IE
S.I. No. 258/1985 - Animal Remedies (Control of Sale) Regulations, 1985.
Table of Provisions (10)
Statutory Text (10 Articles)
1. Where the animal remedy is a substance or preparation to which the Poisons (Control of Residues in Foods of Animal Origin) Regulations, 1985 (
S.I. No. 257 of 1985
), applies, particulars of the time required by those Regulations to be observed as a withdrawal period together with a statement that so observing such period is a requirement of those Regulations.
2. Where the animal remedy comprises or contains any substance specified in Part I of the First Schedule to these Regulations or any substance which is a substance of a class or description so specified, a statement that the animal remedy is to be used only by a veterinary surgeon or under the direct supervision of a veterinary surgeon.
3. (
a
) Subject to subparagraph (
b
) of this paragraph, where the animal remedy comprises or contains any substance specified in Part II or Part III of the First Schedule to these Regulations or any substance which is a substance of a class or description so specified, either a statement that the animal remedy is obtainable on prescription only or the following symbol
POM
(
b
) Subparagraph (
a
) of this paragraph shall not apply to any animal remedy described in Regulation 5 (2) of these Regulations.
GIVEN under my Official Seal, this 7th day of August, 1985.
AUSTIN DEASY,
Minister for Agriculture.
EXPLANATORY NOTE.
These Regulations control the sale of animal remedies containing hormones, antibiotics and antibacterial substances.
4. The particulars set out in the Second Schedule to these Regulations are hereby prescribed for the purposes of paragraph (
d
) of section 5 (1) of the Act.
5. (1) Subject to paragraph (2) of this Regulation, the sale of any animal remedy to which these Regulations apply is hereby prohibited save under licence of the Minister.
(2) Paragraph (1) of this Regulation shall not apply to any animal remedy which—
(
a
) comprises or contains any substance specified in Part III of the First Schedule to these Regulations, and
(
b
) is marketed (whether by being packaged in a particular manner or otherwise) as an intramammary preparation for the prevention of mastitis in animals, and
(
c
) is intended for use exclusively as such a preparation,
and whose container and any outer wrapper bears a notice clearly indicating that the animal remedy is so marketed and is intended for such use.
6. (1) In respect of any animal remedy to which these Regulations apply, a person, whether or not he is the holder of a licence granted for the purposes of these Regulations, shall not—
(
a
) sell any such remedy, from a travelling shop, vehicle or an automatic vending machine, or by mail order, or
(
b
) make visits from house to house for the purpose of soliciting, collecting or obtaining orders for any such remedy.
(2) Paragraph (1) of this Regulation shall not apply for any of the purposes specified in subparagraph (
b
) of that paragraph where house to house visits are made on persons at their respective places of business and those persons are lawfully entitled to sell any such remedy from their respective places of business.
(3) In this Regulation "house" includes land.
7. In any proceedings for an offence in which a contravention of Regulation 5 of these Regulations is alleged, it shall be a defence for the defendant to prove—
(
a
) that the animal remedy to which the alleged offence relates was sold by wholesale to a particular person for the purpose of resale only, and
(
b
) that there were reasonable grounds to believe that such person was
bona fide
engaged in the business of purchasing animal remedies for the purpose of resale only, and
(
c
) either—
(i) that the Poisons Regulations, 1982 to 1984, were complied with as regards the sale, or
(ii) that those Regulations did not apply as regards the sale.
8. (1) These Regulations are in addition to and not in substitution for—
(
a
) the Animal Remedies (Registration of Manufacturers, Importers and Wholesalers) Regulations, 1980 (
S.I. No. 115 of 1980
);
(
b
) Regulation 3 of the European Communities (Control of Stilbene and Thyrostatic Substances) Regulations, 1981 (S.I. No. 366 of 1981);
(
c
) Regulation 3 of the European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 1982 (
S.I. No. 282 of 1982
); and
(
d
) the Poisons Regulations, 1982 to 1984.
(2) Nothing in these Regulations shall be construed as affecting any provision of—
(
a
) the European Communities (Feeding Stuffs) (Additives) Regulations, 1974 to 1984, and
(
b
) the Animal and Poultry Compound Feeding Stuffs (Control of Antibiotics) Regulations, 1972 (
S.I. No. 335 of 1972
).
9. (1) The Animal Remedies (Control of Oestrogenic Substances) Regulations, 1962 (
S.I. No. 96 of 1962
), is hereby amended by the substitution of the following for Regulation 3—
"3. The manufacture, preparation or packing of any animal remedy to which these Regulations apply is hereby prohibited save under licence of the Minister.".
(2) The Animal Remedies (Control of Chloramphenicol) Regulations, 1974 (
S.I. No. 10 of 1974
), are hereby revoked.
FIRST SCHEDULE
PART I
S.I. No. 258 of 1985.
ANIMAL REMEDIES (CONTROL OF SALE) REGULATIONS, 1985.
I, AUSTIN DEASY, Minister for Agriculture, in exercise of the powers conferred on me by
sections 5
and
7
of the
Animal Remedies Act, 1956
(No. 41 of 1956), and after consultation with the Animal Remedies Consultative Committee and the Minister for Health, hereby make the following Regulations