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:—
“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
“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;
“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
pharmaceutical specified by the Secretary of State by order under
“warning symbol” means a prominent symbol the size, colour and design
of which shall be prescribed by the Secretary of State by regulations.
Pharmaceuticals with psychoactive side effects
The Secretary of State shall by order specify such psychoactive
pharmaceuticals as, in his opinion, can lead to impairment of the consumer’s
ability to drive a motor vehicle or operate machinery such that the consumer is
a danger to himself or others.
Specified psychoactive pharmaceuticals shall include on their packaging a
The Secretary of State may by regulations prescribe—
offences for or in connection with a failure to comply with the
provisions of subsection (1),
circumstances in which a person is, or is not, guilty of such offences,
penalties in respect of such offences.
The power conferred by this Act on the Secretary of State to make an order or
regulations shall be exercisable by statutory instrument.
No order or regulations may be made under section 2 or 3(2) unless a draft of
the instrument has been laid before Parliament and approved by a resolution
of each House of Parliament.
Regulations made under section 1 shall be subject to annulment in pursuance
of a resolution of either House of Parliament.
Every power conferred by this Act on the Secretary of State to make an order
or regulations includes power—
to make different provision for different cases (including different
provision in respect of different areas);
to make provision subject to such exemptions and exceptions as the
Secretary of State thinks fit; and
to make such incidental, supplemental, consequential and transitional
provision as the Secretary of State thinks fit.
Short title, commencement and extent
This Act may be cited as the Pharmaceutical Labelling (Warning of Cognitive
Function Impairment) Act 2009.
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
This Act extends to England and Wales only.