European Communities (Animal Remedies) (Amendment) Regulations 2012.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the European Communities (Animal Remedies) (Amendment) Regulations 2012.
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paragraphs: In these Regulations “Animal Remedies Regulations” means European Communities (Animal Remedies)(No. 2) Regulations 2007 ( S.I. No. 786 of 2007 ) as amended by the European Communities (Animal Remedies) (Amendment) Regulations 2009 ( S.I. No. 182 of 2009 ).
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paragraphs: The Animal Remedies Regulations are amended in Regulation 2(1) by—
(a) inserting after the definition of “Board” the following-
“ ‘Commission Regulation (EU) No 37/2010’ means Commission Regulation (EU) No. 37/2010 of 22 December 20093 , as amended by Commission Regulation (EU) No 758/2010 of 24 August 20104 , Commission Regulation (EU) No 759/2010 of 24 August 20105 , Commission Regulation (EU) No 761/2010 of 25 August 20106 , Commission Regulation (EU) No 890/2010 of 8 October 20107 , Commission Regulation (EU) No 914/2010 of 12 October 20108 , Commission Regulation (EU) No 362/2011 of 13 April 20119 , Commission Regulation (EU) No 363/2011 of 13 April 201110 , Commission Implementing Regulation (EU) No 84/2012 of 1 February 201211 , Commission Implementing Regulation (EU) No 85/2012 of 1 February 201212 , Commission Implementing Regulation (EU) No 86/2012 of 1 February 201213 , Commission Implementing Regulation (EU) No 107/2012 of 8 February 201214 , Commission Implementing Regulation (EU) No 122/2012 of 13 February 201215 and Commission Implementing Regulation (EU) No 123/2012 of 13 February 201216 , Commission Implementing Regulation (EU) No 201/2012 of 8 March 201217 , Commission Implementing Regulation (EU) No 202/2012 of 8 March 201218 , Commission Implementing Regulation (EU) No 221/2012 of 14 March 201219 and Commission Implementing Regulation (EU) No 222/2012 of 14 March 201220 ”,
(b) substituting for the definition of “companion animal” the following-
“ ‘companion animal’ means an animal which is not a food producing animal;”,
(c) deleting the definition of “Council Regulation (EEC) No. 2377/90”,
(d) substituting for the definition of “food producing animal”, the following-
“ ‘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 which have not been permanently excluded from the food chain by completion of Part II of Section IX of the identification document provided for in the European Communities (Equine) Regulations 2011 ( S.I. No 357 of 2011 );”
(e) substituting for the definition of “pharmacist”, the following-
“ ‘pharmacist’ means a person registered as a pharmacist under Part 4 of the Pharmacy Act 2007 (No 20 of 2007);”,
(f) substituting for the definition of “pharmacy”, the following-
“ ‘pharmacy’ means a business registered under section 17 of the Pharmacy Act 2007 ;”, and
(g) inserting after the definition of “record” the following-
“ ‘Regulation (EC) No. 470/2009’ means Regulation (EC) No. 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82 of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council;”.
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paragraphs: Regulation 4(5)(b) of the Animal Remedies Regulations is amended by substituting the following subparagraph-
“(b) Subparagraph (a) does not apply to an animal remedy containing a pharmacologically active substance, not listed in Table 1 of the Annex to Commission Regulation (EU) No 37/2010, which is intended for administration to an equid which is a companion animal,”.
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paragraphs: Regulation 6(6)(c) of the Animal Remedies Regulations is amended by the substitution for the reference to “Council Regulation (EEC) No. 2377/90” of “Regulation (EC) No. 470/2009”.
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paragraphs: Regulation 7(2) of the Animal Remedies Regulations is amended by the substitution for the reference to “Council Regulation (EEC) No. 2377/90” of “Regulation (EC) No. 470/2009”.
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paragraphs: Regulation 9 of the Animal Remedies Regulations is amended by the substitution—
(a) in subparagraph (9)(d), for the reference to “Council Regulation (EEC) No. 2377/90” of “Commission Regulation (EU) No. 37/2010”, and
(b) for subparagraph (12), of the following-
“(12)(a) Subject to paragraph (9) and 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 listed in Table 1 of the Annex to Commission Regulation (EU) No 37/2010.
(b) The Board may authorise an animal remedy containing a substance not listed in Table 1 of the Annex to Commission Regulation (EU) No 37/2010 for administration to an equid which is a companion animal, except where—
(i) the substance is listed in Table 2 of the Annex to Commission Regulation (EU) No 37/2010, or
(ii) there is already in force an animal remedies authorisation for treatment of the same condition in an equid.”.
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paragraphs: Regulation 18 of the Animal Remedies Regulations is amended by the substitution-
(a) in subparagraph (3)(a), for “listed in Annex I, II or III to the Council Regulation (EEC) No 2377/90”, of “listed in Table 1 of the Annex to Commission Regulation (EU) No 37/2010”,
(b) for subparagraph (5), of the following-
“(5) Paragraphs (3)(c) and (d) do not apply in the case of a homeopathic animal remedy which contains an active substance classified under Article 14.2(c) of Regulation (EC) No. 470/2009.”, and
(c) for subparagraph (7), of the following-
“For the purposes of paragraph 3(b), identification document has the same meaning as in the European Communities (Equine) Regulations 2011 ( S.I. No 357 of 2011 ).”.
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paragraphs: Regulation 19(2)(b) of the Animal Remedies Regulations is amended by the substitution for the reference to “Council Regulation (EEC) No. 2377/90”, of “Regulation (EC) No. 470/2009”.
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paragraphs: Regulation 30 of the Animal Remedies Regulations is amended by substituting for subparagraph (9), the following-
“(9) Subject to Regulation 49, an animal remedies wholesaler’s licence remains in force for an unlimited period, unless a period of validity is specified on the licence.”.
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paragraphs: Regulation 31 of the Animal Remedies Regulations is amended by substituting for subparagraph (8), the following-
“(8) Subject to Regulation 49, an animal remedies merchant’s licence remains in force for an unlimited period, unless a period of validity is specified on the licence.”.
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paragraphs: Regulation 34 of the Animal Remedies Regulations is amended by substituting the following—
“34.(1) A registered veterinary practitioner or a pharmacist shall—
(a) keep, at his or her premises, a record of purchases and sales (including quantities administered) in respect of each incoming and outgoing transaction, detailing at least—
(i) the date of transaction, and in the case of an animal remedy designated ‘veterinary practitioner only (VPO-1)’, ‘veterinary practitioner only (VPO)’, or prescription only (POM), the serial number of the veterinary prescription,
(ii) the precise identity of the animal remedy or where Regulation 18 applies, the medicinal product, including name, pharmaceutical form and pack size,
(iii) the manufacturer’s batch number,
(iv) the name and address of the supplier or consignee, and
(v) the quantity received or supplied (including the quantity received or returned in accordance with subparagraph (c) or otherwise disposed of),
(b) keep the records referred to in subparagraph (a) for a period of five years from the date of receipt, sale or supply or administration of the animal remedy and these records shall be made available to an authorised officer on request,
(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, and
(d) at least once a year, carry out an audit to reconcile incoming and outgoing supplies with supplies currently in stock and any discrepancies shall be specifically recorded and this 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.
(2) Paragraphs (a), (b) and (d) do not apply in the case of an animal remedy designated ‘companion animal medicine’’.
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paragraphs: Regulation 36(4)(b) of the Animal Remedies Regulations is amended by substituting the following-
“(b) A licence granted under paragraph (3)(a) or (b)-