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PART 1
Introduction
Title and commencement
1
These Regulations may be cited as the Veterinary Medicines Regulations 2006 and come into force on 1st October 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 given in paragraph 1 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 to human or animal health relating to the quality, safety or efficacy of the veterinary medicinal product; 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 in relation to the administration of a product in the course of a procedure licensed 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 product must be administered in accordance with an animal test certificate granted under regulation 8(2).
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 (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 (the manufacture of veterinary medicinal products) has effect.
3
“Manufacture” includes any part of the manufacture of a veterinary medicinal product until the finished product is ready for sale in its final form as specified in the marketing authorisation but does not include the manufacture of an ingredient.
4
However —
a
a holder of a wholesale dealer’s authorisation (in accordance with regulation 13) or a suitably qualified person (in accordance with paragraph 13 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 he or the manufacturer supplies a product that is not completely in accordance with the marketing authorisation.
Classification, supply and possession of the product
7
1
Schedule 3 (classification and supply, wholesale dealers and sheep dip) 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 that specifically states that the medicinal product is for administration under the cascade, either by that veterinary surgeon or under his direction and responsibility) 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 of a marketing authorisation).
2
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.
3
The Secretary of State may suspend or revoke an animal test certificate if this is necessary for reasons of animal or human health.
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 13 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 containing psychotropic drugs or narcotics
11
1
It is an offence to advertise a veterinary medicinal product that —
a
is available on veterinary prescription only; or
b
contains 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 or pharmacists.
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 13 of Schedule 3;
d
other veterinary health care professionals;
e
professional keepers of animals; or
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
Schedule 1 and Part 1 of Schedule 2 do not apply in relation to an inactivated autogenous vaccine that is —
a
manufactured by a person and in premises authorised in accordance with Part 2 of Schedule 2, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal; and
b
used for the treatment of —
i
other animals on the same site;
ii
animals intended to be sent to those premises; or
iii
animals on a site that receives animals from those premises.
3
They do not apply to blood from a blood bank authorised in accordance with Part 3 of Schedule 2, nor to a product manufactured for administration under the cascade by a person and in premises authorised under Part 4 of Schedule 2.
4
Schedule 6 (exemptions for small pet animals) 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 keeper of a food-producing animal must keep proof of purchase of all veterinary medicinal products (or, if he did not buy them, documentary evidence of how he acquired them) acquired for the animal.
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 and the batch number;
c
the date of administration of the product;
d
the amount of product administered;
e
the identification of the animals treated; and
f
the withdrawal period.
2
It is an offence to fail to comply with this regulation.
Food-producing animals: records of acquisition and administration
19
1
When a veterinary medicinal product is bought or otherwise acquired for a food-producing animal the keeper must, at the time, record —
a
the name of the product and the batch number;
b
the date of acquisition;
c
the quantity acquired; and
d
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 withdrawal period; and
e
the identity of the animals treated.
3
If he disposes of any or all of the veterinary medicinal product other than by treating an animal, he must record —
a
the date of disposal;
b
the quantity of product involved; and
c
how and where he disposed of it.
4
It is an offence to fail to comply with this regulation.
Food-producing animals: retention of records
20
1
The keeper of a food-producing animal must keep the documentation on the acquisition of a veterinary medicinal product and the records relating to the product for at least five years following the administration or other disposal of the product, irrespective of whether or not the animal concerned is no longer in his possession or has been slaughtered or has died during that period.
2
It is an offence to fail to comply with this regulation.
Records by a holder 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; and
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 (manufacture) 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 a holder of a wholesale dealer’s authorisation
22
1
A holder of a wholesale dealer’s authorisation must record the following as soon as is reasonably practicable after each incoming or outgoing transaction (including disposal) relating to a veterinary medicinal product —
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 the receipt or supply of prescription products
23
1
When any person permitted under these Regulations to supply a veterinary medicinal product 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 batch number (except that, in the case of a product for a non-food-producing animal, this need only be recorded either on the date he receives the batch or the date he starts to use it);
d
the quantity;
e
the name and address of the supplier or recipient; and
f
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 following the transaction.
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 following the transaction.
4
He must keep the documentation and records for at least five years.
5
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 holder of a wholesale dealer’s authorisation 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
a holder of a wholesale dealer’s authorisation if the possession is for re-export; or
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.
3
It is a defence for a person charged under paragraph (1) to prove that he supplied the veterinary medicinal product for the purposes of research or development of a veterinary medicinal product.
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 he 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 he may decide.
5
The Secretary of State may consult the Committee at any time.
Procedure for suspending, etc. a marketing authorisation or animal test certificate
29
1
If the Secretary of State suspends a marketing authorisation or an animal test certificate, he must notify the holder immediately, and, unless he directs otherwise, the suspension has immediate effect, and continues in effect until any appeals process under this regulation is completed.
2
If the suspension is on the grounds of safety, quality or efficacy, the holder may give notice within 28 days that he wishes to make representations to the Veterinary Products Committee.
3
The Committee must 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 the suspension.
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 his proposed determination and the reasons for it.
8
A person may then 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 not available to the Secretary of State at the time of the suspension) 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 his final determination and the reasons for it.
11
If the Secretary of State, on the grounds of safety, quality or efficacy, 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
vary it other than on the application of the holder;
d
refuse to grant a variation applied for by the holder; or
e
revoke it,
he shall notify the applicant or holder of his intention.
12
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, and the procedure governing suspension shall then apply in the same way as it applies to suspension, except that a variation or revocation shall not take effect until the Secretary of State has made a 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 he 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 may, on producing a duly authenticated document showing his authority if required, enter any premises at any reasonable hour 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 is valid for one month.
6
If an inspector enters any unoccupied premises he must leave them as effectively secured against unauthorised entry as he found them.
7
He may 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
He may carry out an inspection at the request of another member State, the European Commission or the Agency.
9
In this regulation, a reference to a justice of the peace —
a
in Scotland includes a reference to the sheriff and to a magistrate; and
b
in Northern Ireland, is a reference to a lay magistrate.
Powers of an inspector
34
1
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
seize any computers and associated equipment for the purpose of copying documents provided they are returned as soon as practicable;
e
seize any veterinary medicinal product, anything purporting to be a veterinary medicinal product, or any additive, premixture or feedingstuff specified in Schedule 5 and if he does so in circumstances where regulation 40 applies he shall act in accordance with that regulation;
f
carry out any inquiries, examinations and tests;
g
have access to, and inspect and copy any documents or records (in whatever form they are held) relating to these Regulations, and remove them to enable them to be copied; and
h
have access to, inspect and check the operation of any computer and any associated apparatus or material that 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.
2
An officer of any local authority who has entered premises exercising any statutory power of entry for the purposes of enforcing any legislation relating to food hygiene, feed hygiene or animal health, may inspect any records made under these Regulations (in whatever form they are held) relating to food-producing animals, and may remove them to enable them to be copied.
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 or the Pharmaceutical Society of Northern Ireland appointed for the purpose.
Obstruction
36
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 that 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 that 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 that constitute the failure to comply;
c
specifies the measures that, 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 at least equivalent to them, within the period (being not less than 14 days) 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) is by way of complaint, and the Magistrates' Courts Act 1980 applies to the proceedings.
3
An appeal to the sheriff under paragraph (1) is by summary application.
4
The period within which an appeal may be brought is 28 days or the period specified in the improvement notice, whichever ends the earlier.
5
An improvement notice must 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 the notice or confirm it, with or without modification.
Seizure notices
40
1
An inspector must follow the procedures set out in this regulation if, acting under regulation 34, he seizes —
a
any veterinary medicinal product that does not appear to him to be authorised in the United Kingdom;
b
any authorised veterinary medicinal product not lawfully supplied in accordance with these Regulations; or
c
any veterinary medicinal product that has been stored in any way that affects its safety, quality or efficacy.
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 removal of the products from the premises until they are collected by an inspector, and any person other than an inspector who removes products identified under this paragraph from the premises is guilty of an offence.
4
Any person claiming that the product was not liable to seizure may, within 28 days of the seizure, notify his claim to the Secretary of State at the address specified in the seizure notice, setting out the grounds in full.
5
If a notification of a claim is not received within 28 days the Secretary of State shall destroy the product.
6
If a notification of a claim is received within 28 days, the Secretary of State shall either return the goods or take proceedings for an order for the confirmation of the notice and the destruction of the veterinary medicinal product in a magistrates' court (or, in Scotland, the sheriff court), and if the court confirms the notice it shall order its destruction.
7
The person on whom the seizure 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 as he sees 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 is guilty of the offence as well as the body corporate.
3
For the purposes of paragraph (2) 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 that 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 13 of Schedule 3 (approval of premises for suitably qualified persons).
3
The Department of Agriculture and Rural Development is the competent authority for —
a
Regulation (EC) No. 178/2002 (of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety );
b
Regulation (EC) No. 1831/2003 (of the European Parliament and the Council on additives for use in animal nutrition );
c
Regulation (EC) No. 882/2004 (of the European Parliament and the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules ); and
d
Regulation (EC) No. 183/2005 (of the European Parliament and of the Council laying down requirements for feed hygiene ).
4
In proceedings in a magistrates' court relating to an improvement notice under regulation 38 or a seizure notice under regulation 40 the Magistrates' Courts (Northern Ireland) Order 1981 applies.
Revocations and amendments
44
1
The Veterinary Medicines Regulations 2005 are revoked.
2
Schedule 8 (amendments to the Medicines Acts etc.) has effect.
3
Schedule 9 (consequential amendments) has effect.
4
The Medicines (Prohibition of Importation and Possession of Veterinary Drugs) Order (Northern Ireland) 1977 continues in force notwithstanding paragraph (2), and the Medicines Act 1968 continues to apply as if it had not been amended by these Regulations in so far as is necessary for the operation of that Order.
Ben Bradshaw
Parliamentary Under-Secretary of State,
Department for Environment, Food and Rural Affairs
8th August 2006
Kevin Brennan
Claire Ward
Two of the Lords Commissioners of Her Majesty’s Treasury
5th September 2006


type: legislation

jurisdiction: UK

text:
1
1
This Order may be cited as the Crime (International Co-operation) Act 2003 (Commencement No. 3) Order 2006.
2
In this Order “ the Act ” means the Crime (International Co-operation) Act 2003.
2
Sections 32 to 36 of the Act shall come into force on 1st November 2006.
3
Sections 42 to 46 of the Act shall come into force on 1st November 2006.
Joan Ryan
Parliamentary Under Secretary of State
Home Office
19th October 2006


text:
This Order may be cited as the General Dental Council (Professions Complementary to Dentistry) Regulations Order of Council 2006 and shall come into force on 31st July 2006.
A K Galloway
Clerk of the Privy Council


text:
Citation and commencement
1
These Regulations may be cited as the Railway Safety Levy Regulations 2006 and shall come into force on the second day after the day on which they are made.
Interpretation
2
1
In these Regulations —
“the 1974 Act ” means the Health and Safety at Work etc. Act 1974;
“the 1985 Act ” means the Companies Act 1985 ;
“annual accounts” means annual accounts as defined in section 262(1) of the 1985 Act and any like accounts prepared in accordance with section 700(1) of that Act;
“auditor” means an auditor who is eligible for appointment as a company auditor under section 25 of the Companies Act 1989 ;
“company” means a company as defined in section 735(1)(a) of the 1985 Act or an oversea company as defined in section 744 of that Act;
“financial year” means a period of twelve months beginning on 1st April;
“railway safety levy” means the levy imposed by regulation 7;
“railway service provider” means a person described in section 43A(9) of the 1974 Act as a person who provides railway services;
“relevant services” means services provided in the course of managing or controlling, or participating in the management or control of, a transport system falling within paragraph 1(3) of Schedule 3 to the Railways Act 2005; and
“relevant turnover” means the turnover of the railway service provider derived from the provision of relevant services in Great Britain during a financial year after deduction of trade discounts, value added tax, and any other taxes directly related to turnover, and where the railway service provider provided railway services for a period of less than 12 months during the financial year, the relevant turnover shall be the amount which bears the same proportion to the relevant turnover during that period of time as 12 months does to the period of time for which relevant services were provided.
2
In these Regulations —
a
a reference to “accounting standards” or “international accounting standards” is a reference to that term as defined in section 256(1) and section 262(1) of the 1985 Act respectively; and
b
turnover derived from the provision of relevant services includes, in particular, amounts derived from —
i
aid granted to the railway service provider by a public sector operator as defined in section 25 of the Railways Act 1993, if the aid facilitates or promotes the provision of relevant services by the railway service provider;
ii
fares paid in respect of relevant services for the carriage of passengers; and
iii
fees paid in respect of relevant services for the carriage of goods.
Determination of matters by the Office of Rail Regulation
3
1
The Office of Rail Regulation may, in respect of each financial year, determine —
a
the total amount of the railway safety levy to be imposed;
b
the railway service providers by whom the levy is to be paid;
c
the criteria for assessing the proportion of the levy to be paid by a particular railway service provider (which may, in particular, refer to the size of a railway service provider’s income or provide for an amount to be reduced or waived in specified circumstances); and
d
when the levy is to be paid.
2
The Office of Rail Regulation may revise the determination of any matter specified in paragraph (1), whether before, during or after the financial year to which the determination relates.
3
In respect of each financial year, the Office of Rail Regulation may calculate the amount of railway safety levy payable by each railway service provider by whom a levy is to be paid and any such calculation shall be made in accordance with the relevant determinations made under paragraph (1)(a) to (c) and those determinations as they may be revised from time to time.
4
The Office of Rail Regulation shall as soon as reasonably practicable publish each —
a
determination made in accordance with paragraph (1); and
b
revision of a determination made in accordance with paragraph (2);
in any manner which it considers appropriate.
Requests for information
4
1
A railway service provider shall provide the Office of Rail Regulation with such information as it reasonably requests for the purpose of determining or revising a determination of any matter specified in regulation 3(1) or calculating the amount of railway safety levy payable by each railway service provider in accordance with regulation 3(3).
2
Subject to paragraph (4), if the information requested under paragraph (1) constitutes or includes financial information and the relevant turnover of the railway service provider in the relevant financial year is —
a
less than £10,000,000, the railway service provider shall comply, at its discretion, with either regulation 5(1) or regulation 5(2); and
b
£10,000,000 or more, the railway service provider shall comply with regulation 5(2).
3
For the purposes of paragraph (2) the relevant financial year is the financial year preceding the financial year in which the information is requested in accordance with paragraph (1).
4
A railway service provider shall provide the Office of Rail Regulation with such audited accounts as requested if the railway service provider has elected, in accordance with paragraph (2)(a), to comply with regulation 5(1).
5
A request for information referred to in paragraph (1) or (4) shall —
a
be in writing; and
b
specify the date by which the information must be provided, which shall be a date not less than two months from the date of the request.
Certification of financial information
5
1
Where a request has been made under regulation 4(1) and this paragraph applies, any financial information supplied in accordance with that request shall be accompanied by a written statement that is signed by the railway service provider or a person authorised to sign on behalf of the railway service provider.
2
Where a request has been made under regulation 4(1) and this paragraph applies, any financial information supplied in accordance with that request shall be accompanied by a statement signed by an auditor.
3
The statement referred to in paragraphs (1) and (2) shall, in the case of a railway service provider that is —
a
a company, state that the financial information is calculated accurately in accordance with the accounting standards or the international accounting standards, as the case may be, that apply to the preparation of the railway service provider’s annual accounts; and
b
not a company, state that the financial information is calculated accurately in accordance with either the accounting standards or the international accounting standards.
Assumptions
6
1
Where a railway service provider —
a
receives a request for information under regulation 4(1) or 4(4); and
b
fails to provide the information requested by the date specified in that request;
the Office of Rail Regulation may make such assumptions concerning the information as are reasonable in all the circumstances.
2
The Office of Rail Regulation shall notify a railway service provider in writing as soon as reasonably practicable —
a
that it intends to make an assumption in accordance with paragraph (1);
b
details of the assumption; and
c
the reasons for making the assumption.
3
A railway service provider may make representations in writing to the Office of Rail Regulation regarding the assumption within a period of 21 days from the date of the notice sent in accordance with paragraph (2).
4
If a period of 21 days has elapsed since the date of the notice sent in accordance with paragraph (2) the Office of Rail Regulation may apply the assumption, with any modification made as a result of taking into account any representation received from the railway service provider in accordance with paragraph (3), for the purpose of —
a
determining any matter in accordance with regulation 3(1);
b
revising any determination in accordance with regulation 3(2); or
c
calculating the amount of railway safety levy payable by each railway service provider in accordance with regulation 3(3).
Payment of the railway safety levy
7
1
Each railway service provider shall, on receipt of a request in writing, pay to the Office of Rail Regulation the amount of railway safety levy calculated in relation to that provider in accordance with regulation 3(3).
2
The Office of Rail Regulation may recover from a railway service provider, as a civil debt due to the Office of Rail Regulation, any amount payable under a request sent in accordance with paragraph (1) which remains outstanding after the date determined in accordance with regulation 3(1)(d) or 3(2), as the case may be.
Refunds
8
1
The Office of Rail Regulation may refund any payment, or part of a payment, made to it in accordance with regulation 7 where paragraph (2) or (3) applies.
2
This paragraph applies where the Office of Rail Regulation accepts that, due to an error in its calculation or change in circumstances, a railway service provider has paid a greater amount of railway safety levy than the amount due by way of a correct calculation made under regulation 3(3).
3
This paragraph applies where —
a
a determination (in this paragraph called the “original determination”) is revised in accordance with regulation 3(2);
b
the railway service provider has paid the railway safety levy in accordance with regulation 7; and
c
the amount of railway safety levy that railway service provider is liable to pay under the revised determination is less than the amount that the railway service provider paid in accordance with the original determination.
Signed by authority of the Secretary of State for Transport
Derek Twigg
Parliamentary Under Secretary of State
Department for Transport
30th March 2006


text:
PART 1
General
Citation and commencement
1
These Regulations may be cited as the Air Navigation (General) Regulations 2006, and shall come into force on 30th March 2006.
Revocation
2
The Air Navigation (General) Regulations 2005 are revoked.
Interpretation
3
In these Regulations —
a
“ the Order ” means the Air Navigation Order 2005;
b
references to an “article” mean an article of the Order; and
c
other expressions used in these Regulations shall have the same respective meanings as in the Order.
PART 2
Load Sheets and Weighing Requirements
Particulars of load sheet
4
Every load sheet required by article 43(5) shall contain the following particulars —
a
the nationality mark of the aircraft to which the load sheet relates, and the registration mark assigned to that aircraft by the CAA ;
b
particulars of the flight to which the load sheet relates;
c
the total weight of the aircraft as loaded for that flight;
d
the weights of the several items from which the total weight of the aircraft, as so loaded, has been calculated including in particular the weight of the aircraft prepared for service and the respective total weights of the crew (unless included in the weight of the aircraft prepared for service), passengers, baggage and cargo intended to be carried on the flight;
e
the manner in which the load is distributed;
f
the position of the centre of gravity of the aircraft resulting from the particulars mentioned in sub-paragraphs (c), (d) and (e) which may be given approximately if and to the extent that the relevant certificate of airworthiness so permits; and
g
a certificate at the foot or end of the load sheet, signed by the person referred to in article 43(1) as responsible for the supervision of the loading of the aircraft, that the aircraft has been loaded in accordance with the written instructions furnished to him by the operator of the aircraft pursuant to article 43(1).
Weighing requirements — passengers, crew and hand baggage
5
1
Subject to paragraph (2), for the purpose of calculating the total weight of the aircraft the respective total weights of the passengers and crew together with their hand baggage entered in the load sheet shall be computed from the actual weight of each person and their hand baggage and for that purpose each person and their hand baggage shall be separately weighed.
2
The total weights of the passengers and crew together with their hand baggage may, in accordance with paragraphs (3) to (8) and subject to regulation 7, be calculated at not less than the appropriate weights shown in Tables 1 or 2 and the load sheet shall bear a notation to that effect.
3
Subject to paragraph (4) where the total number of passenger seats available on an aircraft is 20 or more, the weights for males and females in columns 1 and 2 of Table 1 shall be applicable.
4
Where the total number of passenger seats available is 30 or more, the “all adult” weights in column 3 of Table 1 may be used for passengers over the age of 12 years.
5
For the purpose of Table 1, “holiday charter” means a flight by an aircraft for the carriage of passengers each of whom is carried pursuant to an agreement which provides for carriage by air to a place outside the United Kingdom and back from that place, or from another place to the United Kingdom (whether or not on the same aircraft) and for accommodation at a place outside the United Kingdom.
Table 1
Aircraft with 20 or more passengers
Passenger Seats Available
20 or more 30 or more Column 1 Column 2 Column 3 Male Female All Adult Passengers on all flights except holiday charters 88kg 70kg 84kg Passengers on holiday charters 83kg 69kg 76kg Children (between 2–12 years) or infants under 2 years of age if occupying a separate seat 35kg 35kg Infants under 2 years of age if sharing a seat with an adult 0kg 0kg Flight crew 85kg 85kg Cabin crew 75kg 75kg
6
Where the total number of passenger seats available on an aircraft is 19 or less the weights in Table 2 shall be applicable.
Table 2
Aircraft with fewer than 20 passenger seats
Passenger Seats Available
1 – 5 6 – 9 10 – 19 Male passengers 104kg 96kg 92kg Female passengers 86kg 78kg 74kg Children (between 2-12 years) or infants under 2 years of age if occupying a separate seat 35kg 35kg 35kg Infants under 2 years of age if sharing a seat with an adult 0kg 0kg 0kg Flight crew 85kg 85kg 85kg Cabin crew 75kg 75kg 75kg
7
On flights where no hand baggage is carried or where such hand baggage is accounted for separately, 6 kg may be deducted from the weight of passengers over 12 years of age when using Table 2.
8
Where an immersion suit is worn or carried by a passenger or crew member, 3kg shall be added to the appropriate weight shown in Table 1 or 2 in each such case.
Weighing requirements — hold baggage and cargo
6
1
Subject to paragraph (2), for the purpose of calculating the total weight of the aircraft the respective total weights of the hold baggage and cargo entered in the load sheet shall be computed from the actual weight of each piece of baggage, cargo or cargo container and for that purpose each piece or container shall be separately weighed.
2
In the case of an aircraft where the total number of passenger seats available is 20 or more, the total weights of the hold baggage may, subject to regulation 7, be calculated at not less than the weights shown in Table 3 and the load sheet shall bear a notation to that effect.
Table 3
Hold Baggage
Journey made by aircraft Hold baggage per aircraft
Domestic journey 11kg European journey 13kg Intercontinental journey 15kg
3
For the purposes of Table 3 —
a “domestic journey” means a journey made by an aircraft which is confined within an area enclosed by rhumb lines joining successively the points shown in Table 4 but excluding any journey to or from Shannon;
Table 4
Domestic journey
N6100.00 W01100.00 N6100.00 E00200.00 N5105.00 E00200.00 N4930.00 W00400.00 N4930.00 W01100.00 N6100.00 W01100.00
a “European journey” is a journey made by an aircraft, not being a domestic journey, which is confined within an area enclosed by the rhumb lines joining successively the points shown in Table 5;
Table 5
European journey
N7200.00 E04500.00 N4000.00 E04500.00 N3500.00 E03700.00 N3000.00 E03700.00 N3000.00 W00600.00 N2700.00 W00900.00 N2700.00 W03000.00 N6700.00 W03000.00 N7200.00 W01000.00 N7200.00 E04500.00
an “intercontinental journey” is a journey made by an aircraft which is neither a domestic journey nor a European journey.
Loading — additional provisions
7
1
If it appears to the person supervising the loading of the aircraft that any of the circumstances described in paragraph (2) arise he shall, if he considers it necessary in the interests of the safety of the aircraft, or if the CAA has so directed in the particular case, require any such person and his hand baggage, passenger or hold baggage, as the case may be, to be weighed for the purpose of the entry to be made in the load sheet.
2
The circumstances referred to in paragraph (1) are —
a
any person and his hand baggage to be carried exceeds the weights set out in Tables 1 or 2;
b
where regulation 5(7) applies, any passenger to be carried exceeds the weights set out in Table 2 as adjusted in accordance with that paragraph; or
c
any hold baggage to be carried exceeds the weights set out in Table 3.
3
If any person and his hand baggage, passenger or any hold baggage has been weighed pursuant to paragraph (1), the weights entered in the load sheet shall take account of —
a
the actual weight of that person and his hand baggage, that passenger or that hold baggage, as the case may be; or
b
the weight determined in accordance with regulation 5(2) or regulation 6(2),
whichever weight shall be the greater.
PART 3
Aircraft Performance
Aeroplanes to which article 44(5) applies
8
1
Aeroplanes to which this regulation applies shall comply with Schedule 1.
2
This regulation applies to aeroplanes for which the CAA has granted a permission under article 44(5) except any aeroplane flying solely for the purpose of training persons to perform duties in aeroplanes.
Helicopters to which article 45(1) applies
9
1
Helicopters to which this regulation applies shall comply with Schedule 2.
2
This regulation applies to helicopters to which article 45(1) applies except any helicopter flying solely for the purpose of training persons to perform duties in helicopters.
Weight and performance — general provisions
10
1
The assessment of the ability of an aeroplane to comply with the requirements of Schedule 1 and of a helicopter to comply with the requirements of Schedule 2 shall be based on the specified information as to its performance.
2
In assessing the ability of an aeroplane to comply with sub-paragraphs (9), (12), (15) and (17) of paragraph 1 of Schedule 1, with sub-paragraphs (8) and (12) of paragraph 6 of Schedule 1 and with sub-paragraph (15) of paragraph 7 of Schedule 1, account may be taken of any reduction of the weight of the aeroplane which may be achieved after the failure of a power unit by such jettisoning of fuel as is feasible and prudent in the circumstances of the flight and in accordance with the flight manual relating to the aircraft.
3
In this Part and in Schedules 1 and 2 —
“specified” in relation to an aircraft means, unless otherwise stated, specified in, or ascertainable by reference to:
the certificate of airworthiness in force in respect of that aircraft; or
the flight manual or performance schedule for that aircraft;
“the accelerate–stop distance” means the distance from the point on the surface of the aerodrome at which the aeroplane can commence its take-off run to the nearest point in the direction of take-off at which the aeroplane cannot roll over the surface of the aerodrome and be brought to rest in an emergency without the risk of accident;
“the landing distance available” means the distance from the point on the surface of the aerodrome at which the aeroplane can commence its landing, having regard to the obstructions in its approach path, to the nearest point in the direction of landing at which the surface of the aerodrome is incapable of bearing the weight of the aeroplane under normal operating conditions or at which there is an obstacle capable of affecting the safety of the aeroplane;
“the take-off distance available” means either the distance from the point on the surface of the aerodrome at which the aeroplane can commence its take-off run to the nearest obstacle in the direction of take-off projecting above the surface of the aerodrome and capable of affecting the safety of the aeroplane, or one and one half times the take-off run available, whichever is the less;
“the take-off run available” means the distance from the point on the surface of the aerodrome at which the aeroplane can commence its take-off run to the nearest point in the direction of take-off at which the surface of the aerodrome is incapable of bearing the weight of the aeroplane under normal operating conditions.
4
For the purposes of Schedules 1 and 2 —
a
the weight of the aircraft at the commencement of the take-off run or of the take-off shall be taken to be its gross weight including everything and everyone carried in or on it at the commencement of the take-off run or of the take-off;
b
the landing weight of the aircraft shall be taken to be the weight of the aircraft at the estimated time of landing allowing for the weight of the fuel and oil expected to be used on the flight to the aerodrome of intended destination or any alternate aerodrome, as the case may be;
c
where any distance referred to in paragraph (3) has been declared in respect of any aerodrome by the authority responsible for regulating air navigation over the territory of the Contracting State in which the aerodrome is situated, and in the case of an aerodrome in the United Kingdom, notified, that distance shall be deemed to be the relevant distance.
PART 4
Noise and vibration, maintenance and aerodrome facilities
Noise and vibration caused by aircraft on aerodromes
11
For the purposes of article 131(1), the conditions under which noise and vibration may be caused by aircraft (including military aircraft) on Government aerodromes, licensed aerodromes or on aerodromes at which the manufacture, repair or maintenance of aircraft is carried out by persons carrying on business as manufacturers or repairers of aircraft, shall be as follows —
a
the aircraft is taking off or landing; or
b
the aircraft is moving on the ground or water; or
c
the engines are being operated in the aircraft —
d
for the purpose of ensuring their satisfactory performance;
e
for the purpose of bringing them to a proper temperature in preparation for, or at the end of, a flight; or
f
for the purpose of ensuring that the instruments, accessories or other components of the aircraft are in a satisfactory condition.
Pilots maintenance — prescribed repairs or replacements
12
For the purposes of article 16(7)(a), the following repairs or replacements are prescribed —
a
replacement of landing gear tyres, landing skids or skid shoes;
b
replacement of elastic shock absorber cord units on landing gear where special tools are not required;
c
replacement of defective safety wiring or split pins excluding those in engine, transmission, flight control and rotor systems;
d
patch-repairs to fabric not requiring rib stitching or the removal of structural parts or control surfaces, if the repairs do not cover up structural damage and do not include repairs to rotor blades;
e
repairs to upholstery and decorative furnishing of the cabin or cockpit interior when repair does not require dismantling of any structure or operating system or interfere with an operating system or affect the structure of the aircraft;
f
repairs, not requiring welding, to fairings, non-structural cover plates and cowlings;
g
replacement of side windows where that work does not interfere with the structure or with any operating system;
h
replacement of safety belts or safety harnesses;
i
replacement of seats or seat parts not involving dismantling of any structure or of any operating system;
j
replacement of bulbs, reflectors, glasses, lenses or lights;
k
replacement of any cowling not requiring removal of the propeller, rotors or disconnection of engine or flight controls;
l
replacement of unserviceable sparking plugs;
m
replacement of batteries;
n
replacement of wings and tail surfaces and controls, the attachments of which are designed to provide for assembly immediately before each flight and dismantling after each flight;
o
replacement of main rotor blades that are designed for removal where special tools are not required;
p
replacement of generator and fan belts designed for removal where special tools are not required;
q
replacement of VHF communication equipment, being equipment which is not combined with navigation equipment.
Aeroplanes flying for the purpose of public transport of passengers — aerodrome facilities for approach to landing and landing
13
1
This regulation shall apply to every aeroplane registered in the United Kingdom engaged on a flight for the purpose of public transport of passengers on a scheduled journey and to every aeroplane so registered whose maximum total weight authorised exceeds 5,700 kg engaged on a flight for such a purpose otherwise than on a scheduled journey.
2
For the purposes of article 42(1)(c)(ii), the following manning and equipment are prescribed in relation to aerodromes intended to be used for landing or as an alternate aerodrome by aircraft to which this regulation applies —
a
air traffic control service or aerodrome flight information service, including the reporting to aircraft of the current meteorological conditions at the aerodrome;
b
very high frequency radiotelephony;
c
at least one of the following radio navigation aids, either at the aerodrome or elsewhere, and in either case for the purpose of assisting the pilot in locating the aerodrome and in making an approach to landing there —
i
radio direction finding equipment utilising emissions in the very high frequency bands;
ii
a non-directional radio beacon transmitting signals in the low or medium frequency bands;
iii
very high frequency omni-directional radio range;
iv
radar equipment.
3
Subject to paragraph (4), an aircraft to which this regulation applies shall not land or make an approach to landing at any aerodrome unless —
a
one of the services and the equipment prescribed by paragraph (2) are provided and are in operation at that aerodrome;
b
such services and equipment can be made use of by that aircraft; and
c
in the case of the navigation aids specified in paragraph (2)(c), instructions and procedures for the use of the aid are included in the operations manual relating to the aircraft.
4
A person shall be deemed not to have contravened paragraph (3) if he proves that —
a
for the time being use could not be made of the radio navigation aids provided under paragraph (2)(c) whether by reason of those aids not being in operation or of the unserviceability of equipment in the aircraft itself; and
b
the approach to landing was made in accordance with instructions and procedures appropriate to that circumstance and included in the operations manual relating to the aircraft.
PART 5
Mandatory Reporting
Reportable occurrences – time and manner of reporting and information to be reported
14
1
For the purposes of article 142(6) but subject to paragraph (2) it is prescribed that a report containing the information referred to in paragraph (3) shall be made to the CAA by post, telex, electronic, facsimile transmission or other similar means which produces a document containing a text of the communication (written in English) within 96 hours of the reportable occurrence coming to the knowledge of the person making the report.
2
If at the expiry of the time allowed by paragraph (1) for making the report any of the information referred to in that paragraph is not in the possession of the person making the report, he shall despatch the report to the CAA by post, telex, electronic, facsimile transmission or other similar means which produces a document containing a text of the communication (written in English) within 96 hours of the information coming into his possession.
3
For the purposes of article 142(6), a report shall, as far as possible, contain the following information —
a
the type, series and registration marks of the aircraft concerned;
b
the name of the operator of the aircraft;
c
the date of the reportable occurrence;
d
if the person making the report has instituted an investigation into the reportable occurrence, whether or not this has been completed;
e
a description of the reportable occurrence, including its effects and any other relevant information;
f
in the case of a reportable occurrence which occurs during flight —
i
the Co-ordinated Universal Time of the occurrence;
ii
the last point of departure and the next point of intended landing of the aircraft at that time; and
iii
the geographical position of the aircraft at that time;
g
in the case of a defect in or malfunctioning of an aircraft or any part or equipment of an aircraft, the name of the manufacturer of the aircraft, part or equipment, as the case may be, and, where appropriate, the part number and modification standard of the part or equipment and its location on the aircraft;
h
the signature and name in block capitals of the person making the report, the name of his employer and the capacity in which he acts for that employer; and
i
in the case of a report made by the commander of an aircraft or a person referred to in sub-paragraphs (f), (g) or (h) of article 142(5), the address or telephone number at which communications should be made to him, if different from that of his place of employment.
Mandatory reporting of birdstrikes – time and manner of reporting and information to be reported
15
1
Subject to paragraph (2), for the purposes of article 143(2) a report containing the information referred to in paragraph (3) shall be made to the CAA by post, telex, electronic, facsimile transmission or other similar means which produce a document containing a text of the communication (written in English) within 96 hours of the birdstrike occurrence coming to the knowledge of the person making the report.
2
If at the expiry of the time allowed by paragraph (1) for making the report any of the information referred to in that paragraph is not in the possession of the person making the report, he shall despatch the report to the CAA by post, telex, electronic, facsimile transmission or other similar means which produce a document containing a text of the communication (written in English) within 96 hours of the information coming into his possession.
3
For the purposes of article 143(2) a report shall, as far as possible, contain the following information —
a
the type, series and registration marks of the aircraft concerned;
b
the name of the operator of the aircraft;
c
the date and the Co-ordinated Universal Time of the birdstrike occurrence;
d
the last point of departure and the next point of intended landing of the aircraft at that time;
e
a description of the birdstrike occurrence, including the part(s) of the aircraft affected, the effect on flight and any other relevant information;
f
the bird species/description;
g
the weather at the time of the occurrence;
h
the runway in use (where relevant);
i
the height and speed of the aircraft;
j
the phase of flight;
k
the position (if en route) of the aircraft at the time of the birdstrike;
l
any other reporting action taken;
m
the signature and name in block capitals of the person making the report;
n
the name of his employer and the capacity in which he acts for that employer; and
o
the address or telephone number at which communications should be made to him.
PART 6
Navigation performance and equipment
Minimum navigation performance and height keeping specifications
16
1
For the purposes of article 56(1) the following navigation performance capability is prescribed, that is to say, a capability to ensure that —
a
the standard deviation of lateral errors in the track of the aircraft is not more than 6.3 nautical miles;
b
the proportion of the flight time of the aircraft during which the actual track of the aircraft is 30 nautical miles or more off the track along which it has been given an air traffic control clearance to fly is less than 5.3 × 10-4, and;
c
the proportion of the flight time of the aircraft during which the actual track of the aircraft is between 50 and 70 nautical miles off the track along which it has been given an air traffic control clearance to fly is less than 13 × 10-5.
2
For the purposes of article 57(1), the following height keeping performance capability is prescribed, that is to say, a capability to ensure that —
a
altimetry system error shall be in compliance with paragraph 2.1.1(2) of Document 7030/4-NAT Part 1 Rules of the Air, Air Traffic Services and Search and Rescue ( ICAO Regional Procedures, Fourth Edition–1987);
b
in respect of aircraft first registered in a Contracting State on or after 1st January 1997 altitude can be automatically controlled within a tolerance band of + / − 65 feet; and
c
in respect of aircraft first registered in a Contracting State before 1st January 1997 altitude can be automatically controlled within a tolerance band of + / − 130 feet.
North Atlantic Minimum Navigation Performance Specification Airspace
17
For the purposes of articles 56(1) and 155(1), the following airspace is prescribed as North Atlantic Minimum Navigation Performance Specification airspace, that is to say, the airspace from flight level 285 to flight level 420 within the area defined by rhumb lines joining successively the following points —
Table 6
North Atlantic Minimum Navigation Performance Specification airspace
N3410.00 W01748.00 North Pole N4152.00 W06700.00 N3630.00 W01500.00 N8200.00 W06000.00 N3900.00 W06700.00 N4200.00 W01500.00 N7800.00 W07500.00 N3835.00 W06853.00 N4300.00 W01300.00 N7600.00 W07600.00 N3830.00 W06915.00 N4500.00 W01300.00 N6500.00 W05745.00 N3830.00 W06000.00 N4500.00 W00800.00 N6500.00 W06000.00 N2700.00 W06000.00 N5100.00 W00800.00 N6400.00 W06300.00 N2700.00 W04000.00 N5100.00 W01500.00 N6100.00 W06300.00 N2218.00 W04000.00 N5400.00 W01500.00 N5700.00 W05900.00 N1700.00 W03730.00 N5434.00 W01000.00 N5300.00 W05400.00 N2400.00 W02500.00 N6100.00 W01000.00 N4900.00 W05100.00 N3000.00 W02500.00 N6100.00 00000.00 N4500.00 W05100.00 N3000.00 W02000.00 N8200.00 00000.00 N4500.00 W05300.00 N3139.00 W01725.00 N8200.00 E03000.00 N4336.00 W06000.00
and from there by that part of the arc of a circle radius 100 nautical miles centred on N3304.00 W01621.00 to N3410.00 W01748.00.
Airborne Collision Avoidance System
18
For the purposes of paragraph 5(1) of Schedule 5 to the Order the prescribed requirements for an airborne collision avoidance system shall be the requirements for ACAS II equipment set out in Volume IV (Third Edition–July 2002), Chapter 4, of Annex 10 to the Chicago Convention.
Mode S Transponder
19
1
For the purposes of paragraph 4 of Schedule 5 to the Order, the capability and functionality prescribed for Mode S Elementary Surveillance shall be that specified for a level 2 transponder in Volumes III (First Edition–July 1995) and IV (Third Edition–July 2002) of Annex 10 (Third Edition) to the Chicago Convention together with the additional functionality specified in paragraph (3).
2
For the purposes of paragraph 4 of Schedule 5 to the Order, the capability and functionality prescribed for Mode S Enhanced Surveillance shall be that specified for a level 2 transponder in Volumes III (First Edition–July 1995) and IV (Third Edition–July 2002) of Annex 10 (Third Edition) to the Chicago Convention together with the additional functionality specified in paragraph (3) and the additional downlinked parameters specified in paragraph (4).
3
The additional functionality referred to in paragraphs (1) and (2) is —
a
capability to support the Interrogator Identifier ( II ) Code and Surveillance Identifier ( SI ) Code functionality;
b
Extended Squitter Functionality which, for this purpose, means functionality that supports Mode S Elementary Surveillance and Mode S Enhanced Surveillance to provide Automatic Dependant Surveillance–Broadcast, using unsolicited transponder broadcasts;
c
ACAS Active Resolution Advisory.
4
The additional downlinked parameters referred to in paragraph (2) are —
a
reporting of the Magnetic Heading Downlinked Aircraft Parameter;
b
reporting of the Indicated Airspeed Downlinked Aircraft Parameter;
c
reporting of the Mach Number Downlinked Aircraft Parameter;
d
reporting of the Vertical Rate Downlinked Aircraft Parameter;
e
reporting of the Roll Angle Downlinked Aircraft Parameter;
f
reporting of the Track Angle Rate Downlinked Aircraft Parameter;
g
reporting of the True Track Angle Downlinked Aircraft Parameter;
h
reporting of the Ground Speed Downlinked Aircraft Parameter;
i
reporting of the Selected Vertical Intent Downlinked Aircraft Parameter (including Barometric Pressure Setting).
Signed by authority of the Secretary of State for Transport
Karen Buck
Parliamentary Under Secretary of State
Department for Transport
6th March 2006