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

S.I. No. 786/2007 - European Communities (Animal Remedies) (No. 2) Regulations 2007 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.

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  3. s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2007 S.I. No. 786/2007 - European Communities (Animal Remedies) (No. 2) Regulations 2007 S.I. No. 786/2007 - European Communities (Animal Remedies) (No. 2) Regulations 2007 AmendmentsLeasuithe Download PDF Íoslódáil PDF ARRANGEMENT OF REGULATIONS PART I PRELIMINARY AND GENERAL 1. Citation and commencement. 2. Interpretation. PART II AUTHORISATION OF AN ANIMAL REMEDY 3. Requirement for an animal remedies authorisation. 4. Application for a veterinary product authorisation. 5. Examination of an application for a veterinary product authorisation. 6. Authorisation of an animal remedy referred to in Articles 13,13a-d of the Directive (‘generics’, ‘bibliographics’ etc.). 7. Authorisation of a homeopathic animal remedy. 8. Mutual recognition. 9. Decision etc. on an application. 10. Validity of a veterinary product authorisation. 11. Certain obligations of a marketing authorisation holder. 12. Pharmacovigilance. 13. Suspension, revocation or variation of a veterinary product authorisation. 14. Recall of an animal remedy. PART III EXCEPTIONAL AUTHORISATION AND ADMINISTRATION OF AN ANIMAL REMEDY 15. Cross border practice. 16. Certain health situations. 17. Miscellaneous situations. 18. ‘The cascade’. 19. Research etc. PART lV MANUFACTURE, IMPORT AND EXPORT OF AN ANIMAL REMEDY AND STARTING MATERIALS 20. Manufacture of an animal remedy. 21. Application for manufacturer’s licence. 22. Decision on application for a manufacturer’s licence. 23. Certain obligations of a holder of a manufacturer’s licence. 24. Validity of a manufacturer’s licence. 25. Revocation, suspension or variation of a manufacturer’s licence. 26. Certification by the Board. 27. Consignment to a person or address in another member state. PART V SALE, SUPPLY AND POSSESSION OF AN ANIMAL REMEDY 28. Restriction on sale of an animal remedy. 29. Restriction on use of a premises. 30. Wholesale of an animal remedy. 31. Retail sale of an animal remedy. 32. Training. 33. Sale of an animal remedy designated ‘companion animal medicine’. 34. Record-keeping and other requirements for a veterinary practitioner and a pharmacist. 35. Prohibition on sale of an animal remedy after expiry date. 36. Fixed premises. 37. Advertising. 38. Possession of certain animal remedies. PART VI ADMINISTRATION OF AN ANIMAL REMEDY AND PROVISIONS RELATING TO ANIMALS AND ANIMAL PRODUCE 39. Administration of an animal remedy. 40. Administration of an animal remedy to a food producing animal. 41. Import of an animal. 42. Animal remedies record and disposal of animal remedies. PART VII VETERINARY PRACTICE AND VETERINARY MEDICINE 43. Prescribing and dispensing. 44. Emergency supply of certain animal remedies by a pharmacist. 45. Certain animal disease situations. PART VIII MISCELLANEOUS 46. Publication of certain decisions. 47. Information to the Agency. 48. Forgery. 49. Licences, registrations and approvals granted under a specified Regulation. 50. Fixed Penalty Notice. 51. Implied condition in certain contracts of sale. 52. Inspection by authorised officers, etc. 53. Search warrant. 54. Search of suspects, etc. 55. Power of arrest. 56. Saving for certain power. 57. Obstruction. 58. Impersonation of an authorised officer, etc. and possession of certainidentity documents. 59. Evidence of class of animal remedies to which a contravention relates. 60. Disposal of things seized. 61. Recoupment of costs of certain disposals. 62. Fees and levies etc. 63. Evidence on certificate, etc. 64. Evidential Burden. 65. Service. 66. Revocation and savers. 67. Offences by bodies corporate, etc. 68. Prosecution of summary proceedings. 69. Offences. ARRANGEMENT OF SCHEDULES SCHEDULE 1 ROUTES OF SALE PART 1 Routes of sale PART II Criteria taken account of by the Board in designating route of sale SCHEDULE 2 LABELLING REQUIREMENTS FOR AN ANIMAL REMEDY PART I General labelling etc. requirements PART II Small containers PART III Package leaflet PART IV Symbols denoting route of sale SCHEDULE 3 A VETERINARY PRESCRIPTION SCHEDULE 4 QUALIFIED PERSON FOR MANUFACTURING PART I Duties of a qualified person PART II Requirements applicable to a qualified person SCHEDULE 5 REQUIREMENTS TO BE MET BY A HOLDER OF A MANUFACTURER’S LICENCE SCHEDULE 6 GENERAL REQUIREMENTS FOR A LICENSED MERCHANT’S PREMISES SCHEDULE 7 ANIMAL REMEDIES RECORD SCHEDULE 8 REQUIREMENTS OF THE PROGRAMME REFERRED TO IN REGULATION 43

(9)S.I. No. 786 of 2007 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (No. 2) REGULATIONS 2007 Notice of the making of this Statutory Instrument was published in “Iris Oifigiúil” of 7th December, 2007. I, MARY COUGHLAN, Minister for Agriculture, Fisheries and Food, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) for the purpose of giving effect to Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products 1 as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 2 and to give further effect to Council Regulation (EEC) No. 2377/90 of 26 June 1990 3 and to give full effect to Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 4 , so far as that Regulation relates to a veterinary medicinal product, hereby make the following regulations: PART I PRELIMINARY AND GENERAL Citation and commencement. 1.
(1)These Regulations may be cited as the European Communities (Animal Remedies) (No. 2) Regulations 2007.
(2)Regulation 43
(9)comes into operation on 1 January 2008. Interpretation. 2.
(1)In these Regulations— “Act” means Animal Remedies Act 1993 (No. 23 of 1993); “Agency” means European Medicines Agency established by Regulation (EC) No. 726/2004; “animal remedies authorisation” means— (
  1. a)a veterinary product authorisation within the meaning of Article 5 of the Directive, issued by the Board, (
  2. b)a licence granted under the Therapeutic Substances Act 1932 (No. 25 of 1932) in respect of an animal remedy named on the licence, until the date of expiry of the licence, (
  3. c)a licence under Regulation 16, 17, or 19, (
  4. d)a marketing authorisation granted under Regulation (EC) No. 726/2004, (
  5. e)a registration granted by the Board in accordance with Regulation 7
(2), or (
  1. f)such other document, registration, licence or authorisation deemed by these Regulations to be an animal remedies authorisation; “animal” has the same meaning as it has in Section 2 of the Act and in the Animal Remedies Act 1993 (Section 2) Order 2005 ( S.I. No. 733 of 2005 ); “authorised officer” means a person who is an authorised officer within the meaning of the Act; “Board” means Irish Medicines Board; “companion animal” includes a domestic dog, cat, rabbit (other than a rabbit kept for human consumption), a small rodent, cage bird, homing pigeon, terrarium animal and an aquarium fish or an equid declared as not intended for use as food for human consumption in accordance with the European Communities (Equine Stud-Book Competition) Regulations 2004 ( S.I. No. 399 of 2004 )); “companion animal medicine” means an animal remedy authorised by the Board for administration to a companion animal only; “companion animal medicine seller” means a person registered under Regulation 33; “Council Regulation (EEC) No. 2377/90” means Council Regulation (EEC) 2377/90 of 26 June, 1990, as amended and any act of an institution of the European Union which amends, extends or replaces the said Council Regulation (EEC) No. 2377/90; “Directive” means Directive 2001/82/EC of the European Parliament and of the Council, of 6 November 2001, as amended by Directive 2004/28/EC, of the European Parliament and of the Council of 31 March 2004; “EEA Agreement” means the Agreement on the European Economic Area signed in Oporto on 2 May 1992 as adjusted by the Protocol to that Agreement done at Brussels on 17 March 1993 5 ; “EEA State” means a state which is a contracting state to the EEA Agreement within the meaning given to that phrase in the European Communities (Amendment) Act 1993 (No. 25 of 1993); “European Economic Area” means the European Economic Area created by the EEA Agreement; “food producing animal” means an animal of the bovine, caprine, ovine or porcine species, poultry, rabbits, deer, fish or honey bees, if such rabbits, deer or fish are intended for use as food for human consumption, or equidae intended for use as food for human consumption in accordance with the European Communities (Equine Stud-Book and Competition) Regulations 2004, ( S.I. No. 399 of 2004 ); “group veterinary practice” means a formally associated group of registered veterinary practitioners who are available to provide services of veterinary medicine and surgery and to carry out clinical procedures on animals under their care; “holder” in respect of a registration, licence, approval or animal remedies authorisation means the person to whom the registration, licence, approval, or animal remedies authorisation is granted and who is identified as the holder on the registration, licence, approval or animal remedies authorisation, and reference to a holder includes a reference to a representative, employee, servant or agent of the holder; “homeopathic animal remedy” has the same meaning as a homeopathic veterinary medicinal product; “human consumption” includes a thing intended for incorporation in, or manufacture into, a food intended for human consumption and kindred words shall be construed accordingly; “immunological animal remedy” has the same meaning as immunological veterinary medicinal product; “imported” means brought into the State from outside the State and “importation” shall be construed accordingly; “intramammary animal remedy” means an animal remedy which is licensed for sale (whether being packaged or otherwise) as an intramammary preparation for the prevention or treatment of mastitis in an animal, is intended for use exclusively as such preparation and whose container and any other outer packaging bears a notice clearly indicating that the animal remedy is sold or supplied for such use only; “meat” includes the edible produce of fish; “medicinal product” has the meaning assigned to it by Directive 2001/83/EC of 6 November 2001 6 ; “medicated feedingstuff” means a mixture of an animal remedy or remedies and feed or feeds which is ready prepared for placing on the market or for use and which is intended to be fed to animals without further processing because of its curative or preventative or other properties as an animal remedy; “pharmacist” means a person lawfully keeping open for dispensing or compounding medical prescriptions or for the sale of poisons under the Pharmacy Acts 1875 to 1977; “pharmacy” means a shop being lawfully kept open for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts 1875 to 1977; “pre-mix for a medicated feedingstuff” means an animal remedy prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs; “record” means a record in writing and— (
  2. a)a disc, tape, sound-track or other device, including an electronic device, in which information, sounds or signals are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in legible or audible form, (
  3. b)a film, tape or other device, including an electronic device, in which visual images are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in visual form, and (
  4. c)a photograph, and a reference to a copy of a record includes— (
  5. i)in the case of a record to which paragraph (
  6. a)refers, a transcript of the sounds or signals embodied in it, (
  7. ii)in the case of a record to which paragraph (
  8. b)refers, a still reproduction of the images embodied in it, and (iii) in the case of a record to which paragraphs (
  9. a)and (
  10. b)refer, such a transcript together with such a still reproduction; “registered veterinary practitioner” means a veterinary practitioner registered under the Veterinary Practice Act 2005 (No. 22 of 2005); “Regulation (EC) No. 726/2004” means Regulation (EC) No. 726/2004 of the European Parliament and of the Council of the 31 March 2004 and any act of an institution of the European Union which amends, extends or replaces that Regulation; “third country” means a state other than a member state of the European Union; “veterinary prescription” means a written prescription (containing the information specified in Schedule 3) issued by a registered veterinary practitioner in respect of an animal under his or her care that provides for the administration of an animal remedy to the animal.
(2)A word or expression used in these Regulations and also used in an act of the institutions of the European Communities has, unless the contrary intention appears, the meaning in these Regulations that it has in the act of the institutions of the European Communities in which it occurs.
(3)A word or expression that is used in these Regulations and is used in the Act has, in these Regulations, unless the contrary intention appears, the same meaning as it has in the Act. PART II AUTHORISATION OF AN ANIMAL REMEDY Requirement for an animal remedies authorisation. 3.
(1)Without prejudice to Regulations 15, 18 and 21, a person shall not import, possess, sell or supply an animal remedy, unless there is in force an animal remedies authorisation in respect of the animal remedy.
(2)Paragraph
(1)does not apply to a homeopathic animal remedy (other than an immunological homeopathic animal remedy) which, on or before 31 December 1993, was registered under the Animal Remedies (Registration of Manufacturers, Importers and Wholesalers) Regulations 1980 ( S.I. No. 115 of 1980 ).
(3)(
  1. a)The Board may, on application, determine— (
  2. i)that a substance does not come within the Directive, or (
  3. ii)in accordance with Article 4
(2)of the Directive that an animal remedy, intended solely for an aquarium fish, a caged bird, a homing pigeon, a terrarium animal, a small rodent, a ferret and a rabbit (kept exclusively as a pet), is exempt from the requirements of paragraph
(1). (
  1. b)An application under this paragraph shall be made in a form, be accompanied by any material and contain any particulars that the Board specifies. (
  2. c)If the Board proposes to refuse an application under this paragraph, it shall— (
  3. i)notify the applicant in writing of the proposal and of the reasons for the proposal, and that he or she may make representation to the Board in relation to the proposal within 14 days of notification, (
  4. ii)consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and (iii) notify the applicant of the decision and the reasons for the decision.
(4)If the Board makes a determination in accordance with paragraph
(3)(a), it shall notify the applicant and the Minister. Application for a veterinary product authorisation. 4.
(1)An application for a veterinary product authorisation shall be made to the Board and shall be in a form and contain the information that the Board requires and be accompanied by the particulars and documents specified in the first subparagraph of Article 12
(3)and in Article 14 of the Directive and Annex 1 to the Directive.
(2)If the documents and particulars which relate to matters referred to in point (j) of the first subparagraph of Article 12
(3)of the Directive are accompanied by detailed and critical summaries, these summaries shall be drafted and signed by experts with the requisite qualifications as specified in Article 15
(1)and
(3)of the Directive.
(3)If an application for a veterinary product authorisation is made in respect of an animal remedy authorised, or under examination, by the competent authority in another member state, the Board may not consider the application unless it is satisfied that the first subparagraph of Article 32
(1)of the Directive has been complied with.
(4)If the Board decides not to consider an application to which paragraph
(3)applies, it shall inform the applicant.
(5)(
  1. a)The Board may not consider an application for a veterinary product authorisation in respect of an animal remedy intended for administration to a food producing animal unless six months have elapsed since the lodgement of a valid application for the establishment of a maximum residue limit with the Agency. (
  2. b)Subparagraph (
  3. a)does not apply to an animal remedy containing a pharmacologically active substance not listed in Annexes I, II or III to Council Regulation (EEC) No. 2377/90 intended for administration to an equid which is a companion animal.
(6)The Board may not consider an application for a veterinary product authorisation unless the applicant is established in a member state. Examination of an application for a veterinary product authorisation. 5.
(1)In examining an application for a veterinary product authorisation, the Board shall take into consideration such criteria as it considers relevant to comply with Articles 12 to 14 of the Directive and in particular, information supplied by the applicant relating to— (
  1. a)the quality, safety and efficacy of the animal remedy, (
  2. b)the proposed indications, sales presentation, labelling and where appropriate, package leaflet relating to the animal remedy, and (
  3. c)the measures, in the case of an animal remedy to be imported from a third country, to ensure that the animal remedy is produced to an equivalent standard to those applicable in the European Community, and an inspection of the manufacturing facility by the Board may be required.
(2)The Board may require an applicant to furnish, without charge, a sample of an animal remedy, its starting materials, active substances, intermediate product, reference standard or other constituent material for testing by a laboratory designated by the Board.
(3)In order to verify the analytical detection methods proposed by the applicant, the Board may consult with any expert it considers appropriate and may require the applicant to supply sufficient quantities of a substance or other material it considers necessary.
(4)If the Board requires further information as specified in Article 23
(4)of the Directive, the time limit referred to in Regulation 9
(2)is suspended until the information required is supplied to the satisfaction of the Board.
(5)When determining an application for a veterinary product authorisation, the Board shall comply with the Council Directives within the meaning of the European Communities (Control of Animal Remedies and their Residues) Regulations 2007 ( S.I. No. 143 of 2007 ). Authorisation of an animal remedy referred to in Articles 13, 13a-d of the Directive (‘generics’, ‘bibliographics’ etc.). 6.
(1)Notwithstanding Regulation 4
(1)and without prejudice to the Patents Act 1992 (No. 1 of 1992), if an applicant can demonstrate to the satisfaction of the Board that— (
  1. a)the animal remedy is a generic animal remedy, and (
  2. b)the reference animal remedy, is or was authorised for not less than 8 years, he or she need not provide the results of safety and residue tests or of pre-clinical and clinical trials referred to and in accordance with Annex I to the Directive.
(2)If a reference animal remedy is authorised in another member state, the applicant shall identify the member state and the Board shall request the competent authority of that member state to transmit confirmation that the animal remedy is or has been authorised, together with the full composition of the animal remedy and any other relevant information.
(3)For the purposes of paragraph
(1)— (
  1. a)different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, and (
  2. b)if, in the opinion of the Board, salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of a substance differ significantly from those in the reference animal remedy, the applicant shall provide additional information as specified in Article 13
(2)(b) of the Directive.
(4)If, in the opinion of the Board, an animal remedy is not a generic animal remedy, or if bio-equivalence cannot be demonstrated through bio-availability studies or in the case of changes to an active substance, therapeutic indications, strength, pharmaceutical form or route of administration vis--vis the reference animal remedy, the applicant shall provide results of appropriate safety and residue tests and pre-clinical tests or clinical trials in accordance with Annex I to the Directive.
(5)If, in the opinion of the Board, a biological animal remedy does not meet in full the definition of a generic animal remedy owing to, in particular, differences relating to raw materials or differences between the manufacturing processes of the biological animal remedy and the reference biological animal remedy, the applicant shall comply with Article 13
(4)of the Directive.
(6)(
  1. a)An applicant need not provide the results of safety and residue tests or of pre-clinical and clinical trials referred to and in accordance with Annex I to the Directive, if he or she can satisfy the Board, on the basis of appropriate scientific literature, that the active substances in the animal remedy have been present in an authorised animal remedy meeting the requirements of Annex 1 to the Directive, for at least 10 years. (
  2. b)The use of scientific literature referred to in subparagraph (
  3. a)shall be justified, to the satisfaction of the Board, by the experts referred to in Regulation 4
(2). (c) For the purposes of subparagraph (a), the Board may accept the assessment report published by the Agency as appropriate scientific literature following the evaluation of an application for the establishment of a maximum residue limit pursuant to Council Regulation (EEC) No. 2377/90.
(7)Notwithstanding paragraph
(1), an application for a veterinary product authorisation in respect of an animal remedy containing two or more active substances, each having been used in an authorised animal remedy, but not previously used in combination in an authorised animal remedy shall, as may be required by the Board, be accompanied by the results of— (a) safety and residue tests relating to the combination, and (b) new pre-clinical tests or new clinical trials, relating to the combination that fulfils the requirements of Article 12
(3)(j) of the Directive.
(8)Notwithstanding paragraph
(1), if an application is made for a veterinary product authorisation in respect of an immunological animal remedy, in exceptional circumstances, the Board may, if it receives a duly substantiated case from the applicant on the basis of Article 13(d) of the Directive and following consultation with the Minister, exempt the applicant from the requirements of Article 12
(3)(j) of the Directive in relation to field trials on a target species.
(9)(a) Notwithstanding Regulation 9
(2), the Board shall not issue a veterinary product authorisation in respect of a generic animal remedy authorised pursuant to paragraph
(1)until 10 years have elapsed from the date of the grant of a marketing authorisation for the reference animal remedy. (b) Notwithstanding subparagraph (a), in the case of an application for an animal remedy for fish or bees or other species designated in accordance with Article 89
(2)of the Directive, the Board shall not issue a veterinary product authorisation until thirteen years have elapsed from the date of the grant of a marketing authorisation for the reference animal remedy. (
  1. c)Notwithstanding subparagraphs (
  2. a)and (b), in the case of a reference animal remedy containing a new active substance— (
  3. i)intended for administration to a food producing species, and (
  4. ii)that was not authorised, by 30 April 2004, the Board shall not issue a veterinary product authorisation in respect of a generic animal remedy for an additional food producing species unless the periods specified in Article 13
(5)of the Directive have elapsed. (
  1. d)Subparagraph (
  2. c)only applies when— (
  3. i)the extension to the veterinary product authorisation referred to in subparagraph (
  4. c)is granted within five years of the grant of the original marketing authorisation for the reference animal remedy, and (
  5. ii)the veterinary product authorisation holder is the person who applied to the Agency for the maximum residue limit for the active substance in the reference animal remedy for the species concerned.
(10)If a person, having availed of the provisions of paragraph
(6)(a), submits new residue studies and clinical trials, with a view to obtaining a veterinary product authorisation in respect of a further food-producing species, another person shall not use the studies or trials in an application for a generic animal remedy for a period of three years thereafter.
(11)The Board, having obtained permission in writing from the holder of a veterinary product authorisation, may take into account data referred to in Article 13c of the Directive when examining another application for a veterinary product authorisation for an animal remedy having the same qualitative and quantitative composition in active substances and the same pharmaceutical form.
(12)This Regulation applies only to a reference animal remedy for which an application for a marketing authorisation is submitted after 30 October 2005.
(13)In this Regulation— “authorised”, in relation to an animal remedy, means authorised in the State, in another Member State or in accordance with Regulation (EC) No. 726/2004; “generic animal remedy” means an animal remedy which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form (which includes various immediate-release oral pharmaceutical forms) as the reference animal remedy and whose bio-equivalence with the reference animal remedy has been demonstrated by bio-availability studies where appropriate; “reference animal remedy” has the meaning assigned to a reference medicinal product by Article 13
(2)(a) of the Directive. Authorisation of a homeopathic animal remedy. 7.
(1)An application for a veterinary product authorisation for a homeopathic animal remedy shall comply with Regulation 4.
(2)(a) Notwithstanding paragraph
(1)and without prejudice to Council Regulation (EEC) No. 2377/90, an application for registration of a homeopathic animal remedy (other than an immunological homeopathic animal remedy) in respect of which it has been demonstrated to the satisfaction of the Board that it— (
  1. i)is to be administered by a route described in the European Pharmacopoeia or in the absence thereof, in the official pharmacopoeias used in a Member State, (
  2. ii)contains no specific therapeutic indications, and (iii) has, in the opinion of the Board, a sufficient degree of dilution and in particular, does not contain more than one part per 10 000 of the mother tincture, is subject to Article 17
(2)of the Directive. (
  1. b)An application for registration of a homeopathic animal remedy to which sub-paragraph (
  2. a)refers shall be made to the Board and be in such form as the Board may require and be accompanied by the particulars and documents specified in Article 18 of the Directive. (
  3. c)Notwithstanding subparagraphs (
  4. a)and (b), the requirements of Regulation 5 apply to an application under this paragraph with the exception of proof of efficacy. (
  5. d)A homeopathic animal remedy, registered in accordance with this paragraph shall be labelled as prescribed by paragraph
(2)of Part I of Schedule
  1. Mutual recognition.
  2. The Board shall comply with Articles 32 to 41 of the Directive in so far as these Articles apply to the Board and may act as a reference or concerned member state (within the meaning of those Articles). Decision etc. on an application. 9.
(1)The Board may grant a veterinary product authorisation, arising from an application under Regulation 4, 6, 7 or 8, refuse an application, attach conditions to a veterinary product authorisation or registration, revoke or vary a condition, or suspend or revoke a veterinary product authorisation or registration.
(2)Subject to Regulations 5
(4)and 8, the Board shall, within 210 days of the receipt of a valid application, notify the applicant of its decision.
(3)The Board may, following consultation with the applicant, grant a veterinary product authorisation subject to annual review and subject to the holder undertaking to meet specific obligations, including— (
  1. a)introduction of specific procedures, in particular, concerning the safety of the animal remedy, and (
  2. b)notification to the Board of all incidents relating to use of the animal remedy.
(4)The Board, except in the case of a homeopathic animal remedy referred to in Regulation 7
(2), shall have regard to Article 25 of the Directive.
(5)The Board shall specify the manner in which an animal remedy shall be packaged, presented and labelled and the particulars which shall appear on the label, container or package leaflet.
(6)For the purposes of paragraph
(5)and without prejudice to Regulation 7
(2), the form of label or package leaflet shall comply with the Directive and Schedule 2 and include any particulars specified by the Board for the purpose of safety or health protection, including any special precautions for use or other warnings resulting from clinical and pharmacological trials, or, from experience gained during the use of the animal remedy and, in particular, matters arising as a result of pharmacovigilance reports.
(7)Without prejudice to paragraph
(1), the Board, where it grants a veterinary product authorisation, shall— (
  1. a)as a condition of the veterinary product authorisation, designate the route of sale for an animal remedy in accordance with Part II of Schedule 1, and (
  2. b)specify the route of sale (for which purpose the symbols set out in Part IV of Schedule 2 may be used) to appear on the container, label and package leaflet relating to the animal remedy.
(8)If the Board proposes to refuse an application, it shall— (
  1. 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, (
  2. b)consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and (
  3. c)notify the applicant concerned of the decision and the reasons for the decision.
(9)The Board shall refuse an application if, in its opinion— (
  1. a)the risk-benefit balance of the animal remedy is unfavourable under the proposed conditions of use, (
  2. b)the animal remedy has no therapeutic effect or the applicant has not provided sufficient proof of such effect in the species of animal to be treated, (
  3. c)the qualitative or quantitative composition of the animal remedy is not as stated, (
  4. d)the withdrawal period recommended by the applicant is not long enough to ensure that a foodstuff obtained from an animal does not contain residues which exceed those prescribed by Council Regulation (EEC) No 2377/90, or other act of the institutions of the European Union, or a limit prescribed by regulations made under the Act or the European Communities Act 1972 , or which might constitute a health hazard to a consumer of produce from an animal, (
  5. e)the labelling or package leaflet proposed by the applicant for the animal remedy does not comply with the Directive or these Regulations, (
  6. f)the animal remedy is, or is to be, offered for sale or supply for a use that is unlawful, (
  7. g)the animal remedy consists of, or contains, a substance the administration of which to the particular class or classes of animal for which the animal remedy is intended, is unlawful, (
  8. h)the animal remedy consists of or contains a substance to which Regulation 3
(1)of the European Communities (Control of Animal Remedies and their Residues) Regulations 2007 ( S.I. No. 143 of 2007 ) applies, (
  1. i)such action is necessary to protect public health, animal health or the environment, (
  2. j)the animal remedy is not manufactured in accordance with the principles and guidelines referred to in Article 50(
  3. f)of the Directive, (
  4. k)a request by the Board for further particulars, to enable compliance with the Directive to be considered, has not been complied with, within the time specified, or (
  5. l)the application does not comply with Regulations 4, 6, 7 or 8.
(10)For the purposes of paragraph
(9)(a), in the case of an animal remedy intended for zootechnical use, the Board shall have particular regard to the benefits for animal health and welfare and consumer safety.
(11)For the purposes of paragraph
(9)(b), an animal remedy is considered to have no therapeutic effect unless it can be shown that it produces the appropriate therapeutic effect for the condition to be treated in the species of animal for which the treatment is intended.
(12)(a) Subject to paragraph
(9)and without prejudice to subparagraph (b), the Board shall not grant a veterinary product authorisation or a registration in respect of an animal remedy intended for administration to a food producing animal unless each substance capable of pharmacological action contained in the animal remedy is mentioned in Annex I, II or III to Council Regulation (EEC) No. 2377/90. (
  1. b)Notwithstanding subparagraph (a), the Board may authorise an animal remedy containing a substance not listed in Annexes I, II or III to Council Regulation (EEC) No. 2377/90 for administration to an equid which is a companion animal, except where— (
  2. i)the substance is listed in Annex IV to Council Regulation (EEC) No. 2377/90, or (
  3. ii)there is already in force an animal remedies authorisation for treatment of the same condition. Validity of a veterinary product authorisation. 10.
(1)Without prejudice to Regulations 9
(3)and 11, a veterinary product authorisation is, unless previously revoked, valid for five years, commencing on the date of the grant of the authorisation.
(2)(
  1. a)A veterinary product authorisation may be renewed by the Board on the basis of an application made by the holder. (
  2. b)An application for renewal of a veterinary product authorisation shall be made in a form, be accompanied by any material and contain any particulars that the Board specifies and, in particular, the information specified in the second subparagraph of Article 28
(2)of the Directive and be submitted no later than six months before expiry of the authorisation which it is to replace.
(3)If application for renewal of a veterinary product authorisation is made no later than six months before the expiry date, that veterinary product authorisation remains in force until determination of the application.
(4)Without prejudice to Regulation 9
(1), a veterinary product authorisation, if renewed, is subject to these Regulations, valid for an unlimited period, unless the Board considers at the time of the grant of a first renewal, on the basis of pharmacovigilance information, that the validity should be limited to one additional five year period following which the Board shall, if it considers it appropriate to do so, renew the authorisation for an unlimited period.
(5)(
  1. a)If an animal remedy in respect of which a veterinary product authorisation has been issued by the Board— (
  2. i)is not placed on the market in the State within three years from the date of authorisation, or (
  3. ii)is not marketed in the State for a period of three consecutive years, the authorisation ceases to be valid on the day following expiry of the three year period. (
  4. b)This paragraph does not apply if the Board is satisfied that the validity of the authorisation should be continued, in particular, on public or animal health grounds. Certain obligations of a marketing authorisation holder. 11.
(1)The holder of an animal remedies authorisation shall, at the request of the Board, supply, within the period specified by the Board, data which the Board considers appropriate in order to demonstrate that the risk-benefit balance of the animal remedy remains favourable.
(2)(a) The holder of an animal remedies authorisation shall take all reasonable steps to ensure that he or she takes account of ongoing scientific progress as regards the manufacturing and control methods specified in Articles 12
(3)(
  1. d)and (
  2. i)of the Directive for the purposes of compliance with Article 27 of the Directive. (
  3. b)The holder of an animal remedies authorisation shall submit for the approval of the Board changes to the methods referred to in subparagraph (a).
(3)The holder of an animal remedies authorisation shall immediately provide to the Board new information relating to an animal remedy which would give rise to an amendment to the particulars or documents furnished for the purposes of Regulations 4, 6, 7 and 8 and in particular,— (
  1. a)new information which would affect the risk-benefit balance of the animal remedy, (
  2. b)prohibitions or restrictions placed on the marketing of an animal remedy in another State or jurisdiction, and (
  3. c)serious unexpected adverse reactions arising out of the administration of the animal remedy.
(4)The holder of an animal remedies authorisation shall submit, for the approval of the Board, amendments to the particulars or documents referred to in paragraph
(3).
(5)The holder of an animal remedies authorisation shall, on request, make available to the Board or an authorised officer— (
  1. a)a quantity of a substance as may be necessary to carry out routine checks for the presence of residues of an animal remedy, and (
  2. b)technical expertise to facilitate implementation of an analytical method for detecting residues of an animal remedy, in a food producing animal or in the flesh or produce of a food producing animal.
(6)The holder of an animal remedies authorisation shall maintain for at least five years records of all undesirable effects observed in animals or humans arising out of the administration of the animal remedy, and shall make them available to the Board on request and shall have arrangements in place to comply with the pharmacovigilance requirements specified in Regulation 12.
(7)The holder of an animal remedies authorisation shall inform the Board of— (
  1. a)the date an animal remedy is placed on the market in the State, and (
  2. b)the date an animal remedy is to cease to be placed on the market in the State and the reasons for this action at least two months in advance of the proposed withdrawal date, except where the applicant demonstrates the existence of exceptional circumstances, to the satisfaction of the Board.
(8)The holder of an animal remedies authorisation shall, at the request of the Board, furnish details of sale or supply of the animal remedy and any data in his or her possession relating to prescriptions of the animal remedy.
(9)(
  1. a)The holder of an animal remedies authorisation, or a person carrying out activities on his or her behalf, shall maintain a system designed to ensure, in accordance with Article 95a of the Directive, that an animal remedy sold or supplied by him or her in the State, which is unused or reaches its expiry date, is disposed of lawfully. (
  2. b)For the purposes of subparagraph (a), the holder of an animal remedies authorisation or a person carrying out activities on his or her behalf shall put in place the necessary arrangements with— (
  3. i)the holder of an animal remedies wholesaler’s licence, (
  4. ii)a registered veterinary practitioner, (iii) a pharmacist, (
  5. iv)the holder of an animal remedies merchant’s licence, or (
  6. v)a person registered in accordance with Regulation 33, to whom he or she sells or supplies an animal remedy, with a view to receiving animal remedies referred to in subparagraph (
  7. a)from those persons having been returned to them.
(10)Without prejudice to Regulation 7
(2), the holder of an animal remedies authorisation shall not sell or supply an animal remedy unless and until the package and label comply with Schedule 2 and the veterinary product authorisation.
(11)A person shall not remove or alter a label or package leaflet prescribed by these Regulations unless authorised by the Board.
(12)(
  1. a)In the case of an immunological animal remedy, the holder of an animal remedies authorisation shall— (
  2. i)if requested by the Board, submit copies of control reports referred to in Article 81
(2)of the Directive, and (ii) if the Board considers it necessary for the purposes of Article 82
(1)of the Directive, submit samples of batches of bulk product or an immunological animal remedy before the product is placed on the market in the State. (b) If subparagraph (a)(ii) applies, the Board shall comply with the second subparagraph of Article 82
(2), and 82
(5)of the Directive.
(13)This Regulation is in addition to and not in substitution for any other obligation imposed on a holder of an animal remedies authorisation by these Regulations or by an animal remedies authorisation. Pharmacovigilance. 12.
(1)The Board shall maintain and implement a pharmacovigilance system in accordance with Title VII of the Directive.
(2)(
  1. a)If, as a result of evaluation of a report under this Regulation, the Board considers that an animal remedies authorisation should be:— (
  2. i)revoked, varied or suspended, (
  3. ii)restricted as to the indications or availability, (iii) varied as to the posology, or (
  4. iv)varied by the addition of a contra-indication or precautionary measure, it shall make this information available to the Minister, the Agency, the appropriate authorities in other member states and the holder of the animal remedies authorisation (who shall be afforded an opportunity to make representations within a period as may be fixed by the Board) forthwith. (
  5. b)An animal remedies authorisation shall not be revoked, varied or suspended until the representations, if any, of the holder of the animal remedies authorisation have been considered. (
  6. c)Notwithstanding sub-paragraph (b), in case of urgency if public or animal health is threatened, the Board may suspend the distribution, sale and supply of an animal remedy.
(3)(
  1. a)The holder of an animal remedies authorisation shall have permanently and continuously at his or her disposal an appropriately qualified person responsible for pharmacovigilance, (“qualified person for pharmacovigilance”). (
  2. b)A qualified person for pharmacovigilance shall reside in a member state and be responsible for carrying out the functions referred to in Article 74 of the Directive.
(4)The holder of an animal remedies authorisation shall comply with Article 75 of the Directive and shall furnish the reports required by and in accordance with that Article.
(5)Notwithstanding paragraph
(4), the Board may, in accordance with Article 74
(7)of the Directive, at the request of the holder of an animal remedies authorisation, amend the periods referred to in Article 75
(5)of the Directive.
(6)(
  1. a)The holder of an animal remedies authorisation shall not release to the general public information to which this Regulation relates without giving prior or simultaneous notification to the Board. (
  2. b)If information relating to adverse reactions is released to the general public, the holder of the animal remedies authorisation shall present the information in a manner that is objective and not misleading.
(7)(
  1. a)The holder of an animal remedies wholesaler’s licence, an animal remedies merchant’s licence or a person registered under Regulation 33, a registered veterinary practitioner or a pharmacist shall report to the Board or the holder of the animal remedies authorisation, any suspected serious or unexpected adverse reaction or human adverse reaction which is reported to him or her, or which otherwise come to his or her attention. (
  2. b)In the case of an adverse reaction referred to in subparagraph (a), the report shall be made at the earliest opportunity and not later than 15 days following receipt of the information. (
  3. c)The Board may prescribe the form in which a report under this paragraph is made.
(8)A person who sells or supplies an animal remedy shall notify the Board of any action taken by him or her to— (
  1. a)suspend the sale or supply, or (
  2. b)recall, an animal remedy together with the reasons for the action if it concerns the efficacy or safety (including the protection of public health) of the animal remedy.
(9)In this Regulation— “adverse reaction” means a reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or modification of physiological function; “human adverse reaction” means a reaction which is noxious and unintended and which occurs in a human being following exposure to an animal remedy; “qualified person for pharmacovigilance” means a person who, as a result of professional qualification, and or education and training, is competent to discharge the responsibilities prescribed by this Regulation; “serious adverse reaction” means an adverse reaction which is fatal, life threatening, lesion producing, disabling, incapacitating or which results in permanent or prolonged symptoms in the animals treated and includes a human adverse reaction; “serious unexpected adverse reaction” means an adverse reaction which is both serious and unexpected; “unexpected adverse reaction” means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics. Suspension, revocation or variation of a veterinary product authorisation. 13.
(1)Without prejudice to the generality of these Regulations, the Board shall suspend, revoke or vary a veterinary product authorisation if it is of the opinion that a circumstance referred to in Article 83
(1)of the Directive applies or if an undertaking given under Regulation 9
(3)has not been honoured or fulfilled.
(2)Without prejudice to Regulation 9
(1), the Board may suspend, revoke or vary a veterinary product authorisation if it is of the opinion that— (a) a circumstance referred to in Article 83
(2)of the Directive applies, (
  1. b)the animal remedy is not manufactured in accordance with the principles and guidelines referred to in Article 50(
  2. f)of the Directive, (
  3. c)the animal remedy is not labelled in accordance with the veterinary product authorisation, or (
  4. d)the animal remedy is not manufactured to the specification of the animal remedies authorisation.
(3)The Board may modify or annul a suspension, revocation or variation.
(4)A person shall comply with a decision of the Board under paragraph
(1).
(5)A person shall not sell or supply an animal remedy to which a suspension or revocation under paragraph
(1)or
(2)relates (including a suspension or revocation subject to representation under paragraph
(7)).
(6)Without prejudice to paragraph
(7), if the Board proposes to suspend, revoke or vary a veterinary product authorisation, it shall— (
  1. 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 7 days of the date of the notification, (
  2. b)consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and (
  3. c)notify the holder of the decision and the reasons for the decision, and the suspension, revocation or variation (under this paragraph) shall not have effect until the Board issues a notification of its decision in accordance with subparagraph (c).
(7)If the Board, for urgent public or animal health reasons, suspends or revokes a veterinary product authorisation 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
(4)) make representations to the Board in relation to the decision within 14 days of the date of the notification, (
  1. b)consider a representation duly made, and (
  2. c)confirm, modify or annul the decision and notify the holder of the decision and the reasons for the decision. Recall of an animal remedy. 14.
(1)The Board may, by notice (“recall notice”), order the recall of an animal remedy or a batch of an animal remedy if it is of the opinion that— (a) a circumstance referred to in Article 84
(1)of the Directive applies, (
  1. b)the animal remedy consists of or contains a substance the administration of which, to a class of animal for which the animal remedy is intended, is unlawful, (
  2. c)the animal remedy is not manufactured in accordance with the animal remedies authorisation or in accordance with the principles and guidelines referred to in Article 50(
  3. f)of the Directive, or (
  4. d)the animal remedy is not labelled in accordance with the animal remedies authorisation.
(2)The Board may modify or annul a recall notice.
(3)The Board may confine a recall notice to wholesaler or retailer level if it considers such action appropriate for the protection of animal or public health or environmental safety.
(4)A person shall comply with a recall notice (including a notice subject to representation under paragraph
(8)).
(5)If a recall notice is issued by the Board, the marketing authorisation holder shall consult with and agree to a requirement or amendment notified by the Board regarding the text of a recall notice or to the publication of the notice.
(6)Records of the recall of an animal remedy shall be available for inspection by an authorised officer of the Board.
(7)Without prejudice to paragraph
(8), if the Board proposes to issue a recall notice, it shall— (
  1. 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 7 days of the notification, (
  2. b)consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and (
  3. c)notify the holder of the decision and the reasons therefor, and the notice shall not have effect until the Board issues a notification of its decision in accordance with subparagraph (c).
(8)If the Board, for urgent public or animal health reasons, issues a recall notice, 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
(4)) make representations to the Board in relation to the decision within 14 days of the date of the notification, (
  1. b)consider a representation duly made, and (
  2. c)confirm, modify or annul the decision and notify the holder of the decision and the reasons therefor. PART III EXCEPTIONAL AUTHORISATION AND ADMINISTRATION OF AN ANIMAL REMEDY Cross border practice. 15.
(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 Regulation 43 and subject to this Regulation, import, possess, 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— (
  1. 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 (
  2. 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 and, in any event, for a period not greater than 5 days.
(5)A veterinary practitioner to whom this Regulation applies shall maintain and keep records within the State of— (
  1. a)the identity of the animal or animals treated, (
  2. b)the date of examination of the animal or animals, (
  3. c)the number of animals treated, (
  4. d)the name and address of the owner or person in charge of the animal or animals, (
  5. e)his or her diagnosis, (
  6. f)the details of the animal remedies administered, prescribed, sold or supplied, (
  7. g)the dosage administered, prescribed, sold or supplied, (
  8. h)the duration of treatment, and (
  9. i)the withdrawal period specified.
(6)The records specified in paragraph
(5)shall be maintained for five years and furnished on request for examination by an authorised officer. Certain health situations. 16.
(1)Notwithstanding Regulation 20, the Minister may, by licence— (
  1. a)if he or she considers that the health situation so requires, authorise the import, possession, sale or supply or administration of an animal remedy, if he or she is satisfied it is authorised in another member state, (
  2. b)in exceptional circumstances, if he or she considers that the health situation so requires, if there is no appropriate animal remedy authorised within the State or in another member state, authorise the manufacture, import, possession, sale or supply or administration of an animal remedy pending consideration of an application for authorisation by the Agency or by the Board, (
  3. c)if he or she considers it appropriate to deal with a serious epizootic disease in accordance with Article 8 of the Directive, authorise the import, possession, sale or supply or administration of an immunological animal remedy in respect of which there is not otherwise in force an animal remedies authorisation, or (
  4. d)in exceptional circumstances, if the animal concerned is to be exported to a third country, authorise the import, possession, sale or supply or administration, of an immunological animal remedy, authorised in that country.
(2)A licence granted under this Regulation shall specify the route of sale of the animal remedy to which it relates in accordance with Schedule 1.
(3)The Minister may not grant a licence under this Regulation if, following consultation with the Board, he or she is of the opinion that it is more appropriate that an application for a veterinary product authorisation be made to, and determined by, the Board.
(4)This Regulation is in addition to and not in substitution for the Diseases of Animals Act 1966 (Control on Animal and Poultry Vaccines) Order 2002 ( S.I. No. 528 of 2002 ). Miscellaneous situations. 17.
(1)Notwithstanding Regulation 20, the Minister may grant a licence to a person authorising the possession, manufacture, import, sale or supply of an animal remedy.
(2)Without prejudice to the generality of paragraph
(1), the Minister shall not grant a licence unless the applicant establishes to the satisfaction of the Minister that all of the animal remedy will be— (
  1. a)administered to animals in the course of a test or trial authorised by a licence granted under Regulation 19, (
  2. b)supplied to the Board or the Minister for the purpose of an application for an animal remedies authorisation, (
  3. c)supplied to a University or other institution concerned with higher education or scientific research or analysis for the purposes of such education or research or analysis, (
  4. d)used for in vitro or other studies or analysis not involving administration to animals, or (
  5. e)exported from the State.
(3)The Minister shall not grant a licence if, in his or her opinion— (
  1. a)the grant of the licence would prejudice public or animal health or trade in animals or animal products from the State, or (
  2. b)in the case of a licence authorising the manufacture of an animal remedy, the staff, premises, equipment, machinery or plant are not suitable to manufacture the animal remedy. ‘The cascade.’ 18.
(1)A person shall not prescribe an animal remedy for, or administer an animal remedy to, a food producing animal other than in accordance with an animal remedies authorisation, unless— (a) he or she is a registered veterinary practitioner, the animal is under his or her care in accordance with Regulation 43 and he or she complies with paragraphs
(2)to
(4),
(6)and
(10), (
  1. b)there is no animal remedy authorised in the State for the treatment of the condition in the animal, and (
  2. c)he or she is satisfied that the treatment is necessary, in particular, to avoid unacceptable suffering to the animal.
(2)Where the conditions in paragraph
(1)are met, a registered veterinary practitioner may prescribe or administer— (
  1. a)an animal remedy authorised in the State for another animal species or for another condition in the same species, or (
  2. b)if there is no animal remedy to which sub-paragraph (
  3. a)refers— (
  4. i)a medicinal product authorised by the Board in accordance with the Medicinal Products (Control of placing on the market) Regulations 2007 ( S.I. No. 540 of 2007 ) or authorised pursuant to Regulation (EC) 726/2004, or (
  5. ii)an animal remedy, imported in accordance with paragraph
(11), which is authorised in another member state in accordance with Article 5 of the Directive for administration to the same species or to another species, or (
  1. c)if there is no animal remedy or medicinal product to which either sub-paragraphs (
  2. a)or (
  3. b)refers, an animal remedy prepared extemporaneously by— (
  4. i)the registered veterinary practitioner, or (
  5. ii)a pharmacist or the holder of a manufacturer’s licence, in accordance with a veterinary prescription.
(3)Where the conditions in paragraphs
(1)and
(2)are met, a registered veterinary practitioner— (
  1. a)may prescribe or administer only an animal remedy or medicinal product containing a substance listed in Annex I, II or III to Council Regulation (EEC) No. 2377/90, and (
  2. b)may, in the case of an equid to which paragraph
(1)applies, in addition to an animal remedy or medicinal product referred to in subparagraph (a), prescribe or administer an animal remedy consisting of or containing a substance listed in the Annex to Commission Regulation (EC) No. 1950/2006 7 for the purposes specified in that Annex, details of which he or she shall enter in the identification document relating to the animal, (c) shall, subject to paragraph
(4), specify a withdrawal period to ensure that food from the animal does not contain a residue which may be harmful for consumers, (
  1. d)shall complete at the time of administering or prescribing the animal remedy, and retain at his or her premises for at least 5 years a record detailing— (
  2. i)the date of examination of the animal, (
  3. ii)the identification of the animal, (iii) the number of animals treated, (
  4. iv)the name and address of the owner or person in charge of the animal, (
  5. v)his or her diagnosis, (
  6. vi)details of the substance administered or prescribed and reasons for the choice of that substance, (vii) the dosage of the substance administered or prescribed, (viii) the duration of treatment, and (
  7. ix)the withdrawal period specified.
(4)For the purposes of paragraph
(3)(c), if an animal remedy or medicinal product administered or prescribed does not indicate a withdrawal period for the species of animal to be treated, the following withdrawal periods are mandatory unless a longer withdrawal period is specified— (
  1. a)in the case of eggs from treated animals, 7 days, (
  2. b)in the case of milk from treated animals, 7 days, (
  3. c)in the case of meat, including fat & offal from poultry and mammals, 28 days, (
  4. d)in the case of meat from fish, 500 degree days, or (
  5. e)in the case of meat from an equid, if paragraph
(3)(b) applies, at least 6 months.
(5)Paragraphs
(3)(
  1. c)and (
  2. d)do not apply in the case of a homeopathic animal remedy which contains an active substance listed in Annex II to Regulation (EEC) No. 2377/90.
(6)Paragraph
(1)applies to the treatment of an individual animal or animals on a premises and does not provide for the general manufacture, possession, sale, supply or administration of a substance to which that paragraph relates.
(7)For the purposes of paragraph
(3)(b), identification document has the same meaning as in the European Communities (Equine Stud-Book and Competition) Regulations 2004 ( S.I. No. 399 of 2004 ).
(8)A person shall not prescribe an animal remedy for, or administer an animal remedy to, a companion animal other than in accordance with an animal remedies authorisation, unless— (a) he or she is a registered veterinary practitioner, the animal is under his or her care in accordance with Regulation 43 and he or she complies with paragraphs
(9)and
(10), (
  1. b)there is no animal remedy authorised in the State for the treatment of the condition in the animal, and (
  2. c)he or she is satisfied that the treatment is necessary, in particular, to avoid unacceptable suffering to the animal.
(9)Where the conditions in paragraph
(8)are met, a registered veterinary practitioner may prescribe or administer— (
  1. a)an animal remedy authorised in the State for another animal species or for another condition in the same species, or (
  2. b)if there is no animal remedy to which subparagraph (
  3. a)refers— (
  4. i)a medicinal product authorised by the Board in accordance with the Medicinal Products (Control of placing on the market) Regulations 2007 ( S.I. No. 540 of 2007 ) or authorised pursuant to Regulation (EC) 726/2004, or (
  5. ii)an animal remedy, imported in accordance with paragraph
(11), which is authorised in another member state in accordance with Article 5 of the Directive for administration to the same species or to another species, or (
  1. c)if there is no animal remedy or medicinal product to which either sub-paragraphs (
  2. a)or (
  3. b)refers, an animal remedy prepared extemporaneously by— (
  4. i)the registered veterinary practitioner, or (
  5. ii)a pharmacist or the holder of a manufacturer’s licence, in accordance with a veterinary prescription.
(10)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 by Regulation 28
(5)and, in addition, in the case of an animal remedy imported in accordance with paragraph
(11), shall include a reference to the serial number of the import licence.
(11)The Minister may, on application authorise by licence the import, possession, sale or supply of an animal remedy for the purposes of paragraph
(2)(b)(ii) or
(9)(b)(
  1. ii)by— (
  2. a)a registered veterinary practitioner, (
  3. b)the holder of an animal remedies wholesaler’s licence, or (
  4. c)a pharmacist who has a veterinary prescription in his or her possession in respect of the animal remedy.
(12)Notwithstanding paragraphs
(1)and
(8), it shall be lawful for the owner or person in charge of an animal to possess and administer an animal remedy in accordance with a veterinary prescription issued in accordance with this Regulation. Research etc. 19.
(1)A person shall not administer an animal remedy to an animal— (a) for the purpose of tests and trials of an animal remedy referred to in Article 12
(3)(
  1. j)of the Directive, or (
  2. 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 Council Regulation (EEC) No. 2377/90.
(3)Notwithstanding Regulation 40, a person, where this Regulation is complied with, 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. 20.
(1)Notwithstanding Regulation 3
(1)and without prejudice to Regulations 16, 17 and 18, 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’) granted by the Board.
(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)(
  1. a)If the quantity to be supplied is less than that available in the smallest proprietary pack size lawfully available in the State, a manufacturer’s licence is not required for dividing up, packaging or presenting an animal remedy, not carried out in advance, by— (
  2. i)a pharmacist in respect of an animal remedy to be sold from a pharmacy, (
  3. 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, or (iii) a responsible person selling or supplying from a premises to which an animal remedies merchant’s licence relates, but only in so far as an intramammary animal remedy is concerned. (
  4. b)Without prejudice to Regulation 28
(5), an animal remedy sold or supplied in accordance with subparagraph (
  1. a)shall be labelled with, or bear, a notice stating— (
  2. i)the proprietary name of the animal remedy, (
  3. ii)the words “for animal treatment only”, (iii) the species to be treated, (
  4. iv)the mode of administration, (
  5. v)the dose rate, (
  6. 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.
(4)A manufacturer’s licence is not required for the extemporaneous preparation in accordance with Regulation 18 of an animal remedy or magistral formula (provided it is not prepared in advance), by— (
  1. a)a registered veterinary practitioner for the treatment of an animal under his or her care, or (
  2. 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)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. 21.
(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— (
  1. 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, (
  2. b)demonstrate that all manufacturing will be carried out in accordance with the principles and guidelines referred to in Article 50(
  3. f)of the Directive, and (
  4. 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. 22.
(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)(
  1. 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. (
  2. b)Without prejudice to the generality of paragraph
(1), the Board shall refuse an application if— (
  1. 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, (
  2. 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, (
  3. 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(
  4. f)of the Directive, or (
  5. 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— (
  1. 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, (
  2. b)consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and (
  3. 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. 23.
(1)The holder of a manufacturer’s licence shall— (
  1. a)keep at his or her premises detailed records of an animal remedy manufactured, sold or supplied by him or her, (
  2. 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)(
  1. a)shall show in respect of each incoming and outgoing transaction for each sale or supply of an animal remedy— (
  2. a)the date, (
  3. b)the name of animal remedy, (
  4. c)the batch number and expiry date, (
  5. d)the quantity supplied, and (
  6. 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. 24.
(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 25
(1), valid for an unlimited period. Revocation, suspension or variation of a manufacturer’s licence. 25.
(1)(a) Without prejudice to Regulation 22
(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— (
  1. 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, (
  2. b)consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and (
  3. 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— (
  1. a)to public or animal health arising from the manner in which the premises is managed, maintained or operated, (
  2. 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 (
  3. 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— (
  4. i)the manufacture of an animal remedy or batch of an animal remedy at the premises or part thereof, or (
  5. 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, (
  1. b)consider a representation duly made, and (
  2. c)confirm, modify or annul the notice and notify the holder of the decision and the reasons for the decision. Certification by the Board. 26.
(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— (
  1. a)the manufacturer is in possession of a manufacturer’s licence to manufacture an animal remedy, and (
  2. b)there is in force an animal remedies authorisation relating to the animal remedy to be exported, or (
  3. 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. 27.
(1)If a person resident or having a place of business in the State sells or supplies an animal remedy to a person or address in another member state, the sale or supply of the animal remedy is, for the purposes of these Regulations, governed by the law of the State.
(2)A person shall not sell or supply an animal remedy to a person in another member state unless— (
  1. a)the animal remedy may be lawfully sold, supplied or administered in that member state, and (
  2. 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— (
  1. a)it was not lawful to sell, supply or administer a particular animal remedy in that member state, or (
  2. 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. 28.
(1)Without prejudice to the generality of these Regulations, a person shall not sell or supply an animal remedy other than in accordance with the routes of sale stipulated in Part I of Schedule 1.
(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— (
  1. 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, (
  2. b)the sale or supply of an authorised animal remedy by a registered veterinary practitioner in accordance with Regulation 43, or (
  3. 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— (
  1. 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, (
  2. 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 (
  3. 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— (
  1. a)his or her name and address, (
  2. b)the serial number of the veterinary prescription, (
  3. c)the name of the prescribing veterinary practitioner, (
  4. d)the date of sale or supply, and (
  5. 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— (
  1. a)he or she is a pharmacist, or (
  2. 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— (
  1. a)he or she is a pharmacist or is under the supervision of a pharmacist in a pharmacy, or (
  2. 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. 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— (
  1. a)a premises in respect of which there is a manufacturer’s licence, (
  2. b)a premises in respect of which there is an animal remedies wholesaler’s licence, (
  3. c)a premises in respect of which there is an animal remedies merchant’s licence, (
  4. d)a premises owned or operated by a person registered in accordance with Regulation 33, (
  5. e)a pharmacy, or (
  6. 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. 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)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— (
  1. 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, (
  2. 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, (
  3. 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, (
  4. 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— (
  5. 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 (
  6. ii)an animal remedy that has given rise to unacceptable adverse reactions, (
  7. 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— (
  8. i)the date of transaction, (
  9. ii)the precise identity of the animal remedy including name and pharmaceutical form and pack sizes, (iii) the manufacturer’s batch number, (
  10. iv)the name and address, as appropriate, of the supplier or consignee, (
  11. v)the quantity received or supplied (including the quantity received and returned in accordance with subparagraph (j), or otherwise disposed of), (
  12. f)keep at his or her premises the records referred to in subparagraph (
  13. 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, (
  14. 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, (
  15. h)furnish to the purchaser with each supply of an animal remedy, information detailing— (
  16. i)the date of supply, (
  17. ii)the precise identity of the animal remedy including proprietary name and pharmaceutical form and pack size, (iii) the quantity supplied, and (
  18. iv)the manufacturer’s batch number, (
  19. i)comply with Article 65
(5)of the Directive, and (
  1. j)have in place the necessary systems to receive from— (
  2. i)a registered veterinary practitioner, (
  3. ii)a pharmacist, (iii) the holder of an animal remedies merchant’s licence, or (
  4. 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— (
  1. a)that person is lawfully entitled to sell or supply an animal remedy, and (
  2. 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— (
  1. a)sale or supply of an animal remedy by a person who manufactured or imported it in accordance with a manufacturer’s licence, or (
  2. 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. 31.
(1)(
  1. a)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”), (
  2. b)Subparagraph (
  3. 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— (
  1. 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, (
  2. 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— (
  3. i)the date of transaction and in the case of an animal remedy designated prescription only, the serial number of the veterinary prescription, (
  4. ii)the precise identity of the animal remedy including name and pharmaceutical form and pack sizes, (iii) the manufacturer’s batch number, (
  5. iv)the name and address, as appropriate, of the supplier or consignee, and (
  6. v)the quantity received or supplied (including the quantity received and or returned in accordance with subparagraph (g), or otherwise disposed of), (
  7. c)keep at his or her premises, the records referred to in subparagraph (
  8. 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, (
  9. d)permit inspections and make available information required to satisfy the Minister that the conditions of the licence are being complied with, (
  10. 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, (
  11. 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— (
  12. 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 (
  13. ii)an animal remedy that has given rise to unacceptable adverse reactions, (
  14. 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 (
  15. h)ensure that an animal remedy is not sold from the premises other than by a responsible person. Subparagraph (
  16. 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— (
  1. a)a pharmacy, or (
  2. 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. 32.
(1)The Minister may approve appropriate training courses 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.
(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’. 33.
(1)A person shall not sell or supply by retail an animal remedy designated ‘companion animal medicine’ unless he or she is registered in the register maintained under this Regulation (“companion animal medicine sellers register”).
(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— (
  1. 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 (
  2. 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— (
  1. a)a registered veterinary practitioner, (
  2. b)a pharmacist, (
  3. c)the holder of an animal remedies merchant’s licence, or (
  4. 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— (
  5. 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— (
  6. 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, (
  7. 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, (
  8. iv)the name and address of the supplier or consignee, and (
  9. v)the quantity received or supplied (including the quantity received or returned in accordance with subparagraph (
  10. c)or otherwise disposed of), (
  11. b)keep the records referred to in subparagraph (
  12. 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 (
  13. 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 (
  14. a)and (
  15. 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. 35. A person shall not sell or supply an animal remedy after the date specified by the manufacturer as the expiry date. Fixed premises. 36.
(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— (
  1. 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, (
  2. 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, (
  3. c)sell or supply an animal remedy from a travelling shop, vehicle or automatic vending machine, or (
  4. 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 (
  5. 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— (
  6. i)a registered veterinary practitioner, (
  7. ii)a pharmacist, (iii) the holder of an animal remedies merchant’s licence, or (
  8. iv)a person entered in the ‘companion animal medicine sellers register’.
(4)(a) The Minister shall not grant a licence under paragraph
(3)(
  1. a)or (
  2. b)unless the applicant is— (
  3. i)the holder of an animal remedies merchant’s licence, or (
  4. ii)a pharmacist. (
  5. b)A licence granted under paragraph
(3)(
  1. a)or (
  2. 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. 37.
(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— (
  1. a)which contains a substance subject to restrictions resulting from implementation of United Nations Conventions on narcotic and psychotropic substances, (
  2. b)which is designated Veterinary Practitioner Only (VPO-1), veterinary practitioner only (VPO) or Prescription Only, or (
  3. 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. 38.
(1)A person shall not have an animal remedy, 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.
(2)Paragraph
(1)does not apply to— (
  1. a)the holder of a manufacturer’s licence, (
  2. b)the holder of an animal remedies wholesaler’s licence, (
  3. c)a registered veterinary practitioner, (
  4. d)a pharmacist, (
  5. 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 (
  6. 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. 39.
(1)Without prejudice to Regulations 15
(1)and 18 and subject to paragraph
(2), a person shall not administer, cause or permit administration of an animal remedy to an animal unless— (
  1. a)there is in force an animal remedies authorisation in respect of the animal remedy, (
  2. b)the administration is carried out in accordance with the animal remedies authorisation, (
  3. c)the animal remedies authorisation authorises administration of the animal remedy to the animal, class of animal or species, (
  4. d)the animal remedies authorisation permits administration of the animal remedy by the person, and (
  5. 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— (
  1. 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, (
  2. b)an animal remedy designated ‘veterinary practitioner only (VPO)’ to an animal unless— (
  3. i)he or she is a registered veterinary practitioner and the animal is under his or her care, (
  4. 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 (
  5. 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. 40.
(1)A person shall not— (
  1. 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, (
  2. 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), (
  3. 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), (
  4. d)process meat, milk, eggs or honey referred to in subparagraph (
  5. 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 (
  6. 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 (
  7. a)or meat, milk, eggs or honey derived from, or produced by, the animal.
(2)(
  1. a)The owner or person in charge of an animal to which an animal remedy has been administered shall— (
  2. i)comply with the conditions of use of the animal remedy to be complied with after administration, (
  3. 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. (
  4. 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. 41. An animal lawfully imported is considered to have been treated with an authorised animal remedy, if— (
  1. a)the animal remedy was administered prior to import, (
  2. b)the animal remedy was administered in accordance with the law of the state where administration occurred, and (
  3. 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. 42.
(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)The owner or person in charge of a food producing animal to which an animal remedy has been administered shall— (
  1. a)enter in the Animal Remedies Record, on each occasion when the animal remedy is administered, the required details in chronological order, and (
  2. 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. 43.
(1)A person shall not prescribe an animal remedy unless he or she is a registered veterinary practitioner, the animal to which the veterinary prescription relates is under his or her care and he or she is satisfied that— (
  1. a)the veterinary prescription will be used to treat the animal to which the prescription relates, (
  2. b)use of the animal remedy is justified for the animal, (
  3. 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 (
  4. 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— (
  1. a)be issued by a registered veterinary practitioner, (
  2. 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, (
  3. 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 (
  4. 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— (
  1. 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, (
  2. b)who has completed dispensing a veterinary prescription shall— (
  3. 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, (
  4. 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 (
  5. 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— (
  1. 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, (
  2. 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, (
  3. 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, (
  4. d)the registered veterinary practitioner is readily available for follow up consultation or monitoring of the condition and evaluation of the therapy, and (
  5. 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: (
  1. a)in relation to each client, a record, containing at least the following— (
  2. 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, (
  3. ii)the identity or other reference to animals clinically examined, (iii) the condition identified, (
  4. iv)details of treatment of each condition, and (
  5. v)a cross-reference to any relevant results of laboratory tests undertaken for the purpose of diagnosis, or any other test results, and (
  6. 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)(
  1. b)shall detail the cost of an animal remedy, administered, sold or supplied separately from a professional veterinary service. (
  2. b)These records may be maintained in the form of a herd health programme. Emergency supply of certain animal remedies by a pharmacist. 44.
(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— (
  1. 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, (
  2. b)the registered veterinary practitioner undertakes to furnish a veterinary prescription within 72 hours, (
  3. c)the animal remedy is sold or supplied in accordance with the directions of the registered veterinary practitioner requesting it, (
  4. 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 ), (
  5. 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 paragr

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AI explanation based on the official legal text. Indicative, not a substitute for legal advice.