The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988

Regulation 2(1)

SCHEDULE 1 STANDARD WITHDRAWAL PERIODS

Animal or product	Withdrawal period
Fish	A number of days ascertained by measuring once each day following treatment with the medicinal product the temperature of the water in which the fish are kept and cumulating that daily temperature until the cumulative total temperature is at least 200 °C
Pigs	10 days
Poultry	7 days
Rabbits	7 days
Other species of animals	28 days
Eggs (from any species of animal)	7 days
Milk (from any species of animal)	7 days

Regulations 4(1) and (2), 7(1) and 8(1)

SCHEDULE 2 STANDARD PARTICULARS REQUIRED IN THE LABELLING OF CONTAINERS AND PACKAGES OF MEDICINAL PRODUCTS AND EXCEPTED MEDICATED FEEDING STUFFS

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.

Regulations 5 and 8(2)

SCHEDULE 3 STANDARD PARTICULARS REQUIRED IN THE LABELLING OF CONTAINERS AND PACKAGES OF MEDICATED FEEDING STUFFS OTHER THAN EXCEPTED MEDICATED FEEDING STUFFS

1.  The name of the medicated feeding stuff, or a description of its nature, and a statement that it is an intermediate medicated feeding stuff or a final medicated feeding stuff.

2.—(a) The name of any medicinal product or excepted medicated feeding stuff incorporated in the medicated feeding stuff, being either a proprietary designation or, if no proprietary designation, the appropriate non-proprietary name, and the number of the product licence (if any) authorising incorporation.

(b) Where any medicinal product or excepted medicated feeding stuff incorporated in the medicated feeding stuff is a prescription only medicine, a statement to that effect.

3.  The appropriate non-proprietary name and quantity (expressed as mg per kg or g per tonne) of each active ingredient contained in the medicated feeding stuff.

4.  The medicinal purpose for which any medicinal product or excepted medicated feeding stuff has been incorporated in the medicated feeding stuff and the species, and categories within species, of animals to which it is intended the feeding stuff should be fed.

5.  Directions for use, including—

(a) instructions for the rate at which the medicated feeding stuff should be given to animals, including the permissible daily level of active ingredient to be fed, where this is specified in the product licence relating to the medicinal product or excepted medicated feeding stuff incorporated in the feeding stuff,

(b) in the case of an intermediate medicated feeding stuff only, the rate or rates of inclusion with other feeding stuffs and the level of active ingredient to be present in the final medicated feeding stuff.

6.—(a) Any warnings or instructions relating to safety, storage or any other matter specified in a product licence relating to any medicinal product or excepted medicated feeding stuff contained in the medicated feeding stuff, which are relevant to the incorporation in feeding stuffs of that medicinal product or excepted medicated feeding stuff.

(b) In the case of an intermediate medicated feeding stuff only, an indication of which of those warnings or instructions are to appear on the label of any container or package of the final medicated feeding stuff.

7.—(a) Where the medicated feeding stuff contains a medicinal product or excepted medicated feeding stuff which has been incorporated in accordance with a product licence, a statement of any withdrawal period specified in that licence.

(b) Where the medicated feeding stuff contains a prescription only medicine which has been incorporated in accordance with a product licence and that licence does not specify a withdrawal period, the words “Withdrawal period—see veterinary written direction”.

8.  The name and address of the manufacturer of the medicated feeding stuff or of the person selling or supplying it within the United Kingdom.

9.  If the period during which any active ingredient in the medicated feeding stuff remains effective is shorter than the period during which the medicated feeding stuff is recommended by the manufacturer as suitable for use as food for animals—

(a) a statement of the date (in terms of month and year) by which that feeding stuff should be consumed if the active ingredient is to be effective, or

(b) a statement of the date (in terms of month and year) of manufacture of that feeding stuff and the period during which that feeding stuff should be consumed if the active ingredient is to be effective.

10.  The manufacturer’s reference number of the batch to which the medicated feeding stuff belongs.

11.  Any other statements or particulars required to be stated on the label of any container or package of the medicated feeding stuff, or to be contained in any leaflet supplied with the medicated feeding stuff, by a product licence relating to any medicinal product or excepted medicated feeding stuff contained in the medicated feeding stuff.

12.  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 5(3), a statement that a leaflet of instructions is supplied with the medicated feeding stuff.

Regulations 6(1) and (3) and 8

SCHEDULE 4 PARTICULARS REQUIRED IN THE LABELLING OF CONTAINERS AND PACKAGES OF MEDICINAL PRODUCTS OR MEDICATED FEEDING STUFFS FOR MEDICINAL TESTS ON ANIMALS

1.  Such designation as will sufficiently identify the animal test.

2.—(a) Where more than one medicinal product or excepted medicated feeding stuff is supplied in the course of the animal test, such designation on the container of each medicinal product or excepted medicated feeding stuff as will sufficiently identify each such medicinal product or excepted medicated feeding stuff.

(b) Where more than one medicinal product or excepted medicated feeding stuff has been incorporated in the medicated feeding stuff which is supplied in the course of the animal test, such designation on the container of the medicated feeding stuff as will sufficiently identify each such medicinal product or excepted medicated feeding stuff.

3.  The quantity of the medicinal product or of each active ingredient contained in the medicated feeding stuff expressed in terms of weight, volume or capacity or number of dosage units.

4.  The purposes for which the medicinal product or medicated feeding stuff is to be used, the species, and categories within species, of animals to which it is to be administered and the directions for use including dosage and any warning statements.

5.  In the case of a medicinal product or intermediate medicated feeding stuff, the directions for incorporation of that medicinal product or intermediate medicated feeding stuff in any animal feeding stuff, and a statement that such incorporation must be in accordance with the terms of a product licence or animal test certificate.

6.  Any special requirements for the handling and storage of the medicinal product or medicated feeding stuff.

7.—(a) In the case of a medicinal product or excepted medicated feeding stuff, the expiry date.

(b) In the case of a medicated feeding stuff (not being an excepted medicated feeding stuff) where the period during which any active ingredient in that feeding stuff remains effective is shorter than the period during which the medicated feeding stuff is recommended by the manufacturer as suitable for use as food for animals—

(i) a statement of the date (in terms of month and year) by which that feeding stuff should be consumed if the active ingredient is to be effective, or

(ii) a statement of the date (in terms of month and year) of manufacture of that feeding stuff and the period during which that feeding stuff should be consumed if the active ingredient is to be effective.

8.  Any other statement or particulars required to be stated on the label of any container or package of the medicinal product or medicated feeding stuff, or to be contained in any leaflet supplied with the medicinal product or medicated feeding stuff, by the provisions of an animal test certificate or product licence.

9.  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 6(3), a statement that a leaflet of instructions is supplied with the medicinal product or medicated feeding stuff.

Regulation 14

SCHEDULE 5 AMENDMENT OF THE MEDICINES (LABELLING) REGULATIONS 1976

1.  In regulation 3(1) thereof (interpretation)—

(a) there shall be inserted at the end of the definition of “medicinal product” the words “or any medicinal product or excepted medicated feeding stuff to which the Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988 apply”;

(b) the definitions of “animal feeding stuff”, “complete feeding stuff”, “feed supplement”, “medicated” and “protein concentrate” shall be omitted.

2.  Regulation 14 thereof and Schedule 4 thereto (medicinal products for incorporation in animal feeding stuffs or which are medicated animal feeding stuffs in respect of which a product licence or animal test certificate has been granted) shall be omitted.

3.  In regulation 18(2)(iv) thereof (exemptions), the words from “, not being” to “are applicable” shall be omitted.

4.  In Schedule 3 thereto (particulars required in the labelling of containers and packages of medicinal products for medicinal tests on animals), paragraph 5 shall be omitted.

(1)

S.I. 1985/1823, amended by S.I. 1986/982, 1997, 1987/1123, 1980.