The Prescription Only Medicines (Human Use) Order 1997

[F1 Prescribing and administration by supplementary prescribers

3B.— (1) Subject to paragraph (2), a supplementary prescriber may—

(a) give a prescription for a medicinal product referred to in article 3; or

(b) if that medicinal product is for parenteral administration—

(i) administer that medicinal product, or

(ii) give directions for the administration of that medicinal product,

only where he complies with the conditions as to the cases or circumstances in which he may do so specified in paragraph (3).

(2) Paragraph (1) does not apply if—

(a) the supplementary prescriber is a district nurse/health visitor prescriber and the medicinal product prescribed or administered, or in respect of which he gives directions for administration, falls within a description or class of medicinal products specified in Schedule 3; or

(b) the supplementary prescriber is an extended formulary nurse prescriber and—

(i) the medicinal product prescribed or administered, or in respect of which he gives directions for administration, falls within a description or class of medicinal products specified in article 3A(1), and

(ii) he satisfies any applicable condition specified by virtue of article 3A(3).

(3) The conditions referred to in paragraph (1) are that—

(a) the supplementary prescriber is acting in accordance with the terms of a clinical management plan which—

(i) relates to the patient for whom the product is prescribed or to whom it is, or is to be, administered,

(ii) is in effect at the time the prescription or direction is given or, as the case may be, the product is administered, and

(iii) includes the particulars specified in Schedule 3B;

(b) at the time the prescription or directions are given or, as the case may be, the product is administered—

(i) a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of the product, or

(ii) the product is, or is to be, administered in the course of a clinical trial [F2 which has been authorised, or is to be treated as having been authorised, by the licensing authority in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2003];

(c) the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any doctor or dentist who is a party to the plan.]

Textual Amendments

F1 Arts. 3B, 3C inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 6

F2 Words in art. 3B(3)(b)(ii) substituted (1.5.2004) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 Pt. 2 para. 13(b)