S.I. No. 786/2007 - European Communities (Animal Remedies) (No. 2) Regulations 2007

• (7) This Regulation does not apply to the manufacture of a medicated feedingstuff or an intermediate product under and in accordance with a licence granted pursuant to Regulation 4 of the European Communities (Animal Remedies and Medicated Feedingstuffs) Regulations 1994 ( S.I. No. 176 of 1994 ).

Application for a manufacturer’s licence.

• (2) Without prejudice to the generality of paragraph (1), an applicant shall—

• (a) provide particulars to demonstrate that he or she has available suitable and sufficient premises, technical equipment and trained staff as regards both manufacture and control and the storage of animal remedies or substances thereof,

• (b) demonstrate that all manufacturing will be carried out in accordance with the principles and guidelines referred to in Article 50(f) of the Directive, and

• (c) satisfy the Board that the services of at least one qualified person, who fulfils the requirements applicable to a qualified person are available to carry out the functions of a qualified person as prescribed by the Directive and specified in Schedule 4.

Decision on application for a manufacturer’s licence.

• (2) Subject to paragraph (5), the Board shall, within 90 days of the receipt of a valid application, notify an applicant of a decision to grant a licence, or of a proposal to refuse an application.

• (3)
• (a) A manufacturer’s licence shall be subject to such conditions as the Board may specify which shall include the requirements set out in Schedule 5.

• (b) Without prejudice to the generality of paragraph (1), the Board shall refuse an application if—

• (i) the manufacture, import, sale, supply or use of an animal remedy to which the application relates is unlawful, or, in the opinion of the Board, the animal remedy would be sold, supplied or used in the State otherwise than for the purpose specified in the application for an animal remedies authorisation,

• (ii) in the opinion of the Board, the staff, premises, equipment, machinery or plant used or to be used by the applicant or licence holder are not suitable to manufacture an animal remedy,

• (iii) the applicant or licence holder does not have the services of a qualified person in relation to the manufacture of an animal remedy to which the application or licence relates,

• (iv) the applicant or licence holder is, in the opinion of the Board, incapable of complying with the principles and guidelines referred to in Article 50(f) of the Directive, or

• (v) in the opinion of the Board, the applicant or licence holder is not, for any other reason (including conviction for an offence or a failure to comply with a condition attached to a manufacturer’s licence or animal remedies authorisation), or having regard to Article 25 of Council Directive 96/23/EC of 29 April 1996 ⁸ , a fit and proper person to hold a manufacturer’s licence.

• (4) If the Board proposes to refuse an application, it shall—

• (a) notify the applicant in writing of the proposal and of the reasons therefor, and that he or she may make representation to the Board in relation to the proposal within 30 days of the notification,

• (b) consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and

• (c) notify the applicant of the decision and the reasons therefor.

• (5) If the Board requires information from an applicant to consider an application, the time limit referred to in paragraph (2) is suspended until the information is supplied.

• (6) The Board, having carried out an inspection at the premises of an animal remedies authorisation holder or a manufacturer of animal remedies or a manufacturer of starting materials or a person carrying out activities on their behalf, shall comply with Article 80(3), (5), (6) and (7) of the Directive.

Certain obligations of a holder of a manufacturer’s licence.

• (a) keep at his or her premises detailed records of an animal remedy manufactured, sold or supplied by him or her,

• (b) not sell or supply an animal remedy to a person unless the person, to whom the animal remedy is to be sold or supplied, is lawfully entitled to sell or supply the animal remedy.

• (2) The record referred to in paragraph (1)(a) shall show in respect of each incoming and outgoing transaction for each sale or supply of an animal remedy—

• (a) the date,

• (b) the name of animal remedy,

• (c) the batch number and expiry date,

• (d) the quantity supplied, and

• (e) the name and address of the recipient.

• (3) A record maintained under this Regulation shall be available for inspection by an authorised officer 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 longer period.

• (4) The holder of a manufacturer’s licence, a manufacturer of starting materials or a person, including a contract laboratory carrying out activities on their behalf, shall submit to an inspection and shall make available records which the Board considers necessary for the purpose of verifying compliance with the Directive and these Regulations.

• (5) In this Regulation and Schedules 4 and 5, ‘starting materials’ means active substances used as ingredients in the manufacture of an animal remedy.

• (6) This Regulation is in addition to and not in substitution for any other obligation imposed on a holder of a manufacturer’s licence by these Regulations or by a manufacturer’s licence.

Validity of a manufacturer’s licence.

• (2) A manufacturer’s licence may be renewed by the Board on the basis of an application by the holder.

• (3) An application for renewal of a manufacturer’s licence shall be in a form, be accompanied by material and contain information that the Board specifies.

• (4) If application for renewal of a manufacturer’s licence is made not later than 90 days before the expiry date of the existing licence, that licence remains in force until the Board determines the application.

• (5) A manufacturer’s licence granted by way of renewal is, subject to Regulation 25(1), valid for an unlimited period.

Revocation, suspension or variation of a manufacturer’s licence.

• (b) Notwithstanding subparagraph (a), the Board may, on application from the holder, vary the conditions attaching to a manufacturer’s licence, within the periods specified in Article 48 of the Directive.

• (2) Without prejudice to paragraph (7), if the Board proposes to suspend, revoke or vary a licence, it shall—

• (a) notify the holder in writing of the proposal and of the reasons therefor, and that he or she may make representation to the Board in relation to the proposal within 30 days of the notification,

• (b) consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and

• (c) notify the holder of the decision and the reasons therefor,

and a suspension, revocation or variation shall not have effect until the Board issues a notification of its decision.

• (3) A person shall comply with a decision of the Board under paragraph (1).

• (4) If the Board is of the opinion that, in respect of a premises for which there is in force a manufacturer’s licence, there is a grave and immediate risk—

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

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

• (c) that an animal remedy, which is on the 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 Directive,

it may serve a notice in writing requiring the cessation of—

• (i) the manufacture of an animal remedy or batch of an animal remedy at the premises or part thereof, or

• (ii) the import, distribution, sale or supply of an animal remedy or batch of an animal remedy,

and the notice, or a subsequent notice, may specify the steps to be taken, or the things to be done, before the premises or part thereof, may be used for the manufacture of an animal remedy to which the notice relates.

• (5) A person upon whom a notice is served under paragraph (4) shall comply with the terms of the notice (including a notice subject to representation under paragraph (7)).

• (6) The Board may, by notice in writing, revoke or vary a notice served under paragraph (4).

• (7) If the Board serves a notice under paragraph (4), it shall—

• (a) notify the holder in writing of the decision and the reasons for the decision, and that he or she may (without prejudice to paragraph (5)) make representation to the Board in relation to the decision within 21 days of the notification,

• (b) consider a representation duly made, and

• (c) confirm, modify or annul the notice and notify the holder of the decision and the reasons for the decision.

Certification by the Board.

• (a) the manufacturer is in possession of a manufacturer’s licence to manufacture an animal remedy, and

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

• (c) the animal remedy has been manufactured for export under a licence granted in accordance with Regulation 17.

• (2) The Board shall have regard to the prevailing administrative arrangements of the World Health Organisation regarding the issue of certification.

• (3) If there is an animal remedies authorisation in force, the Board shall, if requested, supply a copy of the approved summary of product characteristics.

• (4) If there is not an animal remedies authorisation in force 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 an animal remedies authorisation has not been sought.

Consignment to a person or address in another member state.

• (2) A person shall not sell or supply an animal remedy to a person in another member state unless—

• (a) the animal remedy may be lawfully sold, supplied or administered in that member state, and

• (b) the manner in which the animal remedy is sold or supplied is in accordance with the law of that member state.

• (3) In proceedings alleging a breach of paragraph (2), a certificate signed by an officer of a competent authority in another member state, stating that the authority is the competent authority and that on a particular date or during a particular period—

• (a) it was not lawful to sell, supply or administer a particular animal remedy in that member state, or

• (b) the manner in which a particular animal remedy was sold or supplied into that member state was not in accordance with the law of that member state, is, until the contrary is shown, sufficient evidence of the facts stated in the certificate and it is not necessary to prove the signature of the person signing the certificate, that he or she is an officer of the authority or that the authority is a competent authority.

PART V SALE, SUPPLY AND POSSESSION OF AN ANIMAL REMEDY

Restriction on sale of an animal remedy.

• (2) Subject to paragraph (3), a person shall not sell or supply an animal remedy except under and in accordance with a licence or registration granted under Regulation 30, 31 or 33.

• (3) Paragraph (2) does not apply to—

• (a) the sale or supply of an authorised animal remedy by, or under the supervision of, a pharmacist from a pharmacy, in accordance with these Regulations,

• (b) the sale or supply of an authorised animal remedy by a registered veterinary practitioner in accordance with Regulation 43, or

• (c) the sale or supply by wholesale of an authorised animal remedy by the holder of a manufacturer’s licence, if the animal remedy is manufactured by him or her under and in accordance with the manufacturer’s licence.

• (4) Notwithstanding paragraphs (2) and (3), a person shall not sell or supply an animal remedy designated prescription only unless—

• (a) he or she is a pharmacist and he or she has a veterinary prescription relating to the animal remedy in his or her possession,

• (b) he or she is a registered veterinary practitioner, the animal is under his or her care and he or she issues a veterinary prescription in respect of the animal remedy, or

• (c) in the case of an animal remedy which comes within the scope of paragraph 3 (iii) of Part I of Schedule 1, he or she is a responsible person selling or supplying from a premises to which an animal remedies merchant’s licence relates and he or she has a veterinary prescription relating to the animal remedy in his or her possession.

• (5) Without prejudice to Regulation 20(3)(b), a person who sells or supplies an animal remedy designated prescription only shall affix to the animal remedy, at the time of sale or supply, (in a manner that does not obscure the information required by the animal remedies authorisation) a label indicating—

• (a) his or her name and address,

• (b) the serial number of the veterinary prescription,

• (c) the name of the prescribing veterinary practitioner,

• (d) the date of sale or supply, and

• (e) the dosage and duration of treatment (unless indicated on the proprietary label).

• (6)
• (a) Notwithstanding Paragraph (4)(b), a registered veterinary practitioner need not write a veterinary prescription in respect of an animal remedy prescribed for a companion animal, other than an equid, if he or she offers a veterinary prescription to the owner or person in charge of the animal and the offer is declined.

• (b) For the purposes of subparagraph (a), a veterinary practitioner shall display, prominently, at his or her premises, signage which makes clear that a client is entitled to receive a written veterinary prescription.

• (7) Notwithstanding Paragraphs (2) and (3), a person shall not sell or supply an animal remedy designated prescription only exempt unless—

• (a) he or she is a pharmacist, or

• (b) he or she is a registered veterinary practitioner and the animal is under his or her care.

• (8) Notwithstanding Paragraphs (2) and (3), a person shall not sell or supply an animal remedy designated pharmacy only unless—

• (a) he or she is a pharmacist or is under the supervision of a pharmacist in a pharmacy, or

• (b) he or she is a registered veterinary practitioner and the animal is under his or her care.

• (9) Paragraphs (1), (5), (7) and (8) do not apply to the holder of a manufacturer’s licence, or the holder of an animal remedies wholesaler’s licence supplying a person who may lawfully sell or supply the animal remedy.

• (10) A person shall not possess, sell or supply an animal remedy if the label or package leaflet has been altered or if the label or package leaflet has been removed unless authorised by the Board.

Restriction on use of a premises.

• (a) a premises in respect of which there is a manufacturer’s licence,

• (b) a premises in respect of which there is an animal remedies wholesaler’s licence,

• (c) a premises in respect of which there is an animal remedies merchant’s licence,

• (d) a premises owned or operated by a person registered in accordance with Regulation 33,

• (e) a pharmacy, or

• (f) a part of a premises, which is not a retail outlet to which Regulation 31 applies, used by a registered veterinary practitioner in respect of which a certificate of suitability has been granted or deemed to have been granted under Part 9 of the Veterinary Practice Act 2005 (No. 22 of 2005).

Wholesale of an animal remedy.

• (2) 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 an animal remedy.

• (3) An animal remedies wholesaler’s licence may relate to animal remedies generally, to animal remedies of a particular class or description specified in the licence, or to one or more animal remedies specified in the licence.

• (4) An animal remedies wholesaler’s licence may not relate to a premises used for purposes referred to in Regulation 31 or 33.

• (5) Without prejudice to Regulation 49, the holder of an animal remedies wholesaler’s licence, shall—

• (a) sell or supply an animal remedy only to a person who holds an animal remedies wholesaler’s licence, an animal remedies merchant’s licence, or, is a person registered in accordance with Regulation 33, a pharmacist or a registered veterinary practitioner,

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

• (c) undertake procedures for storage, stock rotation and maintenance of records in compliance with the particulars furnished with the application or with other arrangements as may be approved in advance by the Minister,

• (d) immediately withdraw, if directed by the Minister, the Agency, the Board or the marketing authorisation holder, from sale or supply any quantity and, in so far as is practicable, immediately recall any quantity sold or supplied of—

• (i) a batch, or part of a batch, of an animal remedy that does not conform with an animal remedies authorisation, or the strength, quality or purity does not conform with the specification of that animal remedy, or

• (ii) an animal remedy that has given rise to unacceptable adverse reactions,

• (e) keep, at the premises to which the licence refers, records of purchase and sale invoices in respect of each incoming and outgoing transaction detailing at least the following information—

• (i) the date of transaction,

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

• (iii) the manufacturer’s batch number,

• (iv) the name and address, as appropriate, of the supplier or consignee,

• (v) the quantity received or supplied (including the quantity received and returned in accordance with subparagraph (j), or otherwise disposed of),

• (f) keep at his or her premises the records referred to in subparagraph (e) for a period of five years from the date of receipt, sale or supply of the animal remedy and make these records available to an authorised officer on request,

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

• (h) furnish to the purchaser with each supply of an animal remedy, information detailing—

• (i) the date of supply,

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

• (iii) the quantity supplied, and

• (iv) the manufacturer’s batch number,

• (i) comply with Article 65(5) of the Directive, and

• (j) have in place the necessary systems to receive from—

• (i) a registered veterinary practitioner,

• (ii) a pharmacist,

• (iii) the holder of an animal remedies merchant’s licence, or

• (iv) a person registered under Regulation 33,

an animal remedy which is unused or has reached its expiry date, for return to the marketing authorisation holder or other person acting on his or her behalf in accordance with the arrangements put in place by that person.

• (6) The holder of an animal remedies wholesaler’s licence shall not sell or supply an animal remedy to a person unless—

• (a) that person is lawfully entitled to sell or supply an animal remedy, and

• (b) the sale or supply of the animal remedy by that person would not contravene these Regulations.

• (7) The holder of an animal remedies wholesaler’s licence shall, at least once a year, carry out a detailed audit to reconcile 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 at the premises for inspection by an authorised officer for a period of not less than five years.

• (8) This Regulation does not apply to the—

• (a) sale or supply of an animal remedy by a person who manufactured or imported it in accordance with a manufacturer’s licence, or

• (b) sale or supply by a pharmacist to a registered veterinary practitioner for use in accordance with Regulation 18.

• (9) An animal remedies wholesaler’s licence remains in force for a period of three years or for a shorter period as may be specified in the licence, unless it is suspended, varied or revoked at an earlier date.

Retail sale of an animal remedy.

• (b) Subparagraph (a) does not apply to a person registered in accordance with Regulation 33, but only in so far as sale or supply of an animal remedy designated ‘companion animal medicine’ is concerned.

• (2) 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 an animal remedy or class of animal remedy.

• (3) An animal remedies merchant’s licence may relate to animal remedies generally, to animal remedies of a particular class or description specified in the licence, or to one or more animal remedies specified in the licence.

• (4) An animal remedies merchant’s licence may not relate to a premises used for purposes referred to in Regulation 30.

• (5) Without prejudice to Regulation 49, the holder of an animal remedies merchant’s licence, shall—

• (a) provide and maintain premises, equipment and staff and have in operation arrangements necessary to avoid deterioration of an animal remedy and to notify the Minister within seven days of a material change in the premises, equipment, staff or arrangements,

• (b) keep, at the premises to which the licence relates, records of purchase or sale invoices in respect of each incoming and outgoing transaction detailing at least the following information—

• (i) the date of transaction and in the case of an animal remedy designated prescription only, the serial number of the veterinary prescription,

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

• (iii) the manufacturer’s batch number,

• (iv) the name and address, as appropriate, of the supplier or consignee, and

• (v) the quantity received or supplied (including the quantity received and or returned in accordance with subparagraph (g), or otherwise disposed of),

• (c) keep at his or her premises, the records referred to in subparagraph (b) for a period of five years from the date of receipt, sale or supply of the animal remedy and make these records available to an authorised officer on request,

• (d) permit inspections and make available information required to satisfy the Minister that the conditions of the licence are being complied with,

• (e) undertake procedures for storage, stock rotation and maintenance of records specified with the particulars furnished with the application or with such other arrangements as may be approved in advance by the Minister,

• (f) immediately withdraw, if directed by the Minister, the Agency, the Board, the marketing authorisation holder or the holder of an animal remedies wholesalers licence, from sale or supply any quantity, and, in so far as is practicable, immediately recall any quantity sold or supplied of—

• (i) a batch or part of a batch of an animal remedy that does not conform with an animal remedies authorisation or the strength, quality or purity does not conform with the specification of that animal remedy, or

• (ii) an animal remedy that has given rise to unacceptable adverse reactions,

• (g) have in place arrangements to receive from customers for return to the person from whom he or she purchased it, an animal remedy that is unused or has reached its expiry date and in addition take steps to ensure that customers are aware of the arrangements, and

• (h) ensure that an animal remedy is not sold from the premises other than by a responsible person.

Subparagraph (b) does not apply in the case of an animal remedy designated ‘companion animal medicine’.

• (6) The Minister may not grant a licence in respect of a premises unless the premises conforms to the general conditions set out in Schedule 6.

• (7) The holder of an animal remedies merchant’s licence shall not sell or supply an animal remedy for the purpose of sale or supply to a person to whom Regulation 30(5)(a) refers.

• (8) An animal remedies merchant’s licence remains in force for a period of three years, or for a shorter period if specified in the licence unless it is suspended, varied or revoked at an earlier date.

• (9) The holder of an animal remedies merchant’s licence shall, at least once a year, carry out a detailed audit to reconcile incoming and outgoing supplies with supplies currently held in stock and any discrepancies shall be specifically recorded and the record shall be retained and made available at the premises for inspection by an authorised officer for a period of not less than five years.

• (10) This Regulation does not apply to—

• (a) a pharmacy, or

• (b) a part of a premises, which is not a retail outlet to which this Regulation applies, used by a registered veterinary practitioner, in respect of which a certificate of suitability has been granted or deemed to have been granted under Part 9 of the Veterinary Practice Act 2005 (No. 22 of 2005).

Training.

• (2) Without prejudice to Regulation 49, it shall be a condition of approval that the person providing the course shall furnish the Minister with the names and addresses of persons who have successfully completed the course.

• (3)
• (a) A person who has successfully completed a training course approved under paragraph (1) is referred to as “a responsible person”.

• (b) Notwithstanding subparagraph (a), the Minister may require a responsible person to undergo additional training, if the Minister considers it necessary.

• (4) 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 these Regulations.

Sale of an animal remedy designated ‘companion animal medicine’.

• (2) The Minister shall maintain a register of persons selling an animal remedy designated ‘companion animal medicine’ by retail.

• (3) Registration of a person under this Regulation ceases if—

• (a) a notice in writing is served on the Minister by or on behalf of a person to whom an entry in the register relates, stating that the person has ceased to carry on the business of selling an animal remedy designated ‘companion animal medicine’, or

• (b) a person is notified in writing by the Minister of the Minister’s belief that he or she has ceased to carry on the business of selling an animal remedy designated ‘companion animal medicine’.

• (4) On the death of a person registered in the register, the Minister may, on application by the personal representative of that person, enter in the register the name of the personal representative.

• (5) A person registered under this Regulation shall comply with the storage requirements for an animal remedy as specified by the outer packaging, immediate packaging or package leaflet.

• (6) A person registered under this Regulation shall have in place arrangements to receive and return to the person from whom he or she purchased it, an animal remedy that is unused or has reached its expiry date and shall take steps to ensure that customers are aware of these arrangements.

• (7) This Regulation does not apply to—

• (a) a registered veterinary practitioner,

• (b) a pharmacist,

• (c) the holder of an animal remedies merchant’s licence, or

• (d) the holder of an animal remedies wholesaler’s licence.

Record-keeping and other requirements for a veterinary practitioner and a pharmacist.

• (a) keep, at his or her premises, a record of purchases and sales (including quantities administered) in respect of each incoming and outgoing transaction, detailing at least—

• (i) the date of transaction, and in the case of an animal remedy designated ‘veterinary practitioner only (VPO-1)’, ‘veterinary practitioner only (VPO)’, or prescription only (POM), the serial number of the veterinary prescription,

• (ii) the precise identity of the animal remedy or where Regulation 18 applies, the medicinal product, including name, pharmaceutical form and pack size,

• (iii) the manufacturer’s batch number,

• (iv) the name and address of the supplier or consignee, and

• (v) the quantity received or supplied (including the quantity received or returned in accordance with subparagraph (c) or otherwise disposed of),

• (b) keep the records referred to in subparagraph (a) for a period of five years from the date of receipt, sale or supply or administration of the animal remedy and these records shall be made available to an authorised officer on request, and

• (c) have in place arrangements to receive from consignees and return to the person from whom he or she purchased it, an animal remedy that is unused or reached its expiry date and shall take steps to ensure that clients are aware of these arrangements.

Subparagraphs (a) and (b) do not apply in the case of an animal remedy designated ‘companion animal medicine’.

Prohibition on sale of an animal remedy after expiry date.

Fixed premises.

• (2) Paragraph (1) does not apply to the sale or supply of an animal remedy in the course of the provision of a veterinary service by a registered veterinary practitioner for the treatment of an animal under his or her care.

• (3) Subject to paragraph (4)(a), a person shall not—

• (a) except under and in accordance with a licence granted by the Minister, sell or supply an animal remedy by retail, via the internet or by mail order,

• (b) except under and in accordance with a licence granted by the Minister, make a visit from house to house to collect, solicit or obtain an order for an animal remedy,

• (c) sell or supply an animal remedy from a travelling shop, vehicle or automatic vending machine, or

• (d) sell or supply an animal remedy at a trade fair or at a public or private place where animals are placed for exhibition or competition.

Subparagraph (b) does not apply in the case of a visit made by the representative of the holder of an animal remedies wholesaler’s licence to any of the following persons at his or her place of business—

• (i) a registered veterinary practitioner,

• (ii) a pharmacist,

• (iii) the holder of an animal remedies merchant’s licence, or

• (iv) a person entered in the ‘companion animal medicine sellers register’.

• (4)
• (a) The Minister shall not grant a licence under paragraph (3)(a) or (b) unless the applicant is—

• (i) the holder of an animal remedies merchant’s licence, or

• (ii) a pharmacist.

• (b) A licence granted under paragraph (3)(a) or (b) may only relate to an animal remedy referred to in paragraphs 6 and 7 of Part I of Schedule 1.

• (5) In this Regulation:—

“house” includes land or other premises;

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

Advertising.

• (2) Notwithstanding paragraph (1), a person shall not advertise an animal remedy—

• (a) which contains a substance subject to restrictions resulting from implementation of United Nations Conventions on narcotic and psychotropic substances,

• (b) which is designated Veterinary Practitioner Only (VPO-1), veterinary practitioner only (VPO) or Prescription Only, or

• (c) in contravention of an animal remedies authorisation.

• (3) Paragraph (2) does not apply to the advertisement of an animal remedy, which is solely directed at the holder of an animal remedies wholesaler’s licence, a registered veterinary practitioner, a pharmacist or the holder of an animal remedies merchant’s licence.

• (4) A registered veterinary practitioner, the holder of an animal remedies merchant’s licence, a pharmacist or the holder of a registration under Regulation 33 shall display a list of prices of animal remedies held in stock.

Possession of certain animal remedies.

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

• (a) the holder of a manufacturer’s licence,

• (b) the holder of an animal remedies wholesaler’s licence,

• (c) a registered veterinary practitioner,

• (d) a pharmacist,

• (e) the holder of an animal remedies merchant’s licence, but only in the case of an animal remedy referred to in paragraph 3(iii) of Part I of Schedule 1, or

• (f) a person in charge of a companion animal (other than an equid) in the circumstances referred to in Regulation 28(6).

• (3) Paragraph (2) does not make it lawful for a person to whom that paragraph applies, other than a person referred to in subparagraph (c) or (f), to have an animal remedy designated prescription only in his or her possession or under his or her control on a farm or other premises where a food producing animal is kept.

• (4) A person, other than a registered veterinary practitioner, shall not have an animal remedy designated ‘veterinary practitioner only (VPO-1)’ or ‘veterinary practitioner only (VPO)’ in his or her possession or under his or her control on a premises where an animal is kept, sold, supplied or slaughtered.

• (5) A registered veterinary practitioner shall not cause or permit a person (other than a registered veterinary practitioner) to have an animal remedy designated ‘veterinary practitioner only (VPO-1)’ or ‘veterinary practitioner only (VPO)’ in his or her possession or under his or her control.

PART VI ADMINISTRATION OF AN ANIMAL REMEDY AND PROVISIONS RELATING TO ANIMALS AND ANIMAL PRODUCE

Administration of an animal remedy.

• (a) there is in force an animal remedies authorisation in respect of the animal remedy,

• (b) the administration is carried out in accordance with the animal remedies authorisation,

• (c) the animal remedies authorisation authorises administration of the animal remedy to the animal, class of animal or species,

• (d) the animal remedies authorisation permits administration of the animal remedy by the person, and

• (e) the Act and these Regulations have been complied with in respect of the animal remedy.

• (2) Notwithstanding paragraph (1) a person shall not administer—

• (a) an animal remedy designated ‘veterinary practitioner only (VPO-1)’ to an animal unless he or she is a registered veterinary practitioner and the animal is under his or her care,

• (b) an animal remedy designated ‘veterinary practitioner only (VPO)’ to an animal unless—

• (i) he or she is a registered veterinary practitioner and the animal is under his or her care,

• (ii) he or she carries out the administration in the presence and under the direct supervision of the prescribing veterinary practitioner, or

• (iii) in the case of administration of an animal remedy to an animal in a user establishment registered under the Cruelty to Animals Act 1876 (39 & 40 Vict.), he or she has been duly authorised in writing to do so by the appropriate authority of the institution concerned and by the supervising veterinary practitioner, or

• (c) an animal remedy designated ‘prescription only’, unless it has been prescribed by a registered veterinary practitioner and, without prejudice to Regulation 28(6), the person administering the animal remedy has a veterinary prescription in his or her possession relating to that animal remedy and to the animal concerned.

Administration of an animal remedy to a food producing animal.

• (a) notwithstanding Regulations 15 and 18, administer to a food producing animal, an animal remedy which consists of or contains a substance, the administration of which to the animal, species or class of animal, is unlawful,

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

• (c) without prejudice to Regulation 41, import, export, sell or supply for human or animal consumption meat, milk, eggs or honey derived from, or produced by, an animal to which an animal remedy has been administered in contravention of subparagraph (a),

• (d) process meat, milk, eggs or honey referred to in subparagraph (c) or import, export or sell produce of any meat, milk, eggs or honey prepared from, or with, such meat, milk, eggs or honey, or

• (e) 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 (a) or meat, milk, eggs or honey derived from, or produced by, the animal.

• (2)
• (a) The owner or person in charge of an animal to which an animal remedy has been administered shall—

• (i) comply with the conditions of use of the animal remedy to be complied with after administration,

• (ii) ensure that the animal is 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 produce obtained from the animal before the end of a withdrawal period is not disposed of with a view to being offered for human consumption.

• (b) If a person, other than the owner or person in charge of the animal, administers an animal remedy to that animal, he or she shall inform the owner or person in charge of the animal of the obligations specified in subparagraph (a).

• (3) In paragraph (2), “conditions of use” means information and directions that, pursuant to the animal remedies authorisation, are required to appear on the container, outer package and package leaflet of the animal remedy.

Import of an animal.

• (a) the animal remedy was administered prior to import,

• (b) the animal remedy was administered in accordance with the law of the state where administration occurred, and

• (c) the animal remedy does not consist of or contain a substance the administration of which to the class or classes of animal is unlawful.

Animal remedies record and disposal of animal remedies.

• (2) The owner or person in charge of a food producing animal to which an animal remedy has been administered shall—

• (a) enter in the Animal Remedies Record, on each occasion when the animal remedy is administered, the required details in chronological order, and

• (b) retain the Animal Remedies Record at his or her premises for five years after administration of the animal remedy and make this Record available on request to an authorised officer.

• (3) The owner or person in charge of a food producing animal to which an animal remedy designated veterinary practitioner only (VPO-1), veterinary practitioner only (VPO) or prescription only has been administered shall keep, in date order, for five years, a copy of each veterinary prescription issued by a registered veterinary practitioner for the supply and use of the animal remedy administered to an animal under his or her control and make the copies and the record available for inspection on request by an authorised officer.

• (4) The owner or person in charge of an animal shall return an unused animal remedy or an animal remedy which has reached its expiry date to the person from whom he or she purchased that animal remedy and shall record this in the Animal Remedies Record.

PART VII VETERINARY PRACTICE AND VETERINARY MEDICINE

Prescribing and dispensing.

• (a) the veterinary prescription will be used to treat the animal to which the prescription relates,

• (b) use of the animal remedy is justified for the animal,

• (c) administration of the animal remedy is, to the best of his or her knowledge and belief, not incompatible with a current or previous treatment, (where appropriate, by consulting with any other veterinary practitioner who has responsibility for the care of the animals), and

• (d) there is no contra-indication and there will not be an adverse reaction if other animal remedies have been, or are to be, administered or prescribed.

• (2) A registered veterinary practitioner shall only prescribe an animal remedy in a quantity necessary for the treatment of the condition in respect of which the animal remedy is prescribed subject, in the case of a food producing animal, to a maximum quantity of 12 months supply from the date the veterinary prescription is issued.

• (3) Without prejudice to Regulation 28(6), a registered veterinary practitioner who prescribes or administers an animal remedy designated veterinary practitioner only (VPO-1), veterinary practitioner only (VPO), or prescription only for or to an animal shall, at that time, issue a veterinary prescription to the owner or person in charge of the animal.

• (4) Without prejudice to Regulation 28(6), a veterinary prescription shall—

• (a) be issued by a registered veterinary practitioner,

• (b) be written in ink or printed, legible and indelible and be signed in ink by, and bear, in block capital letters, the name and address of, the registered veterinary practitioner,

• (c) be issued in triplicate of which the original and one copy shall be given to the owner or person in charge of the animal to be treated and a copy retained by the registered veterinary practitioner, and

• (d) contain at least the particulars listed in Schedule 3.

• (5) A registered veterinary practitioner shall retain, at his or her premises, a copy of a veterinary prescription for 5 years and make the copy available for inspection on request by an authorised officer.

• (6) If a registered veterinary practitioner issues a veterinary prescription, he or she shall (if there is more than one authorised animal remedy suitable for treatment of the condition to which it applies) specify at least two animal remedies on the veterinary prescription.

• (7) A person—

• (a) who dispenses a veterinary prescription in part, shall immediately record on the prescription and on the copy, in a conspicuous, legible and indelible manner, the quantity of an animal remedy sold or supplied by him or her on foot of the veterinary prescription and the date of each such sale or supply and shall attest to this by means of his or her signature and shall retain a copy (which could be a photocopy) of the prescription,

• (b) who has completed dispensing a veterinary prescription shall—

• (i) at that time write on the prescription and on the copy thereof in a conspicuous, legible and indelible manner, the word “dispensed” and shall attest to this by means of his or her signature and the date,

• (ii) return a copy of the veterinary prescription to the person who presented it, and

• (iii) he or she shall retain, at his or her premises, the original veterinary prescription for five years and shall make this available on request to an authorised officer, and

• (c) not complete dispensing an animal remedy on foot of a veterinary prescription later than 12 months after the date the veterinary prescription is issued.

• (8) For the purposes of this Regulation, an animal is considered to be under the care of a registered veterinary practitioner if—

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

• (b) the registered veterinary practitioner (or other member of the group veterinary practice of which he or she is a member) has sufficient knowledge of the animal, herd or flock to form an opinion of the condition of the animal and for this purpose he or she (or another member of the group veterinary practice), shall have visited the farm or other premises on which the animal, herd or flock is kept (or otherwise examined the animal), sufficiently often and recently enough and, in any event, at least once in a 12 month period, to have acquired an accurate picture of the current health, welfare and disease status of the animals on that farm or premises,

• (c) the registered veterinary practitioner (or other member of the group veterinary practice) is available to respond to requests to provide services of veterinary medicine and surgery and clinical procedures on the animal (or in the herd or flock) in accordance with ethical veterinary practice,

• (d) the registered veterinary practitioner 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 practitioner make it evident that the professional veterinary responsibility for the animal, herd or flock in question is real and not merely nominal.

• (9) The 12 month period, referred to in paragraph (8)(b), does not apply to the prescribing of an intramammary animal remedy, if the animal to be treated belongs to a herd covered by a programme meeting the requirements of Schedule 8.

• (10) In order to comply with paragraph (8)(e), a registered veterinary practitioner shall maintain, at his or her premises, records as follows:

• (a) in relation to each client, a record, containing at least the following—

• (i) the date of each visit to the premises on which the animal, herd or flock is kept or on which the animal was seen,

• (ii) the identity or other reference to animals clinically examined,

• (iii) the condition identified,

• (iv) details of treatment of each condition, and

• (v) a cross-reference to any relevant results of laboratory tests

undertaken for the purpose of diagnosis, or any other test results,

and

• (b) copies of invoices and statements regarding professional services and supply of medicines in respect of each client.

• (11)
• (a) Invoices referred to in paragraph (10)(b) shall detail the cost of an animal remedy, administered, sold or supplied separately from a professional veterinary service.

• (b) These records may be maintained in the form of a herd health programme.

Emergency supply of certain animal remedies by a pharmacist.

• (a) the pharmacist is requested to sell or supply the animal remedy for the treatment of an animal by a registered veterinary practitioner who, by reason of an emergency, is unable to furnish a veterinary prescription immediately,

• (b) the registered veterinary practitioner undertakes to furnish a veterinary prescription within 72 hours,

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

• (d) the animal remedy is not a controlled drug specified in Schedule 1 or 2 to the Misuse of Drugs Regulations1988, ( S.I. No. 328 of 1988 ),

• (e) the animal remedy is labelled in accordance with Regulation 28(5), and

• (f) the pharmacist maintains the records prescribed by Regulation 34.

• (2) A registered veterinary practitioner who makes a request in accordance with paragraph (1) shall immediately issue a veterinary prescription for the animal remedy and shall ensure that the prescription reaches the pharmacist and the owner or person in charge of the animal within the period specified in paragraph 1(b).

• (3) If a registered veterinary practitioner fails to comply with an undertaking under paragraph (1)(b), the pharmacist shall not, at any future date, sell or supply an animal remedy under this Regulation at the request of that registered veterinary practitioner.

Certain animal disease situations.

• (2) An animal to which an animal remedy has been administered under and in accordance with a scheme or programme under paragraph (1) is considered, subject to the terms and conditions of the scheme or programme, to have had an authorised animal remedy administered to it.

PART VIII MISCELLANEOUS

Publication of certain decisions.

Information to the Agency.

• (2) The Board shall make available to the Agency information relating to reports received by it under Regulation 12.

• (3) The Board shall ensure that appropriate information about actions taken pursuant to paragraph (1) or Regulation 12, which may affect the protection of health in a third country, is brought to the attention of the relevant international organisations and the Agency.

Forgery.

• (a) a veterinary prescription,

• (b) an animal remedies authorisation,

• (c) a licence, registration or approval,

• (d) a record required to be kept pursuant to these Regulations, or

• (e) any other document issued or maintained pursuant to these Regulations,

(which document is, in this Regulation, referred to as a “forged document”).

• (2) A person shall not forge an endorsement or other entry purporting to be for any purpose of these Regulations on any document whatsoever required to be kept for the purposes of these Regulations (which document with such entry in this Regulation is referred to as a “falsely endorsed document”).

• (3) A person shall not, with intent to deceive, alter—

• (a) a veterinary prescription issued under these Regulations,

• (b) an animal remedies authorisation,

• (c) a licence, registration or approval,

• (d) a record required to be kept pursuant to these Regulations, or

• (e) any other document issued or maintained pursuant to these Regulations,

(which document if so altered is, in this Regulation, referred to as an “altered document”).

• (4) A person shall not utter a forged document, a falsely endorsed document or an altered document.

• (5) A person shall not have in his or her possession or under his or her control, a forged document, a falsely endorsed document or an altered document.

• (6) Paragraph (5) does not apply to—

• (a) an authorised officer or a member of the Garda Síochána or an officer of Customs and Excise, when acting in the course of his or her duty, or

• (b) a person who has taken into his or her possession a document for the purpose of—

• (i) preventing another from committing or continuing to commit an offence, or

• (ii) delivering it into the custody of a person specified in subparagraph (a).

Licences, registrations and approvals granted under a specified Regulation.

• (2) An application to the Minister for a licence, registration or approval under a specified Regulation shall be made in a form, be accompanied by any material, and fee and contain any particulars that the Minister specifies.

• (3) In the case of an application for an animal remedies wholesaler’s licence, the decision to grant a licence or refuse an application is notified to the applicant within 90 days of receipt of a valid application.

• (4) Without prejudice to the generality of paragraph (1), the Minister may refuse an application or revoke a licence, registration or approval if—

• (a) the applicant or holder has been convicted of, or committed, an offence, whether he or she has been convicted or not, under the Act or these Regulations,

• (b) the applicant or holder has failed to comply with a condition attached to a licence, registration or approval,

• (c) the applicant or holder is not, in the opinion of the Minister, a fit and proper person to hold the licence, registration or approval, or

• (d) in relation to the application, information required has not been furnished or information that is, in the opinion of the Minister, false or misleading, has been furnished.

• (5) Without prejudice to the generality of paragraph (1) and the specified Regulation concerned, the Minister shall refuse an application or revoke a licence, registration or approval under a specified Regulation, if the applicant or person to whom it is granted is convicted, on indictment, of an offence under the Act or these Regulations.

• (6) If the Minister proposes to refuse an application, or to revoke a licence, registration or approval under a specified Regulation, or to attach a condition or vary or revoke a condition attached to a licence, registration or approval, he or she shall—

• (a) notify the applicant or holder in writing of the proposal and of the reasons for the proposal, and that he or she may make representations to the Minister in relation to the proposal within twenty one days of the notification,

• (b) consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and

• (c) notify the applicant or holder of the decision and the reasons for the decision.

• (7) The holder shall not transfer a licence, registration or approval to any other person and any purported transfer is void and of no effect.

• (8) A licence, registration or approval granted under these Regulations has no effect if the holder—

• (a) ceases trading or operation,

• (b) is adjudged bankrupt or, in the case of a body corporate, goes into liquidation, or, in the case of an unincorporated body or partnership is dissolved, or

• (c) sells or otherwise ceases to occupy the premises to which the licence relates.

• (9) In this Regulation “a specified Regulation” means Regulation 16, 17, 18(11), 19, 30, 31, 32, 33 or 36(3)(a) or (b).

Fixed Penalty Notice.

• (a) the person is alleged to have committed the offence or contravention,

• (b) the person may during the period of 28 days from the date of the notice, make to the Minister a payment of €250 accompanied by the notice, and

• (c) a prosecution in respect of the alleged offence will not be instituted during the period specified in the notice and, if the payment specified in the notice is made during that period, no prosecution in respect of the alleged offence will be instituted.

• (2) If notice is given under paragraph (1)—

• (a) the person to whom the notice applies may, during the period specified in the notice, make the payment specified in the notice to the Minister,

• (b) the Minister shall receive the payment, issue a receipt for it and retain the money so paid, and any payment so received shall not be recoverable in any circumstances by the person who made it, and

• (c) a prosecution in respect of the alleged offence shall not be instituted in the period specified in the notice, and if the payment so specified is made during that period, no prosecution in respect of the alleged offence shall be instituted.

• (3) In a prosecution for an offence under the Act or these Regulations, the onus of proving that a payment, pursuant to a notice under this Regulation, has been made, lies on the defendant.

Implied condition in certain contracts of sale.

• (a) in the case of the sale of an animal, that the animal was not treated with any animal remedy and, in the case of an agreement to sell an animal, the animal was not so treated and will not be so treated prior to the time when the property is to pass, and

• (b) in the case of the sale of, or an agreement to sell, the carcase of any animal or food derived from any animal, that the animal had not been treated with any animal remedy,

otherwise than in accordance with these Regulations.

• (2)
• (a) Subject to subparagraph (b), any term of a contract, implied by virtue of paragraph (1), may be negatived or varied by an express term in the contract, in so far as the first-mentioned term relates to an animal remedy—

• (i) which has been administered to an animal before being imported into the State, and

• (ii) in respect of which the Minister has granted an exemption from destruction,

but only if the express term is fair and reasonable and has been specifically brought to the attention of the buyer.

• (b) Subparagraph (a) shall not apply to an animal imported into the State where the sale of the animal would not be in accordance with a condition imposed by the Minister on the exemption.

• (3) Any term of a contract implied by virtue of paragraph (1) may not be negatived or varied in so far as it relates to an animal remedy other than in respect of an animal remedy to which paragraph (2) relates.

Inspection by authorised officers, etc.

• (a) the manufacture, importation, preparation, handling, storage, transport, exportation, distribution, sale, supply or use of an animal remedy or any ingredient for an animal remedy is taking place or has taken place in, on, under or from any land, premises or in, on or from any vehicle,

• (b) an offence is being or has been committed under these Regulations in, on, under or from any land, premises or in, on or from any vehicle,

• (c) any land or premises is used for or in connection with the breeding, rearing, fattening, keeping, exhibiting, selling or transporting of animals,

• (d) any land or premises is a slaughterhouse or is used for or in connection with the slaughter of animals,

• (e) in, on, under or from any land or premises or in, on or from any vehicle, there is or was any animal of any species to which an animal remedy is being or has been administered or there is or was any food derived from such an animal or any carcase of such an animal, or

• (f) in, on, under or from any land or premises or in, on or from any vehicle, there is or was any animal remedy, or any ingredients for animal remedies, or any machinery, instruments or other thing used in the manufacture, preparation, handling, storage, transport, exportation, distribution, sale, supply or use of animal remedies or ingredients for animal remedies,

the authorised officer or member of the Garda Síochána or officer of Customs and Excise (in this section referred to as “the relevant person”) may, subject to paragraph (2), stop any such vehicle or enter (if necessary by force) any such land or premises, or land or premises used in connection with such land or premises, or any such vehicle, and there, or at any other place, and with such authorised officers, members of the Garda Síochána and officers of Customs and Excise (if any) as the relevant person considers appropriate—

• (i) search for and examine, inspect or test any animals, food derived from animals or carcases of animals or anything believed to be an animal remedy or an ingredient for an animal remedy or anything to which subparagraph (f) relates,

• (ii) take such specimens (including blood, urine, faeces, tissue or remains of implants) from any animals, food derived from animals or carcases of animals, and may for that purpose perform or cause to be performed any procedure (including surgery) as is considered necessary on such animals, food or carcases,

• (iii) take such reasonable samples of, or from, any substances, or of or from a thing which may be considered appropriate for the purposes of these Regulations,

• (iv) seize and detain anything to which subparagraph (f) relates or anything which is believed to be or to contain an animal remedy or an ingredient for an animal remedy kept, used or intended to be used in contravention of the provisions of these Regulations,

• (v) search for and examine any document and take extracts from and copies of any such document,

• (vi) seize and detain an animal—

• (I) in respect of which it is, with reasonable grounds, believed by the relevant person that a prohibited animal remedy or ingredient for an animal remedy has been administered to it in contravention of these Regulations, and

• (II) in relation to which either or both—

• (A) the relevant person is aware that an application has been made or will be made for the destruction of the animal, and

• (B) the relevant person has reasonable grounds for believing that the animal has been or may be moved in contravention of any notice duly served, in accordance with these Regulations,

• (vii) require any person who is suspected to be, or to have been engaged in the importation, manufacture, preparation, handling, storage, transport, exportation, distribution, sale, supply or use of, or any person who is suspected to have possession or control of or to have kept or to keep, any animal remedy, ingredient for an animal remedy, animal, food derived from animals, carcases of animals or anything to which subparagraph (f) relates, or any person who is suspected to be, or to have been, engaged in the breeding, rearing, fattening, keeping, exhibiting, selling or transporting or in the possession or control of any animal—

• (I) in the case of any documents in the possession or control of that person or any such remedy, ingredient, animal, food, carcase or thing, to produce them to the relevant person or any authorised officer, member of the Garda Síochána or officer of Customs and Excise,

• (II) in the case of any information in relation to such document, animal remedy, animal, food, carcase or thing which may be required (including the source of that document, remedy, animal, food, carcase or thing), to furnish them to the relevant person or any authorised officer, member of the Garda Síochána or officer of Customs and Excise,

• (viii) require any person, being the owner or the person in charge of animals, or the owner or occupier of, or employed in or on, lands or premises so entered to give assistance, to carry out such instructions and to give such information as may be reasonably necessary for the purposes of subparagraphs (i) to (vii), and

• (ix) require any person who is for the time being in charge or control of any vehicle so stopped or entered—

• (I) to refrain from moving it, and

• (II) to give assistance, to carry out such instructions and to give such information as may be reasonably necessary for the purposes of subparagraphs (i) to (vii).

• (2) The functions of a relevant person under this Regulation may only be exercised in respect of a dwelling or so much of a vehicle or premises as constitutes a dwelling where the relevant person has reasonable cause to suspect that, before a search warrant could be sought in relation to the dwelling under Regulation 53, anything to which the said paragraph (1) relates—

• (a) is being destroyed or disposed of, or

• (b) is likely to be destroyed or disposed of.

• (3) An authorised officer, member of the Garda Síochána or officer of Customs and Excise accompanying the relevant person may exercise all the functions conferred on the relevant person by virtue of paragraph (1) or (2).

Search warrant.

• (a) evidence of or relating to the commission or intended commission of an offence under these Regulations is to be found in, on or under any land or premises or in or on any vehicle and that such land, premises or vehicle or any part thereof consists of a dwelling,