Regulations 4(1) and (2), 7(1) and 8(1)
1. The name of the medicinal product or excepted medicated feeding stuff, being either a proprietary designation or, if no proprietary designation, the appropriate non-proprietary name.
2. Any product licence number as allocated by the licensing authority which relates to the medicinal product or excepted medicated feeding stuff preceded by the letters “PL” in capital letters.
3. A statement, in a conspicuous position, of the quantity (expressed as mg per kg or g per tonne) of each active ingredient in the medicinal product or excepted medicated feeding stuff, identified by its appropriate non-proprietary name.
4. Where under paragraph 1 or 3 above a medicinal product, excepted medicated feeding stuff or ingredient is identified by reference to a name, or abbreviation of such name, at the head of a monograph in a specified publication or in a foreign or international compendium of standards or, in the case of the European Pharmacopoeia, an approved synonym, words or letters identifying the specified publication or compendium and, except where the specified publication or compendium is the current edition, figures giving the edition.
5. Where under paragraph 1 or 3 above a medicinal product, excepted medicated feeding stuff or ingredient is identified by reference to a name, or abbreviation of such name, at the head of a monograph in a specified publication or in a foreign or international compendium of standards or, in the case of the European Pharmacopoeia, an approved synonym, and the international non-proprietary name (if any) of such medicinal product, excepted medicated feeding stuff or ingredient is not the same as such name or approved synonym, that international non-proprietary name followed by the letters “INN” in capital letters, except that particulars of the international non-proprietary name shall not be required to be given where there is an insignificant difference between the spelling of that international non-proprietary name and such name or approved synonym.
6. A description of the pharmaceutical form of the medicinal product or excepted medicated feeding stuff.
7. The purposes for which the medicinal product or excepted medicated feeding stuff is to be used and the directions for use, including—
(a)the permissible daily level of active ingredient to be administered where this is specified in the product licence which relates to the product or excepted medicated feeding stuff, and
(b)the species, and categories within species, of animals to which the medicinal product or excepted medicated feeding stuff is to be administered.
8. In the case of a medicinal product or excepted medicated feeding stuff intended to be incorporated in any animal feeding stuff—
(a)directions for its incorporation in the animal feeding stuff including the quantity of active ingredient to be present in the final medicated feeding stuff, and
(b)a statement that incorporation must be in accordance with the terms of a product licence or animal test certificate relating to the medicinal product or excepted medicated feeding stuff or in accordance with a veterinary written direction.
9. The quantity of the medicinal product or excepted medicated feeding stuff expressed in terms of weight, volume or capacity or number of dosage units.
10.—(a) Contra-indications, warnings and precautions required to be given by the provisions of any product licence which relates to the medicinal product or excepted medicated feeding stuff and thereby required to be addressed to the user of the medicinal product or excepted medicated feeding stuff.
(b)Any restrictions on the purposes for which the medicinal product or excepted medicated feeding stuff may be used in the provisions of any product licence which relates to the medicinal product or excepted medicated feeding stuff.
(c)Any special requirements for the handling and storage of the medicinal product or excepted medicated feeding stuff.
(d)In the case of a medicinal product or excepted medicated feeding stuff intended to be incorporated in any animal feeding stuff, an indication of which of the particulars mentioned in sub-paragraphs (a) to (c) above are to appear on the label of any container or package of the medicated feeding stuff.
11.—(a) Where a product licence relating to the medicinal product or excepted medicated feeding stuff specifies a withdrawal period, the withdrawal period so specified.
(b)Where a product licence relating to a prescription only medicine does not specify a withdrawal period, the words “Withdrawal period—see veterinary written direction”.
12.—(a) In the case of a prescription only medicine, the capital letters “POM” within a rectangle within which there shall be no other matter.
(b)In the case of a medicinal product or excepted medicated feeding stuff which is a veterinary drug specified in Schedule 1, 2 or 4 to the Medicines (Exemptions from Restrictions on the Retail Sale or Supply of Veterinary Drugs) Order 1985(1), the capital letters “PML” within a rectangle within which there shall be no other matter.
(c)In the case of a medicinal product or excepted medicated feeding stuff, not being a prescription only medicine, to which any of the restrictions imposed by section 52 of the Act (sale or supply of medicinal products not on general sale list) apply, the capital letter “P” within a rectangle within which there shall be no other matter.
13. The name and address of the holder of any product licence relating to the medicinal product or excepted medicated feeding stuff and, if different, the name and address of the person responsible for the composition of the medicinal product or excepted medicated feeding stuff.
14. Either the expiry date of the medicinal product or excepted medicated feeding stuff, or the date (in terms of month and year) of manufacture of the medicinal product or excepted medicated feeding stuff and the period during which it should be used.
15. The manufacturer’s reference number of the batch to which the medicinal product or excepted medicated feeding stuff belongs.
16. Any other statements or particulars required to be stated on the label of any container or package of the medicinal product or excepted medicated feeding stuff, or to be contained in any leaflet supplied with the medicinal product or excepted medicated feeding stuff, by the provisions of any product licence which relates to the medicinal product or excepted medicated feeding stuff.
17. In any case where particulars from this Schedule are omitted from a label in accordance with the provisions as to small-sized labels contained in regulation 4(2), a statement that a leaflet of instructions is supplied with the medicinal product or excepted medicated feeding stuff.
S.I. 1985/1823, amended by S.I. 1986/982, 1997, 1987/1123, 1980.