Legalize / Ireland / Statutory Instrument

S.I. No. 734/2005 - Animal Remedies Regulations 2005

Type Statutory Instrument

Publication 2005-11-17

Last updated 2013-09-24

State Repealed superseded text

Text As published

Source Irish Statute Book

articles 25

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

3 amending acts · 2013-09-24, S.I. No. 361/2013 - European Union (Food Safety and Veterinary) (Accession of Croatia) Re…

Reform history JSON API

(II) an animal remedy imported in accordance with paragraph (5) authorised in another Member State for administration in the same species, or in another species, for the condition in question or for another condition,

(iii) if there is no animal remedy or medicinal product to which either subparagraphs (i) or (ii) refers, an animal remedy prepared extemporaneously by —

(I) a pharmacist in accordance with a veterinary prescription,

(II) the registered veterinary practitioner, or

(III) a person licensed to manufacture the animal remedy.

(3) A registered veterinary practitioner who administers or prescribes an animal remedy under this Regulation (or a pharmacist who sells or supplies an animal remedy in accordance with a veterinary prescription) shall label the animal remedy at the time of sale or supply with a notice in the form prescribed and containing the information specified by Regulation 35 and, in addition, in the case of an animal remedy imported in accordance with paragraph (5), shall include a reference to the serial number of the import licence.

(4) An animal remedy prescribed, administered, sold, supplied or held in possession in accordance with this Regulation, is for the purposes of the administration, sale, supply or possession an authorised animal remedy.

(5) The Minister, may by licence, authorise a registered veterinary practitioner or the holder of an animal remedies wholesaler's licence to import an animal remedy for the purposes of paragraph (1)(a)(ii)(II) or (2)(a)(ii)(II).

(6) A registered veterinary practitioner shall comply with paragraphs (1) or (2).

Cross border practice

19.

19. (1) A veterinary practitioner established in another member state who provides cross border veterinary services within the State in accordance with section 43(7) of the Veterinary Practice Act 2005 (No. 22 of 2005), may, in accordance with Regulations 44 and 45 and subject to this Regulation, import, prescribe, sell, supply or administer a small quantity of an animal remedy, (other than an immunological animal remedy), in respect of which there is not in force an animal remedies authorisation.

(2) Paragraph (1) applies only in respect of an animal remedy —

(a) authorised in accordance with the Directive in the Member State where the veterinary practitioner is established, and brought into the State and supplied by the veterinary practitioner in the manufacturer's original packaging, and

(b) in the case of an animal remedy intended for administration to a food producing animal, that has the same qualitative and quantitative composition in terms of active substances as an animal remedy authorised within the State.

(3) A veterinary practitioner who administers an animal remedy in accordance with this Regulation shall inform the owner or person in charge of an animal of the appropriate withdrawal period (in accordance with the law of the State) and shall indicate this period on the label.

(4) A veterinary practitioner, for the purposes of this Regulation, shall only possess an animal remedy to which paragraph (2) applies in a range and quantity as are required for the daily needs of good veterinary practice.

(5) A veterinary practitioner shall not, sell or supply a greater quantity of an animal remedy than is necessary to complete the course prescribed in respect of an animal and in any event a quantity greater than required for 14 days.

(6) A veterinary practitioner to whom this Regulation applies shall maintain and keep records within the State of -

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

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

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

(e) his or her diagnosis,

(f) the details of the animal remedies administered, prescribed, sold or supplied,

(g) the dosage administered, prescribed, sold or supplied,

(h) the duration of treatment, and

(i) the withdrawal period specified.

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

Research etc.

20.

20. (1) A person shall not administer an animal remedy to an animal -

(a) for the purposes of tests and trials of an animal remedy referred to in Article 12(3)(j) of the Directive, or

(b) for the purpose of scientific research or analysis not covered by subparagraph (a),

save under and in accordance with a licence, granted by the Minister following consultation with the Board (referred to in this Regulation as “a research licence”).

(2) A person shall not cause produce derived from an animal which has been administered in the course of a test, trial or research to which this Regulation applies to be used for human consumption unless the Minister determines a withdrawal period which shall -

(a) be at least as laid down in Article 11(2) of the Directive, including as appropriate a safety factor reflecting the nature of the substance being tested or

(b) ensure that the maximum residue limit will not be exceeded in foodstuffs if this limit has been established for the substance concerned in accordance with Regulation (EEC) No 2377/90.

(3) Notwithstanding Regulation 41, 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 research licence relates.

PART IV MANUFACTURE, IMPORT AND EXPORT OF AN ANIMAL REMEDY AND STARTING MATERIALS

Manufacture of an animal remedy

21.

21. (1) Notwithstanding Regulation 4(1) and without prejudice to Regulations 16 and 17, a person shall not manufacture an animal remedy or import an animal remedy from a third country save under and in accordance with a licence (‘manufacturer's licence’).

(2) A manufacturer's licence may relate to animal remedies generally, to animal remedies of a particular class or description or to one or more animal remedies.

(3)
(a) A manufacturer's licence is not required for dividing up, packaging or presenting an animal remedy, not carried out in advance, by —

(i) a pharmacist in respect of an animal remedy to be sold from a pharmacy, or

(ii) a registered veterinary practitioner in respect of an animal remedy supplied by him or her for the treatment of an animal under his or her care,

if the quantity to be supplied is less than that available in the smallest proprietary pack size lawfully available in the State.

(b) An animal remedy sold or supplied in accordance with subparagraph (a) shall be labelled with, or bear, a notice stating -

(i) the proprietary name of the animal remedy,

(ii) the words “for animal treatment only”,

(iii) the species to be treated,

(iv) the mode of administration,

(v) the dose rate,

(vi) the name of the person to whom sold or supplied,

(vii) the name and address of the supplier, and

(viii) precautions regarding administration and withdrawal period, if any.

(c) This paragraph does not apply to a sterile preparation, which animal remedy may only be sold or supplied in the authorised container or package.

(4) A manufacturer's licence is not required for the extemporaneous preparation of an animal remedy or magistral formula not prepared in advance in accordance with Regulation 18 by —

(a) a registered veterinary practitioner for the treatment of an animal under his or her care, or

(b) a pharmacist, in accordance with a veterinary prescription.

(5) A manufacturer's licence is not required to import an animal remedy (accompanied by a copy of the authorisation granted for its importation duly certified by the appropriate authority of the Member State of destination) from a third country if the animal remedy is imported for trans-shipment to another Member State and is not for sale or supply in the State.

(6) Paragraph (1) does not apply to the manufacture of an animal remedy in a laboratory engaged in veterinary or pharmaceutical education, research or analysis and used in the laboratory.

(7) A licence granted under section 7 of the Therapeutic Substances Act, 1932 shall be deemed to be a manufacturer's licence in respect of an animal remedy until the date of expiry of the licence.

(8) 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 ) as amended.

Application for a manufacturer's licence

22.

22. (1) An application for a manufacturer's licence shall be made in a form, be accompanied by any material and contain any particulars that the Board specifies.

(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

23.

23. (1) The Board may grant a manufacturer's licence, refuse an application, attach conditions to a manufacturer's licence, and may revoke or vary a condition, or suspend or revoke 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) if, 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 1996⁷ , 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

(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.

24.

24. (1) The holder of a manufacturer's licence shall -

(a) keep 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,

(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.

25.

25. (1) A Manufacturer's licence, unless previously revoked, remains in force for three years or a shorter period specified in the 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 26(1) valid for an unlimited period.

Revocation, suspension or variation of a manufacturer's licence

26 (1) (a) Without prejudice to Regulation 23(1), the Board may revoke, suspend or vary the conditions of a licence if in its opinion the holder no longer satisfies the requirements for the grant of a licence or if, in the course of a routine inspection 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 animal remedy.

(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

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 therefor, 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

Certification by the Board

27. (1) The Board may, at the request of the holder of a manufacturer's licence, an exporter, or the appropriate authority in a third country, issue a certificate stating that, -

(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

(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.

PART V

SALE, SUPPLY AND POSSESSION OF AN ANIMAL REMEDY

Restriction on sale of an animal remedy

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

(2) Paragraph (1) does not apply to —

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

(b) the sale or supply of an authorised animal remedy by a registered veterinary practitioner in accordance with Regulation 44, 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 licence.

(3) Notwithstanding Paragraphs (1) and (2), 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 or under his or her control,

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

(c) from 1^st January 2007, in the case of an animal remedy referred to in paragraph 3 (iii) of Part I of Schedule 1, he or she is a responsible person 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 or under his or her control.

(4) Notwithstanding Paragraphs (1) and (2), 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.

(5) Notwithstanding Paragraphs (1) and (2), a person shall not sell or supply an animal remedy designated pharmacy only unless -

(a) he or she is a pharmacist or 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,

(6) Paragraphs (3), (4), and (5) 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 under these Regulations.

Restriction on use of a premises

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

(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,

(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, not being a retail outlet used by a registered veterinary practitioner and from the date the Veterinary Council of Ireland prescribes matters under Section 108 of the Veterinary Practice Act 2005 (No. 22 of 2005), in respect of which a certificate of suitability has been granted or deemed to have been granted under that Act.

Wholesale of an animal remedy

30. (1) A person shall not sell or supply an animal remedy by wholesale except under and in accordance with a licence (“animal remedies wholesaler's licence”).

(2) The Minister shall notify the applicant of his or her proposed decision to grant a licence or refuse an application within 90 days of receipt of a valid 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 an animal remedy.

(4) 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.

(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 the premises may not be used for purposes referred to in Regulation 31 or Regulation 33.

(6) Without prejudice to Regulation 51, the Minister, when granting an animal remedies wholesaler's licence, shall require the holder to —

(a) sell or supply an animal remedy only to a person who holds an animal remedies wholesaler's licence, or, 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) have in place an emergency plan to ensure that, on being informed, by the Minister, the Board, the Agency or the manufacturer that -

(i) a batch or part of a batch of an animal remedy is found not to conform with an animal remedies authorisation or as regards strength, quality or purity with the specification of that animal remedy, or

(ii) an animal remedy has been found to give rise to unacceptable adverse reactions,

if so directed, he or she shall immediately withdraw from sale or supply any quantities held and, so far as is practicable, immediately recall all quantities sold or supplied,

(e) keep 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 and expiry date,

(iv) the quantity received or supplied,

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

(vi) quantities received and returned in accordance with subparagraph (k);

(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 these records shall be made 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) give, without payment, a sample of an animal remedy to a person authorised to take the sample,

(i) 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,

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

(k) have in place the necessary systems to receive and ensure that animal remedies returned which are unused or have reached their expiry date, are returned 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.

(7) 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, by virtue of these Regulations or a licence granted there under, 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.

(8) 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.

(9) This Regulation does not apply to -

(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.

(10) An animal remedies wholesaler's licence remains in force for a period of three years or for a shorter period as may be specified by the Minister, unless it is sooner suspended, varied or revoked.

Retail sale of an animal remedy

31. (1) A person shall not sell or supply an animal remedy by retail except under and in accordance with a licence (“animal remedies merchant's licence”) except for a person selling a companion animal medicine in accordance with Regulation 33.

(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 shall specify the location and premises from which the business of retail sale or supply of an animal remedy is to be carried out and the premises may not be used for purposes referred to in Regulation 30.

(5) Without prejudice to Regulation 51, the Minister when granting an animal remedies merchant's licence, shall require the holder to —

(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 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,

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

(iii) the manufacturer's batch number and expiry date,

(iv) the quantity received or supplied,

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

(vi) quantities received and or returned in accordance with subparagraph (h),

(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 these records shall be made 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) give, without payment, a sample of an animal remedy to a person authorised to take a sample,

(f) 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,

(g) ensure, on being informed by the Minister, the Board, the Agency, the holder of a manufacturer's licence or the holder of an animal remedies wholesaler's licence that in respect of -

(i) a batch or part of a batch of an animal remedy found not to conform with an animal remedies authorisation or as regards strength, quality or purity, with the specification of that animal remedy, or

(ii) an animal remedy found to give rise to unacceptable adverse reactions,

if so directed, he or she shall immediately withdraw from sale or supply any quantities, and, in so far as is practicable, immediately recall all quantities sold or supplied,

(h) have in place arrangements to receive and return to the person from whom he or she purchased them, 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

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

(6) The Minister shall 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(6)(a) refers.

(8) An animal remedies merchant's licence, unless it is sooner suspended, varied or revoked, shall remain in force for a period of three years, or for a shorter period if specified by the Minister.

(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 that five years.

(10) This Regulation does not apply to -

(a) a pharmacy, or

(b) a part of a premises, not being a retail outlet used by a registered veterinary practitioner and from the date the Veterinary Council of Ireland prescribes matters under section 108 of the Veterinary Practice Act 2005 (No. 22 of 2005) in respect of which a certificate of suitability has been granted or deemed to have been granted under that Act.

Training

32. (1) For the purpose of ensuring that a person, other than a registered veterinary practitioner 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 may approve appropriate training courses.

(2) Without prejudice to Regulation 51, 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.

Sale of a companion animal medicine

33. (1) A person shall not sell or supply by retail a companion animal medicine unless he or she is registered in the register maintained under this Regulation (“companion animal medicines sellers register”).

(2) The Minister shall maintain a register of persons selling companion animal medicines 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 a 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 a 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 them, 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,

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

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

34. A registered veterinary practitioner or a pharmacist shall -

(a) keep 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,

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

(iii) the manufacturer's batch number and expiry date,

(iv) the quantity received or supplied,

(v) the name and address of the supplier or consignee,

(vi) the quantity of each animal remedy received or returned, in accordance with subparagraph (c).

(b) keep at his or her premises, the records referred to in subparagraph (a) for a period of five years from the date of receipt, sale or supply 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.

Labelling of certain animal remedies

35. A registered veterinary practitioner who prescribes an animal remedy designated prescription only or a pharmacist who dispenses a veterinary prescription shall, at the time of sale or supply, affix (in such manner as not to obscure the information required by the animal remedies authorisation) to the animal remedy a label indicating his or her name and address, the serial number of the prescription, the name of the prescribing practitioner and the date of sale or supply.

Prohibition on sale of an animal remedy after expiry date

36. A person shall not sell or supply an animal remedy after the date specified on the container, label or package leaflet of an animal remedy by the manufacturer in accordance with the terms and conditions of the animal remedies authorisation.

Fixed premises

37. (1) A person shall not sell or supply an animal remedy other than from a 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 except for a visit made to a person at his or her place of business if that person is lawfully entitled to sell or supply an animal remedy from his or her place of business,

(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.

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

(i) the holder of a licence under Regulation 31, or

(ii) a pharmacist.

(b) A licence under paragraph (3) shall not relate to an animal remedy other than 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

38. (1) A person shall not publish or cause to be published an advertisement or other promotion for an animal remedy unless the animal remedy is an authorised animal remedy.

(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 or Prescription Only, or

(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, or a pharmacist.

(4) 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 all animal remedies held in stock.

Possession of certain animal remedies

39. A person, other than the holder of a manufacturer's licence, the holder of an animal remedies wholesaler's licence, a registered veterinary practitioner or a pharmacist, or from 1^st January 2007, the holder of an animal remedies merchant's licence, shall not have an animal remedy intended for a food producing animal, which is designated prescription only, in his or her possession or under his or her control, unless he or she has a veterinary prescription relating to the animal remedy 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

40. (1)(a) A person, other than a registered veterinary practitioner, shall not administer an animal remedy referred to in Regulation 10(1), 11(1), 12(1) or 12A of the Regulations of 1998.

(b) If an animal remedy is designated veterinary practitioner only, a person shall not administer the animal remedy unless he or she is a registered veterinary practitioner, or unless a registered veterinary practitioner, who prescribed the animal remedy, is present, supervises administration and is able to render immediate veterinary assistance.

(2) Without prejudice to paragraph (1) and Regulation 18, a person shall not administer cause or permit administration of an animal remedy to an animal unless -

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

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

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

Administration of an animal remedy to a food producing animal

41. (1) A person shall not —

(a) notwithstanding Regulation 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 42, 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) If an animal remedy is administered to a food producing animal, the owner or person in charge of the animal shall 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.

(3) A food producing animal to which an animal remedy, which is not an authorised animal remedy, has been administered and meat or any other produce derived from that animal are, for the purposes of any enactment, unfit for human consumption.

(4) Meat or meat produce, milk or milk produce, or an egg or egg produce or honey that contains an amount of an animal remedy or residue thereof or of a substance contained in an authorised animal remedy or residue thereof in excess of the maximum levels permitted by law or authorised by the law of the State or by Council Regulation (EEC No. 2377/90 or otherwise authorised by a decision of the European Communities, is unfit for human consumption.

(5)
(a) A person, including a registered veterinary practitioner, who administers, 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 the animal remedy (other than those relating to the treated animal to be complied with after administration), and

(ii) if the person is not the owner or person in charge of the animal inform the owner or person in charge of the animal -

(I) of the conditions of use of the animal remedy relating to the animal to be complied with after administration, and

(II) that the 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.

(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 animal to be complied with after administration,

(ii) not slaughter the animal for human consumption, or export or sell the 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, of produce taken from the animal during the withdrawal period specified in the conditions of use of the animal remedy.

(6) In paragraph (5) “conditions of use”, means -

(a) 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, or

(b) if the animal remedy is sold or supplied by a registered veterinary practitioner in accordance with Regulation 18, the conditions of use stated on the marketing authorisation.

Import of an animal

42. An animal lawfully imported is considered to have been treated with an authorised animal remedy, if -

(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

43. (1) The owner or person in charge of a food producing animal shall keep at his or her premises a record, (“Animal Remedies Record”) of all animal remedies purchased and administered, which shall conform to Schedule 7.

(2)
(a) The owner or person in charge of a food producing animal who administers an animal remedy to that animal shall enter in the Animal Remedies Record, on each occasion when it is administered, the required details in chronological order.

(b) The Animal Remedies Record shall be kept for five years after administration of the animal remedy.

(3) The owner or person in charge of a food producing animal to which a veterinary prescription only animal remedy has been administered shall keep, 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) If an animal remedy to which this Regulation applies is administered by a registered veterinary practitioner, he or she shall give to the owner or person in charge of the animal the information to enable that person to comply with paragraphs (1) and (2).

(5) The owner or person in charge of a food-producing animal shall return to the person from whom he or she purchased them, an unused animal remedy, or an animal remedy which has reached its expiry date and record this in the Animal Remedies Record.

PART V11 VETERINARY PRACTICE AND VETERINARY MEDICINE

Under the care of a veterinary practitioner

44. (1) 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.

(2) For the purposes of paragraph (1)(e), a registered veterinary practitioner shall maintain records as follows:

(a) in relation to each client, a register, 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 and the basis for diagnosis,

(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.

(3)
(a) Invoices referred to in subparagraph (2)(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.

Prescribing and dispensing

45. (1) A registered veterinary practitioner shall not issue a veterinary prescription for an animal remedy unless the animal to which the veterinary prescription relates is under his or her care and he or she is satisfied that -

(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 previous treatment, 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 prescribe an animal remedy only 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 6 months supply from the date the veterinary prescription is issued.

(3) A veterinary prescription shall -

(a) 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,

(b) 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

(4) A registered veterinary practitioner shall retain a copy of a veterinary prescription for 5 years and make the copy available for inspection on request by an authorised officer.

(5) 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 alternative animal remedies on the veterinary prescription.

(6) A person -

(a) who dispenses a veterinary prescription in part shall immediately record on the prescription and on the copy thereof 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,

(b) who has completed dispensing a veterinary prescription shall, at that time write on the prescription and on the copy thereof in a conspicuous, legible and indelible manner, the word “dispensed” and the date and he or she shall return a copy of the veterinary prescription to the person who presented it and he or she shall retain the original veterinary prescription for five years and shall make this available on request to an authorised officer, and

(c) shall not complete dispensing an animal remedy on foot of a veterinary prescription later than 6 months after the date the veterinary prescription is issued.

Emergency supply of certain animal remedies by a pharmacist

46. (1) It is not a contravention of these Regulations for a pharmacist to sell or supply an authorised animal remedy which is designated prescription only, if —

(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, ( SI No 328 of 1988 ),

(e) the animal remedy is labelled in accordance with Regulation 35, 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 written veterinary prescription.

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

Certain animal disease situations

47. (1) These Regulations in so far as they relate to an animal under the care of a registered veterinary practitioner do not apply to the administration of an animal remedy if the animal remedy is administered for the purpose, or in the course, of an official or voluntary scheme or programme authorised and operated by, or on behalf of, the Minister, for the treatment, control, eradication, monitoring, or surveillance of disease (within the meaning of the Diseases of Animals Act, 1966 (No. 6 of 1966)) in an animal or for the determination of the health or disease status of an animal.

(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

48. The Board shall publish notice of the grant or revocation of a veterinary product authorisation in Iris Oifigiúil.

Information to the agency.

49. (1) The Board shall inform the Agency of a decision to grant, refuse, suspend or revoke a veterinary product authorisation or a manufacturer's licence, or to prohibit the sale or supply, or to recall an animal remedy and the reasons for the decision.

(2) The Board shall make available to the Agency information relating to reports received under Regulation 13(2).

(3) The Board shall ensure that appropriate information about actions taken pursuant to paragraph (1) or Regulation 13, 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

50. (1) A person shall not forge a document purporting to be —

(a) a veterinary prescription,

(b) an animal remedies authorisation,

(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 veterinary prescription issued under these Regulations,

an animal remedies authorisation,

a licence, registration or approval,

a record required to be kept pursuant to these Regulations, or

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 in relation to —

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

(b) an authorised officer, or

(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) or (b).

Licences, registrations and approvals granted under a specified Regulation

51. (1) The Minister may grant a licence, registration or approval under a specified Regulation or refuse an application and may attach conditions to a licence, registration or approval, revoke or vary a condition or revoke the licence, registration or approval.

(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) 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 Regulations made thereunder,

(b) the applicant or holder has failed to comply with a condition attached thereto,

(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.

(4) 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 Regulations made under the Act.

(5) 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 thereto, he or she shall -

(a) notify the applicant or holder in writing of the proposal and of the reasons therefor, 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

(6) The holder shall not transfer a licence, registration or approval granted by the Minister to any other person and any purported transfer is void and of no effect.

(7) 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

(8) In this Regulation “a specified Regulation” means Regulation 3, 16, 17, 18(5), 20 30, 31, 32, 33 or 37(3)(a) and (b).

Evidence of certificate etc

52. (1) In proceedings for an offence consisting of a contravention of these Regulations a certificate purporting to be signed by a person employed at a laboratory named in the certificate stating the capacity in which that person is so employed and stating any one or more of the following, namely -

(a) that the person received a sample submitted to the laboratory,

(b) that, for a period as is specified in the certificate, the person had in his or her custody a sample so submitted,

(d) that the person carried out a laboratory examination for the purpose of detecting the presence, in a sample so submitted, of a substance, ingredient for an animal remedy or animal remedy, or

(e) that a particular substance, ingredient for an animal remedy or animal remedy was present in the sample,

is, unless the contrary is proved, evidence of the matters stated in the certificate.

(2) A certificate purporting to be signed by an officer of the Minister and to certify that on a specific day or days or during the whole of a specified period -

(a) a particular person did not stand registered in the register of bulk animal remedies or the companion animal medicines sellers register,

(b) the registration of a particular person in the register of bulk animal remedies or the companion animal medicines sellers register had been revoked,

(d) that a particular registration, licence or approval referred to in this paragraph, was subject to a particular condition or conditions,

is, without proof of the signature of the person purporting to sign the certificate or that he or she is an officer of the Minister, evidence, unless the contrary is shown, of the matters stated in the certificate.

(3) A certificate purporting to be signed by the secretary of the Board and to certify that on a specific day or days or during the whole of a specified period-

(a) a person was or was not the holder of a veterinary product authorisation or registration granted under Regulation 10 or the holder of a manufacturer's licence granted under Regulation 23,

(b) that a particular authorisation, licence or registration, referred to in this paragraph, was subject to a particular condition or conditions,

is, without proof of the signature of the person purporting to sign the certificate or that he or she is an officer of the Board, evidence, unless the contrary is shown, of the matters stated in the certificate.

(4) In proceedings for an offence under these Regulations the court may, if it considers that the interests of justice so require, direct that oral evidence of the matters stated in a certificate under paragraph (1), (2) or (3) be given, and the court may for the purpose of receiving oral evidence adjourn the matter.

(5) In proceedings for an offence, evidence of the Directive, Council Regulation (EEC 2377/90, or Regulation (EC) No. 726/2004 may be given by production of a copy of the said Directive or Regulation certified by an officer of the Minister to be a copy of the said Directive or Regulation, and it is not necessary to prove the signature of the officer or that he or she is an officer of the Minister.

(6) Paragraph (5) is in addition to and not in substitution for the European Communities (Judicial Notice and Documentary Evidence) Regulations 1972 ( S.I. No. 341 of 1972 ).

Service

53. (1) A notification under these Regulations (hereinafter in this Regulation referred to as a “notification”) shall be addressed to the person concerned by name, and may be served on or given to the person in one of the following ways -

(a) by delivering it to the person,

(b) by leaving it at the address at which the person ordinarily resides or if an address for service has been furnished, at that address,

(c) by sending it by post in a prepaid registered letter to the address at which the person ordinarily resides or, if an address for service has been furnished, at that address, or

(d) if the address at which the person ordinarily resides cannot be ascertained by reasonable enquiry and the notice relates to a premises, by delivering it to some person over sixteen years of age resident or employed on the premises or by affixing it in a conspicuous position on or near the premises.

(2) A person shall not at any time within six months after a notification or notice is affixed under paragraph (1)(d) remove, damage or deface the notice without lawful authority.

(3) For the purposes of this Regulation, a company, within the meaning of the Companies Acts 1963 to 2003, is deemed to be ordinarily resident at its registered office and every other body corporate and every unincorporated body is deemed to be ordinarily resident at its principal office or place of business.

Revocations and savers

54. (1) The following are revoked -

(a) The Animal Remedies Regulations 1996 ( S.I. No 179 of 1996 ), other than Regulations 44 and 45,

(b) Regulations 21 and 32 of the Regulations of 1998,

(d) Regulation 3 of the Control of Animal Remedies and their Residues (Amendment) Regulations 2004 ( S.I. No 827 of 2004 ).

(2) Regulations 44 and 45 of the Animal Remedies Regulations 1996 ( S.I. No 179 of 1996 ) are revoked from 1 January 2006.

(3) Each of the following, granted under the Animal Remedies Regulations 1996, that is in force immediately before the revocation of those Regulations remains in force and may be dealt with as if granted under the corresponding provision of these Regulations -

(a) an animal remedies authorisation,

(b) a manufacturer's licence,

(e) a licence under Regulation 16,

(f) a licence under Regulation 26,

(g) a licence under Regulation 41,

(h) an animal remedies merchant's licence,

(i) a registration under Regulation (3) or Regulation (32) or

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