Animal Remedies Act 1967
Animal Remedies Act 1967
Animal Remedies Act 1967
Animal Remedies Act 1967
Public Act |
1967 No 51 |
|
Date of assent |
16 November 1967 |
|
Contents
An Act to consolidate and amend the Stock Remedies Act 1934, and to make better provision for controlling the manufacture, importation, sale, and use of drugs, medicines, remedies, and other therapeutic substances used for treating and preventing animal diseases
BE IT ENACTED by the General Assembly of New Zealand in Parliament assembled, and by the authority of the same, as follows:
1 Short Title and commencement
(1)
This Act may be cited as the Animal Remedies Act 1967.
(2)
This Act shall come into force on the first day of January, nineteen hundred and sixty-eight:
Provided that section 67 of this Act shall come into force on the passing of this Act.
2 Interpretation
(1)
In this Act, unless the context otherwise requires,—
“Advertisement” means any publication to the community or to any section of the community of any words, whether written, printed, or spoken, or of any pictorial representation or design or device, used to promote the sale of any animal remedy; and “to advertise”
has a corresponding meaning:
“Advisory or technical committee” means an advisory or technical committee established under section 10 of this Act:
“Anaerobic vaccine” means a vaccine derived from or containing cultures of anaerobes:
“Analysis” means any examination carried out to ascertain the composition or effectiveness of any animal remedy; and “to analyse”
has a corresponding meaning:
“Analyst” means an analyst appointed under section 16 of this Act:
“Animal” means any mammal (other than a human being), bird, or fish, or any reptile kept in captivity; and includes any other member of the animal kingdom that is declared by any Order in Council for the time being in force to be an animal for the purposes of this Act:
“Animal remedy”, or “remedy”
, means any drug, medicine, remedy, or therapeutic preparation, or any biochemical substance, which is manufactured, imported, or advertised for sale or is sold for any of the following purposes:
(a)
Curing, diagnosing, treating, controlling, or preventing any disease in animals; or
(b)
Destroying or preventing parasites on or in animals; or
(c)
Maintaining or improving the health, condition, productivity, or appearance of any animal,—
but does not include any preparation, substance, or product which is used primarily as a food for animals:
“Antigen” means a suspension of an organism, or a solution or suspension of the special constituent or product of an organism, which is capable of inciting antibody production:
“Antitoxin” means the serum or solutions of the purified proteins of serum separated from the blood of normal animals or animals which have been artificially immunised against a soluble toxin or toxins produced by an organism or organisms:
“Biochemical substance”, or “substance”
, means—
(a)
Any preparation made from animal glands or tissues:
(b)
Any substance manufactured for the purpose of having the same action as a preparation made from animal glands or tissues:
(c)
Any serum, antitoxin, or antigen:
(d)
Any anaerobic vaccine, killed bacterial vaccine, viral vaccine, or living bacterial vaccine:
(e)
Any virus or micro-organism, whether living or not:
(f)
Any product of a virus or micro-organism which is intended for use, or is ordinarily used, in treatment of animals or the diagnosis or detection of animal diseases:
“Board” means the Animal Remedies Board constituted under this Act:
“Container” includes anything in or by which an animal remedy may be cased, covered, enclosed, contained, or packed; and, in the case of any animal remedy sold or carried or intended for sale in more than one container, includes every such container:
“Dealer” means any person, being neither a manufacturer nor an importer of animal remedies, who, either on his own account or as agent for any other person, is engaged in selling animal remedies:
“Director-General” means the Director-General of Agriculture:
“Disease” means a disease within the meaning of the Animals Act 1967:
“Imported”, in relation to any animal remedy, means brought into New Zealand from any other country; and “importer”
has a corresponding meaning:
“Independent contractor” means any agent or independent contractor employed by the holder of a manufacturer’s licence to manufacture the animal remedy specified in the licence:
“Inspector” means an inspector appointed under this Act; and includes an inspector appointed under the Animals Act 1967:
“Killed bacterial vaccine” means a sterile suspension of a killed culture of a micro-organism:
“Label”, in relation to any animal remedy or any container used to contain an animal remedy, means any written, pictorial, or other descriptive matter under which the remedy is sold or to be sold and which purports to give some information about the remedy:
“To label” includes to affix or brand any label on to a container used or to be used to contain an animal remedy or to insert any label in any such container:
“Licence” means a licence issued by the Board under this Act to any person to manufacture or import the animal remedy named in it; and “licensee”
and “licensed”
have corresponding meanings:
“Living bacterial vaccine” means a vaccine containing micro-organisms which have not been treated by any method likely to kill them:
“To manufacture”, in relation to an animal remedy, means to make up, prepare, produce, or process the remedy; and includes the packing of a remedy in any container for the purposes of sale:
“Manufacturer” means any person who manufactures an animal remedy, but does not include an overseas manufacturer:
Provided that where the actual process of manufacturing a remedy is carried on by an independent contractor on behalf of a principal, the principal shall be deemed to be the manufacturer of the remedy for the purposes of this Act:
“Minister” means the Minister of Agriculture:
“Overseas manufacturer” means a person who manufactures in a country outside New Zealand any animal remedy for importation into New Zealand:
“Pharmaceutical chemist” means a person for the time being registered as a pharmaceutical chemist under the Pharmacy Act 1939:
“Prescribed” means prescribed by regulations made under this Act:
“Principal technician”, in relation to the manufacture of a biochemical substance, means the person who has the immediate direction, supervision, and control of the actual process of manufacturing the substance on premises approved by the Board; and includes the licensee of the substance if he himself exercises immediate direction, supervision, and control over manufacture:
“Registrar” means the Registrar of Animal Remedies appointed under this Act:
“Sale”, in relation to any animal remedy, includes barter, and any agreement to sell; and also includes issuing, offering, or exposing for sale, or attempting to sell, or having in possession for sale, or delivering by way of gift or sample, or causing or permitting any sale; and “to sell”
has a corresponding meaning:
“Serum” means the serum or solutions of the purified proteins of serum separated from the blood of normal animals or of animals which have been artificially immunised against cultures of one or more organisms or against antigenic substances prepared from the organism or organisms:
“Trade name”, in relation to any animal remedy, means the name under which the animal remedy is usually marketed or sold:
“Use”, in relation to any animal remedy, includes—
(a)
Applying the remedy to an animal externally:
(b)
Feeding the remedy to an animal orally:
(c)
Mixing the remedy with any food provided for an animal:
(d)
Providing an animal with the remedy in order that it may be consumed by the animal:
(e)
Drenching an animal with the remedy:
(f)
Injecting the remedy into an animal by any route or means whatsoever:
“Veterinary surgeon” means a person for the time being registered as a veterinary surgeon under the Veterinary Surgeons Act 1956; and includes a person authorised under subsection (2) of section 33 of that Act to continue to use the title or description of “veterinary practitioner”
in connection with his business:
“Viral vaccine” means a vaccine containing either living or dead virus.
(2)
For the purposes of this Act and of any regulations made under this Act the cubic centimetre may be used whenever the millilitre is indicated.
(3)
Where any person is required under this Act to give the Board particulars of any address, that person shall give such particulars as will identify the site of the premises represented by that address.
Compare: 1934, No. 5, s. 2
3 Application of Act
(1)
The Minister may from time to time, on the recommendation of the Board, by notice in the Gazette, declare that any animal remedy shall be exempted from such provisions of this Act as may be specified in the notice. Any notice under this subsection may in like manner be amended or revoked.
(2)
Nothing in this Act or in any regulations made under this Act shall apply to any animal remedy (not being a biochemical substance) which is compounded and supplied by or under the personal supervision of a veterinary surgeon, or compounded and supplied by a pharmaceutical chemist pursuant to the prescription of a veterinary surgeon, for use on a specific animal or specific animals under the direct care of that veterinary surgeon.
(3)
The Governor-General may from time to time, by Order in Council, declare that any animal of any species not specified in the definition of the term “animal”
in section 2 of this Act shall be an animal for the purposes of this Act. Any Order in Council under this subsection may in like manner be amended or revoked.
Part I Animal Remedies Board
4 Animal Remedies Board
(1)
There shall be a Board to be known as the Animal Remedies Board.
(2)
The Board shall be a body corporate with perpetual succession and a common seal, and, subject to the provisions of this Act, shall be capable of acquiring, holding, and disposing of real and personal property and of suing and being sued, and of doing and suffering all such acts and things as bodies corporate may do and suffer.
(3)
The Animal Remedies Board constituted under this Act is hereby declared to be the same Board as the Stock Remedies Registration Board existing immediately before the commencement of this Act under the Stock Remedies Act 1934.
Compare: 1934, No. 5, s. 3(1)
5 Membership of the Board
(1)
The Board shall consist of ten members being—
(a)
The Chairman who shall be appointed on the nomination of the Minister:
(b)
The Registrar:
(c)
One person to be appointed on the nomination of the New Zealand Veterinary Association Incorporated:
(d)
One person to be appointed on the nomination of the Pharmacy Board of New Zealand:
(e)
One person, a veterinary surgeon, to be appointed on the nomination of the Veterinary Services Council established under the Veterinary Services Act 1946:
(f)
One person, a registered medical practitioner registered under the Medical Practitioners Act 1950 and employed in the Department of Health, to be appointed on the nomination of the Minister of Health:
(g)
One person, an analytical chemist employed in the Public Service, to be appointed on the nomination of the Minister:
(h)
One person to be appointed on the nomination of the Federated Farmers of New Zealand Incorporated:
(i)
One person to be appointed on the nomination of the New Zealand Agricultural Chemical Manufacturers’ Federation:
(j)
One person to be appointed on the nomination of the New Zealand Ethical Pharmaceutical Association Incorporated.
(2)
The members of the Board shall be appointed by the Governor-General on the advice of the Minister.
(3)
Notwithstanding the reconstitution of the Board by subsection (1) of this section,—
(a)
Every member of the Board who was in office immediately before the commencement of this Act shall, unless he sooner vacates his office under section 6 of this Act, continue in office as a member of the Board until the expiration of the term for which he was appointed:
(b)
The provisions of this Act shall apply to those members of the Board who were appointed under paragraphs (a), (b), (c), (d), (e), (f), and (g) of subsection (2) of section 3 of the Stock Remedies Act 1934 as if they had been appointed under paragraphs (b), (c), (d), (e), (f), (g), and (h) respectively of subsection (1) of this section.
Compare: 1934, No. 5, s. 3(2)–(3)
6 Terms of office of members
(1)
Except as provided in section 15 of this Act and subject to the provisions of this section, every member of the Board shall bold office for a term of three years, but may from time to time be reappointed.
(2)
The following persons shall be incapable of being appointed as a member of the Board or acting as the deputy of a member:
(a)
A bankrupt who has not obtained his final order of discharge or whose order of discharge has been suspended for a term not yet expired or is subject to a condition not yet fulfilled:
(b)
A person convicted of any offence punishable with imprisonment, unless he has received a free pardon:
(c)
A mentally defective person within the meaning of the Mental Health Act 1911:
(d)
An alien.
(3)
The Governor-General may remove from office any member or any person acting as the deputy of a member of the Board who becomes ineligible for appointment under subsection (2) of this section, or is proved to the satisfaction of the Governor-General to be guilty of neglect of duty or misconduct, or is absent without the consent of the Minister from four consecutive sittings of the Board.
(4)
Any member may at any time resign his office by notice in writing addressed to the Minister.
(5)
If any member of the Board (other than the Registrar) dies, resigns, or is removed from office, the Governor-General may appoint some qualified person to fill the vacancy thereby created. Any such appointment shall be made in the same manner as the appointment of the vacating member. Every person so appointed shall hold office for the residue of the term for which his predecessor was appointed.
(6)
Notwithstanding anything to the contrary in this Act, every member of the Board, unless he sooner vacates his office, shall continue in office until his successor comes into office.
(7)
The powers of the Board shall not be affected by any vacancy in its membership.
Compare: 1934, No. 5, s. 3(3)
7 Deputies of members
(1)
In any case where the Minister is satisfied that any member of the Board (other than the Chairman or the Registrar) is incapacitated from performing the duties of his office by illness or by absence from New Zealand or by some other sufficient cause, the Minister may appoint a deputy to act for the member during his incapacity.
(2)
Any deputy appointed under subsection (1) of this section shall be nominated by the person or body who nominated the incapacitated member.
(3)
In the event of the incapacity or absence of the Registrar (from whatever cause arising) or on the position of Registrar becoming vacant (whether by reason of death, resignation, or otherwise) and from time to time while the incapacity, absence, or vacancy continues, all or any of the powers and duties of the Registrar may be exercised and performed by any veterinary surgeon employed in the Animal Health Division of the Department of Agriculture for the time being directed by the Director-General to exercise and perform them, whether the direction has been given before the incapacity, absence, or vacancy occurs or while it continues.
(4)
Except as provided in subsection (5) of section 8 of this Act, in the event of the Chairman becoming incapacitated from performing the duties of his office by illness or by absence from New Zealand or by some other sufficient cause, the Registrar (or the person for the time being acting as his deputy) shall act for the Chairman during his incapacity.
(5)
Any deputy appointed under subsection (1) of this section shall, while acting in that capacity, be deemed to be a member of the Board. Any deputy acting for the Registrar shall, during the period of the Registrar’s incapacity, have and be capable of exercising all the powers of the Registrar under this Act.
(6)
No appointment of a deputy and no acts done by him as such, and no acts done by the Board while any deputy is acting as such, shall be questioned in any proceedings on the ground that the occasion for his appointment had not arisen or had ceased.
8 Board meetings
(1)
The meetings of the Board shall be held at such times and places as the Board or the Chairman from time to time determines.
(2)
The Chairman, or any two members, may at any time call a special meeting of the Board:
Provided that not less than seven clear days’ notice of every special meeting and of the business to be transacted at the meeting shall be given to each member for the time being in New Zealand, and no business other than that specified in the notice shall be transacted at any such special meeting.
(3)
At all meetings of the Board the quorum necessary for the transaction of business shall be six members.
(4)
The Chairman shall preside at all meetings of the Board at which he is present.
(5)
In the absence of the Chairman from any meeting of the Board, the members present shall appoint one of their number to preside at the meeting.
(6)
All questions arising at any meeting of the Board shall be decided by a majority of the valid recorded votes. Any member may demand a poll to decide any question, but otherwise voting shall be carried out by a show of hands.
(7)
At any meeting of the Board the Chairman or other person for the time being presiding shall have a deliberative vote, and, in the case of an equality of votes, shall also have a casting vote.
(8)
Subject to the provisions of this Act and of any regulations made under this Act, the Board may regulate its procedure in such manner as it thinks fit.
Compare: 1934, No. 5, s. 4
9 Temporary members
(1)
The Board may from time to time appoint temporary members, to hold office during such period as may be specified in each case, for the purpose of assisting it in the exercise of its functions under this Act.
(2)
Any appointment under this section may at any time be revoked by the Board.
(3)
During the period of their appointment temporary members shall be deemed to be members of the Board:
Provided that no temporary member shall be entitled to vote on any question before the Board.
10 Delegation by the Board
(1)
The Board may from time to time appoint advisory or technical committees to advise the Board on such matters as are referred to them by the Board, and may from time to time delegate to any such committee any of its powers, duties, and functions.
(2)
Without limiting its powers of delegation under subsection (1) of this section, the Board may from time to time delegate to the Registrar its powers, duties, and functions relating to approval of labels under section 36 of this Act, and approval of advertisements under section 41 of this Act.
(3)
Every such committee may, in addition, furnish to the Board reports on any matter in respect of which the members of the committee have special knowledge or experience.
(4)
Any person may be appointed to be a member of any such committee, notwithstanding that he is not a member of the Board.
(5)
Every such committee or, as the case may be, the Registrar shall be subject in all things to the control of the Board, and shall carry out all directions, general or special, of the Board in relation to the committee or its affairs.
(6)
Subject to the provisions of this section, any such committee or, as the case may be, the Registrar may exercise or perform any function or power so delegated to it or him in the same manner and with the same effect as if it had been conferred on the committee or the Registrar directly by this Act and not by delegation.
(7)
Any delegation under this section may at any time be revoked by the Board.
(8)
Every committee or, as the case may be, the Registrar purporting to act pursuant to any delegation under this section shall, in the absence of proof to the contrary, be presumed to be acting in accordance with the terms of the delegation.
(9)
No delegation under this section shall prevent the exercise of any functions or powers by the Board.
(10)
Subject to the provisions of this Act and of any regulations thereunder, every committee appointed under this section may regulate its procedure in such manner as it thinks fit.
11 Functions and powers of the Board
(1)
The general functions of the Board shall be—
(a)
Subject to the provisions of this Act, to exercise control over the manufacture, importation, sale, and use of animal remedies:
(b)
To ensure that animal remedies are efficient and safe for use on animals:
(c)
To consider and determine applications under this Act for the issue of licences to manufacture or import animal remedies:
(d)
To exercise and perform such functions, powers, and duties as are conferred or imposed on it under this Act or any other enactment.
(2)
It shall also be a function of the Board to report to the Minister and advise him on such matters as may be referred to it by the Minister or as it may consider necessary or advisable.
(3)
The Board shall have all such powers, rights, and privileges as may be reasonably necessary or expedient to enable it to carry out its functions and, in particular, without limiting the generality of subsection (1) of this section, it may from time to time—
(a)
Promote the carrying out of any research or experimental work with a view to testing or improving animal remedies:
(b)
Promote and organise, by such means as the Board thinks fit, the dissemination of information in relation to the safe and efficient use of animal remedies:
(c)
Carry out or have carried out on its behalf tests and analyses of any animal remedy for which a licence has been issued or which is the subject of an application for a licence.
12 Members of Board not to divulge secrets
Except as provided in section 55 of this Act, if any member or temporary member of the Board or any member of any advisory or technical committee wilfully divulges to any person (being a person who is neither a member nor a temporary member of the Board, nor a member of any advisory or technical committee, nor an officer of the Department of Agriculture) any information relating to the composition of any animal remedy and that information is not generally available to the public and was obtained by virtue of his membership of the Board or committee, as the case may be, he commits an offence and is liable on summary conviction to a fine not exceeding four hundred dollars.
13 Protection of members of the Board, etc.
A member (including a temporary member) of the Board, or a member of any advisory or technical committee, or an officer of the Department of Health or the Department of Agriculture, who does any act in pursuance or intended pursuance of the provisions of this Act, or omits to do any act required by this Act, shall not be under any civil or criminal liability as a result of that act or omission, whether on the ground of want of jurisdiction or mistake of law or fact, or any other ground, unless he has acted or omitted to act in bad faith or without reasonable care.
14 Fees and travelling allowances
(1)
The Board is hereby declared to be a statutory Board within the meaning of the Fees and Travelling Allowances Act 1951.
(2)
There may be paid to members of the Board, including temporary members, or of any committee appointed by the Board, remuneration by way of fees, salary, or allowances and travelling allowances and expenses in accordance with the Fees and Travelling Allowances Act 1951, and the provisions of that Act shall apply accordingly.
Compare: 1934, No. 5, s. 3(5)
15 Registrar of Animal Remedies
(1)
There shall be for the purposes of this Act a Registrar of Animal Remedies. He shall be a veterinary surgeon who is an officer of the Animal Health Division of the Department of Agriculture and shall be appointed under the State Services Act 1962.
(2)
The Registrar shall have the powers and the duties laid down in this Act, and shall perform those duties and such other duties as are for the time being prescribed.
Compare: 1934, No. 5, s. 3(2)
16 Appointment of officers
(1)
There may from time to time be appointed under the State Services Act 1962 such analysts, inspectors, and other officers as are required for the purposes of this Act.
(2)
Without limiting subsection (1) of this section, the Director-General may from time to time appoint any suitably qualified person to be a temporary analyst for the purposes of this Act.
(3)
Every analyst and inspector appointed under this section shall have the powers and duties laid down in this Act, and shall, from time to time as required, perform those duties and such further duties as are for the time being prescribed.
Compare: 1934, No. 5, s. 5
17 Members’ contracts
Notwithstanding any enactment or rule of law to the contrary, the validity of the appointment of any member of the Board shall not be affected by the fact that he is directly or indirectly concerned in the manufacture, importation, or selling of any animal remedy, but no such member shall vote on any matter concerning any remedy which he, or any company or partnership of which he is a member or an employee, manufactures, imports, or sells in the ordinary course of business.
Part II Licences to Manufacture or Import Animal Remedies
18 Prohibition on manufacture or importation of animal remedies without licence
(1)
Except as provided in section 3 of this Act, no person shall manufacture or import any animal remedy otherwise than under the authority of a licence for the time being in force under this Act and in accordance with any conditions subject to which the licence was issued:
Provided that nothing in this subsection shall prohibit the manufacture of any remedy by the independent contractor of a principal, notwithstanding that the independent contractor has not been issued a licence in respect of the remedy, if that principal is the holder of a licence to manufacture the remedy and the remedy is supplied only to such a principal.
(2)
Every person who wilfully manufactures or imports any animal remedy in contravention of subsection (1) of this section commits an offence and is liable on summary conviction to a fine not exceeding two thousand dollars.
19 Applications for licences
(1)
Any adult person or persons, or any body corporate empowered by its constitution to manufacture or import any animal remedy, may apply to the Board for the issue of a licence to manufacture or import any animal remedy.
(2)
Every application for a licence to manufacture or import any animal remedy shall be made by the manufacturer or, as the case may be, the importer to the Registrar on a form provided by the Registrar for the purpose, and shall include the following particulars:
(a)
The trade name of the remedy:
(b)
The name and principal business address of the applicant, and the address of every place where he or his independent contractor manufactures the remedy or, in the case of an importer, the address of every place where he carries on the business of importing the remedy:
(c)
Full details of the composition of the remedy, and the recognised scientific name and percentage of each ingredient and the form in which it occurs, or, in the case of any biochemical substance, the general method of preparation:
(d)
Details of the preventive or remedial properties claimed in respect of the remedy.
(3)
Every application under this section shall be accompanied by—
(a)
Four specimen draft copies of every label which is intended to be used in respect of the animal remedy and its container:
(b)
The prescribed fee:
Provided that the Board may in its discretion waive the payment of any fee or part of it, or authorise the refund of any fee or part of it already paid.
(4)
Every applicant under this section shall, if so required by the Board, file a statement with the Board containing—
(a)
The method or methods of analysis used in respect of the animal remedy:
(b)
Such experimental or other evidence as the Board may require in support of any statement contained in the application or in any copy of a label deposited with the application:
(c)
Such particulars as the Board may require relating to—
(i)
The premises where the process of manufacturing the animal remedy is to be carried out:
(ii)
If the animal remedy is a biochemical substance, the principal technician who will supervise the manufacture of the substance and his qualifications:
(iii)
The plant and general techniques to be used in the manufacture of the animal remedy:
(d)
Such other particulars as the Board may require.
(5)
Where any applicant has applied for a manufacturer’s licence and the actual process of manufacturing the animal remedy named in the application is to be carried out by an independent contractor on the applicant’s behalf, the applicant shall, in addition to the documents specified in subsections (2) to (4) of this section, furnish to the Board, if it so requests, a written undertaking (in a form approved by the Board) signed by or on behalf of the independent contractor that, for the period of the validity of the licence issued to the applicant, he will comply with such of the provisions of this Act and regulations made under this Act relating to holders of licences to manufacture animal remedies as the Board may specify.
(6)
Every applicant for a licence to import any animal remedy shall, in addition to the documents specified in subsections (2) to (4) of this section, furnish to the Board, if it so requests, a written undertaking (in a form approved by the Board) signed by or on behalf of the overseas manufacturer of the animal remedy that, for the period of the validity of the licence issued to the importer, he will comply with such of the provisions of this Act and regulations made under this Act relating to holders of licences to manufacture animal remedies as the Board may specify.
(7)
The proportion of any ingredient which, by paragraph (c) of subsection (2) of this section, is required to be shown on the application shall be the minimum proportion, except in the case of ingredients which are poisons within the meaning of the Poisons Act 1960, when the maximum as well as the minimum proportion shall be shown. Every such proportion shall be stated as a percentage by weight in the case of a solid animal remedy, and as a number of grams per hundred millilitres in the case of a liquid remedy. For the purposes of this subsection a semifluid animal remedy shall be deemed to be solid if recommended for use by weight (whether or not it is also recommended for use by volume) and in all other cases shall be deemed to be liquid.
Compare: 1934, No. 5, s. 6(3), (5)–(6)
20 Offence to deliver false application to the Registrar
(1)
Every person commits an offence who, for the purpose of obtaining the grant of any licence under this Act (either for himself or any other person), or for any other purposes in relation to this Act,—
(a)
Makes any declaration, statement, or undertaking which to his knowledge is false in any material particular; or
(b)
Utters, produces, or makes use of any such declaration, statement, or undertaking or any document containing any such declaration, statement, or undertaking; or
(c)
Knowingly utters, produces, or makes use of any document that is not genuine.
(2)
Every person who commits an offence against this section is liable on summary conviction to imprisonment for a term not exceeding three months or to a fine not exceeding four hundred dollars or to both.
21 Grant or refusal of applications
(1)
After duly considering an application for a licence or a provisional licence, the Board may—
(a)
Subject to the provisions of this Act, approve the issue of a full licence to manufacture, or, as the case may be, to import the remedy specified in the application; or
(b)
Subject to section 24 of this Act, approve the issue of a provisional licence to manufacture, or, as the case may be, to import the remedy specified in the application (whether the application was for a full licence or a provisional licence); or
(c)
Decline the issue of a licence on the grounds specified in subsection (2) of this section.
(2)
The Board may decline the issue of a licence in respect of an animal remedy if it is satisfied on reasonable grounds:
(a)
That any particular contained in the application for a licence is materially false, inaccurate, misleading, or inadequate:
(b)
That the remedy does not conform to the standards prescribed by this Act or by any regulations made under this Act:
(c)
That the premises, plant, or techniques proposed to be used for the production of the remedy are inadequate for the production of a safe and efficient remedy, or that the staff to be employed in its production are not suitably qualified:
(d)
That the remedy is a danger to public health or animal health:
(e)
That the remedy is likely to spread, mask, or conceal any disease which is a disease within the meaning of the Animals Act 1967 or the Poultry Act 1924:
(f)
That the remedy contains an ingredient which is incompatible with any other of its ingredients:
(g)
That the remedy is likely to become ineffective or to deteriorate in storage:
(h)
That the remedy is injurious to animals or contains an ingredient which may have a detrimental effect on any animal exposed to it or any product obtained from any animal so exposed:
(i)
That the remedy contains some ingredient which, by reason of any market standard or any enactment for the time being in force in New Zealand or in any country to which animals or their carcasses or products are exported, could prejudice the sale in New Zealand or that other country of any animal treated or exposed to the animal remedy in question, or any part of the carcass or any product obtained from any animal so treated or exposed:
(j)
That, having regard to the composition of the remedy and to the purpose for which it is intended to be used, the efficiency of the animal remedy is substantially inferior to that of other available remedies of a similar type, or is not capable of accomplishing any claim made by the applicant in respect of it:
(k)
That the applicant has an insufficient knowledge of his obligations under this Act, or that he is not suitably qualified to hold the licence applied for.
(3)
The Board shall not issue a licence under this section without the consent of the Poisons Committee established under section 6 of the Poisons Act 1960 if the animal remedy is a prescription poison or restricted drug as defined in section 2 of that Act.
(4)
In any case where the Board refuses to issue a licence, or issues a licence subject to conditions or restrictions, the Registrar shall notify the applicant in writing and shall specify the Board’s reasons for the refusal or, as the case may be, the imposition of conditions or restrictions.
(5)
Nothing in this section shall be construed so as to restrict any manufacturer or importer from making a further application for a licence in any case where the Board’s requirements in respect of the animal remedy are satisfied at some time after notification of refusal to issue a licence has been given to the applicant.
(6)
In every case where the Board issues a licence under this section, the Registrar shall publish in the Gazette a notice containing the following particulars:
(a)
The trade name of the animal remedy:
(b)
The name and principal business address of the manufacturer or importer of the animal remedy:
(c)
The date of issue, number, and period of validity of the licence:
(d)
Any restrictions imposed by the Board on the sale or use of the animal remedy under subsection (2) of section 22 of this Act.
(7)
Every licence issued pursuant to this section shall be numbered and shall be in the form specified by the Board or prescribed by regulations made under this Act, and shall contain the following particulars:
(a)
Reference to the fact that it is a licence issued under this Act:
(b)
The trade name of the animal remedy:
(c)
The name and principal business address of the licensee:
(d)
The address of every place where the animal remedy is being or is to be manufactured:
(e)
The date of issue and period of validity:
(f)
Any special conditions imposed by the Board relating to the manufacturing, importation, marketing, sale, or advertising of the animal remedy:
(g)
In the case of a provisional licence issued pursuant to section 24 of this Act, a statement to the effect that the licence is a provisional one:
(h)
Such other matters relating to the animal remedy as the Board thinks necessary.
(8)
The issue of a licence under this section to any manufacturer shall not confer on that manufacturer any authority to manufacture the animal remedy named in the licence in contravention of—
(a)
Any patent granted to or applied for by any person under the Patents Act 1953 in respect of the remedy by any person other than the said manufacturer:
(b)
Any licence under any patent granted in respect of the remedy pursuant to the Patents Act 1953:
(c)
Any other proprietary rights in the remedy belonging to some person other than the said manufacturer.
Compare: 1934, No. 5, s. 6(7); 1960, No. 28, s. 3(2); 1961, No. 103, s. 2(1)
22 Licences may be issued subject to conditions
(1)
It shall be a condition of every licence that its holder will comply with the provisions of this Act and any regulations made under this Act and with such other terms and conditions as the Board may have imposed in the licence pursuant to its powers under this Act or any regulations made under this Act.
(2)
The Board may, if it thinks desirable to do so having regard to the nature of the animal remedy, impose a condition in any licence issued by it restricting the remedy named in the licence—
(a)
From being sold to any person other than a veterinary surgeon or a dealer, or otherwise than pursuant to the prescription of a veterinary surgeon; and
(b)
From being used otherwise than by or under the supervision of a veterinary surgeon.
(3)
In any case where the actual process of manufacturing an animal remedy is carried out by an independent contractor on behalf of a licensee, the licensee’s licence to manufacture the remedy named in the licence shall be subject to the observance by the independent contractor of any undertaking given by that independent contractor under subsection (5) of section 19 of this Act, and for the purpose of revocation or suspension of the licence any breach of the undertaking by the independent contractor shall be deemed to be a breach by the licensee of a condition of the licence.
(4)
Every licence to import any animal remedy shall be subject to the observance by the overseas manufacturer of the animal remedy of any undertaking given under subsection (6) of section 19 of this Act, and for the purpose of revocation or suspension of the licence any breach of the undertaking by the overseas manufacturer shall be deemed to be a breach of the condition of the importer’s licence.
23 Effect of licences
(1)
A manufacturer’s licence shall authorise the licensee to manufacture and sell the animal remedy specified in the licence in accordance with its terms and conditions and shall, unless sooner cancelled, revoked, or suspended under this Act, continue in force for a period of five years, or such shorter period from the date of its issue as the Board may determine, and shall then expire.
(2)
An importer’s licence shall authorise the licensee to import and sell the animal remedy specified in the licence in accordance with its terms and conditions, and shall, unless sooner cancelled, revoked, or suspended under this Act, continue in force for a period of five years, or such shorter period from the date of its issue as the Board may determine, and shall then expire.
Compare: 1934, No. 5, s. 6(2); 1965, No. 112, s. 2
24 Provisional licences
(1)
A provisional licence for the manufacture or importation of an animal remedy may be issued in any case where the Board is of the opinion that it is desirable that the remedy should be manufactured or imported for sale or use on a restricted basis either for a trial period or for experimental purposes.
(2)
Where the Board issues a provisional licence it may impose conditions restricting the persons to whom the animal remedy specified in the licence may be sold or restricting the area of distribution or may impose such other conditions, not inconsistent with the purposes of subsection (1) of this section, as it thinks fit.
(3)
A manufacturer’s provisional licence shall authorise the licensee to manufacture and sell the animal remedy specified in the licence in accordance with its terms and conditions and shall continue in force for a period of two years, or such shorter period from the date of its issue as the Board may determine, and shall then expire:
Provided that the Board may at any time before the expiration of that period issue a full licence or may revoke the provisional licence on any of the grounds specified in section 28 of this Act.
(4)
An importer’s provisional licence shall authorise the licensee to import and sell the animal remedy specified in the licence in accordance with its terms and conditions and shall continue in force for a period of two years, or such shorter period from the date of its issue as the Board may determine, and shall then expire:
Provided that the Board may at any time before the expiration of that period issue a full licence or may revoke the provisional licence on any of the grounds specified in section 28 of this Act.
(5)
All the provisions of this Act relating to licences except sections 23 and 25 and subsection (1) of section 21 of this Act shall apply to a provisional licence as if it were a full licence.
25 Renewal of licences
(1)
Before the expiry of his licence the licensee may apply to the Board to renew the licence.
(2)
Notwithstanding the provisions of section 23 of this Act, where the Board has received an application for renewal under this section before the expiry of the licence, the licence shall continue in force until the application for renewal has been dealt with by the Board.
(3)
Every application for renewal under this section shall be made and dealt with by the Board in the same manner as an original application for a licence to manufacture or import an animal remedy, and all the provisions of sections 19 to 23 and section 36 of this Act shall apply accordingly, so far as they are applicable and with any necessary modifications:
Provided that the Board may in its discretion waive such requirements relating to applications for renewal under this section as it thinks fit:
Provided also that, on the granting of any renewal of a licence by the Board, the Registrar may endorse the existing licence or may issue a new licence in its place, but every such new licence shall disclose on its face that it is in renewal of a licence.
(4)
Where the Board has renewed any licence the Registrar shall publish in the Gazette a notice of renewal, which shall contain the same particulars as are required to be published in respect of the issue of an original licence.
(5)
If any licence is not renewed, the Registrar shall publish in the Gazette a notice to the effect that the licence has lapsed.
Compare: 1934, No. 5, s. 6(2)
26 Licence not transmissible or assignable
(1)
Every licence shall be personal to the person to whom it was issued, and shall not for any reason whatsoever (including the death or bankruptcy of the licensee or, in the case of a licensee which is a body corporate, the dissolution of the body corporate) be capable of being transmitted to any person by operation of law:
Provided that where a licence is held jointly by two or more persons it may, on the death of any of them, be transmitted to the survivor or survivors of them.
(2)
No licence shall be capable of being assigned, and every purported assignment shall be void and of no effect.
(3)
On the Board being reasonably satisfied that any licence has ceased to be effective as a result of the operation of subsection (1) of this section, it shall cancel the licence.
(4)
Where any licence has been cancelled by the Board under this section, the Registrar shall publish in the Gazette a notice which shall contain the following particulars:
(a)
The trade name of the animal remedy:
(b)
The name and principal business address of the person named in the cancelled licence:
(c)
The number of the licence:
(d)
The fact that the licence has been cancelled.
27 Production of licence
(1)
Every person who manufactures in New Zealand or imports into New Zealand any animal remedy shall, unless the remedy of which he is the manufacturer or importer has been exempted under section 3 of this Act from being licensed, produce the licence (if any) issued in respect of the remedy or some other evidence of its existence whenever requested to do so by an inspector or other person authorised by the Board:
Provided that this subsection shall be deemed to have been complied with if the licence or satisfactory evidence of its existence is produced to an inspector within forty-eight hours of the request.
(2)
Every manufacturer or importer who, without reasonable excuse, fails to produce a licence in respect of the animal remedy being manufactured or imported by him as provided in subsection (1) of this section commits an offence and is liable on summary conviction to a fine not exceeding fifty dollars.
28 Revocation and suspension of licences
(1)
The Board may at any time, by notice in writing addressed to the licensee, revoke or suspend any licence issued for the manufacture or importation of an animal remedy, if it is satisfied on reasonable grounds—
(a)
That the remedy is not being prepared in accordance with the particulars contained in the application or any statement or undertaking in support of it, or that any such particular was materially false, inaccurate, misleading, or inadequate; or
(b)
That the remedy no longer conforms to the standards prescribed by this Act or any regulations made under this Act, or that the holder of the licence has failed to comply with the provisions of this Act, or has broken any condition on which his licence was issued; or
(c)
That, having regard to experience gained or discoveries made since the date of the issue of the licence, it is desirable that the Board should review the issue of the licence; or
(d)
That the licensee is no longer manufacturing or importing the remedy; or
(e)
That without the Board’s consent the manufacture of the remedy is being carried out on premises other than those specified in the licence; or
(f)
That the premises, plant, or techniques being used in the manufacture of the remedy are no longer adequate for the production of a safe and efficient remedy, or that the staff employed in the production of the remedy are not suitably qualified; or
(g)
That the remedy is or has become a danger to public health or animal health; or
(h)
That the remedy spreads, masks, or conceals any animal disease which is a disease within the meaning of the Animals Act 1967 or the Poultry Act 1924; or
(i)
That the remedy has been found to contain an ingredient which is incompatible with any other of its ingredients; or
(j)
That the remedy has become ineffective or is found to deteriorate in storage; or
(k)
That the remedy has become injurious to animals or has been found to contain an ingredient which has a detrimental effect on an animal or an animal product exposed to it; or
(l)
That the remedy has been found to contain an ingredient which, by reason of a market standard or an enactment for the time being in force in New Zealand or in some other country to which animals or their carcasses or products are exported, prejudices the sale in New Zealand or that other country of any animal treated or exposed to the animal remedy in question, or any part of the carcass or any product obtained from any such animal; or
(m)
That, having regard to the composition of the remedy and to the purpose for which it is being used, the remedy is not capable of accomplishing any claim made by the licensee in respect of it; or
(n)
That the licensee has failed or refused to comply with any lawful direction of the Board made pursuant to powers conferred on it by this Act, or any regulations made under this Act; or
(o)
That at the time of issuing the licence the Board had been misled or was labouring under a mistake relating to the particulars contained in the application for the licence and would, had it not been misled or mistaken, have been justified in refusing to issue the licence on any of the grounds specified in section 21 of this Act; or
(p)
That the licensee has purported to assign his licence in contravention of this Act.
(2)
If the Board revokes or suspends any licence under this section, the Registrar shall in writing notify the licensee of the reason for the revocation or suspension.
(3)
If within the time allowed for giving notice of appeal against the Board’s decision to revoke or suspend the licence no such notice is given, or if any notice of appeal is withdrawn before the hearing of it, or if any appeal is disallowed, the Registrar shall publish in the Gazette a notice containing the following particulars:
(a)
The trade name of the animal remedy:
(b)
The name and principal business address of the manufacturer or importer of the animal remedy:
(c)
The number of the licence:
(d)
The fact that the licence has been revoked or, as the case may be, suspended:
Provided that the reason for revocation or suspension shall not be stated.
(4)
In addition to the provisions of subsection (3) of this section, if it appears to the Board that the animal remedy to which the revoked or suspended licence relates could endanger public health or animal health, the Board shall notify the Director-General of Health (in the case of danger to public health) or the Director-General of Agriculture (in the case of danger to animal health), whereupon the Director-General so notified, if he is of the opinion that it is necessary to do so for the purpose of protecting public health or, as the case may be, animal health, may notify the revocation or suspension by such means as he thinks fit.
(5)
Where the Board revokes any licence under paragraph (a) or paragraph (b) or any of the provisions of paragraphs (g) to (m) or paragraph (o) of subsection (1) of this section, it may direct that any stocks of the animal remedy which were manufactured or imported under the revoked licence shall be surrendered to the Board or disposed of in accordance with any regulations made in that behalf under this Act or, if no such regulations have been made, in such manner as it thinks fit; and the manufacturer or, as the case may be, the importer of the remedy shall, on being notified by the Registrar in writing in that behalf, comply with the direction within such time as may be specified in the notice:
Provided that the Board shall not direct the manufacturer or importer to surrender or dispose of any remedy as aforesaid until any appeal against revocation of the licence has been dealt with, or any notice of appeal that has been given has been withdrawn before the hearing, or until the time for giving notice of appeal under this Act has elapsed, whichever last occurs.
(6)
Where the Board has suspended any licence under the powers conferred on it under this Act the licensee shall cease to sell or advertise the animal remedy to which the licence relates, and shall, if the Board so requires,—
(a)
Notify every dealer or other person to whom he has sold the remedy that the remedy is withdrawn from sale; and
(b)
Take all practicable steps to recall any quantities or containers of the remedy that have been sold to any such dealer or person.
(7)
After being notified that the Board has suspended his licence, no licensee shall resume selling the animal remedy until he has received a further notification to the effect that the suspension has been cancelled and that he may resume selling the remedy.
(8)
Every manufacturer or importer of any animal remedy who fails to comply with any lawful direction of the Board under this section or sells any animal remedy in contravention of this section commits an offence and is liable on summary conviction to a fine not exceeding five hundred dollars.
Compare: 1934, No. 5, s. 6(8); 1960, No. 28, s. 3(2); 1961, No. 103, s. 2(2)
29 Board to be notified of variation of particulars contained in application
(1)
Where at any time after any licence has been issued in respect of any animal remedy there is any variation or change in any particular contained in the application for the licence or in any statement or other document in support of the application or in any variation or change in any such particular which has previously been notified to and approved by the Board, the licensee shall immediately notify the Board of the variation or change, and that remedy shall not be sold by the licensee until the approval of the Board to the variation or change has been obtained.
(2)
Every licensee who fails to notify the Board of any variation or change as provided in subsection (1) of this section, or wilfully sells the animal remedy of which he is the licensee in contravention of the said subsection commits an offence, and is liable on summary conviction to a fine not exceeding two hundred dollars.
30 Licensee to notify Board of change of manufacturer
(1)
Every holder of a licence to manufacture an animal remedy who, at any time during the currency of his licence,—
(a)
Engages any independent contractor to manufacture the remedy on his behalf; or
(b)
Ceases to employ any independent contractor manufacturing the remedy on his behalf—
shall immediately notify the Board in writing, giving particulars of the name and principal business address of the independent contractor concerned, and shall, if the Board so requires, obtain from any independent contractor to whom paragraph (a) of this subsection applies the same undertaking as that which he may be required to obtain under subsection (5) of section 19 of this Act; and if, without reasonable excuse, he fails to obtain the undertaking within such reasonable time as may be specified by the Board the Board may suspend his licence.
(2)
Every holder of a licence to import any animal remedy who, at any time during the currency of his licence, commences importing (whether directly or otherwise) the remedy from an overseas manufacturer who is a different person from the overseas manufacturer from whom he was to import it at the time of issue of the licence, or from an additional overseas manufacturer, shall immediately notify the Board in writing, giving particulars of the name and principal business address of the different or additional overseas manufacturer, and shall, if the Board so requires, obtain from that different or additional overseas manufacturer the same undertaking as that which he may be required to obtain from an overseas manufacturer under subsection (6) of section 19 of this Act; and, if without reasonable excuse he fails to obtain the undertaking within such reasonable time as may be specified by the Board, the Board may suspend his licence.
(3)
Every licensee who fails to furnish the Board with any of the particulars required to be given to the Board pursuant to subsection (1) or subsection (2) of this section commits an offence and is liable on summary conviction to a fine not exceeding one hundred dollars.
31 Register of licences to be kept
(1)
The Registrar shall keep and maintain a register of licences issued by the Board under this Act, and shall record in that register every renewal, revocation, cancellation, and suspension of any licence, and such other matters as may be required by this Act or any regulations made under this Act to be recorded in the register.
(2)
There shall be entered in the register in respect of each animal remedy for which a licence has been issued the following particulars:
(a)
The trade name of the remedy:
(b)
The name and principal business address of the licensee and the address of every place where the manufacture or, as the case may be, importation of the remedy is carried on by the licensee:
(c)
In the case of a licence to import a remedy, the name and business address of the overseas manufacturer of the remedy:
(d)
The number and type of the licence, the date on which it was issued, and its period of validity:
(e)
Full details of the composition of the remedy and the recognised scientific name and percentage of each ingredient and the form in which it occurs, or, in the case of any biochemical substance, the general method of preparation:
(f)
A specimen of the label approved under this Act in the form used in respect of the remedy as sold:
(g)
A facsimile copy of the licence:
(h)
Such other particulars as may be prescribed:
(i)
Any variation or change approved by the Board or of which notice has been given to the Registrar in respect of any of the foregoing entries in accordance with the provisions of this Act.
(3)
In addition to the register required to be kept under subsection (1) of this section, the Registrar shall keep and maintain a record of every animal remedy which has been exempted by the Minister from any of the provisions of this Act and every revocation of any such exemption.
(4)
The register shall not be open to inspection by the public, and, except as otherwise provided in this Act, the contents of the register or any application or any other document filed with the Board by any licensee shall not, unless the consent of the licensee has first been obtained, be disclosed to any person other than a member or temporary member of the Board or a member of an advisory or technical committee appointed under section 10 of this Act or an officer of the Department of Agriculture authorised by the Board.
(5)
The register of licences shall, in the absence of proof to the contrary, be sufficient evidence of any matters entered in it as required or authorised by or under this Act to be so entered.
32 Correction of errors
Where a mistake exists in the register of licences, or in any licence, or in any other document made or issued under this Act, by reason of an error or omission on the part of the Board or any of its members, or any officer of the Department of Agriculture, the Registrar may correct the mistake, and for that purpose may require production of the licence or other document held by the licensee.
33 Loss or destruction of licence
Where the Registrar is satisfied that a licence has been lost or destroyed or cannot be produced, he may at any time, on application made to him in the prescribed manner and on payment of the prescribed fee (if any), cause a further licence to be issued to the applicant.
Appeals, etc.
34 Appeal from decision of the Board
(1)
Any person affected by any decision of the Board relating to—
(a)
An application by him for a licence under this Act; or
(b)
An application by him for renewal of a licence; or
(c)
The revocation or suspension of his licence; or
(d)
The refusal to give approval to any proposed label or advertisement, or to approve a proposed label or advertisement except subject to conditions; or
(e)
The forfeiture, surrender, or destruction of an animal remedy or ingredient of a remedy, or any label or container—
may, within twenty-eight days after the date on which notice of the decision has been given to him by the Registrar, give notice of appeal to the Registrar on a form to be provided for the purpose by the Registrar.
(2)
On receipt of the notice of appeal, the Registrar shall immediately inform the Minister, who shall thereupon appoint an appeal tribunal consisting of a Magistrate and two assessors, of whom one shall be nominated by the Board and one by the appellant.
(3)
At any time after the appeal tribunal has been constituted, the Magistrate shall appoint a day and place for the hearing of the appeal, and shall notify the appellant and the Board of the day and place so appointed.
(4)
The appeal tribunal may adjourn the hearing of any appeal from time to time and from place to place.
(5)
All appeals shall be heard in public unless the appeal tribunal in any particular case, due regard being had to the interests of all persons concerned and to the public interest, considers that the hearing or any part of it should take place in private.
(6)
At the hearing of any appeal, the appeal tribunal shall observe the rules of natural justice, and shall hear all evidence tendered and representations made by or on behalf of the appellant, the Board, and other persons which it considers relevant to the subject-matter of the appeal, save that at any time during the hearing it may, if it considers it has sufficient evidence to arrive at a decision on the appeal, decide not to receive further evidence or representations.
(7)
At the hearing of any appeal, the Board may, after the presentation of evidence by the appellant, furnish to the appeal tribunal reasons for the decision appealed against and all available evidence on which that decision was based.
(8)
At the hearing of any appeal, the appellant and the Board may be represented by an advocate or advocates.
(9)
Subject to the provisions of this Act and any regulations made under this Act, the appeal tribunal may regulate its procedure in such manner as it thinks fit, and for this purpose may make such rules as it thinks fit.
(10)
The appeal tribunal, after hearing the appeal, may—
(a)
Confirm the decision of the Board:
(b)
Reverse or vary the decision of the Board subject to such modifications and conditions as the appeal tribunal thinks fit:
(c)
Order that any animal remedy or ingredient of the animal remedy or any label or container (being an animal remedy, ingredient, label, or container which has been impounded, sealed, or secured by any inspector under this Act) be returned to the appellant:
(d)
Order a licence to be granted to the applicant, or order any licence that has expired or is due to expire to be renewed, or order a licence to be restored to its holder, or order the cancellation of any decision of the Board suspending the licence, or make such other order as the case may require:
(e)
Approve any label or advertisement subject to such conditions as it may specify:
Provided that nothing in this subsection shall be construed to give the appeal tribunal power to review any part of the Board’s decision other than the part against which the appellant has appealed.
(11)
When considering any appeal under this section the appeal tribunal shall have regard to the provisions of this Act, and shall, when arriving at its decision, make every effort to ensure that its decision is fully in accordance with the intent, meaning, and spirit of this Act.
(12)
The decision of not less than two members of the appeal tribunal (including the Magistrate) shall be the decision of the tribunal, and, subject to the supervisory jurisdiction of the Supreme Court, that decision shall be final and conclusive.
(13)
Every appeal tribunal shall state reasons for its decision which shall, if so requested by the appellant or the Board, be delivered in writing.
(14)
On any appeal the appeal tribunal may make an order for the payment by or to the Board or the appellant, as the case may be, of the costs incurred in respect of the appeal, including the costs and expenses of the appeal tribunal, and in any such case the costs so awarded may be recovered as a debt due from the party against whom they have been awarded to the party in whose favour they have been awarded.
(15)
Where the Board revokes any licence under this Act or refuses to renew any licence on an application for its renewal, the licence shall (notwithstanding the Board’s decision) be deemed to be only suspended, pending the disposal of any appeal under this section or pending the expiration of the time for giving notice of appeal or the withdrawal of any notice of appeal given under this section, whichever last occurs:
Provided that the Board may in its discretion decide that a licence which it has revoked or suspended shall remain valid pending the disposal of any appeal or the expiration of the time limited for lodging an appeal under this section.
(16)
On any appeal the appeal tribunal shall be deemed to be a Commission of Inquiry under the Commissions of Inquiry Act 1908, and all the provisions of that Act, except sections 2 and 4a and sections 11 to 15, shall apply accordingly. For the purposes of this subsection, the power to issue summonses requiring the attendance of witnesses before the appeal tribunal or the production of documents, or to do any other act preliminary or incidental to the hearing of any matter by the tribunal, may be exercised by the Chairman, or by the Registrar purporting to act by the direction or authority of the Chairman.
Compare: 1934, No. 5, s. 6a; 1960, No. 28, s. 4
35 Rehearing by Board
(1)
Without limiting the provisions of section 34 of this Act, any person affected by any decision of the Board relating to—
(a)
An application by him for a licence under this Act; or
(b)
An application by him for the renewal of his licence; or
(c)
The revocation or suspension of his licence; or
(d)
The refusal to approve a proposed label or advertisement, or to approve a proposed label or advertisement except subject to conditions; or
(e)
The forfeiture, surrender, or destruction of an animal remedy or ingredient of a remedy, or any label or container—
may, within fourteen days after the date on which notice of the decision has been given to him by the Registrar, give notice to the Registrar that he desires the Board to reconsider its decision, whereupon the Registrar shall, after consultation with the person, fix a date, time, and place on which the reconsideration shall take place, and shall notify him accordingly.
(2)
On the date fixed for the reconsideration, the Board or a committee of the Board shall duly consider the said person’s submissions (which may be given orally or in writing) and may then confirm, vary, or reverse the original decision.
(3)
In any reconsideration the Board or committee of the Board may receive such evidence, statements, or documents as in its opinion may assist it to determine the matters before it, whether or not the evidence, statements, or documents would be admissible in a court of law and whether or not the evidence, statements, or documents could have been placed before the Board at the time when it made its original decision.
(4)
The Registrar shall, as soon as the Board or subcommittee has made a decision under subsection (2) of this section, notify the said person in writing of that decision together with a statement of the reasons for it.
(5)
Notwithstanding the provisions of subsection (1) of section 34 of this Act, where any person has applied for a reconsideration as provided in this section, the period of twenty-eight days referred to in the said subsection (1) shall not commence to run until he has been notified of the decision of the Board made under subsection (2) of this section or he has withdrawn the notice given under subsection (1) of this section, whichever first occurs.
(6)
Subject to the provisions of this Act and of any regulations made under this Act, the Board may regulate the procedure to be followed in respect of any reconsideration under this section in such manner as it thinks fit.
Part III Labels and Containers
36 Labelling
(1)
An animal remedy may only be sold under a label containing the following particulars:
(a)
The name of the remedy as entered in the licence under which the remedy is manufactured or imported:
(b)
The name and principal business address of the licensee of the remedy:
(c)
The number of every licence under which the remedy is manufactured or imported, together with the words “licensed under the Animal Remedies Act 1967”
:
(d)
Such particulars of the physical, chemical, or biochemical composition of the remedy as may be required by the Board on approving the label:
(e)
The preventive or remedial properties claimed in respect of the remedy:
(f)
The directions for use of the remedy and, in the case of a remedy intended to be used for the destruction of lice and keds on sheep, such period as the Board may have specified when approving the label within which the remedy is to be used on any sheep after it has been shorn:
(g)
The net weight or net quantity of the remedy:
(h)
Such precautionary advice as may be required by the Director-General of Health for the purpose of safeguarding the health of human beings:
(i)
Such precautionary advice as may be required by the Board for safeguarding the health of animals:
(j)
Where the Board has imposed in the licence issued for the remedy the condition specified in subsection (2) of section 22 of this Act, the words (printed or written in bold print) “to be used only by or under the supervision of a veterinary surgeon”
:
(k)
In the case of a biochemical substance,—
(i)
A distinctive batch number; and
(ii)
The date to which the substance, if kept under the conditions specified in the label, may reasonably be expected to retain its potency:
Provided that the Board may in its discretion waive the requirements of this paragraph:
(l)
If the Board so requires, in the case of a serum or antitoxin, the name of the species of animal in which it has been prepared.
(2)
The Board shall not issue a licence in respect of an animal remedy until it is satisfied that the general form of the label accompanying an application under section 19 of this Act is substantially in accordance with the requirements of this Act and of any regulations made under this Act.
(3)
No label shall be used in connection with any animal remedy unless its general form has been approved by the Board.
(4)
If the Board is of the opinion that any label submitted with an application under section 19 of this Act is misleading, inaccurate, inadequate, or not in conformity with the provisions of this Act or of any regulations made under this Act, it may require the applicant to amend or modify the label.
(5)
When the Board is satisfied that the label is in conformity with the provisions of this Act and of any regulations made under this Act and that any requirement which may have been made under subsection (4) of this section has been complied with, it shall notify the applicant in writing that the label has been approved.
(6)
The applicant shall, before the time when the animal remedy named in the label is first offered for sale, furnish to the Board four copies of the label in the form in which it is to be commercially used.
(7)
During the currency of any licence, the label approved under this section shall not be altered in any material respect without the approval of the Board.
(8)
No reference shall be made in any label to the approval of the animal remedy by the Board or any Government Department or employee, except a reference to the particulars required to be shown on the label by paragraph (c) of subsection (1) of this section.
(9)
Except as provided in any special condition imposed by the Board under subsection (10) of this section, every label under which any animal remedy is sold or to be sold shall—
(a)
Be printed or indelibly marked and shall be conspicuous and legible:
(b)
Be firmly affixed or branded to the remedy’s container:
(c)
Be of such a nature and material that it will not fade or become detached by the action of light, or atmospheric humidity, or dryness, or of normal atmospheric temperatures:
(d)
Be of such a nature and in such a position that it will not be readily defaced in normal handling and use:
(e)
Be in such a position that it is not damaged, defaced, or destroyed, or removed when the container is opened:
(f)
Not be obscured by any other label, folder, or pamphlet.
(10)
The Board may when approving a label under this section impose a special condition specifying the manner in which the licensee is to label the animal remedy or any container to be used to contain the remedy.
(11)
Notwithstanding that the Board has already approved a label for use in respect of an animal remedy under this section, it may, if at any time it is of the opinion that, having regard to experience gained or discoveries made since the approval, the label is false, inaccurate, misleading, or exaggerated, require the licensee by notice in writing to amend or modify any material particular contained in the label; and if, after being given any such notice, the licensee sells the remedy under a label which is not in accordance with the Board’s requirement, the Board may cancel its approval of the label, and on so doing it shall give notice in writing to the licensee accordingly.
Compare: 1934, No. 5, ss. 5(6), 8(3)–(4); 1963, No. 116, s. 2(2)
37 Animal remedies to be sold only in suitable containers
(1)
Except with the express permission of the Board, no person shall sell any animal remedy unless it is securely packed in a container that is suitable having regard to the contents of the container and is labelled in accordance with section 36 of this Act and any condition imposed by the Board under that section.
(2)
Without limiting the effect of subsection (1) of this section, no person shall, unless the permission of the Board has been first obtained, sell—
(a)
Any biochemical substance, unless it has been packed in a sealed container which is made of a material inert towards the contents and the container has previously been sterilised; or
(b)
Any sera, antitoxins, antigens, vaccines of any description, viruses or micro-organisms, unless they have been packed in a sealed container in such a manner as will ensure that the access of micro-organisms is precluded.
38 Offences relating to labels and containers
(1)
Subject to the provisions of this Act, every person commits an offence and is liable on summary conviction to a fine not exceeding one hundred dollars who knowingly sells any animal remedy—
(a)
Otherwise than under a label approved under section 36 of the Act; or
(b)
Otherwise than in a container in accordance with section 37 of this Act.
(2)
Every person commits an offence and is liable on summary conviction to a fine not exceeding one hundred dollars who, while any animal remedy is in his possession for sale, fraudulently removes any label from any container containing the remedy, or fraudulently defaces, obliterates, or alters any label approved under section 36 of this Act.
(3)
Every person commits an offence and is liable on summary conviction to a fine not exceeding two hundred dollars who—
(a)
Makes, produces, writes, or prints any label intended to be used in respect of any animal remedy; or
(b)
Affixes or brands any label onto a container containing any animal remedy; or
(c)
Sells any animal remedy under any label,—
knowing that the label contains some material false, misleading, or inaccurate statement relating to the nature, quality, preventive or remedial properties, strength, purity, composition, weight, volume, origin, or age of the remedy.
(4)
Any person who knowingly sells to any other person, other than a veterinary surgeon or a dealer or otherwise than pursuant to the prescription of a veterinary surgeon, any animal remedy under a label which includes the words “to be used only by or under the supervision of a veterinary surgeon”
commits an offence and is liable on summary conviction to a fine not exceeding two hundred dollars.
(5)
Nothing in subsection (2) or subsection (3) of this section shall apply to anything done by a veterinary surgeon in good faith in the ordinary course of his business.
Compare: 1934, No. 5, ss. 8(1)–(2), 9
Part IV Sale of Animal Remedies
39 Warranties
(1)
In every sale or contract for the sale of any animal remedy by the licensee or any other person there shall be implied a warranty by the licensee of the remedy (whether or not he is otherwise a party to the sale or contract) to the purchaser that the remedy is reasonably fit for the purposes for which its use is recommended (whether by implication or otherwise) in any label used or in any advertisement published in respect of the remedy by or with the consent of the licensee; but no such warranty shall be implied if the purchaser uses the remedy for any other purpose than that recommended or contrary to the label or advertisement.
(2)
The fact that a licence has been issued in respect of any animal remedy, or that a label has been approved under section 36 of this Act, shall not be deemed to imply a warranty by the Crown or by the Board that the remedy is reasonably fit for the purpose for which it is sold or that any statement contained in any such label is correct.
(3)
Nothing in this section shall be construed as limiting any purchaser’s rights under any rule of law or under the Sale of Goods Act 1908 in respect of the purchase of any animal remedy.
(4)
The provisions of subsection (1) of this section shall have effect notwithstanding any agreement to the contrary.
Compare: 1934, No. 5, s. 10
40 Offences relating to sale and use of animal remedies
(1)
Every person commits an offence and is liable on summary conviction to a fine not exceeding four hundred dollars who, being a manufacturer or importer of any animal remedy (not being an animal remedy exempted under section 3 of this Act from being licensed), sells that remedy—
(a)
Before he has received from the Board a licence to manufacture or, as the case may be, import the remedy; or
(b)
After the period for which any licence issued in respect of the remedy has expired and the licence has not been renewed; or
(c)
After he has been notified that the licence issued in respect of the remedy has been revoked, cancelled, suspended, or not renewed, unless the licence remains valid pursuant to the proviso to subsection (15) of section 34 of this Act.
(2)
Every dealer who sells any animal remedy (not being an animal remedy exempted under section 3 of this Act from being licensed) for which there is for the time being no licence in force commits an offence and is liable on summary conviction to a fine not exceeding two hundred dollars:
Provided that in any proceedings under this subsection against any dealer it shall be a good defence if that dealer satisfies the Court that he did not know and could not, with the exercise of reasonable care, have known that there was no licence in force for the remedy at the time he sold it.
(3)
Every person who sells any animal remedy knowing that it has been manufactured or imported in contravention of this Act or of any regulations under this Act or of any condition imposed in any licence issued in respect of the remedy commits an offence and is liable on summary conviction to a fine not exceeding two hundred dollars.
(4)
Every person (being a manufacturer, importer, or dealer) who sells any licensed animal remedy of which the composition differs materially from the description of the composition stated in the application made in respect of that remedy under section 19 of this Act commits an offence and is liable on summary conviction to a fine not exceeding two hundred dollars:
Provided that in any proceedings under this subsection against any person (not being the manufacturer or importer of the remedy) it shall be a good defence if that person satisfies the Court that he did not know and could not, with the exercise of reasonable care, have known that the composition of the remedy differed materially from the aforesaid description at the time he sold the remedy.
(5)
Every person commits an offence and is liable on summary conviction to a fine not exceeding one hundred dollars who, without reasonable excuse,—
(a)
Uses any animal remedy on any animal (other than an animal kept solely for experimental purposes) knowing that the remedy has been manufactured or imported otherwise than pursuant to a licence and that the remedy has not been exempted under section 3 of this Act from being licensed; or
(b)
Knowingly uses any animal remedy on any animal in contravention of any condition imposed by the Board under section 22 of this Act.
Compare: 1934, No. 5, s. 7; 1936, No. 58, s. 74; 1946, No. 9, s. 5; 1960, No. 28, ss. 5, 6
41 Advertisements
(1)
Every licensee or dealer who intends to use any advertisement in order to advertise any animal remedy shall submit to the Board three copies of the advertisement before publishing or reproducing the advertisement in any newspaper, journal, magazine, pamphlet, label, trade circular, or brochure, or any other publication whatsoever, or in any film, or on any gramophone or tape recording, or on any radio or television programme; and he shall not cause it to be so published or reproduced until those copies have been approved by the Board.
(2)
Subject to subsection (5) of this section, where copies of an advertisement have been submitted to the Board as aforesaid, the Board shall immediately consider them and shall approve the advertisement in the form submitted unless some false, inaccurate, misleading, or exaggerated claim is made in respect of any preventive or remedial property of the remedy to be advertised, in which case the Board shall refuse to approve it. When the Board has approved any such advertisement it shall cause a memorandum of its approval to be recorded on the submitted copies, whereupon the Registrar shall return two of them to the licensee or dealer submitting them, and record the other in the appropriate place in the register of licences. If the Board refuses to approve the advertisement, it may either retain the copies submitted to it or return all or any of them to the licensee or dealer submitting them as it sees fit.
(3)
Where the Board has approved an advertisement under subsection (2) of this section, the licensee or dealer, as the case may be, may continue to publish the advertisement in the same form as approved under that subsection, or in any other form, without obtaining a further approval from the Board:
Provided that, where any new or different preventive or remedial property is claimed in respect of the animal remedy or any claim in respect of a preventive or remedial property contained in an advertisement already approved is varied, a copy of the advertisement containing any such new, different, or varied claim shall be submitted to the Board for reapproval, whereupon the provisions of subsection (2) of this section shall apply to that copy as if the Board had never approved the advertisement.
(4)
Notwithstanding anything in subsection (3) of this section, the Board may from time to time give notice to any licensee or dealer who has had an advertisement approved under this section that it requires him to resubmit that advertisement to the Board for approval under subsection (2) of this section on the ground that some claim made in respect of the animal remedy in the advertisement appears to be false, inaccurate, misleading, or exaggerated in the light of discoveries made or experience gained since the advertisement was first approved. Where any such licensee or dealer has received a notice under this subsection, the provisions of subsection (1) of this section shall apply to the advertisement as if it had never been approved under this section.
(5)
Where the Board, on issuing a licence for an animal remedy, has imposed a condition under subsection (2) of section 22 of this Act, it may refuse to approve under this section any advertisement relating to the remedy that does not contain a statement to the effect that the remedy may be sold or used only in accordance with the conditions imposed by the Board under the said subsection (2).
(6)
No reference (other than a reference to the licence number) shall be made in any advertisement which implies the approval of the animal remedy by the Board, the Registrar, or the Department of Agriculture.
(7)
Every licensee or dealer who wilfully causes any advertisement to be published in contravention of this section commits an offence and is liable on summary conviction to a fine not exceeding four hundred dollars.
Compare: 1934, No. 5, s. 8(2)–(4)
Part V Samples and Analyses
42 Power of entry and inspection
(1)
Every manufacturer, independent contractor, importer, and dealer shall at all reasonable times allow any inspector to enter his business premises or any vehicle belonging to him, and shall permit the inspector—
(a)
To inspect those premises or, as the case may be, that vehicle and any stocks of animal remedies kept there, and, in the case of a manufacturer or independent contractor, to inspect any plant, or any animals used for testing purposes, or any ingredients used in the manufacture of any animal remedy, the process of manufacture, and the means employed in testing any biochemical substance manufactured by him:
(b)
To inspect and take copies of any record kept pursuant to subsection (3) of section 49 of this Act or under regulations made pursuant to paragraph (u) of section 65 of this Act.
(2)
If on inspecting any premises or vehicle under subsection (1) of this section an inspector believes on reasonable grounds—
(a)
That any animal remedy found on the premises or in the vehicle is being or has been manufactured, imported, or sold in contravention of this Act; or
(b)
That any animal remedy has been manufactured on premises other than those approved by the Board when granting a licence for the animal remedy; or
(c)
That any animal remedy has not been packed or labelled in accordance with the requirements of this Act or any regulations made under this Act or any conditions lawfully imposed by the Board; or
(d)
That any container or label or any ingredient of any animal remedy is being used or is intended to be used in contravention of this Act or any regulations made under this Act; or
(e)
That any record required to be kept pursuant to subsection (3) of section 49 of this Act or any regulation made under paragraph (u) of section 65 of this Act discloses discrepancies or is not being properly kept—
he may impound, seal, or otherwise secure that remedy, label, container, ingredient, or record, as the case may be.
(3)
Where an inspector impounds, seals, or secures any thing under subsection (2) of this section he shall immediately notify the Board which shall, as soon as practicable, cause the thing to be removed to a place of security, and shall as soon as practicable investigate the circumstances of the case.
(4)
If, after investigating the circumstances surrounding the action of the inspector under subsection (2) of this section, the Board is of the opinion that the inspector’s action was justified, it may order the thing impounded, sealed, or secured to be destroyed or disposed of in such manner as it thinks fit, and may suspend the licence issued in respect of the animal remedy concerned in the case. If it thinks that the action of the inspector was not justified it shall return the thing impounded, sealed, or secured to the person from whom it was taken.
(5)
No thing impounded, sealed, or secured under this section shall be destroyed or otherwise disposed of until after any appeal against the decision of the Board has been dealt with, or until after the time limited for appealing against the decision of the Board under section 34 of this Act has expired, or until any notice of appeal under that section has been withdrawn, whichever event last occurs.
(6)
Every person commits an offence and is liable on summary conviction to a fine not exceeding one hundred dollars who, without the authority of the Board or an inspector, wilfully removes or interferes with any thing that has been impounded, sealed, or secured under this section.
(7)
Every person who wilfully obstructs, hinders, resists, or deceives an inspector in the exercise of his powers under this section commits an offence and is liable on summary conviction to a fine not exceeding two hundred dollars.
(8)
Every inspector who is inspecting or about to inspect the premises of any licensee or dealer shall, if so required by the licensee or dealer, produce a warrant duly authenticated by the Director-General showing the inspector’s authority to exercise the powers conferred on inspectors by this section.
(9)
If a Magistrate is satisfied on oath by an inspector that—
(a)
Entry in exercise of the right conferred by subsection (1) of this section has been refused by any licensee or dealer; or
(b)
There are reasonable grounds for suspecting that an offence against this Act has been or is being committed on the premises of any licensee, dealer, or other person—
the Magistrate may, by warrant under his hand, authorise any inspector or other person named in the warrant, together with any police officer, to enter and search the premises of the licensee or dealer, if necessary by force.
(10)
Every warrant granted under subsection (9) of this section shall continue in force until the purpose for which it was granted has been fulfilled.
Compare: 1934, No. 5, s. 11
43 Procuring of samples
(1)
Without limiting the powers conferred on inspectors under section 42 of this Act, on payment or tender of the current value of the samples referred to in this section to any person engaged in selling, manufacturing, or importing any animal remedy, or to his agent or servant, any inspector may demand and select samples of that remedy for the purpose of having the remedy analysed under section 44 of this Act.
(2)
The inspector shall then, in the presence of the licensee or dealer, as the case may be, if he is available or, if he is unavailable, in the presence of some other witness, take two identical samples of the animal remedy. Each sample taken shall be sufficient for the purpose of having it analysed and shall, unless otherwise directed by the Board, be not less than the minimum size, weight, or volume as offered for sale to the public. In any case where the inspector takes an animal remedy packed in a container, that container shall be taken unopened. Where the remedy sampled is for the time being held in a bulk storage tank or the like, the inspector shall place each of the two samples in a clean dry receptacle.
(3)
After taking the sample the inspector shall—
(a)
Issue to the licensee or dealer a receipt which shall identify the sample and the batch (if any) from which the sample was taken; and
(b)
Seal each of the two samples with an official seal supplied by the Board; and
(c)
Affix to each of the two samples a label in form 1 in the First Schedule to this Act; and
(d)
Deliver one sample to the licensee or, as the case may be, the dealer and forward the other sample to an analyst. Where a sample consists of more than one package or container, the inspector shall seal each package or container.
(4)
On receiving notice from the inspector that a sample of an animal remedy has been forwarded to an analyst under subsection (3) of this section, the Registrar shall forward to the analyst full particulars of the composition of the animal remedy as shown in the register kept pursuant to section 31 of this Act.
(5)
Every person commits an offence and is liable on summary conviction to a fine not exceeding two hundred dollars who refuses or neglects to comply with any demand made by an inspector pursuant to this section, unless he satisfies the Court that he had no knowledge or reason to believe that the sample demanded was required for the purposes of this Act.
Compare: 1934, No. 5, s. 12
44 Analysis of samples
(1)
On receipt of any animal remedy or sample of any animal remedy taken pursuant to section 43 of this Act, the analyst shall divide it into two approximately equal portions one of which he shall place in a suitable receptacle (which shall then be sealed) for production, if required, in any proceedings which may subsequently be taken in connection with the remedy sampled, and the other of which he shall analyse. The first-mentioned portion shall be retained by the analyst for a period of two years or such other period as the Board may direct, and may then be destroyed.
(2)
After completing the analysis the analyst shall compare the results with the particulars of composition sent to him by the Registrar and shall then make a report of his findings which shall include details of the method of analysis, the basis of and reasons for arriving at any conclusion, and such other details as the Board may require. The analyst shall, as soon as he has completed the report, forward it to the Board.
(3)
The Board shall cause a copy of the analyst’s report to be forwarded to the licensee of the animal remedy analysed.
(4)
If there is a material discrepancy between the result of the analysis and the registered or recorded particulars of composition, the Board may, if it thinks fit, suspend the licensee’s licence and require the licensee to withdraw the animal remedy from sale, or, where the sample analysed was taken from an ascertainable batch of the animal remedy, withdraw that batch from sale.
Compare: 1934, No. 5, s. 13
45 Analysis on request of the buyer
(1)
On payment of the prescribed fee, any person in possession of an animal remedy purchased from a licensee or dealer may at any time notify an inspector in writing that he desires him to take a sample of the animal remedy and have it analysed, whereupon the provisions of sections 42 to 44 of this Act shall apply.
(2)
On completion of the analysis and receipt of the analyst’s report, the Registrar shall notify in writing the person who requested the sample to be taken whether or not there was any material discrepancy between the result of the analysis and the registered or recorded particulars of composition of the animal remedy so sampled and analysed.
(3)
If the result of the analysis shows that the animal remedy is not materially different from the particulars in the application for the licence issued in respect of the remedy, the licensee or dealer shall be entitled to any reasonable expenses incurred in making the sample available for analysis, and may recover those expenses as a debt from the person who applied to have the sample taken and analysed.
(4)
Any person who has been notified by the Registrar under subsection (2) of this section that there is a material discrepancy between the analysis and the registered or recorded particulars of composition shall, in addition to any claim for damages or to any other legal remedy that he may have against the licensee or dealer, be entitled to recover as a debt from the licensee of the animal remedy sampled and analysed any fee paid under subsection (1) of this section.
Compare: 1934, No. 5, s. 14
46 Analyst’s certificate prima facie evidence
(1)
In any proceedings for an offence against this Act the production by the prosecutor of a certificate of analysis purporting to be signed by an analyst shall, without proof of the signature of the analyst, be sufficient evidence, in the absence of proof to the contrary, of the facts stated in it, unless the defendant requires the analyst to be called as a witness, in which case the defendant shall give the prosecutor notice seven clear days before the date of the hearing that he requires the analyst to give evidence at the hearing.
(2)
In any such proceedings the production by the defendant of a certificate of analysis purporting to be signed by an analyst shall, without proof of the signature of that analyst, be sufficient evidence, in the absence of proof to the contrary, of the facts stated in it, unless the prosecutor requires the analyst to be called as a witness. The analyst shall forward to the prosecutor seven clear days before the date of the hearing a copy of the certificate to be produced by the defendant.
Compare: 1934, No. 5, s. 15
47 Tampering with sample
Every person commits an offence and is liable on summary conviction to a fine not exceeding four hundred dollars who—
(a)
Knowingly and fraudulently tampers with any animal remedy so as to lead any inspector, analyst, or other person to believe that a sample of the remedy taken pursuant to this Act is a fair sample of the remedy as manufactured, imported, stocked, or sold; or
(b)
Wilfully breaks the seal of or tampers with any part of a sample taken pursuant to this Act.
Compare: 1934, No. 5, s. 17
Part VI Special Provisions Relating to Biochemical Substances
48 Provisions of this Part in addition to rest of Act
Nothing in this Part of this Act shall derogate from any other provision of this Act.
49 Testing of biochemical substances before sale
(1)
Every licensee who manufactures or imports any biochemical substance shall, if so required by the Board,—
(a)
Provide and maintain an adequate and qualified staff, and adequate premises and plant, for carrying out such tests of the substance as, pursuant to this Act or any regulations thereunder, may be required to be carried out by him, and proper housing of animals used for the purposes of those tests; or
(b)
Make arrangements approved by the Board for tests to be carried out on his behalf.
(2)
No licensee shall sell any biochemical substance unless it has been subjected to the general tests and to the appropriate special tests prescribed in regulations made under this Act, as the case may require, and has attained the particular standard of purity prescribed:
Provided that the Board may, in the case of any particular biochemical substance, dispense with the requirements of this subsection either wholly or in part.
(3)
Every licensee shall keep a permanent record of every batch of any biochemical substance manufactured or imported by him which he has sold and of the application of tests thereto in such form as to be available for inspection and to be easily identifiable by reference to the number of the batch as shown on the label of each container; and shall keep every such record for a period of not less than three years from the date on which it was made, or, in the case of a book containing more than one such record, from the date of the last entry in that book.
(4)
Every licensee who manufactures or imports any biochemical substance shall on request furnish to the Board from every batch of the substance, or from such batch or batches as the Board may from time to time specify, a sample of such amount as the Board considers adequate for any analysis or other examination that it requires to be made; and the licensee, if so required, shall furnish to the Board full particulars of the tests which have been applied.
(5)
If the Board so directs, no licensee shall sell any batch of the biochemical substance in respect of which a sample is or particulars are furnished under subsection (4) of this section until a certificate authorising the sale of the substance has been issued to him by the Board.
(6)
The licensee shall, on being informed by the Board that any part of any batch of the substance has been found not to conform to the standards imposed by this Act or any regulations made under this Act, and on being directed to do so, withdraw the remainder of the batch from sale, and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch.
50 Separate laboratories and utensils to be provided
Any licensee, or the independent contractor of any licensee, who manufactures any vaccine, or for any purposes engages in the culture or manipulation of pathogenic spore-bearing micro-organisms, shall, if the Board so requires, provide to its satisfaction separate laboratories, utensils, and apparatus for the process of manufacture, culture, or manipulation, as the case may be, and the laboratories, utensils, and apparatus so provided shall not be used for any other purpose without the consent of the Board.
51 Manufacturers of biochemical substances to advise Board of certain changes
Every licensee engaged in the manufacture of biochemical substances shall immediately notify the Board in writing if at any time during the currency of his licence he or, where he has the biochemical substance specified in his licence manufactured by an independent contractor, his independent contractor—
(a)
Engages any principal technician to supervise the production of the substance; or
(b)
Ceases to employ any principal technician; or
(c)
Makes any material alteration to the premises or plant used in the manufacture of any biochemical substance.
52 Sale of biochemical substances prohibited after prescribed date
No person shall sell any biochemical substance after the expiration of a period commencing with the date of manufacture and ending with any date stated on the substance’s label as the date to which the substance, if kept under suitable conditions, may reasonably be expected to retain its potency.
53 Offence to sell any biochemical substance in contravention of this Part
Every person who wilfully sells any biochemical substance in contravention of this Part of this Act, or fails to carry out any obligation imposed by this Part of this Act or any lawful direction of the Board made under this Part, commits an offence and is liable on summary conviction to a fine not exceeding four hundred dollars.
Part VII Miscellaneous Provisions
54 Expenses of administration
(1)
All fees and other money paid to the Board under this Act shall be paid into the Consolidated Revenue Account.
(2)
All expenses incurred in respect of the administration of this Act shall be paid out of money from time to time appropriated by Parliament for the purpose.
Compare: 1934, No. 5, s. 20
55 Publication of results of analyses and details of animal remedies
The Board may, after previously notifying the licensee (if any) in writing, from time to time in such manner as it thinks fit—
(a)
Publish the results of any experiment or test made on any animal remedy; or
(b)
With the approval of the Minister, publish full details of the composition of any animal remedy, or the results of any analysis of a remedy made under this Act or any particulars relating to any such remedy, if in its opinion, based on information at its disposal, the publication of those details, results, or particulars is necessary for the protection of purchasers or is otherwise in the public interest.
Compare: 1934, No. 5, s. 19
56 Evidence of documents
(1)
A certificate sealed with the seal of the Board and purporting to be signed by the Registrar certifying that any licence has or has not been issued in respect of any animal remedy, or that any other thing which he or the Board is authorised to do under this Act has or has not been done, shall be received in all Courts and at the hearing of any appeal under section 34 of this Act as sufficient evidence of the matter so certified in the absence of proof to the contrary.
(2)
A copy of any licence, entry in the register, application, statement, undertaking, or other document kept pursuant to this Act, or an extract from any such licence, register, application, statement, undertaking, or other document, sealed with the seal of the Board and purporting to be certified by the Registrar, shall be admitted in evidence in all Courts and at the hearing of any appeal under section 34 of this Act without further proof and without production of the original.
57 Service of notices
(1)
Any notice required or authorised to be given or served under this Act shall be in writing and may be sent by registered letter or telegram addressed to the person on whom it is required to be given or served at his usual place of business, or may be given to or served on him personally.
(2)
Where any notice is sent to any person by registered letter as aforesaid, the notice shall be deemed to have been given or served at the time when the letter would have been delivered in the ordinary course of post.
58 Cancellation of licence
(1)
Where any licensee is convicted of any offence against this Act or under any regulations made under this Act, the Magistrate—
(a)
May, if he thinks fit, order that the licence be suspended for such time as may be specified in the order, or that it be cancelled, and may also, if he thinks fit, declare the convicted licensee to be disqualified from holding a licence for such time as he may determine; and
(b)
Shall, unless the licence is so cancelled, cause particulars of the conviction, and of any order made under this subsection, to be endorsed on the licence, and shall cause a copy of those particulars to be sent to the Registrar, who shall thereupon note them on the appropriate register.
(2)
Any licence required by the Magistrate for cancellation or endorsement under this section shall be produced by its holder in such manner and within such time as the Magistrate directs.
(3)
Every person who, without reasonable cause, fails to produce any licence required to be produced under this section commits an offence and is liable on summary conviction to imprisonment for a period not exceeding one month or to a fine not exceeding two hundred dollars.
(4)
On being notified that any licence has been cancelled under subsection (1) of this section, the Registrar shall publish in the Gazette a notice containing the following particulars:
(a)
The trade name of the animal remedy:
(b)
The name and principal business address of the manufacturer or importer of the animal remedy:
(c)
The number of the licence:
(d)
The fact that the licence has been cancelled.
59 Vicarious liability of manufacturers, importers, and dealers
Where an offence is committed against this Act by any person who is the independent contractor or servant of any manufacturer, or is the agent or servant of any importer or dealer, or is otherwise subject to the supervision or instructions of a manufacturer, importer, or dealer, the manufacturer or, as the case may be, the importer or dealer shall be liable under this Act in the same manner and to the same extent as if he had personally committed the offence:
Provided that, in any proceedings which are taken against a manufacturer, importer, or dealer by virtue of this section, it shall be a defence for that person to prove that the offence was committed without his knowledge and that he exercised all due diligence to prevent the commission of the offence.
60 Offences by companies
Where any company is convicted of an offence against this Act, every director and every officer concerned in the management of the company shall also be liable to be convicted of that offence, unless he satisfies the Court that either—
(a)
The offence was committed without his knowledge or consent; or
(b)
He took all reasonable steps to prevent the commission of the offence.
61 Forfeiture of animal remedies
(1)
Where any person is convicted of an offence against this Act in relation to any animal remedy or any ingredient of any remedy, or any label or container, the Magistrate may, in addition to any other penalty he may impose under this Act, order that the remedy, ingredient, label, or container owned by that person and in respect of which the offence was committed be forfeited to the Crown.
(2)
Every animal remedy, ingredient, label, or container forfeited under this section shall become the property of the Crown and shall be disposed of in such manner as the Minister directs.
62 Notification of conviction of veterinary surgeons and pharmaceutical chemists
Where any person, being a veterinary surgeon or pharmaceutical chemist, is convicted of any offence against this Act or against any regulations made under this Act, the Court shall cause particulars of the conviction to be sent to the person charged with the duty of keeping the register on which the name of the convicted person appears as a veterinary surgeon or pharmaceutical chemist, as the case may require.
63 Sending or carrying an animal remedy under a false description
Every person commits an offence and is liable on summary conviction to a fine not exceeding two hundred dollars who knowingly sends or attempts to send or carries or attempts to carry in any ship or aircraft, or knowingly sends or delivers to any warehouse owner or carrier, any animal remedy which is not licensed under this Act or which is falsely described, or who falsely describes the sender or carrier of the remedy, or who knowingly causes or assists in the commission of any such act.
64 Annual report
(1)
The Board shall, not later than the thirtieth day of June in each year, furnish to the Minister a report of its proceedings and operations for the twelve months ending with the thirty-first day of March of that year.
(2)
A copy of the report of the Board shall be laid before Parliament within twenty-eight days after the date of its receipt by the Minister if Parliament is then in session, and, if not, shall be laid before Parliament within twenty-eight days after the date of the commencement of the next ensuing session.
65 Regulations
The Governor-General may from time to time, by Order in Council, make regulations for all or any of the following purposes:
(a)
Governing the procedure for the making of applications for and the issue and renewal of licences and for the approving of labels and advertisements under this Act:
(b)
Prescribing fees payable in respect of any application, licence, or other document under this Act:
(c)
Prescribing the forms or contents of applications, licences, registers, notices, labels, advertisements, and other documents required for the purposes of this Act, or authorising the Director-General or the Board to prescribe such forms:
(d)
Prescribing standards of quality, purity, and strength of any animal remedy or of any ingredient of a remedy, or providing for the colouring of any remedy:
(e)
Prescribing limits of error allowable in setting out, in applications for licences and in labels or advertisements, the proportions of ingredients present in animal remedies:
(f)
Regulating the keeping and maintaining of the register of licences and record of exemptions required to be kept under this Act:
(g)
Regulating the procedure of the Board:
(h)
Prescribing methods of taking samples and conducting analyses and experiments in respect of animal remedies:
(i)
Providing for the disposal or destruction of any animal remedy which the Board has directed to be surrendered to it or disposed of under section 28 of this Act:
(j)
Prohibiting or restricting the sale and distribution of any animal remedy by travelling salesmen, hawkers, and pedlars:
(k)
Prescribing the duties of analysts and inspectors:
(l)
Providing for the licensing of dealers, and prohibiting any person from acting as a dealer except in pursuance of a licence, and prescribing the conditions (including the payment of fees) subject to which such licences may be issued, renewed, and held:
(m)
Imposing requirements as to the construction, structural alteration, and sanitation of premises on which any animal remedy is manufactured or stored or tested, and regulating the type of plant that may be used in the manufacture of any such remedy:
(n)
Regulating the qualifications that any licensee, or any principal technician, independent contractor, or servant of any licensee, is required to hold in respect of the manufacture of such animal remedies as may be specified in the regulations:
(o)
Prescribing the manner in which and the conditions subject to which animal remedies may be stored or used:
(p)
Regulating the issue by veterinary surgeons of prescriptions for the supply of any animal remedy, and regulating the dispensing of animal remedies exempted from the licensing provisions of this Act:
(q)
Restricting the types of animals on which any specified animal remedy may be used:
(r)
Prescribing the general tests to be carried out on biochemical substances and the appropriate special tests to be carried out on specific biochemical substances or specific classes of biochemical substances before sale:
(s)
Prescribing the precautions to be taken in order to prevent the spread of infection or disease by or to animals kept for the testing of biochemical substances:
(t)
Prescribing the requirements for housing animals kept for testing purposes and the procedure to be followed where any such animals become infected with disease or die from any treatment imposed:
(u)
Requiring licensees to keep records of animal remedies manufactured or imported by them and regulating the keeping of any such records:
(v)
Providing for the appointment of assessors and regulating the conduct of appeals under section 34 of this Act:
(w)
Providing for such matters as are contemplated by or necessary for giving full effect to the provisions of this Act and for its due administration:
(x)
Prescribing offences against any such regulations and prescribing fines not exceeding in respect of any one such offence two hundred dollars and, in the case of a continuing offence, ten dollars for every day on which the offence has continued.
Compare: 1934, No. 5, s. 21
66 Other Acts not affected
Nothing in this Act shall be construed to limit or in any way affect the provisions of the Customs Act 1966, the Narcotics Act 1965, the Merchandise Marks Act 1954, the Poisons Act 1960, the Patents Act 1953, the Designs Act 1953, the Trade Marks Act 1953, the Food and Drugs Act 1947, the Poultry Act 1924, the Sale of Goods Act 1908, the Animals Act 1967, or any other Act.
Compare: 1934, No. 5, s. 22
67 Transitional provisions
Notwithstanding the provisions of subsection (1) of section 68 of this Act, and without limiting the provisions of the Acts Interpretation Act 1924, where any certificate of registration issued in respect of any stock remedy under the Stock Remedies Act 1934 is in force immediately before the commencement of this Act, the holder of the certificate may at any time before the expiry of the certificate apply for a renewal under section 25 of this Act as if his certificate were a licence, and all the provisions of that section shall apply accordingly. If the Board grants the application for renewal, a new licence under this Act shall be issued in place of the certificate of registration.
68 Repeals, consequential amendments, and savings
(1)
The enactments specified in the Second Schedule to this Act are hereby repealed.
(2)
The Schedule to the Department of Agriculture Act 1953 is hereby amended as follows:
(a)
By omitting the words “The Stock Remedies Act 1934”
:
(b)
By inserting, in the appropriate alphabetical order, the words “The Animal Remedies Act 1967”
.
(3)
Every reference to the Stock Remedies Registration Board in any Act or regulation, or in any agreement, deed, instrument, application, licence, certificate, notice, or other document whatsoever, shall, after the commencement of this Act, unless the context otherwise requires, be read as a reference to the Animal Remedies Board.
(4)
Every reference in any regulations made pursuant to the Stock Remedies Act 1934 to a biological product shall, after the commencement of this Act, unless the context otherwise requires, be read as a reference to a biochemical substance.
SCHEDULES
FIRST SCHEDULE FORMS
Section 43(3)(c)
Form 1
The Animal Remedies Act 1967
Inspector’s Label
This receptacle, sealed with the official seal, contains a sample of an animal remedy taken by me pursuant to the Animal Remedies Act 1967 for analysis under section 44 of that Act.
Name of animal remedy:
Manufacturer’s, importer’s, or dealer’s name and address:
Purchaser’s full name and address (if sample taken at purchaser’s request under section 45 of the Act):
Premises on which sample taken:
Witness in whose presence the sample was taken:
[Insert the full name and address; if the manufacturer, importer, or dealer, insert simply “manufacturer”
, “importer”
, or “dealer”
, as the case may require.]
This sample is accompanied by a label relating to the said animal remedy, and supplied to me by the (manufacturer, importer, dealer, or purchaser). [Strike out the words that are inapplicable.]
Date on which the sample was taken:
Full name and address of the analyst to whom the sample is forwarded:
Date on which the sample is forwarded:
Licence number of the animal remedy:
(Signature of the inspector).
(Signature of the manufacturer, importer, dealer, or other witness).
SECOND SCHEDULE Enactments Repealed
Section 68
1934, No. 5—The Stock Remedies Act 1934. (1957 Reprint, Vol. 15, p. 279.)
1936, No. 58—The Statutes Amendment Act 1936: Section 72 and sections 74 and 75. (1957 Reprint, Vol. 15, pp. 131, 282, 287, 295.)
1940, No. 18—The Statutes Amendment Act 1940: Section 51. (1957 Reprint, Vol. 15, pp. 143, 295.)
1946, No. 9—The Stock Remedies Amendment Act 1946. (1957 Reprint, Vol. 15, p. 296.)
1947, No. 19—The Stock Remedies Amendment Act 1947. (1957 Reprint, Vol. 15, p. 296.)
1950, No. 66—The Stock Remedies Amendment Act 1950. (1957 Reprint, Vol. 15, p. 297.)
1951, No. 79—The Fees and Travelling Allowances Act 1951: So much of the First Schedule as relates to the Stock Remedies Registration Board established under the Stock Remedies Act 1934; and so much of the Second Schedule as relates to the Stock Remedies Act 1934. (1957 Reprint, Vol. 4, pp. 860, 863.)
1954, No. 42—The Stock Remedies Amendment Act 1954. (1957 Reprint, Vol. 15, p. 297.)
1960, No. 28—The Stock Remedies Amendment Act 1960.
1961, No. 103—The Stock Remedies Amendment Act 1961.
1962, No. 104—The Stock Remedies Amendment Act 1962.
1963, No. 116—The Stock Remedies Amendment Act 1963.
1966, No. 87—The Stock Remedies Amendment Act 1966.
This Act is administered in the Department of Agriculture.