S.I. No. 44/2002 - Animal Remedies (Amendment) Regulations 2002

I, Joe Walsh, Minister for Agriculture, Food and Rural Development, in exercise of the powers conferred on me by section 8 of the Animal Remedies Act 1993 (No. 23 of 1993) (as adapted by the Agriculture and Food (Alteration of Name of Department and Title of Minister) Order 1999 ( S.I. No. 307 of 1999 )), for the purpose, inter alia, of giving effect to Article 96 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 ¹ , after consulting with the Animal Remedies Consultative Committee hereby make the following regulations:

1.         These Regulations may be cited as the Animal Remedies (Amendment) Regulations 2002.

2.         Any reference made in the definitions of the Council Directive and the Council Directives in the Animal Remedies Regulations 1996 ( S.I. No. 179 of 1996 ) to a directive repealed by Article 96 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 ¹ (“the Consolidated Directive”) shall be construed as a reference to the Consolidated Directive and should be read in accordance with the correlation table set out in Annex III to the Consolidated Directive.

3.         The Animal Remedies Regulations 1996 ( S.I. No. 179 of 1996 ) are amended —

(a)        in Regulation 2(1), by the substitution for the definition of “authorised animal remedy” of —

“‘authorised animal remedy’ means an animal remedy that is not a prohibited animal remedy;”,

(b)        in Regulation 6(2), after “may” by the insertion of “be”,

(c)        in Regulation 18 —

(i)       in paragraph (1), after “system” by the insertion of “(that complies with the Consolidated Directive)”,

(ii)      in paragraph (1) (c), after “the” by the insertion of “sale,”,

(iii)     in paragraph (2)(b)(i), after “point” by the insertion of “within the Community”,

(iv)     in paragraph (3), after “shall” by the insertion of “comply with the Articles 74 and 75 of the Consolidated Directive and, in particular,”,

(v)      in paragraph (3)(b), by the substitution for “other than” of “including”,

(vi)     in paragraph (5)(a) and paragraph (6), after “Agency” by the insertion of “,the appropriate authorities in other member states”,

(vii)     in paragraph (8), by the insertion in the definition of “adverse reaction” after “function” of “and includes a human adverse reaction”,

(d)        in Regulation 26(6)(a), by the deletion of “previous”,

(e)        in Regulation 36, the substitution for paragraph (3) of —

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

(a)       save under licence of the Minister sell or supply by retail by mail order,

(b)       save under licence of the Minister make visits from house to house for the purpose of collecting, soliciting or obtaining orders for animal remedies,

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

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

(f)        in Regulation 36, by the insertion after paragraph (4) of —

“(4A) (1)        A licence under paragraph (3)(a) or (b) shall not be granted and, if granted, shall not have effect unless the applicant or person to whom the licence is granted is —

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

(b)       a pharmacist.

(2)        A licence under paragraph (3) shall not relate to an animal remedy other than an animal remedy to which either Regulation 13(1)(e) or 13(1)(f refers.

(3)        A licence under Regulation 36(3) of the Animal Remedies Regulations 1996 ( S.I. No. 179 of 1996 ) that is in force immediately before the commencement of this Regulation shall, subject to paragraph (1), be deemed to have been granted under Regulation 36(3) (inserted by Regulation 3(f) of the Animal Remedies Regulations 2002) of the first mentioned Regulations.”.

(g)        in Regulation 54(6), by the insertion after “Regulation 32” of “or Regulation 36(3)”, and

(h)        in paragraph 4 of Part II of the Second Schedule, by the substitution for “Clopostenol” of Cloprostenol”.

4.         A reference in the Animal Remedies Regulations 1996 to a Companion Animal Seller's licence shall be construed as reference to registration under Regulation 32 (inserted by Regulation 32(f) of the Control of Animal Remedies and Their Residues Regulations 1998 ( S.I. No. 507 of 1998 ) of the first mentioned Regulations.

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal interpretation).

These Regulations give effect to Article 96 of Directive 2001/82/EC of the European Parliament and the Council of 6 November 2001 and further amend the Animal Remedies Regulations 1996.

¹ O.J. No. L 311, 28.11.2001, p. 1.