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Pharmaceutical Labelling (Warning of Cognitive Function Impairment) Bill


Pharmaceutical Labelling (Warning of Cognitive Function Impairment) Bill

1

 

A

Bill

To

make provision for a warning symbol to be prominently displayed on the

packaging of pharmaceuticals which act on the brain and central nervous

system so as to impair dangerously the consumer’s ability to carry out certain

activities; and for connected purposes. 

Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and

consent of the Lords Spiritual and Temporal, and Commons, in this present

Parliament assembled, and by the authority of the same, as follows:—

1       

Interpretation

In this Act—

“consumer” means a person who takes a psychoactive pharmaceutical

whether in the recommended or prescribed dose or otherwise;

“over the counter” means available without prescription from a pharmacy

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or other retail outlet;

“packaging” means such of the external packaging as is clearly on view on

purchase or receipt of the product;

“prescription only” means available only by a prescription from a

registered medical practitioner;

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“psychoactive pharmaceutical” means a pharmaceutical product which

has a clinical effect on the brain and central nervous system, and it is

immaterial whether the psychoactive pharmaceutical is available

through prescription only or over the counter;

“specified psychoactive pharmaceutical” means a psychoactive

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pharmaceutical specified by the Secretary of State by order under

section 2;

“warning symbol” means a prominent symbol the size, colour and design

of which shall be prescribed by the Secretary of State by regulations.

2       

Pharmaceuticals with psychoactive side effects

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The Secretary of State shall by order specify such psychoactive

pharmaceuticals as, in his opinion, can lead to impairment of the consumer’s

 
Bill 50 53/4
 
 

Pharmaceutical Labelling (Warning of Cognitive Function Impairment) Bill

2

 

ability to drive a motor vehicle or operate machinery such that the consumer is

a danger to himself or others.

3       

Warning symbols

(1)   

Specified psychoactive pharmaceuticals shall include on their packaging a

warning symbol.

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(2)   

The Secretary of State may by regulations prescribe—

(a)   

offences for or in connection with a failure to comply with the

provisions of subsection (1),

(b)   

circumstances in which a person is, or is not, guilty of such offences,

and

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(c)   

penalties in respect of such offences.

4       

Orders and regulations

(1)   

The power conferred by this Act on the Secretary of State to make an order or

regulations shall be exercisable by statutory instrument.

(2)   

No order or regulations may be made under section 2 or 3(2) unless a draft of

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the instrument has been laid before Parliament and approved by a resolution

of each House of Parliament.

(3)   

Regulations made under section 1 shall be subject to annulment in pursuance

of a resolution of either House of Parliament.

(4)   

Every power conferred by this Act on the Secretary of State to make an order

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or regulations includes power—

(a)   

to make different provision for different cases (including different

provision in respect of different areas);

(b)   

to make provision subject to such exemptions and exceptions as the

Secretary of State thinks fit; and

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(c)   

to make such incidental, supplemental, consequential and transitional

provision as the Secretary of State thinks fit.

5       

Short title, commencement and extent

(1)   

This Act may be cited as the Pharmaceutical Labelling (Warning of Cognitive

Function Impairment) Act 2005.

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(2)   

Sections 2 and 3 shall come into force on such date as the Secretary of State shall

by order specify, but the date so specified shall be a date before the end of a

period that ends twelve months after the day on which this Act receives Royal

Assent.

(3)   

This Act extends to England and Wales only.

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Revised 2 February 2005