C4C5Part III Further Provisions relating to Dealings with Medicinal Products

Annotations:
Modifications etc. (not altering text)
C4

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

C5

Pt. 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 provisions

C2C6C558C5C1 Medicinal products on prescription only.

C31

The F6Ministers may by order specify descriptions or classes of medicinal products F20as prescription only medicines

F141A

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F211ZA

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F91B

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F162

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F153

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4

Without prejudice to F13 regulation 223(1) of the 2012 Regulations , any order made by the F7 Ministers for the purposes of this section may provide—

a

that F11 regulation 214(1) or (2) of the 2012 Regulations shall have effect subject to such exemptions as may be specified in the order F1F12 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 F17 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.

F24A

An order under this section may provide, in relation to F19an 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.

F2 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.

F2 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 F18 regulation 214(1) or (2) of the 2012 Regulations .

5

Any exemption conferred F3or modification made by an order in accordance with subsection (4)(a) of this section may be conferred F4or made subject to such conditions or limitations as may be specified in the order.

C7 6

Before making an order under this section the F8 Ministers shall consult the appropriate committee F5 ....

F107

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.