S.I. No. 179/1996 - Animal Remedies Regulations, 1996 Arrangement of Regulations

( b ) the application shall provide particulars to establish that the applicant has available suitable and sufficient premises, technical equipment and trained staff as regards both manufacture and control and the storage of animal remedies or ingredients thereof;

( c ) the applicant shall satisfy the Competent Authority that all manufacturing shall be carried out in accordance with the criteria set out in Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products; and

( d ) the applicant shall satisfy the Competent Authority that the services of at least one qualified person within the meaning of the Third Schedule are available in relation to carrying out the necessary controls and functions as prescribed by the Council Directive.

• (3) A Manufacturer's licence shall be subject to such conditions as the Competent Authority may specify and may, in particular, include the general conditions set out in the Fourth Schedule.

• (4) The holder of a Manufacturer's licence may only sell or supply an animal remedy manufactured under such licence in accordance with these Regulations and the law of the State.

• (5) The holder of a Manufacturer's licence shall allow an officer of the Competent Authority or an authorised officer access to the premises where the business of manufacture, control, storage, distribution and associated activities, in relation to the manufacture of animal remedies is carried out.

• (6) ( a ) The holder of a Manufacturer's licence shall keep detailed records of each animal remedy manufactured, sold or supplied by him, including samples, in accordance with these Regulations, the Law of the State or, in the case of an animal remedy exported from the State, the laws of the country of destination;

( b ) The following information at least shall be recorded in respect of each transaction whether or not it is made for payment:

• (i) date,

• (ii) name of animal remedy,

• (iii) batch numbers and expiry date,

• (iv) quantity supplied and

• (v) name and address of the recipient.

( c ) The records required under this paragraph shall be available for inspection by an officer of the Competent Authority, an authorised officer, or an officer of the Minister for a period of not less than five years from the date of manufacture, or, for a period which ends one year after the labelled expiry date of the animal remedy whichever is the lodger period.

• (7) A Manufacturer's licence shall remain in force for a period of three years, or such shorter period as may be specified in the licence, unless it is sooner revoked, suspended or varied by the Competent Authority.

• (8) ( a ) The Competent Authority may grant, revoke, suspend or vary a Manufacturer's licence or refuse an application.

( b ) Without prejudice to the generality of this paragraph the Competent Authority shall refuse an application or revoke, suspend or vary a Manufacturer's licence where —

• (i) the manufacture, import, sale, supply or use of the animal remedy concerned is contrary to the Law of the State, or, in the opinion of the Competent Authority, the animal remedy concerned is being or would be sold, supplied or used in the State otherwise than for the purpose specified in the application for a licence or the veterinary product authorisation, or

• (ii) in the opinion of the Competent Authority the staff, premises, equipment, machinery or plant used or to be used, by the applicant or licence holder, are not or cease to be, suitable for such manufacture, or

• (iii) the applicant, or licence holder, does not have, or ceases to have, the services of a qualified person in relation to the animal remedy or substance concerned as required by the Council Directive, or

• (iv) the applicant or licence holder, as the case may be, is incapable of complying with, ceases to, or has failed to comply with the requirements of Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products, or

• (v) in the course of routine inspections or as a result of investigation of pharmacovigilance reports or other complaints it has been established that an animal remedy to which the licence relates is not being manufactured in accordance with the specification stated in the veterinary product authorisation or other standard relating to the said animal remedy, or

• (vi) if in the opinion of the Competent Authority the person is not, for any other reason, (including conviction of an offence or for failure to comply with the conditions attached to a previous licence or animal remedies authorisation), a fit and proper person to hold a licence.

24 Decision on application for manufacture's licence

24.

24. (1) Subject to paragraph (4) the Competent Authority shall, within 90 days of the receipt of an application, notify an applicant for a Manufacturer's licence of a decision to grant a licence, or a proposal to refuse an application.

• (2) If the Competent Authority proposes to refuse an application, the applicant shall be notified in writing of the reasons for such proposal and be invited to make representations to the Competent Authority, within 30 days of the giving of such notification.

• (3) The Competent Authority having considered any representations made under paragraph (2) shall inform the applicant, in writing, of its decision within 60 days of the notification referred to in that paragraph.

• (4) Where the Competent Authority requires further information from an applicant for the purpose of consideration of an application for a Manufacturer's licence, the time limit referred to in paragraph (1) shall be suspended until the information required has been supplied.

• (5) The Competent Authority may revoke, suspend or vary the conditions of a licence granted under this Regulation.

• (6) If the Competent Authority proposes to revoke or suspend a licence or vary the conditions of a licence, the holder of the licence shall be notified of the reasons for such proposal and invited to make representations in the matter to the Competent Authority within 30 days of the giving of such notification.

• (7) The Competent Authority having considered any representation made under paragraph (6), shall inform the licence holder in writing of its decision regarding such proposed revocation, suspension or variation as mentioned in paragraph (6) within sixty days of the notice referred to in that paragraph.

25 SUSPENSION OF MANUFACTURE'S LICENCE

25.

25. (1) Notwithstanding Regulation 24, whenever in relation to a premises in respect of which there is for the time being in force a Manufacturer's licence, an officer of the Competent Authority, who is an authorised officer for the purposes of these Regulations, is of the opinion that there is a grave and immediate risk —

( a ) to public or animal health arising from the manner in which such premises is managed, maintained or operated, or

( b ) that an animal remedy, which is manufactured on such premises and is intended to be sold or supplied for administration to animals, is liable, if so used, to cause illness or injury to a treated animal or the consumer of the produce of such a treated animal, or

( c ) that an animal remedy, which is on such premises and is intended to be sold or supplied for administration to animals, is, or may become, unfit for such purpose by virtue of non-compliance with a provision of these Regulations or the Council Directives,

then such authorised officer may serve on the holder of the Manufacturer's licence in relation to that premises or on the person who seems to him for the time being in charge of such premises, a notice in writing requiring that -

• (i) the manufacture of animal remedies in such premises or part thereof cease forthwith, or

• (ii) the manufacture of a particular animal remedy or a particular class of animal remedy cease forthwith, or

• (iii) the distribution, sale or supply of a particular animal remedy or a particular class of animal remedy cease forthwith, and the notice, or a subsequent notice, may specify the steps which ought to be taken, or the things that ought to be done , before such premises or part thereof, as the case may be, is used for the manufacture of the animal remedy or remedies to which the said notice relates.

• (2) A person upon whom a notice is served under paragraph (1) shall forthwith comply with the terms of the notice.

• (3) Any person who fails to comply with the terms of a notice under paragraph (1) shall be guilty of an offence.

• (4) An officer of the Competent Authority, who is an authorised officer for the purposes of these Regulations, may at any time, by a notice in writing, revoke or vary a notice served under paragraph (1).

• (5) The service of a notice under paragraph (1) shall not be construed as in any way affecting any proceedings, whether instituted before or after such service, to revoke, vary or suspend a manufacturer's licence, or in which a contravention of any provision of the Act or of Regulations made thereunder is alleged.

• (6) Any person aggrieved by a notice under paragraph (1) may, not later than 21 days after the service of the notice, make representations in the matter to the Competent Authority.

• (7) The Competent Authority shall consider such representations and shall, as it thinks proper, affirm, vary or cancel the notice.

26 POSSESSION ETC. OF A PROHIBITED ANIMAL REMEDY

26.

26. (1) Notwithstanding Regulation 21, a person shall not have possession of, manufacture, import into the State, sell or supply a prohibited animal remedy save under and in accordance with a licence under this Regulation (referred to in this Regulation as "a licence").

• (2) Subject to the subsequent provisions of this Regulation, on application to the Minister in that behalf by or on behalf of a person the Minister may grant a licence to the person authorising the possession, manufacture, import, sale or supply by that person of such quantity as may be specified in the licence of a prohibited animal remedy so specified or the Minister may refuse the application.

• (3) The Minister may, if he or she thinks it appropriate to do so, for the purpose of ensuring compliance with these Regulations and the law of the State and having regard to the provisions of this Regulation, attach conditions to a licence at the time of the grant of the licence or subsequently and may amend or revoke a condition attached to a licence.

• (4) Without prejudice to the generality of paragraph (2) the Minister shall refuse an application for a licence to manufacture a prohibited animal remedy if he or she is not satisfied that all of the prohibited animal remedy or substance is intended to, and will, be —

( a ) administered to animals in the course of a test or trial authorised by a licence granted pursuant to Regulation 41, or

( b ) supplied to the Competent Authority or the Minister for the purpose of an application for an animal remedies authorisation, or

( c ) supplied to a University or other institution concerned with higher education or scientific research or analysis for the purposes of such education or research or analysis, or

( d ) used for in vitro or other studies or analysis not involving administration to animals, or

( c ) exported from the State.

• (5) Without prejudice to the generality of paragraph (2) the Minister shall refuse an application for a licence authorising the possession, import, sale or supply of a prohibited animal remedy if he or she is not satisfied that all of the prohibited animal remedy or substance is intended to, and will, be -

( a ) administered to animals in the course of a test or trial referred to in paragraph (4) (a), or

( b ) supplied to the Competent Authority or the Minister for the purposes referred to in paragraph 4(b), or

( c ) supplied to a University or other institution concerned with higher education or scientific research or analysis for the purposes for the purposes referred to in paragraph 4(c), or

( d ) used for the purposes referred to in paragraph 4(d).

• (6) The Minister shall refuse to grant a licence to a person or shall revoke a licence held by a person if —

( a ) the person has been convicted of, or has committed, an offence, whether he or she has been convicted or not, under the Act or Regulations deemed to have been made thereunder, or for any other conviction, or failure to comply with the conditions attached to a previous licence or animal remedies authorisation, or, is not, in the opinion of the Minister, a fit and proper person to hold a licence; or

( b ) in the opinion of the Minister, the possession, manufacture, import, sale or supply (as may be appropriate having regard to the particular class of licence applied for or held) of the prohibited animal remedy concerned prejudices, or would prejudice, public or animal health or trade in animals or animal products from the State; or

( c ) in the opinion of the Minister, the prohibited animal remedy concerned is being or would be sold, supplied or used in the State otherwise than for a purpose specified in paragraph (4) or (5) of this Regulation; or

( d ) in the case of a licence authorising the manufacture of a prohibited animal remedy, in the opinion of the Minister, the staff, premises, equipment, machinery or plant used, or to be used, are not suitable for the purpose of such manufacture.

27 CERTIFICATES

27.

27. (1) The Minister, or as the case may be, the Competent Authority, shall, at the request of the holder of a Manufacturer's licence, an exporter or the appropriate authority in an importing state, provide a certificate stating that

( a ) the manufacturer is in possession of a valid Manufacturer's licence to manufacture a particular class of animal remedy, and

( b ) there is for the time being in force an animal remedies authorisation relating to the animal remedy to be exported, or

( c ) where there is no such animal remedies authorisation in force the animal remedy to be exported has been manufactured for such purpose pursuant to a licence granted under Regulation 26.

• (2) In granting a certificate under paragraph (1) the Minister and the Competent Authority shall have regard to the prevailing administrative arrangements of the World Health Organisation regarding the issue of certification for animal remedies.

• (3) Where there is for the time being in force an animal remedies authorisation the Minister or the Competent Authority shall, if requested, supply a copy of the approved summary of product characteristics and where such document is not available, an equivalent document.

• (4) Where the manufacturer is not in possession of an animal remedies authorisation in respect of the animal remedy to be exported an application for a certificate under paragraph (1) shall be accompanied by a declaration stating why such an authorisation has not been sought.

PART IV SALE AND SUPPLY OF ANIMAL REMEDIES

28 RESTRICTION ON SALE OF CERTAIN ANIMAL REMEDIES

28.

28. (1) Subject to paragraphs (2) and (3) a person shall not sell or supply an animal remedy save under and in accordance with a licence granted for that purpose by the Minister.

• (2) Paragraph (1) shall not apply to —

( a ) the sale or supply of an animal remedy by, or under the supervision of, a pharmacist, subject to these Regulations, or

( b ) the sale or supply of an animal remedy by a registered veterinary surgeon to a bona fide client in the course of the provision of a professional service, for the treatment of an animal under the care of, and concerning which, such registered veterinary surgeon (or group veterinary practice of which such registered veterinary surgeon is a member), has been consulted in a professional capacity in accordance with Regulation 44 or Regulation 46

( c ) the sale by wholesale of an animal remedy by the holder of a Manufacturer's licence where the animal remedy is manufactured by the said licence holder under and in accordance with a Manufacturer's licence.

• (3) The holder of a Manufacturer's licence or an Animal Remedies Wholesaler's licence shall not sell an animal remedy to a particular person unless —

( a ) the person to whom the animal remedy is to be sold or supplied is lawfully entitled, by virtue of these Regulations or a licence granted thereunder, to sell or supply animal remedies, and

( b ) the sale or supply of such animal remedy by the person to whom the animal remedy is to be sold or supplied would not contravene these Regulations.

• (4) No person shall publish or cause to be published an advertisement or other promotion for an animal remedy unless such animal remedy is an authorised animal remedy.

29 RESTRICTION ON USE OF PREMISES

29.

29. A person shall not use a premises for the sale or supply of an animal remedy unless such premises is —

• (1) a premises in respect of which there is for the time being in force a Manufacturer's licence, or

• (2) a premises in respect of which there is for the time being in force an Animal Remedies Wholesaler's licence, or

• (3) a premises in respect of which there is for the time being in force an Animal Remedies Merchant's licence, or

• (4) a premises in respect of which there is for the time being in force a Companion Animal Medicine Seller's licence, or

• (5) a pharmacy, or

• (6) such part of a premises, not being a shop, as is used by a registered veterinary surgeon in connection with carrying on the practice of veterinary medicine and surgery.

30 WHOLESALE OF ANIMAL REMEDIES

30.

30. (1) No person shall sell or supply an animal remedy by wholesale except under and in accordance with a licence ('Animal Remedies Wholesaler's licence').

• (2) Following consideration of an application for an Animal Remedies Wholesaler's licence the Minister may grant a licence or refuse an application.

• (3) An applicant for an Animal Remedies Wholesaler's licence shall satisfy the Minister that he or she has suitable premises, equipment and staff and suitable arrangements for record-keeping, handling, storage and distribution of the animal remedies which it is proposed to sell.

• (4) An Animal Remedies Wholesaler's licence may relate to animal remedies generally, to animal remedies of a particular class or description specified in such licence, or to one or more animal remedies specified in such licence.

• (5) An Animal Remedies Wholesaler's licence shall specify the location and premises from which the business of sale or supply of animal remedies by wholesale may be carried out and such premises may not be used for the purposes of Regulation 31 or Regulation 32.

• (6) An Animal Remedies Wholesaler's licence shall be subject to such conditions as the Minister may specify and shall, in particular, require that the holder of the licence —

( a ) shall sell or supply an animal remedy only to a person who is the holder of a valid Animal Remedies Wholesaler's licence, or, a valid Animal Remedies Merchant's licence, or, as the case may be, a valid Companion Animal Seller's licence, applicable to the class of animal remedy to be supplied, or to a pharmacist or a registered veterinary surgeon;

( b ) shall not sell or supply an animal remedy

• (i) other than an animal remedy to which the licence relates,

• (ii) which is not the subject of an animal remedies authorisation for the time being in force,

• (iii) otherwise than in conformity with the provisions of the animal remedies authorisation, granted in respect of such animal remedy, as stated on the packaging or labelling in relation to the sale or supply of the animal remedy;

( c ) shall provide and maintain such premises, equipment and staff, and have in operation such arrangements as are necessary to avoid deterioration of the animal remedy to which the licence relates and shall notify the Minister promptly of any material change in such premises, equipment, staff or arrangements;

( d ) shall undertake procedures for storage, stock rotation and maintenance of records which are in compliance with the particulars furnished in connection with the application for the licence or with such other arrangements as may be approved by the Minister from time to time;

( e ) shall, on being informed by the Minister or the Competent Authority or the manufacturer that

• (i) any batch or part of a batch of an animal remedy to which the licence relates has been found not to conform as regards the provisions of the relevant product authorisation in force under these Regulations or as regards strength, quality or purity with the appropriate specification of that animal remedy, or

• (ii) an animal remedy to which the licence relates has been found to give rise to unacceptable adverse reactions,

if so directed by the Minister or the Competent Authority, in relation such animal remedy or batch thereof, immediately withdraw from sale or supply any supplies held by him or her and, so far as is practicable, immediately recall all supplies already sold or supplied by him or her;

• (f) shall keep records, of purchase/sales invoices in a machine readable or other form in respect of which the Minister has given prior approval, in respect of each incoming and outgoing transaction detailing at least the following information

• (i) date of transaction;

• (ii) precise identity of the animal remedy including name and pharmaceutical form and pack sizes;

• (iii) manufacturer's batch number and expiry date;

• (iv) quantity received or supplied;

• (v) name and address of the supplier or consignee.

• (g) shall keep available the records referred to in subparagraph (f) for inspection by an authorised officer or an officer of the Competent Authority for a period of three years from the date of receipt, sale or supply of the animal remedy;

• (h) shall permit such inspections and make available such information as may be required to satisfy the Minister that the conditions of the licence are being complied with,

• (i) shall give without payment, an adequate sample of an animal remedy to a person authorised to take such a sample; and

• (j) shall furnish to the purchaser with each supply of an animal remedy information detailing:

• (i) the date of supply,

• (ii) precise identity of the animal remedy including proprietary name and pharmaceutical form and pack size,

• (iii) the quantity supplied,

• (iv) the name and address of the supplier and consignor and

• (v) the manufacturer's batch number.

• (7) An Animal Remedies Wholesaler's licence shall remain in force for a period of one year, or for such shorter period as may be specified by the Minister, unless it is sooner suspended, varied or revoked.

• (8) The holder of an Animal Remedies Wholesaler's licence shall, at least once a year, carry out a detailed audit to compare incoming and outgoing supplies with supplies currently held in stock and any discrepancies shall be specifically recorded and such record shall be retained and made available for inspection by an authorised officer for a period of not less that three years.

• (9) Notwithstanding paragraph (1) a person who is

• (a) engaged in the lawful wholesale of animal remedies, and

• (b) who is lawfully carrying on such business on the date on which these Regulations come into force, and

• (c) who is registered in accordance with the provisions of the Animal Remedies (Registration of Manufacturers, Importers and Wholesalers) Regulations, 1980 ( S.I. No. 115 of 1980 ),

shall, within three calendar months, apply to be licenced by the Minister pursuant to this Regulation and may sell or supply animal remedies to a person referred to in paragraph (6) (a) in accordance with the provisions of these Regulations until such time as the application is determined.

• (10)
• (a) This Regulation shall not apply to

• (i) arrangements for the distribution of animal remedies amongst themselves by one member of a group of persons not exceeding three in number who cooperate in the purchase by wholesale of animal remedies, or,

• (ii) the sale of an animal remedy by a person who manufactured it in accordance with a Manufacturer's licence.

• (b) "Person" for the purposes of subparagraph (a) (i) means a pharmacist or a registered veterinary surgeon.

• (c) Where an animal remedy is sold or supplied or received in accordance with the provisions of sub paragraph (i) details of each transaction shall be recorded in the manner prescribed by these Regulations for the retail sale or supply of animal remedies.

31 RETAIL SALE OF ANIMAL REMEDIES

31.

31. (1) No person shall sell an animal remedy by retail except under and in accordance with a licence ('Animal Remedies Merchant's licence').

• (2) Following consideration of an application for an Animal Remedies Merchant's licence the Minister may grant a licence or refuse an application.

• (3) An applicant for an Animal Remedies Merchant's licence shall satisfy the Minister that he or she has suitable premises, equipment and staff and suitable arrangements for record-keeping, handling, storage and distribution of each animal remedy or class of animal remedy to which the application relates.

• (4) An Animal Remedies Merchant's licence may relate to animal remedies generally, to animal remedies of a particular class or description, or to one or more animal remedies specified in such licence.

• (5) An Animal Remedies Merchant's licence shall specify the location and premises from which the business of retail sale of animal remedies is to be carried out and such premises may not be used for the purposes of Regulation 30.

• (6) An Animal Remedies Merchant's licence shall be subject to such conditions as the Minister may specify and shall, in particular, require that the holder of the licence

• (a) shall not sell or supply an animal remedy —

• (i) other than an animal remedy to which the licence relates, or

• (ii) which is not the subject of an animal remedies authorisation for the time being in force, or

• (iii) otherwise than in conformity with the provisions of the animal remedies authorisation granted in respect of such animal remedy;

• (iv) other than in accordance with the provisions of these Regulations and the law of the State;

• (v) to a person to whom Regulation 30(6) (a) refers.

• (b) shall provide and maintain such premises, equipment and staff, and have in operation such arrangements as are necessary to avoid deterioration of an animal remedy to which the licence relates and shall notify the Minister within seven days of any material change in such premises, equipment, staff or arrangements,

• (c) shall undertake such procedures for storage, stock rotation and maintenance of records as may be specified in compliance with the particulars furnished in connection with the application for the licence or with such other arrangements as may be approved by the Minister from time to time.

• (d) shall, on being informed by the Minister or the Competent Authority or the manufacturer that

• (i) any batch or part of a batch of an animal remedy to which the licence relates has been found not to conform as regards the provisions of the relevant product authorisation or as regards strength, quality or purity with the appropriate specification of that animal remedy, or

• (ii) an animal remedy to which the licence relates has been found to give rise to unacceptable adverse reactions,

if so directed by the Minister or the Competent Authority, in relation such animal remedy or batch thereof, immediately withdraw from sale or supply any supplies held by him, and, in so far as is practicable, immediately recall all such animal remedies already sold or supplied by him.

• (e) without prejudice to Regulation 37, shall not possess, sell or supply an animal remedy which consists of or contains an organophosphorous substance unless and until a person has completed an appropriate training course approved by the Minister.

• (7) An Animal Remedies Merchant's licence shall remain in force for a period of one year, or for such shorter period as may be specified by the Minister, unless it is sooner suspended, varied or revoked.

• (8) The holder of an Animal Remedies Merchant's licence shall, at least once a year, carry out a detailed audit to compare incoming and outgoing supplies with supplies currently held in stock and any discrepancies shall be specifically recorded and such record shall be retained and made available for inspection by an authorised officer for a period of not less that three years.

• (9) The Minister shall not grant a licence in respect of a premises unless the premises conforms to the general conditions set out in the Fifth Schedule.

32 SALE OF COMPANION ANIMAL REMEDIES

32.

32. (1) (a) No person shall sell an animal remedy to which this Regulation applies except under and in accordance with a licence ('Companion Animal Medicine Seller's Licence') granted by the Minister.

• (b) In this Regulation: "companion animal" means domestic dogs and cats, rabbits (which are not kept for human consumption) small rodents, cage birds, homing pigeons, terrarium animals and aquarium fish.

• (c) The holder of a Companion Animal Medicine Seller's licence may only sell an animal remedy designated as a companion animal medicine.

• (2) Following consideration of an application for a Companion Animal Medicine Seller's licence the Minister may grant a licence or refuse an application.

• (3) A Companion Animal Medicine Seller's licence shall be subject to such conditions as the Minister may specify and, in particular, shall specify the location and premises from which the business of sale of animal remedies is to be carried out and that such premises may not be used for the purposes of Regulation 30 or Regulation 31.

• (4) A person who is engaged in the lawful business of sale of companion animal medicines, who is not a person to whom Regulation 30 or Regulation 31 applies and who is lawfully carrying on such business on the date on which these Regulations come into force, shall, within twelve calendar months apply to be licenced by the Minister pursuant to this Regulation and may continue to carry out such business in accordance with this Regulation until such time as the application is determined.

33 RECORDS

33.

33. (1) This Regulation applies to:—

• (a) an animal remedy which is designated veterinary surgeon only, prescription only, prescription only exempt or pharmacy only by virtue of these Regulations or the Law of the State, or

• (b) an animal remedy intended for administration to food producing animals whose flesh or products may be used for human consumption and in respect of which a withdrawal period must be observed by virtue of these Regulations, Community Law or the Law of the State.

• (2) A person who sells or supplies an animal remedy to which this Regulation applies in a retail sale or in the course of a professional service shall record the following information in relation to each incoming and outgoing transaction —

• (a) date of receipt or, as the case may be, sale or supply,

• (b) proprietary name or, where not applicable, the precise identity of the animal remedy,

• (c) quantity received, sold or supplied.

• (d) name and address of the supplier or, as the case may be, the recipient, and

• (e) where relevant, the name and address of the prescribing veterinary surgeon and a copy of the prescription.

• (3)
• (a) Where a veterinary surgeon sells or supplies an animal remedy to which subparagraph (1) (a) applies it shall be clearly labelled with a notice stating —

• (i) proprietary name if this is not stated on the product label or, where not applicable, the precise identity of the animal remedy;

• (ii) the active ingredient if this is not stated on the product label or, if applicable, on the package insert;

• (iii) the manner and site of administration if this is not stated on the product label or, if applicable, the package insert;

• (iv) the dose rate and withdrawal period to be observed if this is not stated on the product label or, if applicable, the package insert;

• (v) a description of the animal or animals to which the animal remedy is to be administered;

• (vi) the person or class of persons by whom the animal remedy is to be administered:

• (vii) the name and address of the person to whom the animal remedy is being supplied;

• (viii) the name and address of the registered veterinary surgeon supplying the animal remedy; and

• (ix) the date of supply.

• (b) In the case of an animal remedy in relation to which it is not possible to give the particulars specified in subparagraph (3)(a) it shall be sufficient compliance therewith if those particulars are attached to the animal remedy by a means other than by a label provided the name and address of the registered veterinary .surgeon selling or supplying the animal remedy, the name of the person to whom supplied, and the date of such sale or supply are specified on a label attached to the animal remedy.

• (c) Where a registered veterinary surgeon sells or supplies an animal remedy to which this Regulation applies he or she shall, in addition to the particulars prescribed in paragraph (2) record the identity of the animal or animals to be treated.

• (d) Where a label placed on an animal remedy pursuant to an animal remedies authorisation contains any of the information required by paragraph (3), such information need not be repeated on the notice required pursuant to subparagraph (a) provided the aforesaid label is not obscured in any material way.

• (4)
• (a) A pharmacist who has dispensed in part a prescription issued under these Regulations shall immediately record on the prescription and on the copy thereof in a conspicuous and indelible manner the quantity of each animal remedy sold or supplied by him on foot of the prescription and the date on which each such sale or supply was made.

• (b) A pharmacist who has completed the dispensing of a prescription issued under this Regulation shall write on the prescription and on the copy thereof in a conspicuous and indelible manner the word "dispensed" and the date on which the dispensing was completed.

• (c) Where a pharmacist has duly completed the dispensing of a prescription he or she shall return a copy of the prescription to the person who presented it for dispensing and retain the original prescription for a period of three years, such copy to be made available on request to an authorised officer.

• (d) A pharmacist, who sells or supplies an animal remedy to which paragraph (1) (a) applies shall affix (in such manner as not to obscure the information required by the animal remedies authorisation to be stated on the label or container) to such animal remedy a label indicating the name and address of the dispensing pharmacist, the name and address of the person to whom sold or supplied, the name of the prescribing registered veterinary surgeon and the date of sale or .supply.

• (5) A person who sells or supplies an animal remedy, to which this Regulation applies, and who maintains the records prescribed by this Regulation in a machine readable form shall, in respect of each days transactions, make and sign a hard copy of that record which shall be kept on the premises and be made available on request to an authorised officer for a period of not less than three years.

34 EMERGENCY SUPPLY OF CERTAIN ANIMAL REMEDIES BY PHARMACISTS

34.

34. (1) It shall not be a contravention of the Regulations for a pharmacist to sell or supply an authorised animal remedy to which Regulation 14 applies or which is designated prescription only in accordance with Regulation 13 where —

• (a) the pharmacist by whom the animal remedy is to be sold or supplied has been requested to sell or supply the animal remedy for the treatment of a particular animal by a registered veterinary surgeon who by reason of an emergency is unable to furnish a prescription immediately, and

• (b) the registered veterinary surgeon concerned has undertaken to furnish a prescription within 72 hours, and

• (c) the animal remedy is sold or supplied in accordance with the directions of the registered veterinary surgeon requesting it, and

• (d) the animal remedy is not a controlled drug specified in Schedule 1 or 2 to the Misuse of Drugs Regulations, 1988, or an animal remedy consisting of or containing a substance specified in Part I of the Second Schedule, and

• (e) the animal remedy is labelled in accordance with of Regulation 33 (4) and the pharmacist maintains the records prescribed by Regulation 33 (2).

• (2) If a registered veterinary surgeon fails to comply with an undertaking under paragraph (1) (b), the pharmacist may not, in the future, sell or supply an animal remedy under this Regulation at the request of that registered veterinary surgeon.

35 PROHIBITION ON SALE OF ANIMAL REMEDIES AFTER EXPIRY DATE

35.

35. (1) A person shall not sell or supply an animal remedy after the date specified thereon as its expiry date.

• (2) "Expiry date" in relation to an animal remedy means the date specified on the container, label or package insert of the animal remedy by the manufacturer in accordance with the terms and conditions of the veterinary product authorisation.

36 SALE OF ANIMAL REMEDIES RESTRICTED TO FIXED PREMISES

36.

36. (1) Without prejudice to paragraph (2), notwithstanding that the Minister has granted a licence under Regulation 30 or Regulation 31 or Regulation 32 the sale or supply of an animal remedy otherwise than from a fixed premises is hereby prohibited.

• (2)
• (a) Paragraph (1) shall not apply to the sale or supply of an animal remedy in the course of the provision of a professional service by a registered veterinary surgeon in respect of the treatment of animals under the care of such registered veterinary surgeon who has been consulted in a professional capacity and given care of the animals concerned.

• (b) Subparagraph (a) shall only apply to such range and quantity of animal remedies as is generally required for the Daily needs of good veterinary' practice.

• (3) There is hereby prohibited save under licence of the Minister —

• (a) the sale or supply of an animal remedy from a travelling shop, vehicle or automatic vending machine or retail sale or supply by mail order, or

• (b) the making of visits from house to house for the purpose of soliciting, collecting or obtaining orders, or

• (c) the sale or supply of an animal remedy at trade fairs or any public or private place where animals are placed for exhibition or competition.

• (4) Paragraph (3)(b) shall not apply where house to house visits are made to persons at their respective places of business and the persons so visited are lawfully entitled to sell or supply any such animal remedy from their respective places of business.

• (5) In this Regulation:—

"house" includes land or other premises;

"fixed premises" shall not include any vehicle, trailer, caravan, or other thing which may be transported on, in, or attached to a vehicle, or, any tent, awning, or hut, shed, or any unroofed or temporary structure or stall or any yard, field, roadway, or casual trading area.

37 TRAINING OF CERTAIN PERSONS

37.

37. (1) For the purpose of ensuring that a person, other than a registered veterinary surgeon or a pharmacist has adequate training in the proper and safe handling and storage of animal remedies to be responsible for the retail sale or supply of such remedies the Minister shall approve appropriate training courses.

• (2) A person who has successfully completed such a training course shall hereinafter be referred to as a responsible person.

• (3) With effect from three years after the coming into force of these Regulations the Minister shall not grant or renew an Animal Remedies Merchant's licence unless the sale or supply of animal remedies on the premises to which the said licence relates is conducted by or under the personal supervision of such a responsible person.

• (4) Nothing in this Regulation shall entitle a responsible person to sell or supply animal remedies which are designated veterinary surgeon only prescription only, prescription only exempt or pharmacy only, or, to offer advice concerning the treatment of an animal that would contravene the Veterinary Surgeons Acts, 1931 to 1960.

• (5) It shall be a condition of approval of a course that the person providing the course shall furnish the Minister with the names and addresses of persons who have successfully completed such course.

• (6) The Minister may refuse to accept the nomination of a person to be a responsible person, if notwithstanding that the person has successfully completed an approved training course, the person has been convicted of an offence under the Act or Regulations made or deemed to have been made thereunder.

PART V ADMINISTRATION OF ANIMAL REMEDIES AND PROVISIONS RELATING TO ANIMALS AND ANIMAL PRODUCTS

38 Administration of animal remedies

38.

38. (1) Without prejudice to Regulation 40 and subject to paragraph (2), a person shall not, except under and in accordance with a licence under Regulation 41, administer an animal remedy to an animal, or cause or permit any such administration.

• (2) Paragraph (1) shall not apply to the administration of an authorised animal remedy to an animal of any particular kind where —

• (a) the administration is carried out in accordance with the provisions of the conditions of use stated in the animal remedies authorisation, or other conditions of use pursuant to the Council Directives, Law of the State and Community Law, and

• (b) the animal remedies authorisation concerned authorises the administration of the animal remedy to animals of that kind, and

• (c) the animal remedies authorisation authorises the use of the animal remedy by that person, and

• (d) the Act has been complied with in respect of the animal remedy.

• (3)
• (a) A person, including a registered veterinary surgeon, who administers, or authorises, directs or permits the administration of an authorised animal remedy to a food producing animal shall

• (i) act in conformity with the conditions of use of that animal remedy (other than those relating to the treated animal that fall to be complied with after such administration), and

• (ii) if the person is not the owner or the person in charge of the treated animal, inform the owner or person in charge of such animal

• (I) of the conditions of use of the animal remedy relating to the treated animal that fall to be complied with after such administration, and

• (II) that the treated animal may not be slaughtered for human consumption or sold or exported if it is intended to be slaughtered for human consumption, during the withdrawal period specified in the conditions of use of the animal remedy, and

• (III) that the produce of the treated animal may not be sold, supplied or used for human consumption during the withdrawal period specified in the conditions of use of the animal remedy.

• (b) The owner or person in charge of an animal to which an authorised animal remedy has been administered shall —

• (i) comply with the conditions of use of the animal remedy relating to the treated animal that fall to be complied with after such administration, and

• (ii) not slaughter the treated animal for human consumption, or export or sell such animal, if it is intended to slaughter it for human consumption, during the withdrawal period specified in the conditions of use of the animal remedy, and

• (iii) shall not sell, supply or use for human consumption, or permit the sale, supply or use for human consumption, the produce of the treated animal during the withdrawal period specified in the conditions of use of the animal remedy.

• (4) In this Regulation "conditions of use", in relation to an animal remedy, means

• (a) the information and directions that, pursuant to the relevant animal remedies authorisation are required to appear on containers and outer packages of, and package inserts for, the animal remedy, or

• (b) where the animal remedy is sold or supplied by a registered veterinary surgeon in accordance with Regulation 40(1)(a) the conditions of use stated in the product authorisation granted in the State of origin.

• (5) It shall be the duty of the owner or person in charge of an animal to take such care as will ensure that this Regulation is not contravened in relation to such animal.

39 PROVISIONS RELATING TO CERTAIN ANIMALS TO WHICH AN ANIMAL REMEDY HAS BEEN ADMINISTERED

39.

39. A person shall not —

• (1) administer to a food producing animal, by any means whatsoever, an animal remedy or an ingredient for an animal remedy, which consists of or, or contains, a substance the administration of which to such animal, or species or class of animal, is prohibited under these Regulations, the law of the State or Community Law; or

• (2) import, export, sell or supply, or, slaughter for human consumption, a food producing animal to which an animal remedy or an ingredient for an animal remedy has been administered in contravention of subparagraph (1); or

• (3) import, export, sell or supply for human or animal consumption any meat, milk or egg derived from, or produced by, an animal to which an animal remedy has been administered in contravention of subparagraph (1); or

• (4) process meat, milk or egg as referred to in subparagraph (3) or import, export or sell any meat, milk or egg product prepared from, or with, such meat, milk or egg; or

• (5) have in his or her possession or under his or her control a food producing animal to which an animal remedy has been administered in contravention of subparagraph (1) or meat, milk or egg derived from, or produced by, such an animal.

40 ADMINISTRATION OF ANIMAL REMEDIES

40.

40. (1) Notwithstanding Regulation 38 and subject to the subsequent provisions of this Regulation, where there is no authorised animal remedy for the treatment of a condition in a particular species and, where it is necessary in order to avoid causing unacceptable suffering to the animal or animals concerned, a registered veterinary surgeon may administer, sell, supply or prescribe the use of—

• (a) an animal remedy in respect of which there is for the time being in force an animal remedies authorisation authorising the use of such animal remedy in another animal species or for another condition in the same species, or

• (b) if there is no animal remedy such as referred to in subparagraph (a), a medical preparation authorised for human use in accordance with the provisions of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 and 1989 and the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1993 ( S.I. No. 70 of 1993 ), or

• (c) if there is no animal remedy or medical preparation as referred to at subparagraphs (a) or (b), an animal remedy prepared extemporaneously by —

• (i) a pharmacist in accordance with the prescription of a registered veterinary surgeon, or

• (ii) a registered veterinary surgeon, in respect of animals under his or her care concerning which he or she has been consulted in a professional capacity, or

• (iii) a person licensed to manufacture such class of animal remedy in accordance with Regulation 21.

• (2) Where it is necessary to treat a food producing animal in accordance with paragraph (1), the provisions of that paragraph shall only apply to the administration or prescription of substances which are to be found in animal remedies authorised by the Competent Authority or licensed by the Minister for administration to food producing animals.

• (3) Where a registered veterinary surgeon administers or prescribes an animal remedy in accordance with paragraph (1) for administration to food producing animals such registered veterinary surgeon shall specify an appropriate withdrawal period so as to ensure that food produced from the treated animal does not contain residues which may be harmful for consumers of produce derived from treated animals.

• (4) Where an animal remedy or medical preparation administered or prescribed in accordance with paragraph (1) does not indicate a withdrawal period for the species to be treated, the following withdrawal periods shall be mandatory unless a longer withdrawal period is specified in accordance with paragraph (3):—

-	eggs from treated animals	- 7 days
-	milk from treated animals	- 7 days
-	meat, including fat & offal from poultry and mammals	- 28 days
-	meat from fish	- 500 degree days.

• (5) Where a registered veterinary surgeon administers or prescribes an animal remedy in accordance with paragraph (1) a record shall be kept detailing

• (a) date of examination of animals,

• (b) identification of animals,

• (c) number of animals treated,

• (d) name and address of owner or person in charge of the animals,

• (e) diagnosis,

• (f) details of the animal remedy or medicinal product administered or prescribed and reasons for such choice,

• (g) the dosage administered or prescribed,

• (h) the duration of treatment,

• (i) the withdrawal period, if any, specified.

• (6) The records specified in paragraph (5) shall be maintained for three years and be furnished on request for examination by an authorised officer.

• (7) This Regulation applies to the treatment of an individual animal or a small number of animals on a particular holding or premises and shall not be construed so as to provide for the general manufacture, sale, supply or use as an animal remedy of a medical preparation or an animal remedy to which subparagraph (1)(b) or subparagraph (1)(c) applies.

• (8) A registered veterinary surgeon who prescribes, sells or supplies an animal remedy under this Regulation (or a pharmacist who sells or supplies an animal remedy in accordance with the prescription of a registered veterinary surgeon) shall label the animal remedy with a notice in the form prescribed and containing the information specified by Regulation 33 (3).

• (9) This Regulation shall not apply to the administration of an animal remedy to an animal or class of animal where the administration of such animal remedy to such animal or class of animal is specifically prohibited by the animal remedies authorisation or where the animal remedy consists of, or contains, a substance the administration of which to such an animal or class of animal is prohibited by the law of the State or any provision of Community Law.

• (10) An animal remedy administered in accordance with, and for the purposes provided for by, this Regulation, shall for the purposes of such administration be deemed to be an authorised animal remedy.

41 CLINICAL TRIALS

41.

41. (1) Tests and trials of animal remedies for the purposes of Article 5.10 of the Council Directive shall not be performed other than under and in accordance with a license, granted by the Minister (referred to subsequently in this Regulation as "a license") under this Regulation and by persons authorised, at such premises and on such animals as may be specified, in that behalf by the license.

• (2) A person engaged in scientific research or analysis may not administer an animal remedy, other than an authorised animal remedy in accordance with the provisions of the product authorisation, to an animal for the purpose of scientific research or analysis save under and in accordance with a license (referred to in this Regulation as "a license") under this Regulation.

• (3) Subject to the subsequent provisions of this Regulation, on application to the Minister in that behalf by or on behalf of any person , the Minister may, after consultation with the Competent Authority, if he or she is satisfied that the person is qualified and competent to perform on animal remedies the tests, trials, scientific research or analysis aforesaid, grant a license to the person authorising the performance by the person, for the purposes of the said Council Directive or scientific research or analysis, of the said tests, trials, research or analysis on the animal remedy specified in the license.

• (4) The Minister may, if he or she thinks it appropriate to do so for the purpose of ensuring compliance with these Regulations and the law of the State and having regard to the provisions of this Regulation, attach conditions to a license at the time of the grant of the license or subsequently and may amend or revoke a condition attached to a license.

• (5) The Minister shall refuse to grant a license to a person and shall revoke a license held by a person if the person has been convicted of or committed, (whether or not he orshe has been convicted), an offence under the Act or Regulations made or deemed to have been made thereunder, or is for other reasons (including conviction of another offence) not, in the opinion of the Minister, a fit and proper person to hold a license.

• (6) From 1 January, 1997, no produce derived from animals which have been treated in the course of a test, trial or research to which this Regulation applies may be used for human consumption unless a Maximum Residue Limit has been established forthe active ingredient concerned in accordance with the provisions of Council Regulation (EEC) No 2377/90, and the Minister is satisfied that an appropriate withdrawal period has been established to ensure that this maximum residue limit will not be exceeded in the produce.

• (7) Notwithstanding Regulation 39, a person may have in his or her possession or under his or her control and may slaughter, sell, supply or export an animal to which a license under this Regulation relates under and in accordance with such license.

42 WITHDRAWAL PERIODS

42.

42. (1) Where an animal remedy is administered to an animal or animals whose meat, offal or products, including milk, eggs and honey, are intended for human consumption, the owner or person in charge of the animal or animals concerned shall ensure that the treated animal or animals are not slaughtered in order to be offered for human consumption (or sold, supplied or exported in order to be so offered) before the end of the withdrawal period and that the produce obtained from such a treated animal before the end of such a withdrawal period is not disposed of with a view to their being offered for human consumption.

• (2)
• (a) A person who administers an animal remedy in respect of which a withdrawal period must be observed, prior to the slaughter of or the taking of produce from that animal for the purpose of human consumption, shall enter, on each occasion when such an animal remedy is administered or otherwise used in relation to that animal, in a book kept solely, in chronological order, for that purpose by the owner, or person in charge of the animal, and to be known as the "Animal Remedies Record" the particulars contained in the form set out in the Sixth Schedule.

• (b) Notwithstanding that an animal remedy in respect of which a withdrawal period must be observed may have been administered to an animal by a person other than the owner or person in charge, such owner or person in charge shall be responsible for maintaining the Animal Remedies Record.

• (3) An owner or person in charge of a food producing animal to which a prescription only animal remedy has been administered shall keep, for a period of three years, a copy of each prescription issued by a registered surgeon for the supply and use of such an animal remedy administered to animals under his or her control and make such copies and the records prescribed in paragraph (2) available for inspection on request by an authorised officer.

• (4) Where an animal remedy to which this Regulation applies is administered by a registered veterinary surgeon the registered veterinary surgeon concerned shall give to the person referred to in paragraph (1) sufficient information to enable that person to comply with the provisions of paragraphs (1) and (2).

PART VI VETERINARY MEDICINE AND SURGERY

43 CROSS BORDER PRACTICE BY VETERINARY SURGEONS

43.

43. (1) A veterinary surgeon established in another Member State of the European Union, who possesses a qualification mentioned in Council Directive 78/1026/EEC^15, in the course of providing cross border veterinary services within the State in accordance with the provisions of the aforementioned Directive may, subject to the subsequent provisions of this Regulation, import and administer small quantities of proprietary animal remedies in respect of which there is not for the time being in force a veterinary product authorisation.

^15 O.J. No. L 362 of 23.12.78 p.1

• (2) Paragraph (1) shall only apply in respect of an animal remedy —

• (a) which is authorised in accordance with the provisions of Council Directive 81/85 1/EEC in the Member State where the veterinary surgeon is established, and

• (b) which is brought into the State and supplied in the original manufacturer's packaging, and

• (c) in the case of an animal remedy intended for administration to a food producing animal the animal remedy has the same qualitative and quantitative composition in terms of active ingredients as one authorised for such purposes within the State.

• (3) A veterinary surgeon administering an animal remedy in accordance with the provisions of this Regulation shall ensure that the owner or person in charge of the treated animal is made fully aware of any withdrawal period which must elapse before the taking of produce from such animal for human consumption.

• (4) A veterinary surgeon selling or supplying an animal remedy in accordance with the provisions of this Regulation shall sell or supply the owner or person in charge of the animal or animals to be treated with such quantity of the animal remedy, as is necessary to complete the treatment of the animal or animals concerned having regard the condition to which the service relates and, in any event, no more than 31 days supply, and any animal remedy so supplied must, where applicable, be labelled with an appropriate withdrawal period.

• (5) A veterinary surgeon to whom this Regulation applies may only administer, sell or supply an animal remedy in respect of animals under his or her care and concerning which he or she has been consulted in a professional capacity.

• (6) For the purposes of this Regulation a veterinary surgeon may only carry such range and quantity of animal remedies to which this Regulation applies as is generally required for the daily needs of good veterinary practice.

• (7) A veterinary surgeon to which this Regulation applies shall keep records of the following

• (a) identity of the animal or animals treated,

• (b) date of examination of the animal or animals,

• (c) number of animals treated,

• (d) name and address of the owner or person in charge of the animal or animals,

• (f) diagnosis,

• (g) details of the animal remedies administered, sold or supplied ,

• (h) the dosage administered, sold or supplied,

• (i) the duration of treatment, and

• (j) the withdrawal period, if any, specified

• (8) The records specified in paragraph (7) shall be maintained for three years and furnished on request for examination by an authorised officer

• (9) An animal remedy administered, sold, supplied or held in possession in accordance with this Regulation, shall for the purposes of such administration, sale, supply or possession be deemed to be an authorised animal remedy.

44 ANIMALS UNDER THE CARE OF A VETERINARY SURGEON

44.

44. (1) Without prejudice to Regulation 45 and Regulation 46 an animal, or, as the case may be, herd or flock, is deemed to be under the care of a registered veterinary surgeon and he or she is deemed to have been consulted in a professional capacity regarding the care of such animal, herd or flock where —

• (a) the registered veterinary surgeon, or as the case may be, another member of the group veterinary practice of which he or she is a member, has been consulted in a professional capacity and has been given responsibility for the professional care of the animal, herd or flock by the owner or person in charge of such animal, herd or flock, and

• (b) the registered veterinary surgeon has sufficient knowledge of the animal, herd or flock to initiate at least a general or preliminary diagnosis of the medical condition of the animal and, for this purpose, he or she or another member of the group veterinary practice, must have visited the farm or other premises on which the animal, herd or flock is kept sufficiently often and recently enough to have acquired an accurate picture of the current health, welfare and disease status of the animals on that farm or premises, and

• (c) the registered veterinary surgeon (or other member of the group veterinary practice of which he or she is a member) is available to respond to requests to provide such services of veterinary medicine and surgery .and clinical procedures on the animal or in the herd or flock as are in accordance with ethical veterinary practice, and

• (d) the registered veterinary surgeon is readily available for follow up consultation or monitoring of the condition and evaluation of the therapy, and

• (e) the records kept by the registered veterinary surgeon or group veterinary practice make evident that the professional responsibility for the animal, herd or flock in question is real and not merely nominal.

45 PRESCRIPTION FOR ANIMAL REMEDIES

45.

45. (1) This Regulation applies to the issue of a prescription for an animal remedy by a registered veterinary surgeon to a person.

• (2) Without prejudice to Regulation 46 a registered veterinary surgeon shall not issue a prescription for an animal remedy unless —

• (a) the animal or animals to which the prescription relates are under his or her professional care, and concerning which he or she has been consulted in a professional capacity, in accordance with Regulation 44, and

• (b) he or she is satisfied that the prescription will be used (by the person to whom the prescription is issued) for such animal or animals, and

• (c) (i) in the case of an initial prescription for the treatment of a particular condition in an animal, he or she has clinically examined the animal or animals in question for the purpose of diagnosis immediately prior to the issue of a prescription, or

• (ii) where, following consultation with the owner or person in charge of an animal he or she is satisfied that the condition to be treated is the same disease episode, in cohort animals in the same herd or flock on the same farm or premises, as that to which a clinical examination of an animal in accordance with subparagraph (i) has taken place within the preceding 7 days, or

• (iii) in the case of a repeat prescription, following consultation with the owner or person in charge of the animal to be treated where prior clinical examination has not taken place, at the professional discretion, and on the basis, of the registered veterinary surgeon's own knowledge of the health status of the animal and information obtained from the owner or person in charge of the animal provided a clinical examination in accordance with subparagraph (i) has taken place within the preceding 15 days, or

• (iv) in the case of a repeat prescription for the treatment of a chronic disease or injury in an individual animal following consultation with the owner or person in charge provided the registered veterinary surgeon clinically examines the animal at least every 90 days for the purpose of checking the condition of the animal, the efficacy of treatment, the necessity for further treatment and any evidence of adverse drug reaction, or

• (v) where for the purpose of assisting in making a diagnosis the registered veterinary surgeon carried out or caused to have carried out tests or analyses on the animal or cohort animal, or samples taken from the animal or cohort animals in question and on receipt of the results of such test or analysis the registered veterinary surgeon considers that treatment with a different animal remedy is appropriate.

• (4) A registered veterinary surgeon prior to issuing a prescription for an animal remedy, shall be satisfied that —

( a ) the use of the animal remedy to be prescribed is justified for the species concerned,

( b ) administration of the animal remedy to be prescribed is, to the best of his or her knowledge and belief not incompatible with a previous treatment, and

( c ) there is no contra-indication or adverse interaction where other animal remedies have been, or, are to be administered or prescribed.

• (5) A registered veterinary surgeon may prescribe an animal remedy only in such quantity as is necessary for the treatment of the condition in respect of which the animal remedy is prescribed subject, in the case of food producing animals, to a maximum quantity of 31 days supply.

• (6) A prescription to which this Regulation applies shall be in writing and shall contain at least the following particulars —

( a ) the name of the animal remedy to be administered;

( b ) the manner and site of administration;

( c ) the dose rate and withdrawal period to be observed, if applicable;

( d ) a description of the animal or animals to which the prescription relates:

( e ) the person or class of persons by whom the animal remedy is to be administered;

( f ) the name and address of the person to whom the prescription has been granted',

( g ) the name, address and signature of the veterinary surgeon granting the prescription:

( h ) the period during which, and the number of administrations for which, the prescription is valid; and

( i ) a declaration that the prescription is granted in respect of an animal or animals under his or her professional care.

• (7) ( a ) A veterinary prescription shall be issued in triplicate. The original and one copy shall be given to the owner or person in charge of the animal or animals to be treated and a copy shall be retained by the registered veterinary surgeon.

( b ) Copies of veterinary prescriptions are to be retained for 3 years by the registered veterinary surgeon and are to be made available for inspection on request by an authorised officer.

• (8) A veterinary prescription shall be written in ink so as to be indelible and signed in ink by, and bear, in block capital letters the name and address of the issuing registered veterinary surgeon.

• (9) In this Regulation "prescription" includes the supply of an animal remedy which by virtue of the animal remedies authorisation or the Law of the State is designated "prescription only" and the administration to an animal of an animal remedy which is designated "veterinary surgeon use only".

• (10)
• (a) This paragraph applies to an animal remedy for a food producing animal.

• (b) A veterinary surgeon who, in accordance with this Regulation, supplies or administers an animal remedy shall, in lieu of issuing a prescription, enter in the Animal Remedies Record prescribed by Regulation 42 (2) the relevant details of such administration or supply and shall endorse such entry by his or her personal signature.

• (11) This Regulation is in addition to the requirements of Regulations 38, 40 and 42.

46 PRESCRIPTION FOR ANIMALS IN INTENSIVE PRODUCTION SYSTEM

46.

46. (1) Notwithstanding Regulation 45 (2) this Regulation applies to the issue of a prescription for an animal remedy for the treatment of disease associated with the intensive production of pigs, poultry and fish where such pigs, poultry or fish are reared in intensive units or under other intensive systems and where a herd or flock health scheme is in operation in respect of such system.

• (2) For the purpose of issuing a prescription for an animal remedy for an animal to which this Regulation applies the registered veterinary surgeon shall have been given responsibility for the overall herd or flock health scheme by the owner or person in charge of the animal and such registered veterinary surgeon shall,

( a ) have either seen the animal or herd or flock for the purpose of making a diagnosis immediately prior to initiating the treatment or supplying the animal remedy for such treatment, or

( b ) have carried out tests, or have had recourse to the results of tests or analyses carried out on samples taken from the animal or a representative animal from the herd or flock in question, and

( c ) have visited the farm or other premises in which the animal or herd or flock are located within the preceding 60 days, and to have acquired from first hand personal knowledge, and, as necessary, recourse to results of laboratory tests or analyses, an accurate picture of the health and welfare status of animals on that farm or premises, and following consultation with the owner or person in charge of the animal sufficient information to make a diagnosis and prescribe or supply appropriate treatment, and

( d ) shall, save where otherwise provided for by this Regulation, comply with the provisions of Regulation 45 in respect of such supply.

• (3) In this Regulation

"intensive unit" means a building or structure in which animals are kept under a husbandry system relying, for the purpose of providing care for the animals, on automatic equipment to such extent that a failure of that equipment would, if it were not rectified or if some other suitable provision were not made for the care of the animals, cause the animals unnecessary suffering.

"intensive system" means a husbandry method in which animals are kept in such numbers or density or in such conditions or at such production levels that their health and welfare depend upon frequent human attention and includes an intensive unit.