text:
PART 1
Introduction
Title and commencement
1
These Regulations may be cited as the Veterinary Medicines Regulations 2005 and come into force —
a
except for regulation 14 and Schedule 5, on 30th October 2005;
b
in the case of regulation 14 and Schedule 5, on 1st January 2006.
Definition of “veterinary medicinal product”, interpretation and scope
2
1
In these Regulations “veterinary medicinal product” means —
a
any substance or combination of substances presented as having properties for treating or preventing disease in animals; or
b
any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
2
In addition —
“adverse reaction” means a reaction to a veterinary medicinal product that is harmful and unintended and that occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function;
“the Agency” means the European Medicines Agency established by 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 ;
“animal” means all animals other than man and includes birds, reptiles, fish, molluscs, crustacea and bees;
“the cascade” has the meaning assigned in paragraph 2 of Schedule 4;
“immunological veterinary medicinal product” means a veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity;
“risk-benefit balance” means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to —
any risk relating to the quality, safety and efficacy of the veterinary medicinal product as regards animal or human health; or
any risk of undesirable effects on the environment;
“strength” means the amount of active substances in a dosage unit or unit of volume or weight.
3
In these Regulations any reference to a member State is a reference to a member State of the European Union and Norway, Iceland and Liechtenstein.
4
For the avoidance of doubt, these Regulations apply to all veterinary medicinal products irrespective of whether or not there is other legislation controlling a product.
Products to which these Regulations do not apply
3
1
These Regulations do not apply to a veterinary medicinal product based on radio-active isotopes.
2
They do not apply to a veterinary medicinal product that is the subject of a licence granted under the Animals (Scientific Procedure) Act 1986 , except that, if the animals used under that licence are to be put into the human food chain, the veterinary medicinal product must be administered in accordance with an animal test certificate granted under regulation 8(3).
PART 2
Authorised veterinary medicinal products
Placing a veterinary medicinal product on the market
4
1
It is an offence to place a veterinary medicinal product on the market unless that product has been granted a marketing authorisation by the Secretary of State or the Agency.
2
Any person who certifies data in relation to an application for a marketing authorisation or in relation to an existing marketing authorisation and who knows that those data are false, or does not believe that they are accurate, is guilty of an offence.
3
Schedule 1 (provisions relating to marketing authorisations) has effect.
Manufacture of veterinary medicinal products
5
1
The holder of a marketing authorisation must ensure that every stage in the manufacture of the veterinary medicinal product is carried out by the manufacturer specified in the marketing authorisation (who must, if the manufacture is carried out in the United Kingdom, hold a manufacturing authorisation for that type of product granted by the Secretary of State) and failure to do so is an offence.
2
Schedule 2 (provisions relating to the manufacture of veterinary medicinal products) has effect.
3
“Manufacture” includes any part of the manufacture of a veterinary medicinal product and any ingredient of the product until the finished product is packaged, labelled and ready for sale in its final form but does not include the manufacture of starting materials intended for use as an active substance in a veterinary medicinal product.
4
Notwithstanding the above —
a
the holder of a wholesale dealer’s authorisation (in accordance with regulation 13) or a suitably qualified person (in accordance with paragraph 9 of Schedule 3) may break open packages (other than the immediate packaging of the veterinary medicinal product);
b
a pharmacist may break open any package other than the immediate packaging of injectable products; and
c
a veterinary surgeon may break open any package.
The finished product
6
The holder of a marketing authorisation for a veterinary medicinal product is guilty of an offence if the finished product supplied by him or the manufacturer is not completely in accordance with the marketing authorisation.
Classification, supply and possession of the product
7
1
Part I of Schedule 3 (Classification and supply of authorised veterinary medicinal products) has effect.
2
Any person who supplies a veterinary medicinal product that has passed its expiry date is guilty of an offence.
3
Any person who supplies a medicinal product authorised for human use for administration to an animal (other than in accordance with a prescription from a veterinary surgeon for administration under the cascade) is guilty of an offence.
4
Any person in possession of a veterinary medicinal product that was supplied to him other than in accordance with Schedule 3 is guilty of an offence.
Administration of the product
8
1
It is an offence to administer a veterinary medicinal product to an animal unless —
a
the product has a marketing authorisation authorising its administration in the United Kingdom, and the administration is in accordance with that marketing authorisation; or
b
it is administered in accordance with Schedule 4 (Administration of a veterinary medicinal product outside the terms a marketing authorisation).
2
It is an offence to administer a veterinary medicinal product to a food-producing animal unless it was prescribed in accordance with Schedule 3 or is administered in accordance with Schedule 4.
3
This regulation does not apply in the case of a product administered for research purposes in accordance with a certificate (“an animal test certificate”) granted for the purpose by the Secretary of State.
Importation of authorised veterinary medicinal products
9
1
It is an offence to import a veterinary medicinal product authorised for use in the United Kingdom except in accordance with this regulation.
2
A holder of a marketing authorisation may import a veterinary medicinal product for which he holds the marketing authorisation.
3
A holder of a manufacturing authorisation may import a veterinary medicinal product to which his authorisation relates.
4
An authorised wholesale dealer may import a veterinary medicinal product if —
a
his authorisation covers the product;
b
the importation is in accordance with a certificate issued for the purpose by the Secretary of State; and
c
he has notified the holder of the marketing authorisation in writing before he imports it.
5
A veterinary surgeon or a pharmacist may import any authorised veterinary medicinal product.
6
A suitably qualified person (in accordance with paragraph 9 of Schedule 3) may import any authorised veterinary medicinal product that he is permitted to supply.
7
There are no restrictions on the importation of an authorised veterinary medicinal product in category AVM-GSL.
Advertising the product
10
1
It is an offence to advertise a veterinary medicinal product if the advertisement is misleading or contains any medicinal claim that is not in the summary of product characteristics.
2
It is an offence to advertise a human medicine for administration to animals (including sending a price list of or including human medicines to a veterinary surgeon or veterinary practice).
3
Paragraph (2) does not apply to the holder of a wholesale dealer’s authorisation who supplies a list of human medicines, together with prices, to a veterinary surgeon for use under the cascade provided that —
a
the list is sent following a request from the veterinary surgeon to whom it is sent;
b
the veterinary surgeon has specified the type of human medicinal product he wishes to use, and the list is confined to human medicines of that type;
c
the list states clearly that the product does not have a marketing authorisation as a veterinary medicinal product, and may only be administered under the cascade; and
d
it only includes human medicines that may be administered legally under the cascade.
Advertising of prescription products and products with psychotropic drugs or narcotics
11
1
It is an offence to advertise veterinary medicinal products that —
a
are available on veterinary prescription only; or
b
contain psychotropic drugs or narcotics.
2
In the case of a product containing psychotropic drugs or narcotics, this does not apply to advertisements aimed at veterinary surgeons.
3
In the case of POM-V medicines, this does not apply to price lists, or to advertisements aimed at veterinary surgeons, pharmacists or professional keepers of animals.
4
In the case of POM-VPS medicines, this does not apply to price lists, or to advertisements aimed at —
a
veterinary surgeons;
b
pharmacists;
c
suitably qualified persons registered in accordance with paragraph 9 of Schedule 3;
d
other veterinary health care professionals;
e
professional keepers of animals;
f
owners or keepers of horses.
Defence of publication in the course of business
12
In proceedings for an offence under these Regulations relating to advertising, it is a defence for the person charged to prove —
a
that he is a person whose business it is to publish or arrange for the publication of advertisements, and
b
that he received the advertisement in the ordinary course of business and did not know and had no reason to suspect that its publication would amount to an offence under these Regulations.
Wholesale dealing
13
It is an offence to buy a veterinary medicinal product, other than by retail or for the purposes of retail supply in accordance with Schedule 3, unless the buyer has a wholesale dealer’s authorisation granted by the Secretary of State under this regulation and Schedule 3.
Feedingstuffs
14
Schedule 5 (medicated feedingstuffs and specified feed additives) has effect.
Exemptions
15
1
These Regulations do not apply to an inactivated autogenous vaccine that is manufactured, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal and used for the treatment of that animal.
2
The requirements relating to marketing authorisations and manufacturing authorisations under Part 1 of Schedule 2 do not apply to an inactivated autogenous vaccine that is manufactured, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal and used for the treatment of other animals on the same site if the product has been manufactured in accordance with Part 2 of Schedule 2.
3
They do not apply in relation to blood from blood banks operated in accordance with Part 3 of Schedule 2.
4
Schedule 6 (small animals exemption) has effect.
Fees
16
Schedule 7 (fees) has effect.
PART 3
Records
Food-producing animals: proof of purchase of veterinary medicinal products
17
1
The owner or keeper of food-producing animals must keep proof of purchase of all veterinary medicinal products acquired for those animals.
2
It is an offence to fail to comply with this regulation.
Food-producing animals: records of administration by a veterinary surgeon
18
1
If a veterinary surgeon administers a veterinary medicinal product to a food-producing animal he must either enter the following information himself in the keeper’s records or give it to the keeper in writing (in which case the keeper must enter the following into his records) —
a
the name of the veterinary surgeon;
b
the name of the product;
c
the date of administration of the product;
d
the amount of product administered;
e
the identification of the animals treated;
f
the withdrawal period.
2
It is an offence to fail to comply with this regulation.
Food-producing animals: records of purchase and administration
19
1
When a veterinary medicinal product is bought for a food-producing animal the keeper must record, at the time of purchase —
a
the name of the product;
b
the date of purchase;
c
the quantity purchased;
d
the withdrawal period;
e
the name and address of the supplier.
2
At the time of administration (unless the administration is by a veterinary surgeon in which case the record must be in accordance with regulation 18) he must record —
a
the name of the product;
b
the date of administration;
c
the quantity administered;
d
the identity of the animals treated.
3
If he disposes of it other than by treating an animal, he must record the date and route of disposal.
4
It is an offence to fail to comply with this regulation.
Food-producing animals: retention of records
20
1
The keeper must retain the proof of purchase and the record for at least five years following the administration or other disposal of the product, irrespective of whether or not the animals concerned are no longer in his possession or have been slaughtered or have died during that period.
2
It is an offence to fail to comply with this regulation.
Records by holders of a manufacturing authorisation
21
1
A holder of a manufacturing authorisation must, as soon as is reasonably practicable, make a record of each batch of veterinary medicinal product manufactured, assembled or supplied by him, which must include —
a
the name of the product;
b
the quantity manufactured, assembled or supplied;
c
the date of manufacture, assembly or supply;
d
the batch number and expiry date;
e
in the case of supply, the name and address of the recipient.
2
He must keep with the record all certification provided by the qualified person (manufacturing) in relation to that batch.
3
He must keep all records and certificates for at least five years from the date the veterinary medicinal product is placed on the market.
4
It is an offence to fail to comply with this regulation.
Records by wholesale dealers
22
1
A wholesale dealer must record, as soon as is reasonably practicable after each incoming or outgoing transaction (including disposals), the following —
a
the date and nature of the transaction;
b
the identity of the veterinary medicinal product;
c
the manufacturer’s batch number;
d
the expiry date;
e
the quantity; and
f
the name and address of the supplier or recipient.
2
He must keep the records for at least three years.
3
It is an offence to fail to comply with this regulation.
Records of products supplied on prescription
23
1
When any person permitted under these Regulations to supply veterinary medicinal products classified as POM-V or POM-VPS receives or supplies any such veterinary medicinal product he must keep all documents relating to the transaction, which must include —
a
the date;
b
the identity of the veterinary medicinal product;
c
the quantity;
d
the name and address of the supplier or recipient;
e
if there is a written prescription, the name and address of the person who wrote the prescription and a copy of the prescription.
2
If the documents do not include this information he must make a record of the missing information as soon as is reasonably practicable.
3
As an alternative to paragraphs (1) and (2) he may make a record of all the information required there provided that he does so as soon as is reasonably practicable.
4
When he starts to use the veterinary medicinal product he must also record the batch number and the date.
5
He must keep the documentation and records for at least five years.
6
It is an offence to fail to comply with this regulation.
Records of products administered to a food-producing animal under the cascade
24
1
A veterinary surgeon administering a veterinary medicinal product to a food-producing animal under the cascade, or permitting another person to administer it under his responsibility, must, as soon as is reasonably practicable, record —
a
the date he examined the animals;
b
the name and address of the owner;
c
the identification and number of animals treated;
d
the diagnosis;
e
the trade name of the product if there is one;
f
the manufacturer’s batch number shown on the product if there is one;
g
the name and quantity of the active substances;
h
the doses administered;
i
the duration of treatment; and
j
the withdrawal period.
2
He must keep the record for at least five years.
3
It is an offence to fail to comply with this regulation.
PART 4
Unauthorised veterinary medicinal products
Importation of an unauthorised veterinary medicinal product
25
1
It is an offence to import an unauthorised veterinary medicinal product except in accordance with this regulation.
2
A marketing authorisation holder may import an unauthorised veterinary medicinal product if it is for the purpose of the manufacture of a veterinary medicinal product for which he holds the marketing authorisation.
3
A holder of a manufacturing authorisation may import an unauthorised veterinary medicinal product if it is for the manufacture of a veterinary medicinal product that he is permitted to manufacture.
4
A wholesale dealer may import an unauthorised veterinary medicinal product for the purposes of re-export.
5
A veterinary surgeon may import an unauthorised veterinary medicinal product that is authorised in another member State if it is for the purpose of administration by him or under his supervision under the cascade or administration in exceptional circumstances in accordance with Schedule 4; the import must be in accordance with the appropriate certificate granted by the Secretary of State, and the product may be imported by the veterinary surgeon himself or by using a wholesale dealer or pharmacist as his agent.
6
A wholesale dealer or a pharmacist may import an unauthorised veterinary medicinal product for the purpose of storing it pending administration by a veterinary surgeon under the cascade or administration in exceptional circumstances in accordance with Schedule 4 if —
a
the veterinary medicinal product is authorised in another member State or a third country;
b
the Secretary of State has issued a certificate certifying that —
i
the disease or condition is such that the veterinary medicinal product is likely to be needed as a matter of urgency for the treatment of an animal;
ii
delay in administering the product will seriously affect the health or welfare of the animal; and
iii
there is no suitable veterinary medicinal product authorised in the United Kingdom; and
c
in the case of a wholesale dealer, the product is within the terms of his authorisation.
Possession of an unauthorised veterinary medicinal product
26
1
It is an offence to be in possession of an unauthorised veterinary medicinal product.
2
This regulation does not apply to —
a
a veterinary medicinal product imported in accordance with a certificate granted by the Secretary of State under these Regulations;
b
a veterinary medicinal product prescribed by a veterinary surgeon under the cascade;
c
wholesale dealers if the possession is for re-export;
d
a holder of a manufacturer’s authorisation or marketing authorisation if the intention is to manufacture a veterinary medicinal product.
3
It is a defence for a person charged under paragraph (1) to prove that he was in possession of the veterinary medicinal product for the purposes of research or development of a veterinary medicinal product.
Supply of an unauthorised veterinary medicinal product
27
1
It is an offence to supply an unauthorised veterinary medicinal product.
2
This regulation does not apply to —
a
a veterinary medicinal product prescribed by a veterinary surgeon under the cascade; or
b
a product supplied in accordance with a certificate granted by the Secretary of State under these Regulations.
PART 5
Miscellaneous provisions, enforcement and offences
The Veterinary Products Committee
28
1
There shall continue to be a Veterinary Products Committee.
2
The Secretary of State shall appoint members of the Committee from professional people who are eminent in their field; and any lay members as she shall see fit.
3
The function of the Committee is to provide scientific advice on any aspect of veterinary medicinal products asked for by the Secretary of State and to carry out any functions specified in these Regulations.
4
The Secretary of State may pay members of the Committee such amounts as she may decide.
5
The Secretary of State may consult the Committee at any time.
Representations to the Veterinary Products Committee
29
1
If the Secretary of State, on the grounds of the safety, quality or efficacy of the product intends to —
a
refuse to grant a marketing authorisation or animal test certificate;
b
grant one that is different from that which was applied for;
c
suspend it;
d
vary it other than on the application of the holder;
e
refuse to grant a variation applied for by the holder; or
f
revoke it,
she shall notify the applicant or holder of her intention.
2
The applicant or holder may within 28 days of the notification give notice that he wishes to make representations to the Veterinary Products Committee concerning the notice.
3
The Committee shall consider those representations.
4
The representations may be written or oral, but may not include any data not available to the Secretary of State at the time of her decision.
5
The Committee shall report in writing to the Secretary of State.
6
If the appellant so requests, the Secretary of State shall give him a copy of the report.
7
The Secretary of State shall give to the appellant written notification of her proposed determination and the reasons for it.
8
A person may make representations concerning the Secretary of State’s proposed determination to a person appointed for the purpose by the Secretary of State.
9
The appointed person shall consider the representations (but shall not consider any data that was not available to the Secretary of State at the time of her decision) and report in writing, with a recommended course of action, to the Secretary of State.
10
The Secretary of State shall give written notification of her final determination and the reasons for it.
11
If the notification concerns suspension of a marketing authorisation, unless the Secretary of State directs otherwise, the suspension shall take effect when the notification is made and shall continue in force until she makes her final determination.
Duties on the Secretary of State relating to exports
30
1
At the request of any person exporting a veterinary medicinal product to a third country, or the competent authorities of a third country to which a veterinary medicinal product is to be exported, the Secretary of State shall provide a certificate that the veterinary medicinal product was manufactured in accordance with the marketing authorisation, if there is one, and, if there is no marketing authorisation, that the manufacturer holds a manufacturing authorisation for that type of product.
2
When she issues the certificate the Secretary of State shall take account of the model certificates issued by the World Health Organization .
3
If the veterinary medicinal product is authorised in the United Kingdom the Secretary of State shall ensure that the exporter or the competent authorities of the third country has access to the summary of product characteristics.
Time limits
31
1
In any provision in these Regulations requiring the Secretary of State to issue an authorisation within a set time, the clock does not start until the Secretary of State has checked that the application dossier is in accordance with these Regulations and has validated the application.
2
The clock is stopped during any period that the Secretary of State requires an applicant to provide further data until all the further data required have been provided.
3
The clock is also stopped during any period that the applicant is given to provide oral or written explanations.
4
The Secretary of State may stop the clock pending payment of outstanding fees.
Appointment of inspectors
32
The Secretary of State shall appoint inspectors for the purposes of the enforcement of these Regulations.
Powers of entry
33
1
An inspector shall, on producing, if so required, some duly authenticated document showing his authority, have a right at all reasonable hours, to enter any premises for the purpose of ensuring that the provisions of these Regulations are being complied with; and in this regulation “premises” includes any place, any vehicle or trailer, any container, any stall or moveable structure, and any ship or aircraft.
2
He may take with him —
a
such other persons as he considers necessary; and
b
any representative of the European Commission acting for the purpose of the enforcement of a Community obligation.
3
Admission to any premises used only as a private dwellinghouse shall not be demanded as of right unless 24 hours notice of the intended entry has been given to the occupier, or the entry is in accordance with a warrant granted under this regulation.
4
If a justice of the peace, on sworn information in writing, is satisfied that there are reasonable grounds for entry into any premises for the purposes of the enforcement of these Regulations, and either —
a
admission has been refused, or a refusal is expected, and (in either case) that notice to apply for a warrant has been given to the occupier;
b
asking for admission, or the giving of such a notice, would defeat the object of the entry;
c
the case is one of urgency; or
d
the premises are unoccupied or the occupier is temporarily absent,
the justice may by warrant signed by him authorise the inspector to enter the premises, if need be by reasonable force.
5
A warrant under this section shall continue in force for one month.
6
If an inspector enters any unoccupied premises he shall leave them as effectively secured against unauthorised entry as he found them.
7
An inspector shall have the right to enter the premises of manufacturers of active substances used as starting materials for veterinary medicinal products, and of the premises of the marketing authorisation holder.
8
In addition, an inspector may carry out an inspection at the request of another member State, the European Commission or the Agency.
9
In the application of this regulation to Scotland a reference to a justice of the peace includes a reference to the sheriff and to a magistrate.
Powers of inspectors
34
An inspector entering premises under the previous regulation may —
a
inspect the premises, and any plant, machinery or equipment;
b
search the premises;
c
take samples;
d
examine or seize any documents or records (including financial records);
e
seize any computers and associated equipment for the purpose of copying documents provided they are returned as soon as practicable;
f
seize any veterinary medicinal product or anything purporting to be a veterinary medicinal product, and if he does so in circumstances where regulation 40 applies he shall act in accordance with that regulation;
g
carry out any inquiries, examinations and tests;
h
have access to, and inspect and copy any documents or records (in whatever form they are held) kept under these Regulations, or remove such records to enable them to be copied;
i
have access to, inspect and check the operation of any computer and any associated apparatus or material which is or has been in use in connection with the records; and for this purpose may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material to afford him such assistance as he may reasonably require and, where a record is kept by means of a computer, may require the records to be produced in a form in which they may be taken away.
Inspection of pharmacies
35
In relation to a pharmacy, all the powers of an inspector to enforce these Regulations may also be exercised by an officer of the Royal Pharmaceutical Society of Great Britain appointed for the purpose.
Obstruction
36
1
Any person who —
a
intentionally obstructs any person acting in the execution of these Regulations;
b
without reasonable cause, fails to give to any person acting in the execution of these Regulations any assistance or information which that person may reasonably require of him for the performance of his functions under these Regulations;
c
furnishes to any person acting in the execution of these Regulations any information which he knows to be false or misleading, or
d
fails to produce a record when required to do so to any person acting in the execution of these Regulations,
is guilty of an offence.
Improvement notices
37
1
If an inspector has reasonable grounds for believing that any person is failing to comply with these Regulations he may serve a notice on that person (in these Regulations referred to as an “improvement notice”) that —
a
states the inspector’s grounds for believing this;
b
specifies the matters which constitute the failure so to comply;
c
specifies the measures which, in the officer’s opinion, the person must take in order to secure compliance; and
d
requires the person to take those measures, or measures which are at least equivalent to them, within such period (not being less than 14 days) as may be specified in the notice.
2
It is an offence to fail to comply with an improvement notice.
Appeals against improvement notices
38
1
Any person who is aggrieved by an improvement notice may appeal to a magistrates' court or, in Scotland, to the sheriff.
2
The procedure on an appeal to a magistrates' court under paragraph (1) shall be by way of complaint, and the Magistrates' Courts Act 1980 shall apply to the proceedings.
3
An appeal to the sheriff under paragraph (1) shall be by summary application.
4
The period within which an appeal may be brought shall be one month or the period specified in the improvement notice, whichever ends the earlier.
5
An improvement notice shall state —
a
the right of appeal to a magistrates' court or to the sheriff; and
b
the period within which such an appeal may be brought.
6
A court may suspend an improvement notice pending an appeal.
Powers of a court on appeal
39
On an appeal against an improvement notice, the court may either cancel or affirm the notice and, if it affirms it, may do so either in its original form or with such modifications as the court may in the circumstances think fit.
Seizure notices
40
1
If an inspector finds any veterinary medicinal product that does not appear to him to be authorised in the United Kingdom, or any authorised veterinary medicinal product not lawfully supplied in accordance with these Regulations, he may seize it.
2
He shall give to the person appearing to him to be in charge of the veterinary medicinal product a notice (referred to in these Regulations as a “seizure notice”) —
a
giving the grounds for seizing the product; and
b
informing him of his rights under this regulation to make a claim, and the address for the service of the claim.
3
If an inspector is not able to remove products seized under this regulation immediately, he may mark the products in any way that he sees fit, and serve a notice on the person in charge of the products identifying them, and prohibiting the movement of the products until they are collected, and any person who moves products identified under this paragraph is guilty of an offence.
4
Any person claiming that the product was not liable to seizure shall, within one month of the seizure notify his claim to the Secretary of State at the address specified in the original notice, setting out the grounds in full.
5
If a notification of a claim is not received within one month the Secretary of State shall destroy the product.
6
If a notification of a claim is received within one month, the Secretary of State shall either return the goods or take proceedings for an order for the destruction of the veterinary medicinal product in a magistrates' court (or, in Scotland, the sheriff court), and if the court finds that the veterinary medicinal product did not have a marketing authorisation in the United Kingdom, or had not been supplied in accordance with these Regulations, it shall order its destruction.
7
The person on whom the original notice was served is liable for the costs of destruction.
8
This regulation applies to additives, premixtures and feedingstuffs specified in Schedule 5 in the same way as it applies to veterinary medicinal products.
Publication of notices
41
The Secretary of State shall publicise improvement notices and seizure notices in such manner as she shall see fit.
Penalties
42
1
A person guilty of an offence under these Regulations is liable —
a
on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or
b
on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.
2
Where a body corporate is guilty of an offence under these Regulations, and that offence is proved to have been committed with the consent or connivance of, or to have been attributable to any neglect on the part of —
a
a qualified person appointed as such for the purposes of these Regulations;
b
any director, manager, secretary or other similar person of the body corporate, or
c
any person who was purporting to act in any such capacity,
he, as well as the body corporate, is guilty of the offence and is liable to be proceeded against and punished accordingly.
3
For the purposes of paragraph (2)(b) above, “director”, in relation to a body corporate whose affairs are managed by its members, means a member of the body corporate.
4
Where an offence which has been committed by a Scottish partnership is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner, he as well as the partnership is guilty of the offence.
Northern Ireland
43
1
This regulation has effect in relation to Northern Ireland.
2
The Department of Agriculture and Rural Development or the Department of Health, Social Services and Public Safety (or both Departments acting jointly) instead of the Secretary of State shall exercise the powers of the Secretary of State in —
a
regulation 32 (appointment of inspectors);
b
regulation 40 (seizure notices);
c
regulation 41 (publication of notices); and
d
sub-paragraph (4) of paragraph 9 of Schedule 3 (approval of premises for suitably qualified persons).
3
In proceedings in a magistrate’s court relating to an improvement notice under regulation 38, the Magistrates' Courts (Northern Ireland) Order 1981 shall apply.
Revocations and amendments
44
1
The Medicines Act 1968 does not apply in relation to veterinary medicinal products.
2
The Medicines (Prohibition of Importation and Possession of Veterinary Drugs Order (Northern Ireland) 1977 continues in force notwithstanding paragraph (1), and the Medicines Act 1968 shall continue to apply in so far as is necessary for the operation of that Order.
3
The Consumer Protection Act 1987 does not apply in relation to veterinary medicinal products.
4
The instruments in Part 1 of Schedule 8 are revoked.
5
The instruments in Part 2 of that Schedule are revoked on 1st January 2006.
6
The instruments in Part 3 of that Schedule have effect subject to the amendments specified.
7
Part 4 of that Schedule (transitional provisions) has effect, and the provisions relating to feedingstuffs have effect on 1st January 2006.
8
For the avoidance of doubt, the fact that the Medicines Act 1968 does not apply in relation to veterinary medicinal products does not prevent the preparation of information on veterinary medicinal products in the British Pharmacopoeia.
Ben Bradshaw
Parliamentary Under-Secretary of State
Department for Environment, Food and Rural Affairs
17th September 2005
Joan Ryan
Vernon Coaker
Two of the Lords Commissioners of Her Majesty’s Treasury
6th October 2005


type: legislation

jurisdiction: UK

text:
This Order may be cited as the Nursing and Midwifery Council (Election Scheme) Rules Order of Council 2005 and shall come into force on 12th September 2005.
A. K. Galloway
Clerk of the Privy Council


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Inheritance Tax (Double Charges Relief) Regulations 2005, and shall come into force on 4th January 2006.
2
In these Regulations —
“the Commissioners” means the Commissioners for Her Majesty’s Revenue and Customs;
“the debt” means the debt mentioned in regulation 3(2);
“the relevant property” has the meaning given in regulation 3(6).
General
2
1
These Regulations apply in the circumstances specified in regulation 3.
2
They apply for the purposes of paragraph (d) of section 104(1) of the Finance Act 1986 (which refers to circumstances appearing to the Commissioners to be circumstances similar to those referred to in paragraphs (a) to (c) of that provision).
3
To the extent specified in regulation 4, these Regulations apply for the avoidance of double charges to tax.
Circumstances in which these Regulations apply
3
1
These Regulations apply where conditions A to D are met.
2
Condition A is that an individual (“the deceased”) enters into arrangements (“the arrangements”) under which —
a
the disposal condition or the contribution condition is met as respects the relevant property, and
b
the deceased makes a transfer of value as a result of which a third party becomes entitled to the benefit of a debt (“the debt”) owed to the deceased.
3
Condition B is that, before the deceased’s death, any outstanding part of the debt is wholly written off, waived or released, and the write-off, waiver or release is made otherwise than for full consideration in money or money’s worth.
4
Condition C is that the deceased dies on or after 6th April 2005.
5
Condition D is that —
a
on the deceased’s death, the transfer of value treated as made immediately before the deceased’s death included the relevant property (or any property then representing the relevant property), and
b
as a result of the deceased’s death, the transfer of value referred to in paragraph (2)(b) has become a chargeable transfer.
6
In these Regulations “the relevant property” means property which, immediately after the carrying out of the arrangements, falls within the definition of “the relevant property” given in paragraph 11(9) of Schedule 15 to the Finance Act 2004 .
7
In paragraph (2)(a) “the disposal condition” and “the contribution condition” are to be construed in accordance with Schedule 15 to the Finance Act 2004.
Avoidance of double charge: amounts to be calculated
4
1
Where these Regulations apply, amounts A and B must be calculated separately.
2
Amount A is the total tax chargeable as a consequence of the death of the deceased, but disregarding the value transferred represented by the relevant property (or by any property which, at the time of the death, represents the relevant property).
3
Amount B is the total tax chargeable as a consequence of the death of the deceased, but disregarding the value transferred by the transfer of value specified in regulation 3(2)(b).
4
The total tax chargeable is reduced to amount A or to amount B (whichever is the greater).
Michael Hanson
Paul. R.C. Gray
Two of the Commissioners for Her Majesty’s Revenue and Customs
14th December 2005


text:
Citation and commencement
1
These Regulations may be cited as the Road Vehicles (Construction and Use) (Amendment) (No.3) Regulations 2005 and shall come into force on 12th December 2005.
Modification of the Road Vehicles (Construction and Use) Regulations
2
The following provisions shall be added to the Road Vehicles (Construction and Use) Regulations 1986 .
3
After regulation 41 there shall be added —
Alternative means of compliance
41A
A minibus which is required by regulation 41 to meet the requirements specified in Schedule 6 need not meet them if it meets the requirements of such of the Annexes to Directive 2001/85/ EC of the European Parliament and of the Council of 20 November 2001, relating to special provisions for vehicles used for the carriage of passengers comprising more than eight seats in addition to the driver’s seat, and amending Directives 70/156/ EEC and 97/27/EC , as apply to that minibus.
4
After regulation 53B there shall be added —
Alternative means of compliance
53C
A coach which is required by either regulation 53A or 53B, as the case may be, to meet the requirements specified in that particular provision, need not meet them if it meets the requirements of such of the Annexes to Directive 2001/85/EC of the European Parliament and of the Council of 20 November 2001, relating to special provisions for vehicles used for the carriage of passengers comprising more than eight seats in addition to the driver’s seat, and amending Directives 70/156/EEC and 97/27/EC , as apply to that coach..
Signed by authority of the Secretary of State
S.J. Ladyman
Minister of State
Department for Transport
27th October 2005


text:
Citation, commencement and extent
1
1
These Regulations may be cited as the Education (Student Support) (Amendment) (No. 2) Regulations 2005 and shall come into force on 1st September 2005.
2
These Regulations extend to England and Wales.
Interpretation
2
In these Regulations —
“the 2002 Regulations ” means the Education (Student Support) (No. 2) Regulations 2002 ;
“the 2005 Regulations ” means the Education (Student Support) Regulations 2005 .
Amendment of the 2002 Regulations
3
1
Paragraph 9 of Schedule 1 to the 2002 Regulations is amended as follows.
2
The words “or the child of such a national” are omitted.
3
The word “and” is omitted at the end of sub-paragraph (b).
4
After sub-paragraph (c) there is inserted —
d
who, where he is a national of the United Kingdom, has a right to be treated no less favourably than a national of another Member State by virtue of having exercised a Community right of free movement; and
e
who, in a case where his ordinary residence referred to in sub-paragraph (c) was wholly or mainly for the purpose of receiving full time education, was ordinarily resident in the European Economic Area immediately prior to the period of ordinary residence referred to in sub-paragraph (c).
.
Amendment of the 2005 Regulations
4
1
Regulation 18 of the 2005 Regulations is amended as follows.
2
In paragraph (4)(a), there is substituted for the figure “£114.75” the figure “£148.75”.
3
In paragraph (4)(b), there is substituted for the figure “£170” the figure “£255”.
4
In paragraph (7), there is substituted for the definition of “approved childcare provider” the following —
“approved childcare provider” means a childcare provider approved in accordance with the Tax Credit (New Category of Child Care Provider) Regulations 1999 or the Tax Credits (Approval of Child Care Providers) Scheme 2005 ; and
.
5
1
Paragraph 9 of Schedule 2 to the 2005 Regulations is amended as follows.
2
The words “or the child of such a national” are omitted.
3
The word “and” is omitted at the end of sub-paragraph (a).
4
After sub-paragraph (b) there is inserted —
c
who, where he is a national of the United Kingdom, has a right to be treated no less favourably than a national of another Member State by virtue of having exercised a Community right of free movement; and
d
who, in a case where his ordinary residence referred to in sub-paragraph (b) was wholly or mainly for the purpose of receiving full time education, was ordinarily resident in the European Economic Area immediately prior to the period of ordinary residence referred to in sub-paragraph (b).
.
6
1
Schedule 5 to the 2005 Regulations is amended as follows.
2
In paragraph 5(3) —
a
the words “, as a result of some event beyond his control,” are omitted; and
b
for “household income” there is substituted “parent’s income”.
3
In paragraph 5(4), for “as a result of some event beyond his control” there is substituted “as a result of any event”.
Bill Rammell
Minister of State
Department for Education and Skills
26th July 2005


text:
Citation, commencement and application
1
1
This Order may be cited as the Town and Country Planning (Blight Provisions) (England) Order 2005 and shall come into force on 1st April 2005.
2
This Order applies to England.
Limit of annual value
2
The amount prescribed for the purposes of section 149(3)(a) of the Town and Country Planning Act 1990 is £29,200.
Revocation
3
The Town and Country Planning (Blight Provisions) (England) Order 2000 is hereby revoked.
Signed by authority of the First Secretary of State
Keith Hill
Minister of State Office of the Deputy Prime Minister
28th February 2005


text:
Citation and commencement
1
This Order may be cited as the Transport for London (Consequential Provisions) Order 2005 and shall come into force on 14th February 2005.
Modification of the London Local Authorities Act 1995
2
1
Schedule 1 (which amends provisions of the London Local Authorities Act 1995 in respect of Transport for London) shall have effect.
2
Paragraph 2 of Schedule 1 shall cease to have effect on the coming into force of the repeal of section 4 of the London Local Authorities Act 1995 by Part 1 of Schedule 12 to the Traffic Management Act 2004 .
Modification of London Local Authorities Act 2000
3
1
Schedule 2 (which amends provisions of the London Local Authorities Act 2000 in respect of Transport for London) shall have effect.
2
In the case of each of paragraphs 2 to 11 of Schedule 2 that paragraph shall cease to have effect on the coming into force of the repeal, by Part 1 of Schedule 12 to the Traffic Management Act 2004, of the section of the London Local Authorities Act 2000 to which the paragraph relates.
Signed by authority of the Secretary of State
Charlotte Atkins
Parliamentary Under Secretary of State,
Department for Transport
17th January 2005


text:
Citation and commencement
1
These Regulations may be cited as the Occupational Pension Schemes (Regulatory Own Funds) Regulations 2005 and shall come into force on 30th December 2005.
Interpretation
2
1
In these Regulations —
“the 1995 Act ” means the Pensions Act 1995 ;
“the 2004 Act ” means the Pensions Act 2004;
“actuarial valuation” has the meaning given by section 224(2)(a) of the 2004 Act;
“the actuary”, in relation to a scheme, means the actuary appointed under section 47(1)(b) of the 1995 Act (professional advisers) in relation to that scheme;
“biometric risk” means liability risks linked to death, disability and longevity;
“the commencement date” means 30th December 2005;
“employer” has the meaning given by section 318(1) of the 2004 Act (general interpretation);
“the effective date” of an actuarial valuation is the date by reference to which the assets are valued and the technical provisions and regulatory own funds requirement calculated;
“regulatory own funds requirement” has the meaning given by regulation 3;
“the relevant accounts” of a scheme are audited accounts for the scheme —
which comply with the requirements imposed under section 41 of the 1995 Act (provision of documents for members); and
which are prepared for the purpose of an actuarial valuation in respect of a period ending with the effective date of the valuation;
“the Regulator” has the meaning given by section 1 of the 2004 Act (the Pensions Regulator);
“schedule of contributions” has the meaning given by section 227(2) of the 2004 Act (schedule of contributions);
“the Scheme Funding Regulations ” means the Occupational Pension Schemes (Scheme Funding) Regulations 2005 ;
“statutory funding objective” has the meaning given by section 222(1) of the 2004 Act (the statutory funding objective);
“the Taxes Act ” means the Income and Corporation Taxes Act 1988 ;
“technical provisions” has the meaning given by section 222(2) of the 2004 Act.
Regulatory own funds requirement
3
1
An occupational pension scheme to which paragraph (3) applies must hold on a permanent basis additional assets above the aggregate of the scheme’s technical provisions, in order to absorb discrepancies between the anticipated and actual expenses and profits of the scheme (“the regulatory own funds requirement”).
2
The additional assets required under paragraph (1) must be —
a
no less than the amount calculated in accordance with regulation 4; and
b
free of all foreseeable liabilities.
3
This paragraph applies to a scheme, where the scheme and not any employer in relation to that scheme —
a
underwrites any liability to cover against biometric risk;
b
guarantees an investment performance; or
c
guarantees a level of benefits.
4
Where any requirement of this regulation is not complied with, section 10(3) to (9) of the 1995 Act (civil penalties) applies to a trustee or manager who has failed to take all reasonable steps to ensure compliance, as if this regulation was made under Part 1 of that Act.
Calculation of the amount of the regulatory own funds requirement
4
1
The amount of the regulatory own funds requirement is the aggregate of —
a
a sum equal to 4% of the technical provisions of the occupational pension scheme; plus
b
a sum equal to 0.3% of the capital at risk for members of the scheme in respect of which the capital at risk is not a negative figure, and where the capital at risk is as calculated in paragraph (2).
2
For the purposes of paragraph (1)(b) “capital at risk” means —
a
to the extent that the benefit payable on death in respect of a member of the scheme comprises a lump sum benefit, the amount of that lump sum payable on death; and
b
to the extent that the benefit payable on death comprises the purchase of an annuity, payment of a sum by instalments or any other kind of periodical payments, the present value of that benefit calculated in a way consistent with the determination of the scheme’s technical provisions,
less the scheme’s technical provisions in relation to those members.
3
Where any requirement of this regulation is not complied with, section 10(3) to (9) of the 1995 Act applies to a trustee or manager who has failed to take all reasonable steps to ensure compliance, as if this regulation was made under Part 1 of that Act.
Modification of Part 3 of the 2004 Act and the Scheme Funding Regulations
5
1
Part 3 of the 2004 Act (scheme funding) shall be modified in its application to an occupational pension scheme that is subject to the regulatory own funds requirement so that it applies as if —
a
in section 221 of the 2004 Act (pension schemes to which Part 3 of the 2004 Act applies) —
i
for “occupational pension scheme other than — ” in subsection (1) there is substituted “occupational pension scheme except a scheme of a kind specified in regulation 15 of the Occupational Pension Schemes (Regulatory Own Funds) Regulations 2005”,
ii
paragraphs (a) and (b) of that subsection are omitted, and
iii
subsection (2) is omitted;
b
in section 224 of the 2004 Act —
i
the words after “one year” in subsection (1)(a) are omitted,
ii
for “scheme’s assets and calculating its technical provisions” in subsection (2)(a) there is substituted “scheme’s assets, and calculating its technical provisions and the amount of the regulatory own funds requirement”,
iii
paragraphs (c) and (d) of subsection (2) are omitted,
iv
the word “and” at the end of paragraph (a) of subsection (3) and paragraph (b) of that subsection are omitted, and
v
the words “or report” in subsections (4), (6) and (7) and the words “or reports” in subsection (5) are omitted;
c
in section 226 of the 2004 Act (recovery plan) —
i
for “they must, within the prescribed time — ” in subsection (1) there is substituted “they must take such steps as are necessary to ensure that the statutory funding objective is met within two years after that date.”,
ii
paragraphs (a) and (b) of that subsection are omitted, and
iii
subsections (2) to (6) are omitted;
d
in section 227(6)(b)(i) of the 2004 Act, for “by the end of the period specified in the recovery plan” there is substituted “within two years after that date”; and
e
in section 231 of the 2004 Act (powers of the Regulator), the words after “section 226” in subsection (1)(d) are omitted.
2
The Scheme Funding Regulations shall be modified in their application to an occupational pension scheme that is subject to the regulatory own funds requirement so that they apply as if —
a
in regulations 6(2) and (3)(a) (statement of funding principles), 7(2)(a) (actuarial valuations and reports), 9(1) and (2)(a) (schedule of contributions) and 13 (period for obtaining employer’s agreement), for “15 months” there is substituted “12 months”;
b
regulations 7(5) and 8 (recovery plan) are omitted;
c
in regulation 10 (content and certification of schedules of contributions) —
i
in paragraph (2), for “five years after the date on which the schedule is certified, or in a case where — ” there is substituted “two years after the date on which the schedule is certified”, and the words “that longer period” are omitted,
ii
sub-paragraphs (a) and (b) of that paragraph are omitted, and
iii
in paragraph (4), for the words “give effect to a recovery plan”, there is substituted “comply with section 226 or any regulatory own funds requirement”; and
d
regulations 17 (general exemptions) and 18 (exemption connected with winding up) are omitted.
Certification of additional assets requirement
6
1
If an occupational pension scheme is subject to the regulatory own funds requirement, the calculation of the amount of the regulatory own funds requirement must be certified by the actuary.
2
An actuarial valuation of the scheme must include the actuary’s certification of the calculation of the amount of the regulatory own funds requirement in the form set out in the Schedule.
3
If the actuary cannot certify the calculation of the amount of the regulatory own funds requirement, he must report the matter in writing to the Regulator within a reasonable period after the end of the period within which the actuarial valuation must be received by the trustees or managers.
4
Where the actuary fails to take all reasonable steps to ensure compliance with this regulation, section 10(3) to (9) of the 1995 Act applies, as if this regulation was made under Part 1 of that Act.
Restoration of regulatory own funds
7
1
If, having obtained an actuarial valuation and certification of the calculation of the regulatory own funds requirement for an occupational pension scheme, it appears to the trustees or managers of that scheme that the regulatory own funds requirement was not met as at the effective date of the actuarial valuation, the trustees or managers must take such steps as are necessary to ensure that the regulatory own funds requirement is met within two years after the effective date of that valuation.
2
The trustees or managers must send the Regulator a report of the steps to be taken under paragraph (1), within a reasonable period after having obtained the actuarial valuation and certification of the calculation of the amount of the regulatory own funds requirement.
3
Where paragraph (1) or (2) is not complied with the Regulator may by order exercise either or both of the following powers —
a
it may modify the scheme as regards the future accrual of benefits;
b
it may impose a schedule of contributions specifying —
i
the rates of contributions payable towards the scheme by or on behalf of the employer and the active members of the scheme, and
ii
the dates on or before which such contributions are to be paid.
4
Where paragraph (1) or (2) is not complied with, section 10(3) to (9) of the 1995 Act applies to a trustee or manager who has failed to take all reasonable steps to ensure compliance, as if this regulation was made under Part 1 of that Act.
Certification of schedule of contributions
8
1
If an occupational pension scheme is subject to the regulatory own funds requirement the certification of the schedule of contributions for the scheme must also include certification of the schedule of contributions in respect of the additional assets requirement in the form set out in the Schedule.
2
Where paragraph (1) is not complied with, section 10(3) to (9) of the 1995 Act applies to a trustee or manager who has failed to take all reasonable steps to ensure compliance, as if this regulation was made under Part 1 of that Act.
Statement of funding principles
9
The policy of the trustees or managers of a scheme for securing that the regulatory own funds requirement in relation to the scheme is met is a prescribed matter for the purposes of section 223(1)(b) of the 2004 Act (statement of funding principles).
Postponement
10
1
If an occupational pension scheme had insufficient assets on 23rd September 2005 to comply with the regulatory own funds requirement, compliance with regulation 3(1) is postponed until 22nd September 2010 (the “postponement period”), after which date compliance with the regulatory own funds requirement cannot be further postponed.
2
If compliance with regulation 3(1) is postponed in accordance with paragraph (1) the trustees or managers must notify the Regulator of the postponement and the postponement period within a reasonable period after the effective date of the first valuation under Part 3 of the 2004 Act.
3
During the postponement period a trustee or manager must not —
a
accept any contributions from a European employer under section 287 of the 2004 Act (occupational pension scheme receiving contributions from European employer);
b
apply for authorisation by the Regulator to accept any contributions from a European employer under section 288 of the 2004 Act (general authorisation to accept contributions from European employers); or
c
apply for approval by the Regulator in relation to a particular European employer under section 289 of the 2004 Act (approval in relation to a particular European employer).
4
If at any time during the postponement period, the trustees or managers are satisfied, having taken actuarial advice, that the scheme has sufficient assets to meet the regulatory own funds requirement, they may resolve or determine that the regulatory own funds requirement applies to the scheme.
5
If the trustees or managers resolve or determine in accordance with paragraph (4), that the regulatory own funds requirement applies to the scheme from a date before the expiry of the postponement period, they must, within one month of the resolution or determination, notify the Regulator of the resolution or determination and the date from which the regulatory own funds requirement applies to the scheme.
6
If the trustees or managers resolve or determine in accordance with paragraph (4), that the regulatory own funds requirement applies to the scheme from a date before the expiry of the postponement period, they must not subsequently resolve or determine to reapply the postponement period to the scheme.
7
Where any requirement of this regulation is not complied with, section 10(3) to (9) of the 1995 Act applies to a trustee or manager who has failed to take all reasonable steps to ensure compliance, as if this regulation was made under Part 1 of that Act.
8
In this regulation, “European employer” has the meaning given in regulation 11.
Meaning of “European employer”
11
1
Subject to paragraphs (2) to (4), in Part 7 of the Act “European employer” in relation to a scheme means a person who —
a
either —
i
employs qualifying persons, or
ii
is a qualifying self-employed person, and
is making (or proposes to make) contributions to that scheme either in respect of a qualifying person or in respect of himself as a qualifying self-employed person.
2
But an employer is not to be regarded as a European employer in relation to any persons whom he employs who are not qualifying persons.
3
Where —
a
the Regulator has approved the trustees or managers of a scheme in relation to a European employer, and
b
benefits are, or will become, payable under the scheme rules to or in respect of any member who is or was a qualifying person in relation to that European employer, or to or in respect of any member who is or was a qualifying self-employed person,
“European employer” shall include the persons specified in paragraph (4).
4
The persons referred to in paragraph (3) are —
a
in a case where the approval was granted in relation to a body corporate which has since ceased to be an employer of qualifying persons, that body corporate,
b
in a case where —
i
the approval was granted in relation to a European employer who is not a body corporate, and
ii
that European employer has ceased to be an employer of qualifying persons,
the person who was the employer of qualifying persons who were, in accordance with that approval, members of the scheme immediately before the time at which the scheme ceased to have any such active members, and
c
in a case where the approval was granted in relation to a qualifying self-employed person who has ceased to be such a person, that person.
Scheme annual report, accounts and actuarial valuation
12
1
If an occupational pension scheme (other than a scheme to which paragraph (3) applies) is subject to the regulatory own funds requirement the scheme’s annual report, relevant accounts and annual actuarial valuation must —
a
include a statement that the regulatory own funds requirement applies to the scheme;
b
include the effective date from which the requirement applies;
c
show the amount of the regulatory own funds requirement calculated as at the date of the scheme’s last actuarial valuation; and
d
show the amount of additional assets held by the scheme to cover the requirement.
2
In this regulation the effective date is the date by reference to which the regulatory own funds requirement applies to a scheme.
3
If compliance with regulation 3(1) is postponed in accordance with regulation 10(1), the scheme’s annual reports, relevant accounts and annual actuarial valuation must include a statement that compliance with the regulatory own funds requirement is postponed until 22nd September 2010.
4
Where any requirement of this regulation is not complied with, section 10(3) to (9) of the 1995 Act applies to a trustee or manager if he fails to take all reasonable steps to ensure compliance, as if this regulation was made under Part 1 of that Act.
Improvement notices and third party notices
13
For the purposes of compliance with these Regulations, sections 13(7) (improvement notices), 14(8) (third party notices) and 90(6) (codes of practice) of the 2004 Act shall be read as if the definition of “pensions legislation” includes these Regulations.
Registrable information
14
Whether the regulatory own funds requirement applies to the scheme and, if it applies, the date from which it applies, is prescribed registrable information for the purposes of section 60(2)(h) of the 2004 Act (registrable information).
Exemptions
15
1
These Regulations do not apply to —
a
a scheme which —
i
is established by or under an enactment (including a local Act), and
ii
is guaranteed by a public authority;
b
a pay-as-you-go scheme;
c
a scheme which is made under section 2 of the Parliamentary and other Pensions Act 1987 (power to provide for pensions for Members of the House of Commons etc. );
d
a scheme which is treated as such by virtue of paragraph 4 or 5 of Schedule 2 to the Scheme Funding Regulations (modifications of the 2004 Act and the Scheme Funding Regulations) and —
i
in the cases described in paragraphs 4(2) and 5(2)(a) of that Schedule, applies to members in employment outside the member States, and
ii
in the cases described in paragraphs 4(3) and 5(2)(b) of that Schedule, applies to members in employment outside the United Kingdom;
e
a scheme which —
i
provides relevant benefits,
ii
is neither a relevant statutory scheme nor a tax approved scheme, nor, from 6th April 2006, a tax registered scheme, and
iii
has fewer than 100 members;
f
a section 615(6) scheme which has fewer than 100 members;
g
a scheme which has fewer than two members;
h
a scheme which has fewer than 12 members, where all the members are trustees of the scheme and either —
i
the provisions of the scheme provide that all decisions which fall to be made by the trustees are made by the unanimous agreement of the trustees who are members of the scheme, or
ii
the scheme has a trustee who is an independent trustee in relation to the scheme for the purposes of section 23 of the 1995 Act (power to appoint independent trustees) and is registered in the register maintained by the Regulator in accordance with regulations made under subsection (4) of that section;
i
a scheme which has fewer than 12 members, where a company is a trustee of the scheme and all the members of the scheme are directors of the company and either —
i
the provisions of the scheme provide that any decision made by the company in its capacity as trustee is made only by the unanimous agreement of the directors who are members of the scheme, or
ii
one of the directors is a trustee who is independent in relation to the scheme for the purposes of section 23 of the 1995 Act and is registered in the register maintained by the Regulator in accordance with regulations made under subsection (4) of that section;
j
a scheme which is subject to the regulatory own funds requirement merely because it provides for the payment of death benefits under the scheme, but only if the death benefits are secured by insurance policies or annuity contracts;
k
a scheme which is the subject of a scheme failure notice under section 122 (insolvency practitioner’s duty to issue notices confirming status of scheme) or 130 (Board’s duty where application or notification received under section 129) of the 2004 Act; or
l
subject to regulation 16, a scheme which is being wound up.
2
This regulation does not apply to a scheme of a kind referred to in paragraphs (1)(a) and (d) to (i) if it is a scheme undertaking cross-border activities.
3
In this regulation —
“enactment” includes an enactment comprised in, or in an instrument under, an Act of the Scottish Parliament;
“pay-as-you-go scheme” means an occupational pension scheme under which there is no requirement for assets to be set aside in advance for the purpose of providing benefits under the scheme (disregarding any requirements relating to additional voluntary contributions);
“public authority” means —
a Minister of the Crown (within the meaning of the Ministers of the Crown Act 1975 );
a government department (including any body or authority exercising statutory functions on behalf of the Crown);
the Scottish Ministers;
the National Assembly for Wales; or
a local authority;
“relevant benefits” has the meaning given in section 612(1) of the Taxes Act (interpretative provisions and regulations for the purposes of Chapter 1 of Part 14 of the Taxes Act) or, from 6th April 2006, section 393B of the Income Tax (Earnings and Pensions) Act 2003 (relevant benefits);
“relevant statutory scheme” has the meaning given in section 611A(1) of the Taxes Act (definition of relevant statutory scheme);
“section 615(6) scheme” means a scheme with such a superannuation fund as is mentioned in section 615(6) of the Taxes Act (funds for the provision of benefits in respect of employment outside the United Kingdom);
“scheme undertaking cross-border activities” means a scheme in relation to which the trustees or managers are —
authorised under section 288 of the 2004 Act (general authorisation to accept contributions from European employers); or
approved under section 289 of the 2004 Act in relation to a European employer;
“tax approved scheme” means a scheme which is approved or was formerly approved under section 590 or 591 of the Taxes Act (approval of retirement benefit schemes) or in respect of which an application for such approval has been duly made but has not been determined;
“tax registered scheme” means a scheme which from 6th April 2006 is, or is treated as, registered under Chapter 2 of Part 4 of the Finance Act 2004 (registration of pension schemes).
4
In paragraph (3), “local authority” means —
a
in relation to England, a county council, a district council, a London borough council, the Greater London Authority, the Common Council of the City of London in its capacity as a local authority, or the Council of the Isles of Scilly;
b
in relation to Wales, a county council or county borough council;
c
in relation to Scotland, a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 (constitution of councils);
d
an administering authority as defined in Schedule 1 to the Local Government Pension Scheme Regulations 1997 (interpretation).
5
Where these Regulations cease to apply to a scheme to which they previously applied, because the scheme is of a kind referred to in paragraph (1), that does not affect any rights or obligations arising before these Regulations ceased to apply.
Exemption connected with winding up
16
1
Where the winding up of a scheme begins on or after the commencement date, the exemption provided for in regulation 15(1)(l) is subject to the condition set out in paragraph (2).
2
The condition referred to in paragraph (1) is that the trustees or managers of the scheme ensure that they receive, before the end of each scheme year following the scheme year in which the winding up of the scheme begins, the actuary’s estimate of the solvency of the scheme as at the end of the preceding scheme year.
3
In paragraph (2) —
“the actuary’s estimate of solvency of the scheme” means —
except in the case referred to in sub-paragraph (b), an estimate by the actuary of whether, at the end of the relevant scheme year, the value of assets of the scheme to be taken into account under paragraph (1) of regulation 3 of the Scheme Funding Regulations (determination of assets and liabilities) exceeded or fell short of the sum of —
the cost of purchasing annuities, of the type described in section 74(3)(c) of the 1995 Act (discharge of liability by insurance, etc.) and on terms consistent with those in the available market, which would be sufficient to satisfy the liabilities to be taken into account under paragraph (2) of that regulation, and
the other expenses which, in the opinion of the actuary, would be likely to be incurred in connection with the winding up of the scheme,
and the amount of the excess or, as the case may be, the shortfall;
where the actuary considers that it is not practicable to make an estimate in accordance with sub-paragraph (a), an estimate of the solvency of the scheme at the end of the relevant scheme year made in such manner as the actuary considers appropriate in the circumstances of the case;
“scheme year” means —
either —
a year specified for the purposes of the scheme rules in any document which contains those rules, or
if no such year is specified, the period of 12 months commencing on 1st April or on such date as the trustees or managers select; or
such other period (if any) exceeding six months but not exceeding 18 months as is selected by the trustees or managers in connection with —
the commencement or termination of the scheme, or
a variation of the date on which the year or period referred to in sub-paragraph (a) is to commence.
Signed by authority of the Secretary of State for
Stephen C. Timms
Minister of State,
Department for Work and Pensions
8th December 2005


text:
Citation and commencement
1
These Regulations may be cited as the Public Service Vehicles (Conditions of Fitness, Equipment, Use and Certification) (Amendment) (No. 2) Regulations 2005 and shall come into force on 30th September 2005.
Increase in fees
2
1
The Public Service Vehicles (Conditions of Fitness, Equipment, Use and Certification) Regulations 1981 shall be amended as follows.
2
In the regulations specified in column (1) of the following Table for the amounts specified in column (2) there shall be substituted the amounts specified in column (3).
TABLE
(1) (2) (3) Regulation Existing Amount (£) Substituted Amount (£)
46(2)(a) 215 243 46(2)(b)(i) 215 243 46(2)(b)(ii) 26 29 50(a) 1245 1407 114 129 50(b) 615 695 50(c) 2664 3010 53 24 27 57(5) 17 19
Signed by authority of the Secretary of State
S J Ladyman
Minister of State
Department for Transport
20th August 2005


text:
Citation, commencement and interpretation
1
1
These Regulations may be cited as the Medicines (Advisory Bodies) Regulations 2005 and, subject to paragraph (2), shall come into force on 30th October 2005.
2
Regulation 7 shall come into force on 31st May 2005 for the purposes of making regulations under paragraph 6 of Schedule 1A to the Act , as inserted by that regulation.
3
In these Regulations —
“the Act” means the Medicines Act 1968 ; and
“the Marketing Authorisation Regulations ” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 .
Abolition of the Medicines Commission
2
1
The Medicines Commission is abolished.
2
Section 2 of the Act (establishment of the Medicines Commission) is hereby repealed.
Establishment of the Commission on Human Medicines
3
After section 2 of the Act insert the following section —
Establishment of the Commission on Human Medicines
2A
1
There shall be established a body of persons to be called the Commission on Human Medicines (referred to in this Act as “the Commission”) to perform the functions assigned to the Commission by or under this Act.
2
The Ministers shall appoint the members of the Commission.
3
The Commission shall have at least eight members.
4
The Ministers shall appoint the chairmen of the Expert Advisory Groups referred to in paragraphs (a) to (c) of paragraph 4(1) of Schedule 1A to this Act as members of the Commission.
5
The Ministers shall appoint one of the members of the Commission to be chairman of the Commission.
.
Functions of the Commission on Human Medicines
4
For section 3 of the Act (general functions of the Commission) , substitute —
Functions of the Commission
3
1
The Commission shall give to any one or more of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act advice on matters —
a
relating to the execution of this Act,
b
relating to the exercise of any power conferred by this Act,
c
relating to the execution of the Marketing Authorisation Regulations or the Clinical Trials Regulations,
d
relating to the exercise of any power conferred by those regulations, or
e
otherwise relating to medicinal products,
where either the Commission consider it expedient, or they are requested by the Minister or Ministers in question, to do so.
2
Without prejudice to the preceding subsection, and to any other duties or powers imposed or conferred on the Commission by or under this Act, the Marketing Authorisation Regulations or the Clinical Trials Regulations, it shall be the duty of the Commission —
a
to —
i
give advice with respect to safety, quality or efficacy in relation to medicinal products,
ii
promote the collection and investigation of information relating to adverse reactions, for the purposes of enabling such advice to be given, and
iii
undertake the functions mentioned in section 4(4) of this Act,
except in so far as those functions are for the time being assigned to a committee established under section 4 of this Act; and
b
to advise the licensing authority in cases where the authority —
i
are required by the provisions of Part 2 of this Act, or by the provisions of the Marketing Authorisation Regulations or the Clinical Trial Regulations, to consult the Commission with respect to any matter arising under those provisions, or
ii
without being required to do so, elect to consult the Commission with respect to any matter arising under any of those provisions.
.
Amendment of section 4 of the Act
5
1
Section 4 of the Act (establishment of committees) shall be amended as follows.
2
In subsection (1), omit the words from “, having regard to” to “consider appropriate,”.
3
In subsection (2)(a), before “or the Clinical Trials Regulations”, insert “, the Marketing Authorisation Regulations”.
4
After subsection (4), insert the following subsection —
4A
A committee established under this section shall have at least eight members.
.
5
For subsection (6), substitute —
6
In this Act “the appropriate committee”, for the purposes of any provision of this Act under which a function falls to be performed, means —
a
in a case where —
i
a committee has been established under this section for purposes which consist of or include any of those specified in subsection (3) of this section, and
ii
the authority performing that function considers it to be the appropriate committee in the circumstances,
that committee; and
b
in any other case, the Commission.
.
Amendment of section 5 of the Act
6
1
Section 5 of the Act (supplementary provisions as to Commission and committees) shall be amended as follows.
2
In subsection (1), for “Schedule 1” substitute “Schedule 1A”.
3
For subsection (2) substitute —
2
The Commission shall, at such time in each year as the Ministers may direct, send to the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act a report with respect to —
a
the performance of their functions; and
b
the performance of functions by any Expert Advisory Group appointed by them under paragraph 3 of Schedule 1A to this Act, including any Expert Advisory Group which is jointly appointed by them and another Advisory Body or Bodies,
and the Secretary of State shall lay before Parliament a copy of every such report.
.
4
For subsection (3) substitute —
3
Each committee established under section 4 of this Act shall, at such time in each year as the Ministers may direct, send to the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act a report with respect to —
a
the performance of their functions; and
b
the performance of functions by any Expert Advisory Group appointed by them under paragraph 3 of Schedule 1A to this Act, including any Expert Advisory Group which is jointly appointed by them and another Advisory Body or Bodies,
and the Secretary of State shall lay before Parliament a copy of every such report.
.
5
In subsection (4), in paragraph (a), for “Schedule 1” substitute “Schedule 1A”.
Provisions relating to Commission on Human Medicines and other committees
7
1
Schedule 1 to the Act (provisions relating to Medicines Commission and committees) is hereby repealed.
2
After Schedule 1 to the Act, insert the following Schedule —
SCHEDULE 1A
PROVISIONS RELATING TO COMMISSION AND COMMITTEES
Section 5
Interpretation
1
In this Act, “Advisory Body” means the Commission or a committee established under section 4 of this Act.
Co-opted members
2
1
Subject to the approval of the Secretary of State, at any meeting of an Advisory Body, that Advisory Body may co-opt additional members.
2
A co-opted member shall hold office only in relation to the meeting for which he is co-opted.
Expert Advisory Groups
3
1
Subject to paragraph 4 of this Schedule, an Advisory Body, or any two or more Advisory Bodies acting jointly, may, subject to the approval of the Secretary of State, appoint sub-committees, to be known as Expert Advisory Groups.
2
The Secretary of State may direct an Advisory Body to appoint an Expert Advisory Group to advise on such matters as may be specified in the direction.
3
An Expert Advisory Group may include or consist of persons who are not members of the Advisory Body or Bodies which appointed that Expert Advisory Group.
4
Subject to paragraph 4(2) of this Schedule, the Advisory Body or Bodies which appointed the Expert Advisory Group shall appoint one of the members of the Expert Advisory Group as chairman.
5
At any meeting of an Expert Advisory Group, the chairman of that Group may, after consulting the chairman or chairmen of the Advisory Body or Bodies which appointed that Group, co-opt additional members of that Group.
6
Members co-opted in accordance with sub-paragraph (5) of this paragraph shall hold office only in relation to the meeting for which they are co-opted.
Appointment by the Commission of Expert Advisory Groups
4
1
The Commission shall establish —
a
an Expert Advisory Group to be called “the Biologicals Expert Advisory Group”, to advise on the safety, quality and efficacy of medicinal products of biological or bio-technological origin, including vaccines;
b
an Expert Advisory Group to be called “the Chemistry, Pharmacy and Standards Expert Advisory Group”, to advise on the quality, and quality in relation to safety and efficacy, of medicinal products which are the subject of an application for a product licence under this Act, a marketing authorization under the Marketing Authorisation Regulations, or a request for authorisation pursuant to regulation 17 of the Clinical Trials Regulations;
c
an Expert Advisory Group to be called “the Pharmacovigilance Expert Advisory Group”, to advise on pharmacovigilance and other issues relating to the safety of medicinal products; and
d
such other Expert Advisory Groups as it considers appropriate.
2
The chairmen of the Expert Advisory Groups referred to in paragraphs (a) to (c) of sub-paragraph (1) above shall be appointed by the Ministers.
Delegation of functions by Advisory Bodies
5
1
Subject to sub-paragraph (2) of this paragraph, an Advisory Body may delegate to an Expert Advisory Group such of its functions as it thinks fit.
2
Subject to sub-paragraph (3) of this paragraph, an Advisory Body may not delegate any function which consists of advising the licensing authority in cases where the licensing authority is required to consult that Advisory Body pursuant to the provisions of —
a
Part 2 of this Act;
b
the Clinical Trials Regulations;
c
the Homoeopathic Regulations; or
d
the Marketing Authorisation Regulations.
3
An Advisory Body may arrange for an Expert Advisory Group to provide advice or assistance in relation to the performance of any function referred to in sub-paragraph (2) of this paragraph.
Terms of office of members
6
The Ministers may make provision by regulations with respect to one or more of the following matters —
a
the terms on which members of Advisory Bodies shall hold and vacate office, including the terms on which any person appointed as chairman of such a Body shall hold and vacate office as chairman; and
b
the terms on which members of Expert Advisory Groups shall hold and vacate office, including the terms on which any person appointed as chairman of such a Group shall hold and vacate office as chairman.
Staff, premises and facilities
7
The Ministers shall provide each Advisory Body and any committee appointed under section 60 of this Act with such staff and such accommodation, services and other facilities as appear to the Ministers to be necessary or expedient for the proper performance of their functions.
Validity of proceedings
8
The validity of any proceedings of an Advisory Body, Expert Advisory Group or any committee appointed under section 60 of this Act shall not be affected by —
a
a vacancy among the members of that Advisory Body, Expert Advisory Group, or committee, or
b
a defect in the appointment of any member of that Advisory Body, Expert Advisory Group or committee.
Proceedings
9
1
An Advisory Body may, subject to approval by the Secretary of State, make such provision as it thinks fit to regulate its own proceedings.
2
The Secretary of State may make such provision as he thinks fit to regulate the proceedings of Expert Advisory Groups.
3
A committee established under section 60 of this Act shall have the power to regulate their procedure.
Remuneration and expenses of members
10
The Ministers may pay to the members of each Advisory Body and Expert Advisory Group and of any committee appointed under section 60 of this Act such remuneration (if any) and such allowances as may be determined by the Ministers with the consent of the Treasury.
Expenses of Advisory Bodies and Expert Advisory Groups
11
The Ministers shall defray any expenses incurred with their approval by each Advisory Body and Expert Advisory Group or by any committee appointed under section 60 of this Act.
Status
12
No Advisory Body, no Expert Advisory Group and no committee appointed under section 60 of this Act shall be taken to be the servant or agent of the Crown or to enjoy any status or immunity of the Crown.
.
Consequential and other amendments to the Act
8
The amendments to the Act set out in Schedule 1 shall have effect.
Consequential and other amendments to the Marketing Authorisation Regulations
9
The amendments to the Marketing Authorisation Regulations set out in Schedule 2 shall have effect.
Amendments to other enactments
10
The provisions of the enactments specified in Schedule 3 shall be amended as there specified.
Revocations
11
The Medicines Commission and Committees Regulations 1970 and the Medicines (Committee on Safety of Medicines) Order 1970 are hereby revoked.
Transfer of properties, rights and liabilities
12
On 30th October 2005, all property, rights and liabilities to which the Medicines Commission was entitled or subject immediately before that date shall transfer to the Secretary of State.
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State,
Department of Health
4th April 2005