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

• Citation: S.I. 2001/1646
• Sections: 35

Section 1 Title and commencement

This Order may be cited as the Medicines (Veterinary Drugs) (Prescription Only) Order 2001 and shall come into force on 27th May 2001.

Section 2 Interpretation

In this Order, unless the context requires otherwise—

“ the Act ” means the Medicines Act 1968;

“controlled drug” has the meaning given by section 2 of the Misuse of Drugs Act 1971 ;

“marketing authorisation” has the meaning given by regulation 2(4) of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 ;

“the Misuse of Drugs Regulations ” means in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 1985 and, in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986 ;

“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 ;

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

Section 3 Appropriate practitioners

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.

Section 4 Medicinal products on prescription only

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 ), after the coming into force of this Order.

Section 5 Exemptions for certain persons

(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.

Section 6 Prescriptions

(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.

Section 7 Due diligence exemptions

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.

Section 8 Revocation

The Medicines (Veterinary Drugs) (Prescription Only) Order 1991 and the Medicines (Veterinary Drugs) (Prescription Only) (Amendment) Order 1991 are revoked.

Section 1

Persons selling or supplying prescription only medicines to institutions of higher education or institutions concerned with research.

Section 1

All prescription only medicines.

Section 1

The sale or supply shall be—

(a) limited to the medicine which is the subject of the education or research with which the institution is concerned; and

(b) subject to the presentation of an order signed by the principal of the institution or (in the case of research) the head of department in charge of the research stating—

(i) the name of the institution for which the medicine is required,

(ii) the research being conducted,

(iii) the purpose for which the medicine is required, and

(iv) the total quantity required.

Section 1

Persons who are authorised as members of a group by a group authority granted under regulation 8(3) or 9(3) of the Misuse of Drugs Regulations to supply a controlled drug by way of administration only.

Section 1

Prescription only medicines that are specified in the group authority.

Section 1

The administration shall be in accordance with the group authority.

Section 2

Persons selling or supplying prescription only medicines to any of the following—

(a) a public analyst appointed under section 27 of the Food Safety Act 1990 or article 27(1) of the Food Safety (Northern Ireland) Order 1991 ,

(b) an authorised officer of a food authority within the meaning of the Food Safety Act 1990 or an authorised officer within the meaning of the Food Safety (Northern Ireland) Order 1991,

(c) an agricultural analyst or a deputy agricultural analyst appointed under section 67 of the Agriculture Act 1970 ,

(d) a person duly authorised by an enforcement authority under sections 111 and 112 of the Act, or

(e) a sampling officer within the meaning of Schedule 3 to the Act.

Section 2

All prescription only medicines.

Section 2

The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in column 1, paragraph 2(a), (b), (c), (d) or (e) stating the status of the person signing it and the amount of the prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions.

Section 2

Persons who have in their charge or who maintain animals for the purposes of and in the course of carrying on a business either as their sole business activity or as a part of their business activities.

Section 2

Any veterinary drug such as is described in a list kept under article 3 of the Merchants Exemption Order which, so far as it is for parenteral administration, is a prescription only medicine.

Section 2

The administration shall be only to animals in their charge or under their maintenance for the purposes of and in the course of carrying on the business.

Section 3

Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Act.

Section 3

Any veterinary drug such as is described in the list kept under article 3 of the Merchants Exemption Order which, so far as it is for parenteral administration, is a prescription only medicine.

Section 3

No conditions.

Section 4

Persons the sale or supply by whom is exempted by article 4 or 7 of the Merchants Exemption Order from the restrictions imposed by section 52 of the Act.

Section 4

Any veterinary drug such as is described in the list kept under article 3 of the Merchants Exemption Order which, so far as it is for parenteral administration, is a prescription only medicine.

Section 4

The sale or supply shall be subject to the conditions specified in articles 6 and 7 of the Merchants Exemption Order.

Section 5

Persons selling or supplying prescription only medicines to veterinary surgeons and veterinary practitioners.

Section 5

All prescription only medicines.

Section 5

No conditions.

Section 6

Persons selling or supplying prescription only medicines to the British Standards Institution.

Section 6

All prescription only medicines.

Section 6

The sale or supply shall be—

(a) subject to the presentation of an order signed on behalf of the British Standards Institution stating the status of the person signing it and the amount of the prescription only medicine required, and

(b) only for the purpose of testing containers of medicinal products or determining the standards for such containers.

Section 7

Holders of a marketing authorisation or of a manufacturer’s licence.

Section 7

Prescription only medicines referred to in the authorisation or licence.

Section 7

The sale or supply shall be only—

(a) to a pharmacist,

(b) so as to enable that pharmacist to prepare an entry relating to the prescription only medicine in question in a tablet or capsule identification guide or similar publication, and

(c) of no greater quantity than is reasonably necessary for that purpose.