Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 32

  (1)   A person must not:

  (a)   molest, obstruct or try to intimidate or influence an authorised officer in the execution of his or her powers or the performance of his or her duties under these Regulations; or

  (b)   on being asked by an authorised officer, fail:

  (i)   to show the authorised officer the place where any therapeutic goods are kept; or

  (ii)   to admit the authorised officer to a place where therapeutic goods are kept; or

  (iii)   to show the authorised officer, or let the authorised officer inspect, therapeutic goods kept by the person; or

  (iv)   to allow a sample of therapeutic goods to be taken in accordance with these Regulations; or

  (v)   to give an authorised officer information required by the authorised officer, being information relevant to the manufacture and testing of therapeutic goods that the person is able to provide; or

  (vi)   to assist the authorised officer in the execution of his or her powers or the performance of his or her duties under these Regulations; or

  (c)   on being asked by an official analyst, fail to give any information required by the official analyst, being information relevant to the testing of therapeutic goods, that that person is able to provide.

Penalty:   10 penalty units.

  (1A)   For the purposes of an offence under paragraph   (1)(a), strict liability applies to the physical element that the duties mentioned in that paragraph are duties under these Regulations.

Note:   For strict liability , see section   6.1 of the Criminal Code .

  (1B)   An offence under paragraph   (1)(b) or   (c) is an offence of strict liability.

Note:   For strict liability , see section   6.1 of the Criminal Code .

  (1C)   It is a defence to a prosecution under paragraph   (1)(b) or   (c) if the person has a reasonable excuse.

Note:   A defendant bears an evidential burden in relation to the matter mentioned in subregulation   (1C) (see section   13.3 of the Criminal Code ).

  (2)   It is a reasonable excuse for a person to fail to comply with a request for information under paragraph   (1)(b) or (c) if compliance with that request would tend to incriminate that person.