text:
Citation and commencement
1
These Regulations may be cited as the Value Added Tax, etc (Correction of Errors, etc) Regulations 2008 and come into force on 1st July 2008.
Value added tax
2
1
In regulation 34(3) of the Value Added Tax Regulations 1995 (the VAT Regulations) for “£2,000” substitute “£50,000”, then after “regulation.” start a new line and continue —
But if Box 6 of the taxable person’s return for the prescribed accounting period must contain a total less than £5,000,000, the difference must not for these purposes exceed 1% of that total unless the difference is less than £10,000.
(Box 6 must contain the total value of sales and all other outputs excluding any VAT – see regulation 25 and Schedule 1 Forms 4 and 5.)
.
2
These amendments only have effect in relation to the overstatements or understatements of liability to VAT in regulation 34(3) of the VAT Regulations which taxable persons first discover during their prescribed accounting periods that begin on 1st July 2008 or later.
(See regulations 34(1) to 34(3) of the VAT Regulations for the meaning carried by “overstatements or understatements”; sections 96(1) and 3 of the Value Added Tax Act 1994 for, respectively, “VAT” and “taxable person”; regulations 2(1), 25 and 99(1) of the VAT Regulations for the meaning carried by “prescribed accounting period”.)
Insurance premium tax
3
1
In regulation 13(3) of the Insurance Premium Tax Regulations 1994 (the IPT Regulations) —
a
for each “£2,000”, substitute “£50,000”;
b
for “the box opposite the legend “Overdeclarations from previous periods””, substitute “Boxes 6 to 8 (overdeclarations), as appropriate,”;
c
for “the box opposite the legend “Underdeclarations from previous periods””, substitute “Boxes 3 and 4 (underdeclarations), as appropriate,”;
d
then, after “accordingly.”, start a new line and continue —
But if Box 10 of the registrable person’s return for the accounting period requires an entry for net value of taxable premiums (excluding tax) that is less than £5,000,000 (see regulation 12 and Forms 4 and 5 in the Schedule), the total mentioned in sub-paragraph (a) or (b) must not for these purposes exceed 1% of that net value unless the respective total is less than £10,000.
.
2
In regulation 13(4) of the IPT Regulations, omit in both places “not exceeding £2,000”.
3
Substitute the forms in Schedule 1 as, respectively, Form 4 (IPT 100) and Form 5 (IPT 100L) in the Schedule to the IPT Regulations (insurance premium tax returns).
4
The amendments in paragraphs (1) and (2) only have effect in relation to the overdeclarations or underdeclarations in regulation 13(3) of the IPT Regulations which registrable persons first discover in their accounting periods that begin on 1st July 2008 or later.
Those in paragraph (3) only have effect in respect of or as regards accounting periods that begin on 1st July 2008 or later.
(See regulation 13(1) of the IPT Regulations for the meaning of “overdeclaration” and “underdeclaration”; section 73(3A) of the Finance Act 1994 for “registrable person”; regulation 2(1) of the IPT Regulations for the meaning of “accounting period”.)
Air passenger duty
4
1
Substitute the form in Schedule 2 for the one set out in Schedule 3 to the Air Passenger Duty Regulations 1994 (the APD Regulations) (Form APD 2 – air passenger duty return).
2
This amendment only has effect in relation to accounting periods that end on 31st July 2008 or later.
(See regulations 2(1) and 9(1) of the APD Regulations for the meaning carried by “accounting period”.)
Landfill tax, climate change levy, aggregates levy
5
1
Omit regulation 13(3) of the Landfill Tax Regulations 1996 (the LT Regulations).
2
Insert “overdeclarations or” —
a
in regulation 13(4)(a) of the LT Regulations after “more”;
b
in regulation 13(4)(b) of the LT Regulations, in each place, after “those”;
c
in the full out words to regulation 13(4) of the LT Regulations after “enter the”.
3
In regulation 13(4)(b) of the LT Regulations —
a
for “of any overdeclarations”, substitute “respectively of any underdeclarations or overdeclarations”;
b
for “£2,000”, substitute “£50,000”.
4
In regulation 13(4) of the LT Regulations, for everything from “the box opposite” to “general notes)”.” substitute “Box 2 (underdeclarations) or Box 4 (overdeclarations), as appropriate (see Form 5 in the Schedule).”.
Then start a new line and continue —
But if the registrable person’s VAT turnover is small, the total mentioned in sub-paragraph (b) must not for these purposes exceed 1% of that turnover unless the total is less than £10,000.
And if that person is not registered for VAT, the total mentioned in sub-paragraph (b) must not for these purposes exceed £10,000.
.
5
In regulation 13(5) of the LT Regulations, omit “(3) or”.
6
Substitute the form in Schedule 3 as Form 5 in the Schedule to the LT Regulations (landfill tax return).
7
The amendments in paragraphs (1) to (5) (and the related amendment in regulation 8) only have effect in relation to overdeclarations or underdeclarations in regulation 13 of the LT Regulations which registrable persons first discover in their accounting periods that begin on 1st July 2008 or later.
That in paragraph (6) only has effect in relation to returns that relate to periods that begin on 1st July 2008 or later.
(See regulation 13(1) of the LT Regulations for the meaning of “overdeclaration” and “underdeclaration”; section 47(10) of the Finance Act 1996 for “registrable person”; regulations 2(1) and 11 of the LT Regulations for the meaning carried by “accounting period” and “return”.)
6
1
In regulations 14(2)(b), 17(3)(b) and 28(4) of, and Schedule 1 paragraph 8(2)(b) to, the Climate Change Levy (General) Regulations 2001 (the CCL Regulations), for each “£2,000” substitute “£50,000”.
2
After regulation 28(4) of the CCL Regulations, insert —
4A
But if the registrable person’s VAT turnover is small, each aggregate in paragraph (4) must not for those purposes exceed 1% of that turnover unless the aggregate is less than £10,000.
And if that person is not registered for VAT, each aggregate must not for those purposes exceed £10,000.
.
3
In regulation 28(5) of the CCL Regulations, for “paragraph (4)” substitute “paragraphs (4) and (4A)”.
4
These amendments (and the related amendment in regulation 8) only have effect in relation to under-calculations or over-calculations respectively in regulations 28(2) and 28(3) of the CCL Regulations which registrable persons first discover in their accounting periods that start on 1st July 2008 or later.
(See regulation 28(4) of the CCL Regulations for the meaning of “under-calculation” and “over-calculation”; regulation 2(1) of the CCL Regulations for the meaning of “registrable person”; regulation 3 of the CCL Regulations for the meaning carried by “accounting period”.)
7
1
In regulations 15(4)(b), 18(3)(b) and 29(6) of the Aggregates Levy (General) Regulations 2002 (the AL Regulations), for each “£2,000” substitute “£50,000”.
2
Then, in regulation 29(6) of the AL Regulations, start a new line and continue —
But if the registrable person’s VAT turnover is small, this total must not for these purposes exceed 1% of that turnover unless the total is less than £10,000.
And if that person is not registered for VAT, the total net amount must not for these purposes exceed £10,000.
.
3
These amendments (and the related amendment in regulation 8) only have effect in relation to under-calculations or over-calculations respectively in regulations 29(2) and 29(3) of the AL Regulations which registrable persons first discover in their accounting periods that start on 1st July 2008 or later.
(See regulation 29(4) of the AL Regulations for the meaning of “under-calculation” and “over-calculation”; regulation 2 of the AL Regulations for the meaning of “registrable person”; regulation 5 of the AL Regulations for the meaning carried by “accounting period”.)
8
In regulation 13(4) of the LT Regulations as amended by regulations 5(2) to 5(4), regulation 28(4A) of the CCL Regulations inserted by regulation 6(2), and regulation 29(6) of the AL Regulations as amended by regulations 7(1) and 7(2), in each case after “exceed £10,000.” start a new line and continue —
The VAT turnover is small only if Box 6 of that person’s value added tax return for the prescribed accounting period in which the discovery is made must contain a total less than £5,000,000 (total value of sales and all other outputs excluding any value added tax).
(See sections 96(1) and 1 of the Value Added Tax Act 1994 for “VAT” and “value added tax”, and sections 96(2) and 3 of and Schedules 1 to 3A to that Act about being registered for VAT; regulations 2(1) and 25 of and Schedule 1 Forms 4 and 5 to the Value Added Tax Regulations 1995 for the meaning carried by “Box 6” and “return”; sections 96(1) and 25(1) of that Act and regulations 2(1), 25 and 99(1) of those Regulations for the meaning carried by “prescribed accounting period”; section 24(2) of that Act for “output tax”.)
.
Mike Eland
Mike Hanson
Two of the Commissioners for Her Majesty’s Revenue and Customs
9th June 2008


type: legislation

jurisdiction: UK

text:
Citation, commencement and interpretation
1
These Regulations may be cited as the Immigration (Disposal of Property) Regulations 2008 and shall come into force on 17th April 2008.
2
In these Regulations —
a
“the 2007 Act ” means the UK Borders Act 2007.
Property to which these Regulations apply
3
These Regulations apply to property where —
a
the owner has not been ascertained,
b
an order under section 26(2) of the 2007 Act (disposal of property: court order) cannot be made because of subsection (4)(a) of that section, or
c
a court has declined to make an order under section 26(2) of the 2007 Act on the grounds that the court is not satisfied of the matters specified in subsection (4)(b) of that section.
Restrictions on disposal of property
4
1
Subject to regulation 5(2), property to which these Regulations apply, other than money —
a
which has been the subject of a forfeiture order under section 25C of the Immigration Act 1971 (forfeiture of vehicle, ship or aircraft) or section 25 of the 2007 Act (forfeiture of detained property) shall not be disposed of until it has remained in the possession of the Secretary of State for six months beginning with the date on which the forfeiture order was made; and
b
which has not been the subject of a forfeiture order under section 25C of the Immigration Act 1971 or section 25 of the 2007 Act shall not be disposed of until it has remained in the possession of the Secretary of State for a year.
2
Money which is property to which these Regulations apply shall be paid into the Consolidated Fund as soon as is reasonably practicable.
Sale of property
5
1
Subject to paragraph (2), after the expiration of the relevant period referred to in regulation 4, property to which these Regulations apply other than money may be sold.
2
Where the property is a perishable article or its custody involves unreasonable expense or inconvenience it may be sold at any time.
3
Subject to paragraph (4), the proceeds of all sales under these Regulations shall be paid into the Consolidated Fund as soon as is reasonably practicable.
4
The Secretary of State may apply the proceeds of all sales under these Regulations, and any money which is property to which these Regulations apply, to defray reasonable expenses incurred in the conveyance, storage, and safe custody of the property and in connection with its sale and otherwise in acting pursuant to these Regulations.
Retention of property
6
After the expiration of the relevant period referred to in regulation 4, if, in the opinion of the Secretary of State, property to which these Regulations apply (other than money) can be used in the course of, or in connection with, a function under the Immigration Acts, the Secretary of State may determine that the property is to be retained by her and the property shall vest in the Secretary of State on the making of the determination.
Other disposal of property in the public interest
7
If the Secretary of State is satisfied that the nature of any property to which these Regulations apply is such that it is not in the public interest that it should be sold or retained, it shall, after the expiration of the relevant period referred to in regulation 4, be destroyed or otherwise disposed of in accordance with the direction of the Secretary of State.
Liam Byrne
Minister of State
Home Office
20th March 2008


text:
Citation, commencement and extent
1
1
These Regulations may be cited as the Removal, Storage and Disposal of Vehicles (Prescribed Sums and Charges) Regulations 2008 and shall come into force on 1st October 2008.
2
These Regulations extend to England and Wales.
Revocation and transitional provisions
2
1
Subject to paragraph (2), the Removal, Storage and Disposal of Vehicles (Prescribed Sums and Charges etc ) Regulations 1989 are revoked.
2
In relation to vehicles removed prior to 1 October 2008, nothing in these Regulations shall have effect and the provisions mentioned in paragraph (1) shall continue to have effect.
Interpretation
3
1
In these Regulations —
“the 1978 Act ” means the Refuse Disposal (Amenity) Act 1978;
“the 1984 Act ” means the Road Traffic Regulation Act 1984;
“laden” means that the vehicle is carrying a load;
“load” means anything other than —
the body and all parts of the vehicle which are necessary to or ordinarily used with the vehicle when working on a road;
any water, fuel or accumulators used for the purpose of the supply of power for the propulsion of the vehicle;
the driver, any passengers and their personal effects;
a crane, works truck as defined in regulation 3(2) of the Road Vehicles (Construction and Use) Regulations 1986 , or other special appliance or apparatus which is a permanent or essentially permanent fixture of the vehicle; and
any containers or other equipment intended or adapted for the purpose of holding or carrying a load by the vehicle;
“ MAM ” means maximum authorised mass as defined in regulation 3(1) of the Motor Vehicles (Driving Licences) Regulations 1999 ;
“off road” means that no part of the vehicle is in contact with the road;
“on road” means that any part of the vehicle is in contact with the road;
“road” means any length of highway or of any other road to which the public has access, and includes bridges over which a road passes;
“substantially damaged” means such damage to a vehicle that in the reasonable opinion of a constable it cannot be driven safely on the road;
“two wheeled vehicle” means a mechanically propelled vehicle constructed or adapted to have two wheels or less and the MAM of which does not exceed 3.5 tonnes;
“unladen” means that the vehicle is not carrying a load;
“vehicle” has the same meaning as in section 99(5) of the 1984 Act.
2
For the purposes of regulation 4, a vehicle will only be considered upright if all parts of the vehicle are upright.
3
Each period of 24 hours referred to in regulation 5 shall be reckoned from noon on the first day after removal during which the place at which the vehicle is stored is open for the claiming of vehicles before noon.
4
For the purposes of regulations 4, 5 and 6 the MAM of a vehicle includes the MAM of any trailer attached to that vehicle.
Charges in relation to the removal of vehicles
4
The prescribed sum in respect of removal, for the purposes of sections 101A(3), 101A(4) and 102(2)(a) of the 1984 Act and sections 4(5) , 4(6) and 5(1)(a) of the 1978 Act, in respect of vehicles set out in column 1 of Table 1 shall be the sum specified in relation to those vehicles in columns 2 to 5 of that Table, the particular sum to be determined by reference to the MAM of the vehicle as described in row 1 of that Table and, for vehicles exceeding 7.5 tonnes MAM and not falling within row 2, whether the vehicle is laden or unladen.
Table 1 – Regulation 4
1 2 3 4 5 1 Vehicle position and condition Vehicle equal to or less than 3.5 tonnes MAM Vehicle exceeding 3.5 tonnes MAM but equal to or less than 7.5 tonnes Vehicle exceeding 7.5 tonnes MAM but equal to or less than 18 MAM Vehicle exceeding 18 tonnes MAM
2 Vehicle on road, upright and not substantially damaged or any two wheeled vehicle whatever its condition or position on or off the road £150 £200 £350 £350 3 Vehicle, excluding a two wheeled vehicle, on road but either not upright or substantially damaged or both £250 £650 Unladen–£2000 Unladen–£3000 Laden–£3000 Laden–£4500 4 Vehicle, excluding a two wheeled vehicle, off road, upright and not substantially damaged £200 £400 Unladen–£1000 Unladen–£1500 Laden–£1500 Laden–£2000 5 Vehicle, excluding a two wheeled vehicle, off road but either not upright or substantially damaged or both £300 £850 Unladen–£3000 Unladen–£4500 Laden–£4500 Laden–£6000
Charges in relation to the storage of vehicles
5
The prescribed sum or prescribed scale in respect of storage, for the purposes of sections 101A(3), 101A(4) and 102(2)(b) of the 1984 Act and sections 4(5), 4(6) and 5(1)(b) of the 1978 Act, for each period of 24 hours or a part thereof during which the vehicle is in the custody of the chief officer of a police force or the local authority as the case may be, with regards to vehicles set out in row 1 of Table 2, shall be the sum specified in relation to those vehicles in row 2 of that Table.
Table 2 – Regulation 5
1 2 3 4 5 1 Two wheeled vehicle Vehicle, not including a two wheeled vehicle, equal to or less than 3.5 tonnes MAM Vehicle exceeding 3.5 tonnes MAM but equal to or less than 7.5 tonnes MAM Vehicle exceeding 7.5 tonnes MAM but equal to or less than 18 MAM Vehicle exceeding 18 tonnes MAM
2 £10 £20 £25 £30 £35
Charges in relation to the disposal of vehicles
6
1
The prescribed sum for determining the charges recoverable for the disposal of vehicles for the purpose of section 4(6) of the 1978 Act in respect of vehicles set out in row 1 of Table 3 shall be the sum specified in relation to those vehicles in row 2 of that Table.
2
The prescribed manner for determining the charges recoverable for the disposal of vehicles for the purposes of sections 102(2)(c) of the 1984 Act and 5(1)(c) of the 1978 Act in respect of vehicles set out in row 1 of Table 3 shall be by reference to a single sum specified in relation to those vehicles in row 2 of that Table.
Table 3 – Regulations 6
1 2 3 4 5 1 Two wheeled vehicle Vehicle, not including a two wheeled vehicle, equal to or less than 3.5 tonnes MAM Vehicle exceeding 3.5 tonnes MAM but equal to or less than 7.5 tonnes MAM Vehicle exceeding 7.5 tonnes MAM but equal to or less than 18 MAM Vehicle exceeding 18 tonnes MAM
2 £50 £75 £100 £125 £150
Vernon Coaker
Parliamentary Under Secretary of State
Home Office
28th July 2008


text:
PART 1 General
Citation and commencement
1
These Regulations may be cited as the Medicines (Products for Human Use-Fees) Regulations 2008 and shall come into force on 1st April 2008.
Interpretation
2
1
In these Regulations, unless the context requires otherwise —
“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 ;
“the 1994 Regulations ” means the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 ;
“ the Act ” means the Medicines Act 1968 and, except as provided below, expressions used in these Regulations have the same meaning as in the Act;
“API manufacturer” means a person, other than the holder of a manufacturer’s licence, engaged in the manufacture or assembly of active substances used as starting materials in the manufacture of medicinal products;
“application”, in relation to a clinical trial authorisation, means a request for authorisation to conduct a clinical trial made in accordance with regulation 17 (request for authorisation to conduct a clinical trial) of the Clinical Trials Regulations , and “applicant”, in relation to such authorisation, means the person making the request;
“authorised medicinal product” means a medicinal product in respect of which a marketing authorization has been granted;
“blood product” means any medicinal product derived from human blood or human plasma and includes albumin, coagulating factor and immunoglobulin of human origin;
“capital fee” means any fee, other than a periodic fee, payable under the provisions of these Regulations;
“change of ownership application” means an application —
for —
a marketing authorization for a medicinal product in respect of which another person holds a marketing authorization,
a manufacturing authorisation for activities in respect of which another person holds a manufacturing authorisation,
a traditional herbal registration for a medicinal product in respect of which another person holds a traditional herbal registration,
a manufacturer’s licence for activities in respect of which another person holds a manufacturer’s licence, or
a wholesale dealer’s licence for activities in respect of which another person holds a wholesale dealer’s licence;
which refers to particulars which are in all material respects identical to the particulars of the marketing authorization, manufacturing authorisation, traditional herbal registration, manufacturer’s licence, or wholesale dealer’s licence which is held by that other person; and
which includes a statement to the effect that that other person intends to cease the activities to which his marketing authorization, manufacturing authorisation, traditional herbal registration or licence relates and has consented in writing to the making of the application,
and in this definition particulars do not include particulars relating to the name and address of the applicant, the labelling of any medicinal product or the content of any leaflet relating to such a product;
“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended —
to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;
to identify any adverse reactions to one or more such products; or
to study absorption, distribution, metabolism and excretion of one or more such products,
with the object of ascertaining the safety or efficacy of those products;
“clinical trial authorisation” means authorisation of the conduct of a clinical trial —
by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving general medicinal products for gene therapy etc. ) or 20 (authorisation procedure for clinical trials involving general medicinal products with special characteristics) of the Clinical Trials Regulations; or
which is treated as having been given by the licensing authority by virtue of Schedule 12 to those Regulations;
“Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004 ;
“ Commission Regulation (EC) No. 1084/2003 ” means 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 ;
“ Community marketing authorization ” means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 or Regulation (EC) No. 726/2004 ;
“concerned member State” means an EEA State , the competent authorities of which receive an application to obtain recognition, according to the procedure laid down in Title III , Chapter 4 of the 2001 Directive, of a United Kingdom marketing authorization;
“conditions and principles of good clinical practice” means the conditions and principles specified in Schedule 1(conditions and principles of good clinical practice and for the protection of clinical trial subjects) to the Clinical Trials Regulations;
“contract laboratory” means a laboratory carrying out the examinations and tests referred to in —
paragraph 5A(2) of Schedule 2 (standard provisions for manufacturer’s licences and manufacturer’s licences of right) to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 ; and
Article 11(1) of Directive 2003/94/EC ,
on behalf of the holder of a manufacturing authorisation, manufacturer’s licence or wholesale dealer’s licence, pursuant to Article 11(2) of that Directive and Article 20(b) of the 2001 Directive;
“ Council Regulation (EEC) No. 2309/93 ” means Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products ;
“ Directive 75/319/EEC ” means Council Directive 75/319/ EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products ;
“Directive 2003/94/EC” means Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use ;
“EEA State” means a member State, Norway, Iceland or Liechtenstein;
“exempt imported product” means a medicinal product, as defined in Article 1(2) of the 2001 Directive, to which paragraph 1 of Schedule 1 (exemptions and exceptions from the provisions of regulation 3) to the 1994 Regulations applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;
“fee period” means the period beginning with the first day of April in any year and ending with the last day of March in the following year;
“ Herbal Regulations ” means the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 ;
“herbal substances” has the meaning given by Article 1(31) of the 2001 Directive;
“holder”, in relation to a clinical trial authorisation, means —
in the case of an authorisation treated as having been given by the licensing authority by virtue of Schedule 12 (transitional provisions) to the Clinical Trials Regulations, the person acting as sponsor of the clinical trial for the purposes of those Regulations; or
in any other case, the person who made the request for that authorisation;
“homoeopathic medicinal product” means any medicinal product (which may contain a number of principles) prepared from substances called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State;
“immunological product” means any medicinal product which is a vaccine, toxin, serum or allergen product;
“manufacturer’s licence” means a manufacturer’s licence which relates wholly or partly to medicinal products for human use;
“manufacturing authorisation” means a manufacturing authorisation granted for the purposes of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products) of the Clinical Trials Regulations;
“marketing authorization” means, except in regulation 3 —
a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations;
a Community marketing authorization; or
a product licence, including one which is a licence of right or one which has effect as a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to the 1994 Regulations,
which relates to a medicinal product for human use;
“medicinal product” includes any medicinal product for human use to which the 2001 Directive applies and any substance or article specified in any order for the time being in force made under section 104 (application of the Act to certain articles and substances) or 105(1)(a) (application of the Act to certain other substances which are not medicinal products) of the Act which directs that Part II of the Act or the Clinical Trials Regulations shall have effect in relation to such substance or article;
“national homoeopathic product” means a homoeopathic medicinal product which –
does not satisfy the conditions set out in article 14(1) of the 2001 Directive; and
is indicated for the relief or treatment of minor symptoms or minor conditions in humans;
“operator”, in relation to a contract laboratory, means the person having control of the contract laboratory;
“orphan medicinal product” has the meaning given in article 2(b) of Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16th December 1999 on orphan medicinal products ;
“parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under the 1994 Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA State in accordance with the rules of Community law relating to parallel imports;
“penalty fee” means a fee payable under regulation 41;
“periodic fee” means the fee payable under regulation 31 or 32 by the holder of a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturing authorisation, a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial authorisation for the holding of the authorization, registration, authorisation or licence;
“Periodic Safety Update Report” means a report prepared to meet the requirements of the 2001 Directive;
“product licence of right” means a product licence within the meaning of section 7 (general provisions as to dealing with medicinal products) of the Act which is a licence of right within the meaning of section 25(4) (entitlement to licence of right) of the Act;
“Regulation (EC) No. 726/2004 ” means Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ;
“relevant fee period” means any fee period during any part of which a marketing authorization, a traditional herbal registration, a clinical trial authorisation, manufacturing authorisation or licence in respect of which a periodic fee is payable is in force;
“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply other than–
a traditional herbal medicinal product, or
a homoeopathic medicinal product that fulfils the conditions laid down in Article 14(1) of the 2001 Directive;
“special import notice” means a written notice given to the licensing authority in accordance with paragraph 7(2) of Schedule 2 (standard provisions which may be incorporated in a manufacturer’s licence relating to the import of relevant medicinal products from a third country) to, or paragraph 3(2) of Schedule 4 (standard provisions which may be incorporated in a wholesale dealer’s licence) to, the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 ;
“traditional herbal medicinal product” has the meaning given by Article 1(29) of the 2001 Directive;
“traditional herbal registration” means a registration granted by the licensing authority under the Herbal Regulations;
“United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the 1994 Regulations;
“variation” —
in relation to —
a United Kingdom marketing authorization, or
a product licence which has effect as such a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to those Regulations,
means “variation to the terms of a marketing authorization” as defined in Article 3(1) of Commission Regulation (EC) No. 1084/2003 ;
in relation to a traditional herbal registration, means a variation of the provisions of a traditional herbal registration;
“wholesale dealer’s licence” means a wholesale dealer’s licence which relates wholly or partly to medicinal products for human use;
and Part 1 of Schedule 1 shall have effect for the purpose of interpreting that Schedule.
2
For the purposes of these Regulations, a clinical trial authorisation is in force unless the licensing authority has —
a
received notification of the conclusion of the clinical trial to which the authorisation relates, in accordance with regulation 27 (conclusion of clinical trial) of the Clinical Trials Regulations; or
b
suspended or terminated the trial at all sites at which that clinical trial was conducted, in accordance with regulation 31 (suspension or termination of clinical trial) of those Regulations .
3
In these Regulations any reference to an application for the variation of a marketing authorization includes a reference to a notification of such a variation and any reference to an applicant for a variation to a marketing authorization includes a reference to a person who submits such a notification.
PART 2 Capital Fees for Pre-Application Meetings
Interpretation of Part 2
3
In this Part —
“clinical development” means the conduct of studies of a medicinal product in human subjects in order to —
discover or verify the effects of such a product;
identify any adverse reaction to such a product; or
study absorption, distribution, metabolism and excretion of such a product,
with the object of ascertaining the safety or efficacy of that product, in accordance with section 5 of Part 1 of Annex 1 to the 2001 Directive;
“EC marketing authorization” means —
a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations;
a marketing authorization granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive; or
a Community marketing authorization;
“pharmacovigilance advice” means advice, other than scientific advice, which falls within one or more of the descriptions specified in paragraphs (a) and (b) —
the advice is in connection with an application for an EC marketing authorization, or is given with a view to a person making such an application, and relates to —
the obligations that would relate to the holder of such an authorization by virtue of Title IX of the 2001 Directive or Chapter 3 of the Title II of Regulation (EC) No. 726/2004 ,
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, or
a post-authorization safety study protocol;
the advice is given to the holder of a United Kingdom marketing authorization or a Community marketing authorization and relates to —
compliance with the obligations that relate to him by virtue of Title IX of the 2001 Directive or Chapter 3 of Title II of Regulation (EC) No. 726/2004 ,
the pharmacovigilance and risk-management systems that he has introduced in accordance with Article 8(3)(ia) of the 2001 Directive, or
a post-authorization safety study protocol;
“post-authorization safety study protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a post-authorization safety study;
“product range” means one or more medicinal products containing the same active substance in relation to which the same person holds more than one EC marketing authorization;
“quality development” means the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a relevant medicinal product, in accordance with section 3 of Part 1 of Annex 1 to the 2001 Directive;
“regulatory advice” means advice, other than scientific advice, in relation to the requirements of the 2001 Directive or Regulation (EC) No. 726/2004 and which falls within one or more of the descriptions specified in paragraphs (a) to (c) —
the advice is in connection with a change to the dates for renewal of one or more EC marketing authorizations relating to a product range pursuant to Article 24 of the 2001 Directive;
the advice is in connection with —
a referral pursuant to Article 30, 31 or 36 of the 2001 Directive, or
the procedure referred to in Article 35(2) of the 2001 Directive,
in relation to a product range; or
the advice is given to a person with a view to him making —
an application for the variation or renewal of one or more EC marketing authorizations, or
an application to amend the time periods for submitting Periodic Safety Update Reports under Article 104(6) of the 2001 Directive,
in relation to a product range;
“scientific advice” means advice in connection with the quality, safety or clinical development for a relevant medicinal product;
“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply; and
“safety development” means the toxicological and pharmacological testing necessary to demonstrate the safety of a relevant medicinal product, in accordance with section 4 of Part 1 of Annex 1 to the 2001 Directive.
Fee for scientific advice: application for or variation to EC marketing authorization
4
Unless regulation 5 or 44 apply, the fee payable by a person with whom the licensing authority holds a meeting in order to provide scientific advice with a view to that person making an application for an EC marketing authorization or an application for the variation of a marketing authorization, is —
a
£2,227, if the advice provided at that meeting consists of advice in connection with —
i
quality development only, or
ii
safety development only;
b
£2,797, if the advice provided at that meeting consists only of advice in connection with clinical development;
c
£3,099, if the advice provided at that meeting consists only of advice in connection with quality and safety development;
d
£3,669, if the advice provided at that meeting consists of advice in connection with —
i
quality and clinical development, or
ii
safety and clinical development;
e
£4,542, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.
Fee for scientific advice: classification of a medicinal product
5
1
Unless regulation 44 applies, the fee payable by a person with whom the licensing authority holds a meeting to provide scientific advice in connection with the classification of a relevant medicinal product, is —
a
£2,797, if the advice relates to a product which if reclassified will be available on general sale; and
b
£3,699, if the advice relates to a product which if reclassified will be available without a prescription from a pharmacy.
2
For the purposes of this regulation a product is on general sale if it is a medicinal product of a description, or falling within a class specified in an order made under section 51 (general sale lists) of the Act .
Fee for advertising advice
6
Unless regulation 44 applies, the fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide advice before the publication of advertising of a medicinal product by his undertaking on whether that advertising conforms to the requirements of Title VIII of the 2001 Directive, is £2,227.
Fee for pharmacovigilance advice
7
1
Unless regulation 44 applies, the fee payable by a person with whom the licensing authority holds a meeting in order to provide pharmacovigilance advice is —
a
£3,699, in a case where the time taken by the licensing authority to prepare for and attend the meeting is more than six hours;
b
£3,099, in any other case.
2
The time taken by the licensing authority for the purposes of paragraph (1) shall be the aggregate of times spent by each individual engaged in preparing for or attending the meeting on behalf of the authority.
Fee for advice on labelling or leaflets
8
Unless regulation 44 applies, the fee payable by the holder of one or more marketing authorizations with whom the licensing authority holds a meeting in order to provide advice on proposed changes to the labelling or the package leaflets of the medicinal products to which those authorizations relate, is £2,227.
Fee for regulatory advice
9
Unless regulation 44 applies, the fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide regulatory advice to that person, is £2,797.
Fee for advice for other purposes
10
1
Unless regulation 44 applies, the fee payable by a person specified in paragraph (2) with whom the licensing authority holds a meeting for a purpose specified in paragraph (3) is £4,579.
2
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 medicinal 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),
is a specified person for the purpose of paragraph (1).
3
A meeting referred to in paragraph (1) is for a specified purpose if it is held to provide 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 risk 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.
4
This regulation does not apply to a meeting for the purpose of providing only any advice specified in regulations 4 to 9.
5
In this regulation —
“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC ;
“Directive 93/42/EEC ” means Council Directive 93/42/EEC concerning medical devices ;
“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;
“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;
“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;
“sponsor” shall be construed in accordance with regulation 3 (sponsor of a clinical trial) of the Clinical Trials Regulations ;
and a reference to the development of a medicinal product or a type of medicinal product is a reference to development for the purposes of —
a
obtaining an EC marketing authorization, or making a variation to an EC marketing authorization, for that product or a product of that type, or
b
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.
Time for payment of fees under regulations 4 to 10
11
Unless regulation 44 applies, all sums payable by way of fees under regulations 4 to 10 must be paid within 14 days following written notice from the licensing authority requiring payment of those fees.
PART 3 Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections
Fees for applications for authorizations, licences or certificates, etc
12
1
Unless regulation 44, or 48 applies, the application fee for a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturer’s licence, a manufacturing authorisation, a wholesale dealer’s licence or a clinical trial authorisation is —
a
the fee prescribed for that application in Part 2 of Schedule 1; and
b
in respect of an inspection of a site made in connection with that application the fee payable in accordance with regulations 27 to 29.
2
Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.
Fee for applications for copy certificates of good manufacturing practice
13
The fee payable by an applicant for a certified copy of a certificate of good manufacturing practice issued pursuant to Article 111(5) of the 2001 Directive is £63.
Fees for applications for certificates and copy certificates by exporters of medicinal products
14
1
The fee payable by an applicant for a certificate issued under section 50 (export certificates) of the Act , is —
a
£141, if the applicant requests the certificate to be issued within 24 hours of receipt of the application; and
b
£63 in any other case.
2
The fee in sub-paragraphs (a) and (b) is for three identical signed certificates.
3
The fee payable by the applicant for a copy of the certificate referred to in paragraph (1) is £31 for a certified copy of the certificate.
PART 4 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States
Meaning of “set of applications”
15
For the purposes of this Part and Part 3 of Schedule 1, a “set of applications” means —
a
a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in other EEA States, but only if all the applications relate to applications for marketing authorizations in other EEA States that have the same 90 day assessment period for the purposes of Article 28.4 of the 2001 Directive; or
b
a number of applications to competent authorities of other EEA States for marketing authorizations relating to a single United Kingdom marketing authorization, but only if all the applications have the same 90 day assessment period for the purposes of Article 28.4 of the 2001 Directive.
Fees for applications for regulatory assistance under the mutual recognition procedure
16
Unless regulation 44 applies, the fee payable by an applicant to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in another EEA State or in other EEA States, is the fee prescribed in Part 3 of Schedule 1 in connection with the application or set of applications.
Time for payment of fees under regulation 16
17
Unless regulation 39 or 44 applies, all sums payable by way of fees under regulation 16 must be paid at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated.
PART 5 Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Certificates and for Associated Inspections
Fees for variations of authorizations, registrations, licences and authorisations
18
1
Unless regulations 44 or 48 applies, the fee for an application —
a
under regulation 4 (applications for the grant, renewal or variation of a United Kingdom marketing authorization) of the 1994 Regulations for the variation of a United Kingdom marketing authorization;
b
under regulation 6 (consideration and grant or refusal, of an application for, or for renewal or variation of, a traditional herbal registration) of the Herbal Regulations for the variation of a traditional herbal registration;
c
under section 30 (variation of licence on application of holder) of the Act for the variation of a product licence, a manufacturer’s licence or a wholesale dealer’s licence; or
d
under regulation 44 (variation of manufacturing authorisation) of the Clinical Trials Regulations for the variation of a manufacturing authorisation,
is the fee mentioned in paragraph (2).
2
The fee referred to in paragraph (1) is —
a
the fee prescribed in Part 4 of Schedule 1 in connection with the application; and
b
in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29.
3
Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.
Fees for amendments to clinical trial authorisations
19
1
A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations relating to amendment of the dossier accompanying a request for authorisation in accordance with paragraph 11 of Part 2 of Schedule 3 (request for authorisation) to those Regulations must pay the fees mentioned in paragraph (2).
2
The fees referred to in paragraph (1) are —
a
the fee prescribed in paragraph 23 of Part 4 of Schedule 1 in connection with that amendment; and
b
in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29.
Applications for multiple variations
20
1
Unless paragraph (2) applies, a separate fee is payable in respect of each variation of each provision of a marketing authorization, traditional herbal registration, manufacturing authorisation or licence applied for in any one application.
2
A separate fee is not payable for a variation which is wholly consequential upon another variation of a provision of a marketing authorization, traditional herbal registration, manufacturing authorisation or licence which is applied for in the same application.
PART 6 Capital Fees for Assessment of Labels and Leaflets
Meaning of “set of proposed changes”
21
For the purposes of this Part and Part 5 of Schedule 1, a “set of proposed changes” means a number of proposed changes to the labelling or package leaflet of a medicinal product, where —
a
if there is more than one version of the labelling or package leaflet for that product, those changes all relate to the same version; and
b
those changes are submitted to the licensing authority at the same time.
Fees for assessment of a set of proposed changes to labels and leaflets
22
1
Unless paragraph (2) or regulation 44 apply, where —
a
a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a United Kingdom marketing authorization (other than a parallel import licence) is submitted to the licensing authority in accordance with Article 61(3) of the 2001 Directive; or
b
a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a parallel import licence is submitted to the licensing authority,
the fee payable by the holder of that authorization or licence is the fee prescribed in Part 5 of Schedule 1 in connection with that change.
2
Paragraph (1) does not apply where a change to the labelling or package leaflet of a medicinal product is proposed in connection with an application for the variation of the marketing authorization for that product.
Time for payment of fees under regulation 22
23
Unless regulation 44 applies, all sums payable by way of fees under regulation 22 (1) must be paid at the time when the proposed changes are submitted to the licensing authority.
PART 7 Capital Fees for Applications for Renewals of Certain Manufacturer’s Licences and for Associated Inspections
Fees for renewals of certain manufacturer’s licences
24
1
Unless regulation 44 applies, the fee payable by the applicant for an application to renew a manufacturer’s licence which falls within the description in paragraph (2) is £165.
2
The licence referred to in paragraph (1) is one —
a
which is solely for the manufacture of medicinal products the sale or supply of which does not require a marketing authorization or a product licence; and
b
to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies.
3
But if an inspection of a site is made in connection with the application an inspection fee of £273 is also payable by the applicant.
Fees for renewals in terms which are not identical to the existing authorization, licence or certificate
25
Where an applicant applies for renewal of a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturer’s licence or a wholesale dealer’s licence so as to contain provisions which are not identical to those in the authorization, registration or licence as in force at the date of the application, the fee payable under this Part of these Regulations is increased by an amount equal to the fee which would have been payable under Part 5 of these Regulations had he made a separate application for variation of that authorization, registration or licence in respect of each provision which is not identical.
PART 8 Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations
Fees for regulatory assistance for certain marketing authorizations
26
1
Unless regulation 44 applies, where —
a
an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization for a medicinal product which has been subject to the procedures specified in paragraph (2); and
b
the United Kingdom is to provide regulatory assistance acting as reference member State in relation to that application,
the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 1 in connection with that regulatory assistance.
2
The procedures referred to in paragraph (1) are —
a
the procedures laid down in Articles 7 and 7a of Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and in Articles 17 and 18 of the 2001 Directive;
b
the procedures laid down in Article 9(4) of Directive 75/319/EEC and in Article 28 of the 2001 Directive;
c
the procedures laid down in Articles 10 to 14 of Directive 75/319/EEC and in Articles 29 to 34 of the 2001 Directive;
d
referral to the Committee for Propriety Medicinal Products in accordance with Council Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology , if the opinion of the Committee in accordance with Article 4.1 of that Directive was given before 1st January 1995.
3
For the purposes of this regulation and Part 6 of Schedule 1, the United Kingdom provides regulatory assistance acting as reference member State if —
a
the licensing authority prepares or updates an assessment report in respect of the medicinal product to which the renewal application relates in order to make it available to the competent authorities of another EEA State; and
b
an application to renew the marketing authorization relating to that product has been made in that other EEA State.
PART 9 Capital Fees for Inspections
Fees for inspections
27
1
Unless regulation 44 or 48 applies, a fee in accordance with paragraphs 1 to 7 of Schedule 2 is payable for any inspection of a site made in connection with an application for, or during the currency of, a marketing authorization, a traditional herbal registration, a clinical trial authorisation, a manufacturing authorisation, a manufacturer’s licence or a wholesale dealer’s licence, except for an inspection for which a fee is payable under regulations 24 or 30.
2
Unless regulation 28 or 29 applies, the fee in paragraph (1) is payable by the holder of or applicant for, as the case may be, the authorization, registration, authorisation or licence in relation to which the inspection is made.
Payer of inspection fee (contract laboratories and API manufacturing sites)
28
Where an inspection is made of a contract laboratory or a site used by an API manufacturer the fee is payable by the operator of that laboratory, or, as the case may be, that API manufacturer.
Inspections in connection with multiple applications.
29
1
Where an inspection is made outside the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product —
a
in more than one marketing authorization, clinical trial authorisation, traditional herbal registration; or
b
by more than one applicant for such an authorisation or licence,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by the holders of, or as the case may be, applicants for, the authorization, authorisation, licence or registration.
2
In paragraph (1), the reference to an applicant for a clinical trial authorisation is a reference to a person who sends a valid notice of amendment as mentioned in regulation 19(1).
3
Where an inspection is made in the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product —
a
in more than one manufacturer’s licence or manufacturing authorisation; or
b
by more than one applicant for such a licence or authorisation,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by each applicant.
4
But this regulation does not apply if the inspection is made of a contract laboratory or a site used by an API manufacturer.
Fees for inspections relating to good clinical practice in clinical trials
30
Unless regulation 44 applies a fee in accordance with paragraphs 2 and 3 of Schedule 2 is payable by a person in respect of an inspection of one or more sites for the purpose of ascertaining whether that person —
a
is —
i
conducting, or has conducted, a clinical trial, or
ii
performing, or has performed, the functions of a sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor),
in accordance with the conditions and principles of good clinical practice, pursuant to regulation 28(1) (good clinical practice and protection of clinical trial subjects) of the Clinical Trials Regulations; or
b
has put and kept in place arrangements for the purpose of ensuring that with regard to a clinical trial the conditions and principles of good clinical practice are satisfied or adhered to, pursuant to regulation 28(2) of those Regulations.
PART 10 Periodic Fees for Marketing Authorizations and Licences
Periodic fees
31
1
Unless paragraphs (2), (4), (5) or (6) or regulation 44 or 48 applies, the periodic fee must be paid for each fee period during which the authorization, registration, authorisation or licence is in force, even if it is in force for only part of that fee period.
2
Marketing authorizations of a type referred to in Part 3 of Schedule 3 shall be treated for the purposes of paragraph (1) as if they were one marketing authorization and only one periodic fee in respect of each relevant fee period is payable in connection with the holding of such authorizations.
3
The periodic fee is the appropriate fee prescribed in Part 3 of Schedule 3 and, for the purposes of that Part, Parts 1 and 2 of that Schedule have effect.
4
No periodic fee is payable in respect of the fee period during which a marketing authorization or a traditional herbal registration is first granted unless the authorization or registration is granted pursuant to —
a
a change of ownership application; or
b
an application for a marketing authorization or traditional herbal registration which —
i
is for a product for which an authorization or registration has expired,
ii
will contain identical provisions to those contained in the expired authorization or registration,
iii
is made by the person who held the expired authorization or registration, and
iv
is made no later than three months after the expiry of the authorization or registration referred to in sub-paragraph (i),
and, in each case, a periodic fee has not been paid in respect of that fee period in connection with the expired marketing authorization or a traditional herbal registration.
5
An authorization, registration, authorisation or licence which is in force is treated for the purposes of this regulation as not being in force during any part of a fee period if —
a
at least three months before the commencement of that fee period, the holder of that authorization, registration, authorisation or licence has given written notice to the licensing authority indicating that he wishes it to cease to have effect before the commencement of that period; and
b
no products are sold, supplied or manufactured pursuant to that authorization, registration authorisation or licence within that fee period.
6
No periodic fee is payable in respect of the fee period during which a manufacturing authorisation, a manufacturer’s or wholesale dealer’s licence is first granted unless —
a
that authorisation or licence is granted pursuant to a change of ownership application; and
b
a periodic fee has not been paid in respect of that fee period in connection with the manufacturing authorisation or manufacturer’s or wholesale dealer’s licence which is mentioned in that application in the statement of intention to cease activities.
Periodic fees for clinical trial authorisations
32
1
Unless paragraph (3) or regulation 44 applies, the holder of a clinical trial authorisation must pay the periodic fee for each fee period during which the authorisation is in force, even if the authorisation is in force for only part of that fee period.
2
The periodic fee is the fee prescribed in paragraph 16 of Part 3 of Schedule 3.
3
No periodic fee is payable in respect of the fee period during which the clinical trial to which the authorisation relates was authorised by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving medicinal products for gene therapy etc.) or 20 (authorisation procedure for clinical trials involving medicinal products with special characteristics) of the Clinical Trials Regulations .
PART 11 Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
Meaning of “good clinical practice accreditation” scheme
33
In this Part —
“good clinical practice accreditation scheme” means the non-statutory voluntary scheme of accreditation operated by the licensing authority in relation to Phase 1 trials which participants may join following satisfactory completion of a good clinical practice inspection; and
“Phase I trials” are clinical trials to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial.
Fees for applications for membership and certificate
34
1
The fee payable by an applicant for membership of the good clinical practice accreditation scheme is £120.
2
The fee payable by an applicant for a certificate of membership of the good clinical practice accreditation scheme is £63.
PART 12 Capital Fees for Persons Appointed Hearing
Fees for persons appointed hearing
35
1
The fee payable by an applicant or holder of an authorization who gives notice under paragraph 11 (right to be heard by a person appointed or to make further representations) or 16 (right to be heard by a person appointed) of Schedule 2 to the 1994 Regulations of his wish to appear before or be heard by a person appointed by the licensing authority is £10,000.
2
But the licensing authority will refund to that person —
a
60% of that fee if the person withdraws the notice two weeks before the commencement of the hearing before the person appointed;
b
100% of that fee if the decision notified by the licensing authority in accordance with sub-paragraph (10) of paragraph 17 (hearing before person appointed) of Schedule 2 to the 1994 Regulations is —
i
not to revoke, vary or suspend the authorization, or
ii
to grant or renew the authorization in accordance with the application submitted under regulation 4(1) (applications for the grant, renewal or variation of a UK marketing authorization) of the 1994 Regulations.
Time for payment under regulation 35
36
The fee in regulation 35 is payable at the time the notice is given.
PART 13 Administration
Payment of fees to Ministers
37
Any sums which under the provisions of these Regulations become payable by way of, or on account of, fees must be paid to one of the Ministers.
Time for payment of capital fees in connection with applications or inspections
38
1
Except where regulation 11, 17, 23 or 36 applies and subject to paragraph (2) and to regulations 39 and 44, all sums payable by way of capital fees under these Regulations in connection with any application must be paid at the time of the application.
2
All sums payable by way of fees in respect of inspections made either in connection with an application for, or during the currency of, an authorization, licence or certificate must be paid within 14 days following receipt of written notice from the licensing authority requiring payment of those fees.
Time for payment of capital fees – applications made by small companies
39
1
Schedule 4 shall have effect with respect to the capital fee payable in connection with an application made by or on behalf of a small company.
2
For the purpose of these Regulations, a company is a small company if, for the financial year before that in which the application is made, the amount of its turnover for the financial year is not more than the amount for the time being specified under the heading “Small company” in section 247(3) (qualification of company as small or medium-sized) of the Companies Act 1985 ; and
a
its balance sheet total (as defined in section 247(5) of that Act) is not more than the amount for the time being specified under the heading “Small company” in section 247(3) of that Act; or
b
the average number of persons employed by the company in the financial year before that in which the application is made (determined on a weekly basis) does not exceed the number for the time being specified under the heading “Small company” in section 247(3) of that Act.
Time for payment of periodic fees
40
All periodic fees must be paid on the first day of the fee period to which they relate.
Penalty fees for late payment of periodic fees
41
1
Subject to paragraph (2), if a person has failed to pay a periodic fee at the time it should have been paid under regulation 40, a penalty fee is payable by that person.
2
A penalty fee is payable only if after 60 days following written notice from the licensing authority requiring payment of that fee, the fee remains unpaid.
3
Unless regulation 42 applies, the penalty fee is —
a
£100 where the total periodic fee unpaid by a person after 60 days following the notice referred to in paragraph (2) exceeds £200; or
b
£50 where the total periodic fee unpaid by a person after such period does not exceed £200.
4
In paragraph (3), the “total periodic fee” means the aggregate of all the periodic fees payable by a person in connection with all the authorizations, registrations, authorisations or licences held by that person.
Daily penalty fees for late payment of periodic fees
42
If the periodic fee and penalty fee under regulation 41 (“the outstanding amount”) have not been paid within 90 days following the written notice from the licensing authority, the amount of penalty fee payable shall be the amount specified in regulation 41(3) plus £5 for each day of the period which —
a
begins with the day 90 days from the date of the written notice; and
b
ends with the day before that on which payment of the outstanding amount is actually made.
Refund or waiver of fees under regulation 41 or 42
43
The licensing authority may refund or waive payment of the penalty fee, or reduce the amount payable, where it is satisfied that the holder of the authorization, registration, authorisation or licence was not responsible for the failure to pay the periodic fee within the period specified in regulation 41(2) or 42.
Adjustment, waiver, reduction or refund of fees
44
1
If after a capital or periodic fee is paid it becomes apparent that —
a
a lesser fee should have been paid, the excess shall be refunded to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned; or
b
a higher fee should have been paid, the balance due shall be payable within 14 days following written notice from the licensing authority to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned requiring payment of that balance.
2
The licensing authority shall, to the extent provided in Schedule 5 in relation to capital fees or in Schedule 6 in relation to periodic fees —
a
adjust, waive payment of or reduce any fee or part of a fee otherwise payable under these Regulations; or
b
refund the whole or part of any fee already paid.
Suspension of licences and certificates
45
Where any sum due by way of, or on account of, any fee or any part thereof payable under these Regulations remains unpaid by the holder of a product licence or a product licence of right, a manufacturer’s licence or a wholesale dealer’s licence, the licensing authority may serve a written notice on him requiring payment of the sum unpaid and, if after a period of one month from the date of service of such notice, or such longer period as the licensing authority may allow, the said sum remains unpaid, the licensing authority may forthwith suspend the licence until such sum has been paid.
Civil proceedings to recover unpaid fees
46
All unpaid sums due by way of, or on account of, any fees payable under these Regulations shall be recoverable as debts due to the Crown.
PART 14
Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
47
1
The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 are amended as follows.
2
In regulation 14 (fees for variation of certificates) —
a
in paragraph (1)(a), for “£110” substitute “£127”;
b
in paragraph (1)(b)(i), for £110” substitute “£127”;
c
in paragraph (1)(b)(ii), for “£55” substitute “£63.50”;
d
in paragraph (2)(a), for “£237” substitute “£250”;
e
in paragraph (2)(b)(i), for “£237” substitute “£250”;
f
in paragraph (2)(b)(ii), for “”£237” substitute “£250”;
g
in paragraph 2(b)(iii), for “£120” substitute “£127”; and
h
in paragraph 2(b)(iv), for “£60”, substitute “£62.50”.
3
In regulation 15 (fees payable by holders of certificates), in paragraph (1), for “£19” substitute “£22”.
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 “£155” substitute “£164”,
ii
for “£466” substitute “£492”,
iii
for “£488” substitute “£516”, and
iv
for “£770” substitute “£813”.
b
in column (3) (fees for other applications) —
i
for “£383” substitute “£405”,
ii
for “£686” substitute “£725”,
iii
for “£622” substitute “£657”, and
iv
for “£1,007” substitute “£1,064”.
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 “£279” substitute “£295”; and
b
in sub-paragraph (b), for “£365” substitute “£386”.
PART 15 Revocationand Savings
Revocation and savings
48
1
The Regulations listed in Schedule 7 are revoked to the extent specified in that Schedule.
2
But —
a
in relation to capital fees, the Medicines (Products for Human Use – Fees ) Regulations 1995 continue to apply as if they had not been revoked to any application or inspection made before the date on which these Regulations come into force;
b
the Medicines (Products for Human Use – Fees ) Regulations 1995 continue to apply as if they had not been revoked to any periodic fee payable in relation to a fee period ending before the date on which these Regulations come into force;
c
paragraph (1) does not affect any proceedings constituted under the revoked Regulations for the recovery of any fees due as debts to the Crown.
3
For the purpose of this regulation “capital fee” and “periodic fee” have the same meaning as is given in the Medicines (Products for Human Use – Fees ) Regulations 1995.
Signed by authority of the Secretary of State for Health.
Dawn Primarolo
Minister for Health,
Department of Health
27th February 2008
Michael McGimpsey
Minister for Health, Social Services and Public Safety
27th February 2008
Michelle Gildernew
Minister for Agriculture and Rural Development
28th February 2008
Alan Campbell
Steve McCabe
Two of the Lords Commissioners of Her Majesty’s Treasury
26th February 2008


text:
Citation, commencement and application
1
1
These Regulations may be cited as the Schools Forums (England) (Amendment) Regulations 2008 and come into force on 11th February 2008.
2
These Regulations apply only in relation to England.
Amendment of the Schools Forums (England) Regulations 2002
2
1
The Schools Forums (England) Regulations 2002 are amended as follows.
2
In regulation 1(3), insert where they fall alphabetically —
“local authority 14-19 partnership” means an arrangement made by a local education authority to promote co-operation between itself, the Learning and Skills Council for England and any other person in the area who exercises functions in relation to, or is engaged in activities relevant to, the provision of education and training for 14-19 year olds;
“PVI providers” means persons other than governing bodies of primary schools, local education authorities or the proprietors of Academies who provide nursery education for three and four year olds for which no charge is made.
.
3
In regulation 3(2), for “fifth”, substitute “third”.
4
In regulation 4(3) —
a
before sub-paragraph (a), insert —
aa
“head teacher’s representative” means a senior member of staff representing a head teacher;
;
b
in paragraph (c), after the words “head teacher”, add the words “(or head teacher’s representative)”;
c
after paragraph (c), insert —
ca
senior member of staff means a principal, deputy head teacher, bursar or other person responsible for the financial management of the school; and
.
5
In regulation 4A(4), after the words “head teachers”, in both places where those words occur, insert —
(or head teachers’ representatives)
.
6
For regulation 5, substitute —
5
1
Subject to paragraph (3), where the relevant authority determine that they will appoint non-schools members to their forum, they shall by 1st September 2008 (or, if the determination is made later, on making the determination) —
a
appoint one or more persons to represent the local authority 14-19 partnership and one or more persons to represent PVI providers; and
b
identify bodies appropriate for representation on the forum (“appropriate bodies”), seek nominations from, and appoint representatives of, those bodies.
2
In identifying appropriate bodies for the purposes of paragraph (1)(b), the relevant authority shall consider whether the following should be appropriate bodies —
a
the Diocesan Board of Education for any diocese any part of which is comprised in the relevant authority’s area;
b
the bishop of any Roman Catholic Diocese any part of which is comprised in the relevant authority’s area;
c
where there are schools within the relevant authority’s area, other than Church of England or Roman Catholic schools, designated under section 69(3) of the 1998 Act as having a religious character, the appropriate faith group in respect of any such schools.
3
The following may not be appointed as non-schools members —
a
any executive member or relevant officer of the authority;
b
any representative of —
i
the local learning and skills council (“the LSC ”) or regional learning and skills council for the relevant authority , or
ii
the Learning and Skills Council for England.
4
Within one month of the appointment of any non-schools member, the relevant authority shall inform schools maintained by them of the name of the member and the body that member is representing.
7
After regulation 6(2), insert —
2A
At or after such time as LSCs have ceased to exist, the Learning and Skills Council for England shall be entitled to nominate an observer who shall be entitled to attend all meetings of the forum. This does not prevent a person who has already been nominated under paragraph (2) from being nominated under this paragraph.
8
In regulation 6(7), before the words, “The members of the forum shall determine their own voting procedures.” insert “Subject to paragraph (11),”.
9
In regulation 6, after paragraph (10), add —
11
The relevant authority shall consult the forum on arrangements for allowing substitutes to attend and vote at meetings of the forum on behalf of schools members and non-schools members, and shall implement such arrangements having taken into account the views of the forum.
.
10
Regulation 7 is omitted.
Jim Knight
Minister of State
Department for Children, Schools and Families
10th January 2008


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Concessionary Bus Travel (Permits)(England) Regulations 2008 and shall come into force on 21st March 2008.
2
In these Regulations–
“blue”, in relation to a colour strip on a permit, means–
at the top of that strip, the colour created by combining coloured printing inks in the measures Cyan 100, Magenta 0, Yellow 0 and Black 0,
at the bottom of the strip, the colour created by combining coloured printing inks in the measures Cyan 100, Magenta 76, Yellow 0 and Black 0,
between those areas a shade of blue that graduates between those specified for the top and bottom of the strip;
“issuing authority” means an authority that issues a permit;
“orange”, in relation to a colour strip on a permit, means–
at the top of that strip, the colour created by combining coloured printing inks in the measures Cyan 0, Magenta 25, Yellow 100 and Black 0,
at the bottom of the strip, the colour created by combining coloured printing inks in the measures Cyan 0, Magenta 50, Yellow 100 and Black 0,
between those areas a shade of orange that graduates between those specified for the top and bottom of the strip;
“permit”, save where the context requires otherwise, means–
a permit issued by a travel concession authority in England pursuant to section 145A(4) of the Transport Act 2000, and
a travel concession permit issued by a London authority pursuant to Chapter 8 of Part 4 of the Greater London Authority Act 1999; and
“red” means the colour created by combining coloured printing inks in the measures Cyan 0, Magenta 100, Yellow 100 and Black 20.
Form and period of validity of permit
2
1
The form of any permit shall be as follows.
2
The permit shall bear on its face–
a
a rose symbol–
i
in the form and position shown in the form of permit in Schedule 1 and indicated on that permit by the letter “A”; and
ii
coloured red;
b
a ribbon symbol–
i
in the form and position shown in the form of permit in Schedule 1 and indicated on that permit by the letter “B”; and
ii
coloured red;
c
an indication of the identity of the issuing authority in the place marked by the letter “C” on the form of permit in Schedule 1;
d
a hologram in the form and position shown in the form of permit in Schedule 1 and indicated on that permit by the letter “D” and which has been issued by the Secretary of State;
e
a colour strip in the form and position shown in the form of permit in Schedule 1 and indicated on that permit by the letter “E” and coloured in accordance with paragraph (4);
f
a picture of the person to whom the permit is issued in the position shown in the form of permit in Schedule 1 and indicated on that permit by the letter “F”;
g
a trademark in the form and position shown in the form of permit in Schedule 1 and indicated on that permit by the letter “G” and coloured in accordance with paragraph (5);
h
the expiry date of the permit (including an expiry date heading) in the form and position shown in the form of permit in Schedule 1;
i
the name of the person to whom the permit is issued in the position shown in the form of permit in Schedule 1 and in the form of either–
i
the first name and the family name of the person (in that order); or
ii
a single initial letter denoting the first name of the person together with that person’s family name (in that order);
j
a unique number allocated to that permit in the form and position shown in the form of permit in Schedule 1; and
k
the words “Concessionary travel funded by HM Government with your local authority” in the form and position shown in the form of permit in Schedule 1.
3
The indication of identity required by paragraph (2)(c) shall be such indication as is sufficient to enable the issuing authority to be readily identified and shall be in the form of–
i
the name or initials of the issuing authority and a symbol connected with that authority;
ii
the name of the issuing authority; or
iii
a symbol connected with that authority.
4
The colour strip shall be–
a
in the case of a permit issued to an elderly person, blue;
b
in the case of a permit issued to a disabled person, orange;
c
in the case of a permit issued to a person who is both elderly and disabled, either blue or orange.
5
In the case of–
a
a permit on which the colour strip is blue, the trademark shall appear on that strip with the text shown in blue on a white background; and
b
a permit on which the colour stripe is orange, the trademark shall appear on that strip with the text shown in white on an blue background.
6
The period for which any permit is issued shall be not more than a period of five years beginning with the date on which that permit starts to have effect.
7
The size of the permit and the size and layout of each item to be included upon its face shall comply as nearly as is reasonably possible with the dimensions specified in Schedule 2.
8
The expiry date heading, expiry date, name of the person to whom the permit is issued, unique number allocated to the permit and the words “Concessionary travel funded by HM Government with your local authority” shall appear on the permit in black lettering and in the font and size specified in Schedule 3.
9
No other words, letters, symbols or other material may appear on the face of the permit, save that the issuing authority may, in the place marked “C” on the form of permit in Schedule 1, also include such words or symbols as it considers appropriate in order to indicate the nature or extent of the concession that may be obtained by use of the permit.
10
On the reverse of the permit there shall be–
a
a statement indicating that there are terms and conditions that apply to the use of the permit; and
b
a telephone number that may be used to report the loss or theft of the permit.
11
The permit shall contain an electronic chip in the form of the electronic media device specified in ITSO version 2.1.2 ( ISBN 0-9548042-2-8) published by ITSO Limited on 28th June 2007 or any earlier version of such device which is compatible with that specified in ITSO version 2.1.2.
Transitional provision: authorities in Greater London
3
1
Notwithstanding regulation 2, on or before 31st March 2010 the form of permit issued by an issuing authority whose area is in Greater London may alternatively be an adhesive sticker, fixed to a permit issued by that authority pursuant to Chapter 8 of Part 4 of the Greater London Authority Act 1999 in the position shown in Schedule 4.
2
That adhesive sticker shall include on its face–
a
a rose symbol–
i
in the form and position shown in the forms of permit in Schedule 4; and
ii
coloured red; and
b
the expiry date of the permit.
3
The expiry date on the permit may not be a date after 31st March 2010.
Transitional provision: authorities outside Greater London
4
1
Notwithstanding regulation 2, on or before 30th September 2008 the form of any permit issued by an issuing authority whose area is outside Greater London may alternatively be as follows.
2
The permit shall have on its face–
a
the words “Temporary Pass” in the form, colour and position shown in the form of permit shown in Schedule 5;
b
a rose symbol–
i
in the form and position shown in the form of permit in Schedule 5; and
ii
coloured red;
c
a ribbon symbol–
i
in the form and position shown in the form of permit shown in Schedule 5; and
ii
coloured red;
d
a hologram in the form and position shown in the form of permit shown in Schedule 5 and which has been issued by the Secretary of State;
e
the expiry date of the permit (including an expiry date heading) in the form and position shown in the form of permit shown in Schedule 5;
f
the name of the person to whom the permit is issued in the position shown in the form of permit shown in Schedule 5;
g
a unique number allocated to that permit in the form and position shown in the form of permit shown in Schedule 5;
h
the number of another permit issued by the issuing authority pursuant to section 145 of the Transport Act 2000 to the person to whom the permit is issued, if that other permit bears a number, in the position shown in the form of permit shown in Schedule 5; and
i
the words “Concessionary travel funded by HM Government with your local authority” in the form and position shown in the form of permit shown in Schedule 5.
3
The size of the permit and the size and layout of each item to be included upon its face shall comply as nearly as is reasonably possible with the dimensions shown in Schedule 5.
4
The expiry date of the permit shall be 30th September 2008.
Dates in permits
5
1
A date required by these Regulations to be included in a permit shall be expressed as follows–
a
first, the day of the month, expressed in two digits,
b
secondly, the month, expressed by means of the first three letters of the name of the month,
c
thirdly, the year, expressed in four digits.
2
This regulation does not apply in relation to any date required to be included in a permit by virtue of regulation 3.
Signed by authority of the Secretary of State
Rosie Winterton
Minister of State
Department for Transport
20th February 2008


text:
Title, application and commencement
1
This Order may be cited as the Specified Animal Pathogens Order 2008, applies in England, and comes into force on 28th April 2008.
Extension of the definition of “animal”, “poultry” and “disease”
2
For the purposes of the Animal Health Act 1981 in relation to this Order —
a
the definition of “animal” is extended so as to comprise any kind of mammal except man, and any kind of four-footed beast which is not a mammal;
b
the definition of “poultry” is extended so as to comprise any species of bird; and
c
the definition of “disease” is extended so as to comprise any disease of animals and poultry which may be caused by one or more specified animal pathogens.
Interpretation
3
1
In this Order —
“animal” includes poultry;
“carrier” means any living creature except man which may carry or transmit a specified animal pathogen or the tissue, cell culture, body fluid, excreta, carcase or part of a carcase of such creature by or by means of which a specified animal pathogen may be transmitted or carried;
“premises” includes any land, building or other place; and
“specified animal pathogen” means an animal pathogen listed in Schedule 1, including —
intact pathogens;
pathogens which have been attenuated or genetically modified by any means; and
any nucleic acid derived from an animal pathogen listed in that Schedule that could produce that pathogen when introduced into a biological system in which the nucleic acid is capable of replicating.
2
In this Order “inspector” does not include an inspector appointed by a local authority.
3
A licence or notice issued under this Order must be in writing, may be subject to conditions and may be amended, suspended or revoked by notice in writing at any time.
Prohibitions in relation to specified animal pathogens
4
1
No person may have in their possession —
a
any animal pathogen specified in Part 1 of Schedule 1; or
b
any carrier in which they know such a pathogen is present,
except under the authority of a licence issued by the Secretary of State.
2
No person may deliberately introduce into any animal any animal pathogen specified in either Part 1 or Part 2 of that Schedule, except under the authority of a licence issued by the Secretary of State.
3
A person must immediately notify the Secretary of State if that person —
a
has possession of any thing in respect of which they have reasonable grounds for suspecting that an animal pathogen specified in Part 1 of Schedule 1 is present, and
b
does not have a licence in respect of that pathogen.
Exceptions
5
1
Article 4 does not apply to any person who is transporting a pathogen or carrier and who does not own or have any rights in that pathogen or carrier.
2
It does not apply in relation to any pathogen or carrier contained in a product —
a
authorised to be placed on the market in the United Kingdom as a veterinary medicinal product, or authorised to be administered to an animal in the United Kingdom;
b
authorised to be placed on the market under the Medicines for Human Use (Marketing Authorisations etc ) Regulations 1994 ;
c
licensed in accordance with the provisions of section 7(2) of the Medicines Act 1968 .
Powers of inspectors
6
In addition to the powers set out in the Animal Health Act 1981, an inspector enforcing this Order has the powers set out in Schedule 2.
Improvement notices
7
1
If an inspector is of the opinion that a person —
a
is carrying on any activity contravening one or more of the conditions of a licence issued to them under this Order, or
b
has contravened one or more of those conditions in circumstances that make it likely that the contravention will continue or be repeated,
that inspector may serve on that person a notice (“an improvement notice”).
2
An improvement notice must —
a
specify the conditions of the licence that have been contravened;
b
explain the reasons why the inspector is of that opinion; and
c
require that person to remedy the contravention or the matters occasioning it, within such period as may be specified in the notice.
3
A notice must include directions as to the measures to be taken to remedy any contravention or matter to which the notice relates; and any such directions may be framed so as to afford the person on whom the notice is served a choice between different ways of remedying the contravention or matter.
Prohibition notices
8
1
This paragraph applies to any activities for which a licence is required under this Order.
2
If an inspector is of the opinion that the activities involve or may involve a risk of serious harm to animals, the inspector may serve on that person a notice (“a prohibition notice”).
3
A prohibition notice must —
a
state that the inspector is of that opinion;
b
specify the matters which in that inspector’s opinion give or may give rise to a risk of serious harm to animals; and
c
direct that the activities to which the notice relates must not be carried on unless the matters specified in the notice have been remedied.
4
A direction contained in a prohibition notice under sub-paragraph (3)(c) takes effect —
a
at the end of the period specified in the notice; or
b
if the notice so declares, immediately.
Appeals against improvement and prohibition notices
9
1
A person on whom an improvement or prohibition notice is served may within 21 days appeal against the notice to a person appointed for the purpose by the Secretary of State.
2
The appointed person must consider the appeal and any representations made by the Secretary of State and report in writing, with a recommended course of action, to the Secretary of State.
3
The Secretary of State may then either cancel the notice or confirm it, with or without modifications, and must notify the appellant, together with the reasons.
Licences
10
No person may contravene a licence condition imposed on that person.
Enforcement
11
This Order is enforced by the Secretary of State.
Revocations
12
The following Orders are revoked —
a
the Specified Animal Pathogens Order 1998 in its application to England; and
b
the Specified Animal Pathogens (Amendment) (England) Order 2006 .
Jeff Rooker
Minister of State
Department for Environment, Food and Rural Affairs
1st April 2008


text:
Citation, commencement and application
1
1
These Regulations may be cited as the Mental Health (Approved Mental Health Professionals) (Approval) (England) Regulations 2008 and shall come into force on 3rd November 2008.
2
These Regulations apply to England only.
Interpretation
2
In these Regulations —
“ the Act ” means the Mental Health Act 1983;
“ AMHP ” means an approved mental health professional;
“approve” and “approval” include “re-approve” and “re-approval”;
“approving LSSA ” means the local social services authority in England that has approved the person to act as an AMHP;
“Care Council for Wales” has the meaning given by section 54(1) of the Care Standards Act 2000 ;
“General Social Care Council” has the meaning given by section 54(1) of the Care Standards Act 2000;
“LSSA” means a local social services authority in England;
“professional requirements” means the requirements set out in Schedule 1.
Granting approval
3
1
An LSSA may only approve a person to act as an AMHP if it is satisfied that the person has appropriate competence in dealing with persons who are suffering from mental disorder.
2
In determining whether it is satisfied a person has appropriate competence, the LSSA must take into account the following factors —
a
that the person fulfils at least one of the professional requirements, and
b
the matters set out in Schedule 2.
3
Before an LSSA may approve a person to act as an AMHP who has not been approved, or been treated as approved, before in England and Wales, the person must have completed within the last five years a course approved by the General Social Care Council or the Care Council for Wales.
Period of approval
4
An LSSA may approve a person to act as an AMHP for a period of five years.
Conditions
5
When any approval is granted under these Regulations, it shall be subject to the following conditions —
a
in each year that the AMHP is approved, the AMHP shall complete at least 18 hours of training agreed with the approving LSSA as being relevant to their role as an AMHP;
b
the AMHP shall undertake to notify the approving LSSA in writing as soon as reasonably practicable if they agree to act as an AMHP on behalf of another LSSA, and when such agreement ends;
c
the AMHP shall undertake to cease to act as an AMHP and to notify the approving LSSA immediately if they are suspended from any of the registers or listings referred to in the professional competencies, or if any such suspension ends, and
d
the AMHP shall undertake to cease to act as an AMHP and to notify the approving LSSA immediately if they no longer meet at least one of the professional requirements.
Suspension of approval
6
1
If at any time after being approved, the registration or listing required by the professional requirements of a person approved to act as an AMHP is suspended, the approving LSSA shall suspend that AMHP’s approval for as long as the AMHP’s registration or listing is suspended.
2
Where an AMHP’s approval is suspended, that person may not act as an AMHP unless and until the suspension of approval is ended by the approving LSSA in accordance with subsection (3).
3
Where the approving LSSA is notified that the suspension of the AMHP’s registration or listing has ended, the approving LSSA shall, unless it is not satisfied the AMHP has appropriate competence in dealing with persons suffering from mental disorder, end the suspension of approval.
4
Where the suspension of approval has ended, the approval shall continue to run for any unexpired period of approval, unless the approving LSSA ends it earlier in accordance with regulation 7.
End of approval
7
1
Except where paragraph (2) applies, a person shall cease to be approved to act as an AMHP at the end of the day on which their period of approval expires.
2
Except where regulation 6 applies, the approving LSSA shall end the approval of a person it has approved to act as an AMHP before their period of approval expires —
a
in accordance with a request in writing to do so from that AMHP;
b
if it is no longer satisfied that the AMHP has appropriate competence taking into account the matters set out in Schedule 2;
c
immediately upon becoming aware that the AMHP —
i
is no longer a person who meets at least one of the professional requirements;
ii
is in breach of any of the conditions set out in regulation 5, or
iii
has been approved to act as an AMHP by another LSSA.
3
When an approval ends, the approving LSSA shall notify the AMHP immediately that the approval has ended and give reasons for ending the approval.
4
When an approval ends, the approving LSSA shall notify that fact to any other LSSA for whom it knows the AMHP has agreed to act as an AMHP.
5
If an LSSA approves a person as an AMHP knowing that that AMHP is already approved by another LSSA, it shall notify the previous approving LSSA.
Records
8
1
The approving LSSA shall keep a record of each AMHP it approves which shall include —
a
the name of the AMHP;
b
the AMHP’s profession;
c
the AMHP’s date of approval;
d
details of any period of suspension under regulation 6;
e
details of the completion of training to comply with regulation 5(a);
f
details of any previous approvals as an AMHP within the previous five years;
g
the names of other LSSAs for whom the AMHP has agreed to act as an AMHP, and
h
the date of and reason for the end of approval, if applicable.
2
The record referred to in paragraph (1) shall be retained by the approving LSSA for a period of five years commencing with the day on which the AMHP’s approval ended.
Signed by authority of the Secretary of State for Health.
Ivan Lewis
Parliamentary Under-Secretary of State
Department of Health
28th April 2008


text:
Citation and extent
1
1
This Order may be cited as the Criminal Justice Act 2003 (Commencement No. 19) Order 2008.
2
This Order extends to Northern Ireland.
Commencement on 1st April 2008
2
The following provisions of the Criminal Justice Act 2003 shall come into force on 1st April 2008 —
Schedule 35, paragraph 5.
Paul Goggins
Minister of State
Northern Ireland Office
10th March 2008