Medicines Act 1981

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36 Control of established medicines

(1)

Without limiting subsection (5) of section 24, if the Director-General has reason to believe that any medicine, not being a new medicine, may be unsafe or ineffective for the therapeutic purpose for which it is sold, he may, by notice in writing to an importer or manufacturer in New Zealand, state the reasons for his belief and require the importer or manufacturer to satisfy him of the safety or efficacy of that medicine.

(2)

If the Director-General is not satisfied, by evidence supplied to him pursuant to a notice under subsection (1) or otherwise, of the safety and efficacy of a medicine to which that notice relates, he may at any time after the expiration of 60 days from the date of that notice refer a description of the medicine to the appropriate committee, and shall forthwith by notice in writing inform the importer or manufacturer that he has done so.

(3)

In any case to which this section applies, the Minister may, by notice in writing to the importer or manufacturer,—

(a)

prohibit the importer or manufacturer, either indefinitely or for such period as may be specified in the notice, from selling or supplying the medicine; or

(b)

impose such conditions as may be specified in the notice on the sale or supply of the medicine by the importer or manufacturer.

(4)

The Minister may at any time, by a like notice, revoke any notice given under subsection (3), or vary, revoke, or add to any conditions imposed in any such notice.

(5)

Every person commits an offence and is liable on conviction to imprisonment for a term not exceeding 6 months or a fine not exceeding $5,000 who sells or supplies any medicine in contravention of a notice given under subsection (3), or of a condition imposed in any such notice or in a notice given under subsection (4).

Section 36(5): amended, on 1 July 2013, by section 413 of the Criminal Procedure Act 2011 (2011 No 81).