Medicines Regulations 1984

  • This version was replaced on 7 November 2018 to make corrections to Schedule 1 Part 1 item 787 under section 25(1)(j)(ii) of the Legislation Act 2012.

Part 9 Withdrawal of medicines, etc

50 Withdrawal of medicines, etc

(1)

The Director-General may issue to any importer, manufacturer, or seller of any medicine, related product, or medical device an order—

(a)

directing the withdrawal from sale of any medicine, related product, or medical device in respect of which there is in force a notice given by the Minister under section 35 or section 37 of the Act, or of any portion of the produced quantity of any such medicine, related product, or medical device, if the Director-General believes on reasonable grounds that such withdrawal is necessary to protect the public; or

(b)

directing the withdrawal from sale of any medicine, related product, or medical device, or any portion of the produced quantity of any medicine, related product, or medical device, that does not conform to the specifications claimed for that medicine, related product, or medical device; or

(c)

requiring the disposal of any medicine or related product, or any specific quantity of a medicine or related product, that has been directed to be withdrawn under paragraph (a) or paragraph (b); or

(d)

requiring the disposal or destruction of any medical device, or any specific quantity of any medical device, that has been directed to be withdrawn under paragraph (a) or paragraph (b).

(2)

The importer, manufacturer, or seller shall, on receipt of an order made under subclause (1), advise the Director-General of the manner and time in which he proposes to comply with the order, and shall give written notice to the Director-General when the order has been complied with.

(3)

Notwithstanding anything in subclause (2), the Director-General may issue directions to the recipient of an order made under subclause (1) as to the manner and time in which the order is to be complied with.