The Veterinary Medicines Regulations 2013

PART 7U.K.Labelling and package leaflets

Approval by the Secretary of StateU.K.

45.  The Secretary of State, when issuing a marketing authorisation, must approve all containers, packaging, labels and package leaflets.

Reference to being authorisedE+W+S

46.  A label and package leaflet of an authorised veterinary medicinal product may contain in legible characters the words “UK authorised veterinary medicinal product” or, if the marketing authorisation provides, other wording specified in the authorisation indicating that the product is authorised in the United Kingdom.

Reference to being authorisedN.I.

46.  A label and package leaflet of an authorised veterinary medicinal product may contain in legible characters the words “[F12UK(NI)] authorised veterinary medicinal product” or, if the marketing authorisation provides, other wording specified in the authorisation indicating that the product is authorised in [F13Northern Ireland].

LanguageU.K.

47.—(1) All labels and package leaflets must be in English, but may contain other languages provided that the information given is identical in all the languages.

(2) This requirement does not apply in the case of a product imported by a veterinary surgeon and administered by or under the responsibility of that same veterinary surgeon.

[F3Labelling of immediate packaging of veterinary medicinal productsE+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.]

Labelling with all the information on the immediate packagingN.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.

[F4Labelling of the outer packaging of veterinary medicinal productsE+W+S

49.—(1) The following information must be provided on any outer packaging of a veterinary medicinal product—

(a)the information referred to in paragraph 48(1);

(b)the contents by weight, volume or number of the immediate packaging units of the veterinary medicinal product;

(c)a warning that the veterinary medicinal product must be kept out of the sight and reach of children;

(d)a warning that the veterinary medicinal product is “for animal treatment only”;

(e)a recommendation to read the package leaflet, if there is one;

(f)in the case of a veterinary medicinal product not subject to a veterinary prescription, the indication for use;

(g)the marketing authorisation number.

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

Products with immediate and outer packagingN.I.

49.—(1) If it is not reasonably practicable to have all the required information on the immediate packaging then this paragraph applies.

(2) The immediate packaging must have at least the following information—

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

(b)the name and proportion of each active substance, and of any excipient if knowledge of the excipient is needed for safety reasons;

(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 words “Keep the container in the outer carton”.

(3) In addition, the immediate packaging must have as much of the required information as is reasonably practicable.

(4) The outer packaging must contain all the required information if it is reasonably practicable to do this, and if it is not reasonably practicable to do this a package leaflet must be supplied with the product in accordance with the following paragraph.

[F5Labelling of small immediate packaging units of veterinary medicinal productsE+W+S

50.—(1) Where the immediate packaging units of a veterinary medicinal product are too small to include in a legible form all of the information set out in paragraph 48, the immediate packaging must instead provide the following information—

(a)the name of the veterinary medicinal product;

(b)the quantitative particulars of the active substances contained in the product;

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

(d)the expiry date, in the form ‘mm/yyyy’, preceded by the abbreviation “Exp”.

(2) The immediate packaging units mentioned in sub-paragraph (1) must be packed within outer packaging which provides the information required by paragraph 49.]

Package leafletsN.I.

50.—(1) If it is not reasonably practicable to have all the required information on the immediate packaging or all of this information on the outer packaging, there must be a package leaflet supplied with the product, containing all the required information except for the batch number and the expiry date, and including the name of both the marketing authorisation holder and, if different, the name of the distributor named in the marketing authorisation.

(2) If there is a package leaflet, the immediate packaging and the outer packaging must both refer the user to it.

(3) A package leaflet must relate solely to the veterinary medicinal product with which it is included.

(4) It must be written in plain English.

(5) Only a package leaflet approved in the marketing authorisation may be included with the veterinary medicinal product.

[F6Package leaflet of veterinary medicinal productsE+W+S

51.—(1) Subject to sub-paragraphs (5) and (7), a package leaflet must be supplied with each veterinary medicinal product.

(2) The package leaflet must provide the following information—

(a)the name and address of the marketing authorisation holder and of the manufacturer and, where applicable, the distributor;

(b)the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;

(c)the qualitative and quantitative composition of any active substance;

(d)the target species, the dosage for each species, the method and route of administration and if necessary, advice on the correct administration;

(e)the indications for use;

(f)the contra-indications and adverse events;

(g)if applicable, the withdrawal period for each species, even if such a period is zero;

(h)special storage precautions, if any;

(i)information essential for safety or health protection, including any special precautions relating to use and any other warnings;

(j)the words “use take-back schemes for the disposal of any unused veterinary medicinal product or associated waste materials in accordance with local requirements and with any applicable national collection schemes”;

(k)the marketing authorisation number;

(l)contact details for the marketing authorisation holder or its representative, as appropriate, for the reporting of suspected adverse events;

(m)classification of the veterinary medicinal product as referred to in the summary of product characteristics.

(3) Providing that it complies with the marketing authorisation, the package leaflet may include additional information concerning distribution, possession or any necessary precaution required, provided that this information is not promotional in character.

(4) The package leaflet must be in legible form and designed to be clear and understandable, in terms that are comprehensible to the general public.

(5) Only a package leaflet approved in the marketing authorisation may be published or included with the veterinary medicinal product.

(6) The Secretary of State may require the information set out in sub-paragraph (2) to be made available in written form or electronically, or both.

(7) Where the Secretary of State requires the leaflet to be made available electronically—

(a)an electronic package information leaflet which includes the information required by this paragraph must be provided in place of a leaflet in written form;

(b)the packaging of the veterinary medicinal product must include—

(i)a statement that the information which must be included on a package leaflet is provided electronically;

(ii)any necessary electronic link in order to access the relevant part of the website where the electronic package information leaflet is to be found;

(iii)a statement that a copy of the information in written form may be obtained on request; and

(iv)instructions on how to obtain such a copy.

(8) Any information required by this paragraph to be provided on a package leaflet in written form may be otherwise provided on the packaging of the veterinary medicinal product.]

AmpoulesN.I.

51.—(1) In the case of ampoules or other unit dose forms, where the container cannot bear legibly the required information, only the following information must be shown on the immediate packaging—

(a)the name of the veterinary medicinal product;

(b)the name and strength of the active ingredient;

(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”.

(2) The outer packaging must contain all the required information if it is reasonably practicable to do this, and if it is not reasonably practicable to do this a package leaflet must be supplied with the product, except that the ampoule need not refer to the package leaflet.

Small containers other than ampoulesU.K.

[F752.  As regards small immediate packaging containing a single dose, other than ampoules, on which it is impossible to give the required information, all the required information must appear on the outer packaging or outer packaging and package leaflet, but the immediate packaging must be labelled with the batch number and the expiry date and, if there is room, the other information in the preceding paragraph.]

Homeopathic remediesE+W+S

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);

[F8(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; F9...

(l)the registration number; [F10and]

[F11(m)the withdrawal period, where applicable.]

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.

VariationsU.K.

54.  The Secretary of State may permit variations in the above in any individual marketing authorisation if this is necessary for public or animal health purposes or the protection of the environment.