Statutory Instrument 2001 No. 1646

The Medicines (Veterinary Drugs) (Prescription Only) Order 2001

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© Crown Copyright 2001

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"controlled drug" has the meaning given by section 2 of the Misuse of Drugs Act 1971[5];

"marketing authorisation" has the meaning given by regulation 2(4) of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994[6];

"the Misuse of Drugs Regulations" means in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 1985[7] and, in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986[8];

"parenteral administration" means administration to an animal by breach of the skin or mucous membrane;

"prescription only medicine" means a medicinal product of a description or falling within a class specified in article 4 of this Order;

"repeatable prescription" means a prescription which contains a direction that it may be dispensed more than once;

"selling" means selling by retail within section 131 of the Act and "sale" has a corresponding meaning;

"supply" means supply in circumstances corresponding to retail sale within section 131 of the Act;

"the Merchants Exemption Order" means the Medicines (Exemptions for Merchants in Veterinary Drugs) Order 1998[9];

and references to a numbered article or Schedule are references to the article or Schedule so numbered in this Order.

Appropriate practitioners
     3. For the purposes of section 58 of the Act (medicinal products on prescription only), veterinary surgeons and veterinary practitioners shall be appropriate practitioners in relation to the medicinal products specified in article 4.

Medicinal products on prescription only
     4. The following descriptions or classes of medicinal products are specified for the purposes of section 58 of the Act - 

(a) veterinary drugs specified in Schedule 1;

(b) veterinary drugs which contain controlled drugs;

(c) veterinary drugs for parenteral administration which do not fall within paragraph (a) or (b) above;

(d) veterinary drugs - 


(i) which do not fall within paragraph (a), (b) or (c) above; and

(ii) in respect of which there is a marketing authorisation granted or varied after 30th March 2001 in accordance with an application containing a provision to the effect that the method of sale or supply of the veterinary drug in question is to be only in accordance with a prescription given by an appropriate practitioner; and



(e) veterinary drugs granted a marketing authorisation, in accordance with the provisions of Council Regulation (EEC) No. 2309/93 (laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products[10]), after the coming into force of this Order.

Exemptions for certain persons
     5.  - (1) The prohibition imposed by section 58(2)(a) of the Act (sale or supply) shall not apply to - 

(a) the sale or supply by a person within a paragraph of column 1 of Part I of Schedule 2 of a medicinal product within the corresponding paragraph of column 2 in accordance with any conditions specified in the corresponding paragraph of column 3, or

(b) supply in accordance with a licence granted under regulation 5 of the Misuse of Drugs Regulations.

    (2) The prohibition imposed by section 58(2)(b) of the Act (administration) shall not apply to the administration by a person within a paragraph of column 1 of Part II of Schedule 2 of a medicinal product within the corresponding paragraph of column 2 in accordance with any conditions specified in the corresponding paragraph of column 3.

Prescriptions
     6.  - (1) For the purposes of section 58(2)(a) of the Act a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions specified in paragraphs (2) to (5) below are fulfilled.

    (2) The veterinary surgeon or veterinary practitioner giving the prescription shall - 

(a) sign in ink with his own name;

(b) without prejudice to sub-paragraph (a) above, write the prescription in ink or otherwise so as to be indelible;

(c) include in the prescription - 


(i) his address,

(ii) the date;

(iii) such particulars as indicate whether he is a veterinary surgeon or veterinary practitioner,

(iv) the name and address of the person to whom the prescription only medicine is to be delivered, and

(v) his declaration that the prescription only medicine is prescribed for an animal or herd under his care.

    (3) The prescription shall not be dispensed after the end of the period of six months from the date of signature, unless it is a repeatable prescription in which case it shall not be dispensed for the first time after the end of that period.

    (4) If the prescription is a repeatable prescription containing a direction, the prescription shall be dispensed only in accordance with that direction.

    (5) If the prescription is a repeatable prescription which does not specify the number of times it may be dispensed, the prescription shall not be dispensed on more than two occasions.

Due diligence exemptions
     7. The prohibition imposed by section 58(2)(a) of the Act (sale and supply) shall not apply to a sale or supply of a prescription only medicine where the person selling or supplying the prescription only medicine - 

(a) in a way which is not in accordance with a prescription given by an appropriate practitioner by reason only that a condition specified in article 6(2) to (5) is not fulfilled, believes on reasonable grounds, having exercised all due diligence, that the condition is fulfilled in relation to that sale or supply;

(b) believes on reasonable grounds, having exercised all due diligence, that the product sold or supplied is not a prescription only medicine; or

(c) in accordance with a forged prescription, believes on reasonable grounds, having exercised all due diligence, that the prescription is genuine.

Revocation
     8. The Medicines (Veterinary Drugs) (Prescription Only) Order 1991[11] and the Medicines (Veterinary Drugs) (Prescription Only) (Amendment) Order 1991[12] are revoked.


Hayman
Minister of State, Ministry of Agriculture, Fisheries and Food

25th April 2001



Signed by authority of the Secretary of State for Health


Hunt
Minister of State, Department of Health

25th April 2001


Bairbre de Brún
Minister of Health, Social Services and Public Safety

30th April 2001


Brid Rodgers
Minister of Agriculture and Rural Development

26th April 2001

[2] In the case of the Minister of Agriculture, Fisheries and Food (so far as concerns functions previously vested in the Secretaries of State respectively concerned with agriculture in Scotland and - in consequence of S.I. 1978/272 - Wales) by virtue of articles 2(2) and 5 of, and the Schedule to, the Transfer of Functions (Medicines and Poisons) Order 1999 (S.I. 1999/3142); in the case of the Secretary of State concerned with health in England (so far as concerns functions previously vested in the Secretaries of State respectively concerned with health in Scotland and - in consequence of S.I. 1969/388 - Wales) by virtue of articles 2(1) and 5, of and the Schedule to, the Transfer of Functions (Medicines and Poisons) Order 1999; and in the case of the Minister of Health, Social Services and Public Safety and the Minister of Agriculture and Rural Development by virtue of section 95(5) of, and paragraph 10(1)(b) of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) and article 3(4) and (6) of the Departments (Northern Ireland) Order 1999 (S.I. 1999/283 (N.I. 1)).back

[3] See section 129(6) of the Medicines Act 1968.back

[4] See sections 58(6) and 129(7) of the Medicines Act 1968.back

[5] 1971 c. 38.back

[6] S.I. 1994/3142, to which there are amendments not relevant to these Regulations.back

[7] S.I. 1985/2066, to which there are amendments not relevant to these Regulations.back

[8] S.R. (N.I.) 1986 No. 52, to which there are amendments not relevant to these Regulations.back

[9] S.I. 1998/1044, amended by S.I. 2000/2686.back

[10] OJ No. L214, 24.8.93, p.1.back

[11] S.I. 1991/1392, as amended by S.I. 1991/2568, 1994/3142.back

[12] S.I. 1991/2568.back

[13] 1990 c. 16; section 27 was amended by the Food Standards Act 1999 (c. 28), Schedule 5, paragraph 8.back

[14] S.I. 1991 No. 762 (N.1.7); article 27 was amended by the Food Standards Act 1999 (c. 28), Schedule 5, paragraph 34.back

[15] 1970 c. 40; section 67 was modified (in relation to Great Britain) by regulation 9 of the Feeding Stuffs (Enforcement) Regulations 1999 (S.I. 1999/2325).back