Medicinal Labelling Bill (HL Bill 11)
A
BILL
TO
Require a declaration relating to the use of animal research to be placed on
medicinal products’ labels.
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 Medicinal product labelling
(1)
All medicinal products’ labels shall state that the product has been produced
as a result of research on animals.
This label will be required on the individual packet of each medicinal product
5sold within the United Kingdom.
This label will be required on the individual packet of each medicinal product
sold within the United Kingdom.
(2)
A pharmaceutical company is guilty of an offence it if fails to label its products
under subsection (1) and is liable—
(a)
10on summary conviction, to a fine not exceeding the statutory
maximum,
(b) on conviction on indictment, to a fine.
This penalty is applicable for each medicinal product sold or dispensed.
2 Definition
15In this Act—
-
“medicinal product” means any drug, medicine or vaccine as listed in the
British National Formulary whether prescribed or bought over the
counter, where animals have been used at any stage of the
development, production or manufacture of the medicinal product, or
20where animals have been used to assess its safety or efficacy; -
“animal” refers to any animal, other than human, which is vertebrate.
3 Short title, commencement and extent
(1) This Act may be cited as the Medicinal Labelling Act 2013.
Medicinal Labelling BillPage 2
(2)
This Act, with the exception of section 1(2), shall come into force on the day on
which it is passed.
(3)
Section 1(2) shall come into force at the end of the period of six months
beginning with the day on which it is passed.
(4) 5This Act extends to England and Wales, Scotland and Northern Ireland.