C12C13Part III Further Provisions relating to Dealings with Medicinal Products

Annotations:
Modifications etc. (not altering text)
C12

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

C13

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

C2C14C1358C13C1 Medicinal products on prescription only.

C31

The F12Ministers may by order specify descriptions or classes of medicinal products F45as prescription only medicines

F341A

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F461ZA

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F151B

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F362

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F353

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4

Without prejudice to F33 regulation 223(1) of the 2012 Regulations , any order made by the F13 Ministers for the purposes of this section may provide—

a

that F31 regulation 214(1) or (2) of the 2012 Regulations shall have effect subject to such exemptions as may be specified in the order F1F32 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 F37 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 F39an 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 F38 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.

C15 6

Before making an order under this section the F14 Ministers shall consult the appropriate committee F6 ....

F307

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.

C14C4C5 58A F5F21Requirement to specify certain products as prescription-only products

1

The F16 ... Ministers shall, subject to subsection (4) of this section, so exercise their powers under section 58(1) of this Act as to secure that every product—

F40a

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F40b

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c

to which subsection (2) of this section applies;

F41is specified as a prescription only medicine.

2

This subsection applies to any product which—

a

is likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor or dentist; or

b

is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health; or

c

contains substances or preparations of substances of which the activity requires, or the side-effects require, further investigation; or

d

is normally prescribed by a doctor or dentist for parenteral administration.

3

In considering whether subsection (2) of this section applies to a product the F17 ... Ministers shall take into account whether the product—

a

contains a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or

b

contains a substance which is listed in any of Schedules I to IV of the Psychotropic Substances Convention (where the pro duct is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention); or

c

is likely, if incorrectly used—

i

to present a substantial risk of medicinal abuse, or

ii

to lead to addiction, or

iii

to be used for illegal purposes; or

d

contains a substance which, by reason of its novelty or properties, might fall within paragraph (c) above, but as to which there is insufficient information available to determine whether it does so fall; or

e

by reason of its pharmaceutical characteristics or novelty, or in the interests of public health, is reserved for treatments which can only be followed in a hospital; or

f

is used in the treatment of conditions which must be diagnosed in a hospital or in an institution with special diagnostic facilities (although administration and subsequent supervision may be carried out elsewhere); or

g

is intended for outpatients but may produce very serious sideeffects which would require a prescription drawn up as required by a specialist and special supervision throughout the treatment.

4

Subsection (1) of this section shall not apply in relation to any product if the F18 ... Ministers so determine having regard to—

a

the maximum single dose;

b

the maximum daily dose;

c

the strength of the product;

d

its pharmaceutical form;

e

its packaging; or

f

such other circumstances relating to its use as may be specified in the determination.

5

In this section F19 ...—

“the Narcotic Drugs Convention" means the Single Convention on Narcotic Drugs signed by the United Kingdom on 30th March 1961 as amended by the Protocol Amending the Single Convention on Narcotic Drugs signed by the United Kingdom on 25th March 1972 X1 ; and

“the Psychotropic Substances Convention" means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971 X2 .

F2058B Requirement to specify certain products for veterinary use as prescription-only products.

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F2959 Special provisions in relation to new medicinal products.

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F2960 Restricted sale, supply and administration of certain medicinal products.

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F2961 Special restrictions on persons to be supplied with medicinal products.

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C7 62 C6 Prohibition of sale or supply, or importation, of medicinal products of specified description F11 ....

1

Subject to the following provisions of this section, the F26 ... Ministers, where it appears to them to be necessary to do so in the interests of safety, may by order—

C8a

prohibit the sale or supply, or the importation, of medicinal products of any description, or falling within any class, specified in the order, or (in such manner as may appear to them to be sufficient to identify the products in question) designate particular medicinal products and prohibit the sale or supply, or the importation, of those particular products;

F27b

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C82

A prohibition imposed by order under this section may be a total prohibition or may be imposed subject to such exceptions as may be specified in the order.

C8C163

Before making an order under this section the F22 Ministers , unless in their opinion it is essential to make the order with immediate effect to avoid serious danger to health F23 ..., shall consult the appropriate committee F7 ....

C84

Where an order is made under this section without prior consultation with the appropriate committee F8 ... in accordance with subsection (3) of this section, the prohibition imposed by the order shall not have effect after the end of such period, not exceeding three months from the date on which it comes into operation, as may be specified in the order, but without prejudice to the making of any further order in accordance with the provisions of this section (including this subsection).

C85

If any organisation consulted in pursuance of section 129(6) of this Act with respect to a proposal to make an order under this section have given notice to the F24Ministers of their desire to be heard under this subsection, or have made representations in writing to F25the Ministers with respect to that proposal, then before making the order—

a

if the organisation have given notice of their desire to be heard, the F24Ministers shall arrange for them to have an opportunity of appearing before, and being heard by, the F9appropriate committee, or

b

if they have made representations in writing, the F24Ministers shall refer those representations to the F9appropriate committee,

and, where the organisation have availed themselves of the opportunity of being heard, or after considering the representations, as the case may be, the Commission shall report their findings and conclusions to the F24Ministers and F25the Ministers shall take that report into account in determining whether to make the order.

C86

Subsection (5) of this section shall not have effect where in the opinion of the F28 ... Ministers it is essential to make the order with immediate effect as mentioned in subsection (3) of this section.

C8F107

If an order is made under this section and either—

a

the appropriate committee have not considered the proposal to make the order, or

b

the order is made contrary to the advice of the appropriate committee,

the order shall include a statement of the fact that it has been so made.

F428

In this section “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.

C1063 Adulteration of medicinal products. C9

No person shall—

a

add any substance to, or abstract any substance from, a medicinal product so as to affect injuriously the composition of the product, with intent that the product shall be sold or supplied in that state, or

b

sell or supply, or offer or expose for sale or supply, or have in his possession for the purpose of sale or supply, any medicinal product whose composition has been injuriously affected by the addition or abstraction of any substance.

Annotations:
Modifications etc. (not altering text)
C10

S. 63 applied (1.1.1995) by S.I 1994/3142, reg. 18(2)

C9

Ss. 63–65 extended by S.I. 1984/187, art. 2

64 Protection of purchasers of medicinal products. C11

1

No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.

2

For the purposes of this section the sale of a medicinal product shall not be taken to be otherwise than to the prejudice of the purchaser by reason only that the purchaser buys the product for the purpose of analysis or examination.

3

Subsection (1) of this section shall not be taken to be contravened by reason only that a medicinal product contains some extraneous matter, if it is proved that the presence of that matter was an inevitable consequence of the process of manufacture of the product.

4

Subsection (1) of this section shall not be taken to be contravened by reason only that a substance has been added to, or abstracted from, the medicinal product, if it is proved that—

a

the addition or abstraction was not carried out fraudulently, and did not injuriously affect the composition of the product, and

b

the product was sold having attached to it, or to a container or package in which it was sold, a conspicuous notice of adequate size and legibly printed, specifying the substance added or abstracted.

5

Where a medicinal product is sold or supplied in pursuance of a prescription given by F43an appropriate practitioner, the preceding provisions of this section shall have effect as if—

a

in those provisions any reference to sale included a reference to supply and (except as provided by the following paragraph) any reference to the purchaser included a reference to the person (if any) for whom the product was prescribed by the practitioner, and

b

in subsection (1) of this section, for the words “demanded by the purchaser", there were substituted the words “specified in the prescription".

F4465 Compliance with standards specified in monographs in certain publications.

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F4466 Further powers to regulate dealings with medicinal products.

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