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

Modifications etc. (not altering text)

C1Part III (ss.51-68) modified (1.1.1995) by S.I. 1994/3144, reg. 9(9)

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 for the purposes of this section; and, in relation to any description or class so specified, the order shall state which of the following, that is to say—

(a)doctors,

(b)dentists, and

(c)veterinary surgeons and veterinary practitioners, [F2and

[F3(d)registered nurses or midwives who are of such a description and comply with such conditions as may be specified in the order]][F4, and

(e)other persons who are of such a description and comply with such conditions as may be specified in the order]

[F5(1A)The descriptions of persons which may be specified in an order by virtue of subsection (1)(e) are the following, or any sub-category of such a description—

[F6(a)persons who are registered in the register maintained under article 5 of [F7the Health and Social Work Professions Order 2001];]

(b)persons who are pharmacists;

(c)persons whose names are entered in a roll or record established by the General Dental Council by virtue of section 45 of the Dentists Act 1984 (c. 24) (dental auxiliaries);

(d)persons who are registered in either of the registers of ophthalmic opticians kept under section 7(a) of the Opticians Act 1989 (c. 44);

(e)persons who are registered osteopaths within the meaning of the Osteopaths Act 1993 (c. 21);

(f)persons who are registered chiropractors within the meaning of the Chiropractors Act 1994 (c. 17);

(g)persons who are registered in any register established, continued or maintained under an Order in Council under section 60(1) of the Health Act 1999 (c. 8);

(h)any other description of persons which appears to the [F8Ministers] to be a description of persons whose profession is regulated by or under a provision of, or made under, an Act of the Scottish Parliament or Northern Ireland legislation and which the [F8Ministers] consider it appropriate to specify.

[F9(1ZA)Paragraphs (a) and (g) of subsection (1A) do not apply to persons in so far as they are registered as members of the social work profession in England or social care workers in England (each of those expressions having the same meaning as in section 60 of the Health Act 1999).]

(1B)F10...

(2)Subject to the following provisions of this section—

( a )no person shall sell by retail, or supply in circumstances corresponding to retail sale, a medicinal product of a description, or falling within a class, specified in an order under this section except in accordance with a prescription given by an appropriate practitioner; and

(b)no person shall administer (otherwise than to himself) any such medicinal product unless he is an appropriate practitioner or a person acting in accordance with the directions of an appropriate practitioner.

(3)Subsection (2)(a) of this section shall not apply—

(a)to the sale or supply of a medicinal product to a patient of his by a doctor or dentist who is an appropriate practitioner, F11...

F11( b ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4)Without prejudice to the last preceding subsection, any order made by the [F12Ministers] for the purposes of this section may provide—

(a)that paragraph (a) or paragraph (b) of subsection (2) of this section, or both those paragraphs, shall have effect subject to such exemptions as may be specified in the order [F13or, where the appropriate practitioner is [F14a registered nurse or midwife,][F15or is an appropriate practitioner by virtue of provision made under subsection (1)(e) of this section,]such modifications as may be so specified];

(b)that, for the purpose of paragraph (a) of that subsection, 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.

[F16(4A)An order under this section may provide, in relation to a person who is an appropriate practitioner by virtue of subsection (1)(d) or (e), 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.

F16( 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.

F16( 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 subsection (2)(a) or (b) of this section.]

(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 .... ]

Textual Amendments

F2S. 58(1)(d) and preceeding word inserted (3.10.1994) by Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28), s. 1(1); S.I. 1994/2408, art. 2

F3S. 58(1)(d) substituted (27.6.2003) by S.I. 2002/253, arts. 1(2), 54, Sch. 5 para. 2(a); London Gazettte: Issue number 567984

F4S. 58(4)(e) and preceding word inserted (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(2); S.I. 2002/1095, art. 2(1)

F5S. 58(1A)(1B) inserted (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(3); S.I. 2002/1095, art. 2(1)

F7Words in s. 58(1A)(a) substituted (1.8.2012) by Health and Social Care Act 2012 (c. 7), ss. 213(7)(b), 306(4) (with s. 230(6)); S.I. 2012/1319, art. 2(4)

F11S. 58(3)(b) and word omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 29(d) (with regs. 2(4), 3)

F13Words 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

F14Words in s. 58(4)(a) substituted (27.6.2003) by S.I. 2002/253, arts. 1(2), 54, Sch. 5 para. 2(b); London Gazette: Issue number 567984

F15Words in s. 58(4)(a) inserted (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(4); S.I. 2002/1095, art. 2(1)

F16S. 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)