Part IIIU.K. Further Provisions relating to Dealings with Medicinal Products

Modifications etc. (not altering text)

C2Pt. III amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)

Additional provisionsU.K.

58 Medicinal products on prescription only. U.K.

(1)The [F1Ministers] may by order specify descriptions or classes of medicinal products [F2as prescription only medicines]

F3(1A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4(1ZA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F5(1B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Without prejudice to [F8 regulation 223(1) of the 2012 Regulations] , any order made by the [F9 Ministers ] for the purposes of this section may provide—

(a) that [F10 regulation 214(1) or (2) of the 2012 Regulations] shall have effect subject to such exemptions as may be specified in the order [F11[F12 or, in the case of an appropriate practitioner, other than a doctor or dentist, ] such modifications as may be so specified ] ;

(b) that, for the purpose of [F13 regulation 214(1) of the 2012 Regulations] , a medicinal product shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless such conditions as are prescribed by the order are fulfilled.

[F14(4A)An order under this section may provide, in relation to [F15an appropriate practitioner, other than a doctor or dentist], that such a person may—

(a)give a prescription for a medicinal product falling within a description or class specified in the order;

(b)administer any such medicinal product; or

(c)give directions for the administration of any such medicinal product,

only where he complies with such conditions as may be specified in the order in respect of the cases or circumstances in which he may do so.

F14( 4B )An order under this section may provide, in relation to a condition specified by virtue of subsection (4A), for the condition to have effect subject to such exemptions as may be specified in the order.

F14( 4C ) Where a condition is specified by virtue of subsection (4A), any prescription or direction given by a person in contravention of the condition is not (subject to such exemptions or modifications as may be specified in the order by virtue of subsection (4)(a) of this section) given by an appropriate practitioner for the purposes of [F16 regulation 214(1) or (2) of the 2012 Regulations] . ]

(5)Any exemption conferred [F17or modification made] by an order in accordance with subsection (4)(a) of this section may be conferred [F18or made] subject to such conditions or limitations as may be specified in the order.

( 6 ) Before making an order under this section the [F19 Ministers ] shall consult the appropriate committee F20 ....

[F21(7)In subsection (6) “the appropriate committee” means whichever the Ministers consider appropriate of—

(a)the Commission; or

(b)an expert committee appointed by the Ministers, or by one of them acting alone.]

Textual Amendments

F8Words in s. 58(4) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 5(c) (with Sch. 32)

F11Words in s. 58(4)(a) inserted (3.10.1994) by Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28), s. 1(2); S.I. 1994/2408, art. 2

F13Words in s. 58(4)(b) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 5(e) (with Sch. 32)

F14S. 58(4A)-(4C) inserted (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(5); S.I. 2002/1095, art. 2(1)

F17Words in s. 58(5) inserted (3.10.1994) by Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28), s. 1(3)(a); S.I. 1994/2408, art. 2

F18Words in s. 58(5) inserted (3.10.1994) by Medicinal Products: Prescripion by Nurses etc. Act 1992 (c. 28), s. 1(3)(b); S.I. 1994/2408, art. 2

Modifications etc. (not altering text)

C3Ss. 57, 58, 61 extended by S.I. 1984/187, art. 2

S. 58 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch. 5

C4S. 58 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

S. 58 modified (1.1.1995) by S.I. 1994/3144, reg. 9(10)

C5 Ss. 58 58A amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759) , regs. 1(a) , 2(12)

C6S. 58(1) restricted (1.1.1995) by S.I. 1994/3144, reg. 8(4)