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The Veterinary Medicines Regulations 2013
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Homeopathic remediesE+W+S
This section has no associated Explanatory Memorandum
53.—(1) A homeopathic remedy registered under these Regulations must be labelled in accordance with this paragraph.
(2) There must be no specific therapeutic indication on the labelling or in any information relating to it.
(3) The labelling (or labelling and package leaflet) must contain the following and no other information—
(a)the words “homeopathic remedy without approved therapeutic indications for veterinary use”;
(b)the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used (if the homeopathic remedy is composed of more than one stock, the labelling may mention an invented name in addition to the scientific names of the stocks);
[F3(c)the name or company name and the permanent address or registered place of business of the registration holder and of the manufacturer]
(d)the method and, if necessary, route of administration;
(e)the expiry date;
(f)the pharmaceutical form;
(g)the contents of the pack;
(h)any special storage precautions;
(i)the target species;
(j)any necessary special warnings;
(k)the batch number; F4...
(l)the registration number; [F5and]
[F6(m)the withdrawal period, where applicable.]
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F3Sch. 1 para. 53(3)(c) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 66(a) (with reg. 200)
F4Word in Sch. 1 para. 53(3) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 66(b) (with reg. 200)
F5Word in Sch. 1 para. 53(3) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 66(c) (with reg. 200)
F6Sch. 1 para. 53(3)(m) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 66(d) (with reg. 200)
Homeopathic remediesN.I.
53.—(1) A homeopathic remedy registered under these Regulations must be labelled in accordance with this paragraph.
(2) There must be no specific therapeutic indication on the labelling or in any information relating to it.
(3) The labelling (or labelling and package leaflet) must contain the following and no other information—
(a)the words “homeopathic remedy without approved therapeutic indications for veterinary use”;
(b)the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used (if the homeopathic remedy is composed of more than one stock, the labelling may mention an invented name in addition to the scientific names of the stocks);
(c)the name and address of the registration holder and (on the package leaflet) of the manufacturer;
(d)the method and, if necessary, route of administration;
(e)the expiry date;
(f)the pharmaceutical form;
(g)the contents of the pack;
(h)any special storage precautions;
(i)the target species;
(j)any necessary special warnings;
(k)the batch number; and
(l)the registration number.
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
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