SCHEDULE 1 U.K.Marketing authorisations [F1 in Great Britain] [F2 in Northern Ireland]

Textual Amendments

F1 Words in Sch. 1 heading inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(7)(a)

F2 Words in Sch. 1 heading inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(a)

PART 7 U.K.Labelling and package leaflets

[F3 Labelling of immediate packaging of veterinary medicinal products E+W+S

48.— (1) Subject to paragraph 50, the following information must be provided on the immediate packaging of a veterinary medicinal product—

(a) the name of the product, followed by its strength and pharmaceutical form;

(b) a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;

(c) the batch number, preceded by the word “Lot”;

(d) the name or company name or logo of the marketing authorisation holder;

(e) the target species;

(f) the expiry date, in the format ‘mm/yyyy’, preceded by the abbreviation “Exp.”;

(g) special storage precautions, if any;

(h) the route of administration;

(i) if applicable, the withdrawal period, even if such period is zero.

(2) Where there is no outer packaging for the product, the information set out in paragraph 49 must be included on the immediate packaging of the veterinary medicinal product.

(3) The information referred to in paragraph (1) must appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms.]

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F3 Sch. 1 para. 48 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 61 (with reg. 200)

Labelling with all the information on the immediate packaging N.I.

48.—(1) If it is reasonably practicable to do so, the following must be provided on the immediate packaging, in legible characters—

(a) the name, strength and pharmaceutical form of the veterinary medicinal product;

(b) the name and strength of each active substance, and of any excipient if this is required under paragraph 2 of the summary of product characteristics;

(c) the route of administration (if not immediately apparent);

(d) the batch number;

(e) the expiry date;

(f) the words “For animal treatment only” and, if appropriate, “To be supplied only on veterinary prescription”;

(g) the contents by weight, volume or number of dose units;

(h) the marketing authorisation number;

(i) the name and address of the marketing authorisation holder or, if there is a distributor authorised in the marketing authorisation, that distributor;

(j) a suitably labelled space to record discard date (if relevant);

(k) the target species;

(l) the distribution category;

(m) the words “Keep out of reach of children”;

(n) storage instructions;

(o) the in-use shelf-life (if appropriate);

(p) for food-producing species, the withdrawal period for each species or animal product concerned;

(q) any warning specified in the marketing authorisation;

(r) disposal advice;

(s) full indications;

(t) dosage instructions;

(u) contra-indications;

(v) further information required in the marketing authorisation;

(w) if the product is one that requires a dose to be specified for the animal being treated, a space for this.

(2) If all this is on the immediate packaging, there is no need for any outer packaging or a package leaflet.

Extent Information

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only