20 Restrictions on sale or supply of new medicines

(1)

Except as provided in sections 25, 26(4), 28, 30, 31, and 32, this section applies to new medicines.

(2)

No person shall—

(a)

sell; or

(b)

distribute by way of gift or loan or sample or in any other way; or

(c)

advertise the availability of—

any medicine to which this section applies before the consent or provisional consent of the Minister to the distribution of the medicine has been notified in the Gazette, or otherwise than in accordance with such conditions as may be imposed by the Minister on giving his consent or provisional consent and notified in the Gazette.

(3)

No consent given under this section shall be deemed to warrant the safety or efficacy of the medicine to which the consent relates.

(4)

A person who contravenes subsection (2) commits an offence, and is liable on conviction—

(a)

in the case of an individual, to imprisonment for a term not exceeding 6 months or a fine not exceeding $20,000:

(b)

in the case of a body corporate, to a fine not exceeding $100,000.

(5)

In any proceedings for an offence against subsection (4) in which it is alleged that this section applies to a medicine by reason of subsection (1), it shall be presumed that the medicine is a medicine to which this section applies until the contrary is proved.

(6)

The provisions of this section are in addition to, and not in substitution for, the provisions of any other enactment prohibiting, regulating, or restricting the sale or distribution of medicines, and nothing in any such other enactment shall authorise any person to act in contravention of the provisions of this section; but in the event of any conflict, the provisions of this section shall prevail.

(6A)

The Minister, after having given consent or provisional consent to the distribution of any medicine in accordance with this Act, shall give written notification to the EPA of the consent or provisional consent and any condition attached to that consent.

(7)

Any consent that was given in respect of any medicine by the Minister under section 12(2) of the Food and Drug Act 1969 and in force immediately before the commencement of this Act shall be deemed for the purposes of this section and section 35 to have been given under this section.

Compare: 1969 No 7 s 12

Section 20(4): substituted, on 19 May 1998, by section 11 of the Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 (1998 No 20).

Section 20(6A): inserted, on 2 July 2001, by section 149 of the Hazardous Substances and New Organisms Act 1996 (1996 No 30).

Section 20(6A): amended, on 1 July 2011, by section 53(1) of the Environmental Protection Authority Act 2011 (2011 No 14).