994, shipments to which Article 62 (transition rules) applies are subject to the provisions of those Regulations.
Ben Bradshaw
Minister of State
Department for Environment, Food and Rural Affairs
12th June 2007


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


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Social Security Benefit (Computation of Earnings) (Amendment) Regulations 2007.
2
This regulation and regulation 2(1) and (5) shall come into force on 1st October 2007.
3
Paragraphs (2) and (3) of regulation 2, in so far as they relate to a particular beneficiary, shall come into force on the first day of the first benefit week to commence for that beneficiary on or after 1st October 2007.
4
Regulation 2(4), in so far as it relates to a particular beneficiary, shall come into force on the first day of the first benefit week to commence for that beneficiary on or after 7th April 2008.
5
In these Regulations —
“benefit week” has the meaning given in regulation 2(1) of the Computation of Earnings Regulations ;
“the Computation of Earnings Regulations” means the Social Security Benefit (Computation of Earnings) Regulations 1996 .
Amendment of the Computation of Earnings Regulations
2
1
The Computation of Earnings Regulations are amended as follows.
2
In regulation 12 (earnings of self-employed earners) —
a
in paragraph (1), omit “Subject to paragraph (2),”;
b
omit paragraph (2).
3
In regulation 13 (calculation of net profit of self-employed earners) , after paragraph (6)(f) add —
g
where the claimant provides accommodation to another person in the dwelling the claimant occupies as his home, any expenses defrayed by the claimant in providing the accommodation to that person (including any defrayed in providing board as well as lodging).
.
4
In Schedule 1 (sums to be disregarded in the calculation of earnings), for paragraph 2(a) and (b) substitute —
a
where the aggregate of any payments made in respect of any one week in respect of the occupation of that dwelling by that person or a member of his family, or by that person and a member of his family, is less than £20, the whole of that amount; or
b
where the aggregate of any such payments is £20 or more per week, £20.
;
5
Also in Schedule 1, after paragraph 11 add —
12
1
Any earnings, other than items to which sub-paragraph (2) applies, paid or due to be paid from the claimant’s employment as an employed earner which ended before the day in respect of which the claimant first satisfies the conditions for entitlement to the benefit, pension or allowance to which the claim relates.
2
This sub-paragraph applies to —
a
any payment by way of occupational or personal pension; and
b
except in a case where the claimant’s employment terminated by reason of retirement at a time when he had attained pensionable age (within the meaning given by rules in paragraph 1 of Schedule 4 to the Pensions Act 1995 ) —
i
any payment or remuneration of the nature described in regulation 9(1)(e) or (j), and
ii
any award or sum of the nature described in regulation 9(1)(g) or (h) (including any payment made following the settlement of a complaint to an employment tribunal or of court proceedings).
3
Sub-paragraph (1) is subject to the following provisions.
4
Sub-paragraph (1) does not apply in relation to a claim for, or an award of, incapacity benefit (within the meaning given by paragraph 11 of Schedule 4 to the Welfare Reform Act 2007 ) or severe disablement allowance (also within the meaning given by that paragraph).
5
Sub-paragraph (1) applies in relation to a claim for an increase in benefit under Part IV of the Contributions and Benefits Act (increases in respect of dependants) only in a case where —
a
the spouse or partner or other adult in respect of whom that claim is made was in employment as an employed earner, but
b
that employment ended before the day referred to in sub-paragraph (1).
.
Dave Watts
Steve McCabe
Two of the Lords Commissioners of Her Majesty’s Treasury
7th September 2007
The Secretary of State for Work and Pensions concurs.
Bill McKenzie
Parliamentary Under Secretary of State
Department for Work and Pensions
3rd September 2007


text:
Citation and commencement
1
This Order may be cited as the Competition Act 1998 (Public Policy Exclusion) Order 2007 and shall come into force on 3rd August 2007.
Interpretation
2
In this Order —
“Complex Weapon” means a strategic or tactical weapon which relies on guidance systems to produce precision effects and which is developed or manufactured for the Secretary of State but excludes torpedoes;
“Core Competence” means the ability in relation to the whole or part of a Complex Weapon or a Supporting Technology to provide research, development, manufacture, upgrades or support in service or on disposal;
“Supporting Technology” means the design, development and integration of technology which supports and enables the use of a Complex Weapon including —
mission critical software;
guidance and control algorithms;
safety and arming functions;
insensitive propulsion systems and warheads;
compatibility with other weapons systems and platforms;
directed energy and electro-optic countermeasures;
aerodynamics;
radiation compatibility;
electro-magnetic compatibility; and
stealth;
“ Team CW ” means the Secretary of State together with such persons as comply with the conditions set out in article 3.
Membership of Team CW
3
In order to be a member of Team CW, a person shall —
a
have one or more Core Competences; and
b
be a party to one or more agreements with the Secretary of State which
i
concern a Complex Weapon or Supporting Technology; and
ii
designate that person as a member of Team CW.
Exclusion from the Chapter I and II prohibitions
4
1
The prohibitions contained in Chapters I and II of the Competition Act 1998 shall not apply to —
a
any agreement between two or more members of Team CW or between a member of Team CW and any other person; or
b
any conduct by a member of Team CW
which relates to a Complex Weapon or a Supporting Technology and is made in the circumstances set out in paragraph (2).
2
The circumstances referred to in paragraph (1), are —
a
the purpose of the agreement or conduct is to protect the essential security interests of the United Kingdom and to maintain or develop a Core Competence in relation to the whole or part of a Complex Weapon or a Supporting Technology; and
b
the agreement or conduct does not have as its object or effect the prevention, restriction or distortion of competition within the United Kingdom except in relation to the market for the whole or part of a Complex Weapon or a Supporting Technology.
John Hutton
Secretary of State
Department of Business, Enterprise and Regulatory Reform
2nd July 2007


text:
Citation, commencement and application
1
1
These Regulations may be cited as the Housing (Right to Buy)(Prescribed Forms)(Amendment)(England) Regulations 2007 and shall come into force on 3rd April 2007.
2
These Regulations apply in relation to dwelling-houses in England only.
Amendment of Regulations
2
The Housing (Right to Buy) (Prescribed Forms) Regulations 1986 are amended by the substitution, for the form set out in Schedule 1, of the form set out in the Schedule to these Regulations.
Signed by authority of the Secretary of State for Communities and Local Government
Yvette Cooper
Minister of State
Department for Communities and Local Government
9th March 2007


text:
Citation, commencement and interpretation
1
1
This Order may be cited as the South Tees Hospitals National Health Service Trust (Transfer of Trust Property) Order 2007 and shall come into force on 1 st December 2007.
2
In this Order —
“the old Trust” means the South Tees Hospitals National Health Service Trust ;
“the new Trust” means the North Yorkshire and York Primary Care Trust; and
“the trust property” means the property specified in the schedule of trust property prepared and agreed by the old Trust and the new Trust and signed on behalf of the old Trust on 9 th October 2007 and on behalf of the new Trust on 17 th October 2007.
Transfer of trust property
2
1
On the date that this Order comes into force the trust property, and any rights and liabilities arising from that property, shall be transferred from the old Trust to the new Trust.
2
In any instrument relating to the trust property, any reference in relation to the trust property to the trustees of the trust property or to the old Trust shall be construed as a reference to the new Trust.
Signed by authority of the Secretary of State for Health
Ben Bradshaw
Minister of Health
Department of Health
31st October 2007


text:
Citation and commencement
1
This Order may be cited as the Land Registration (Proper Office) Order 2007 and shall come into force on 1 April 2008.
Applications to which this Order applies
2
1
This Order applies to any application to the registrar except an application delivered to the registrar —
a
in accordance with a written arrangement as to delivery made between the registrar and the applicant or between the registrar and the applicant’s conveyancer, or
b
under the provisions of any relevant notice given under Schedule 2 to the Land Registration Rules 2003 .
2
In this article “conveyancer” means —
a
a solicitor,
b
a licensed conveyancer within the meaning of section 11(2) of the Administration of Justice Act 1985 ,
c
a fellow of the Institute of Legal Executives, or
d
a duly certificated notary public.
Designation of the proper office
3
1
The proper office for the receipt of an application to which this Order applies is any office of the land registry specified in column 1 of the Schedule which is opposite an administrative area shown in column 2 of the Schedule in which the land to which that application relates is wholly or partly situated.
2
In the Schedule, a reference to a named office of the land registry does not include a reference to any sub-office of that office.
Revocation
4
The Land Registration (Proper Office) Order 2003 and the Land Registration (Proper Office) (Amendment) Order 2005 are revoked.
Signed by authority of the Lord Chancellor
Michael Wills
Minister of State
Ministry of Justice
13th December 2007


text:
Citation and commencement
1
This Order may be cited as the Staffordshire Ambulance Service National Health Service Trust (Dissolution) Order 2007 and shall come into force on 1st October 2007.
Dissolution of NHS trust
2
The Staffordshire Ambulance Service National Health Service Trust established by the Staffordshire Ambulance Service National Health Service Trust (Establishment) Order 1991 is dissolved, and accordingly that Order, and the Staffordshire Ambulance Service National Health Service Trust (Establishment) Amendment Order 1997 , are revoked.
Signed by authority of the Secretary of State for Health
Ann Keen
Parliamentary Under Secretary of State
Department of Health
18th September 2007


text:
Citation, commencement, application and interpretation
1
1
These Regulations may be cited as the Public Health (Aircraft and Ships) (Amendment) (England) Regulations 2007.
2
These Regulations shall come into force on 15th June 2007, and in the case of regulations 3 and 4, immediately before the coming into force of the Ships Amendment Regulations .
3
These Regulations apply in relation to England only.
4
In these Regulations —
a
“the Aircraft Regulations ” means the Public Health (Aircraft) Regulations 1979 ; and
b
“the Ships Amendment Regulations” means the Public Health (Ships) (Amendment) (England) Regulations 2007 .
Amendment of regulation 2 of the Aircraft Regulations
2
In regulation 2(1) of the Aircraft Regulations (interpretation) omit the definition of “local authority”.
Amendment of regulation 2 of the Ships Amendment Regulations
3
In regulation 2(1)(l) of the Ships Amendment Regulations (amendment of regulation 2 of the principal Regulations), for the definition of “local authority” substitute —
“local authority” means —
in relation to a port health district the port health authority; and
in relation to any other district —
the district council,
the county council for the county in which a district is where there is no district council for that district,
the London borough council for a London borough, or
the Common Council of the City of London for the City of London;
.
Amendment of regulation 8 of the Ships Amendment Regulations
4
In regulation 8 of the Ships Amendment Regulations (amendment of regulation 9 of the principal Regulations), omit the paragraph number “(1)”, and for sub-paragraph (b) substitute —
b
for paragraph (7), substitute —
7
The medical officer shall immediately notify the local authority of any directions given to him by the Secretary of State under this regulation.
.
.
Signed by authority of the Secretary of State for Health
Caroline Flint
Minister of State
Department of Health
4th June 2007
We consent
Mike Hanson
Mike Eland
Two of the Commissioners for Her Majesty’s Revenue and Customs
4th June 2007