Commonwealth Numbered Acts

THERAPEUTIC GOODS AMENDMENT ACT (NO. 1) 2002 NO. 23, 2002 - SCHEDULE 1

Therapeutic Goods Act 1989

1 After section 18

Insert:

18A Exemption because of emergency

Minister's power

(1)

The Minister may exempt from the operation of Division 2 of this Part:

(a)

specified therapeutic goods; or

(b)

therapeutic goods in a specified class.

The exemption must be made in writing.

(2)

The Minister may exempt goods under subsection (1) only if the Minister is satisfied that, in the national interest:

(a)

the exemption should be made so that the goods may be stockpiled as quickly as possible in order to create a preparedness to deal with a potential threat to public health that may be caused by a possible future emergency; or

(b)

the exemption should be made so that the goods can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.

When the exemption has effect

(3)

The exemption takes effect:

(a)

on the day on which the exemption is made; or

(b)

on a later day that is specified in the exemption.

(4)

The exemption ceases to have effect:

(a)

at the end of the period specified by the Minister in the exemption as the period for which the exemption is to have effect; or

(b)

when the exemption is revoked;

whichever first occurs.

(5)

The exemption ceases to have effect in relation to particular therapeutic goods:

(a)

when those goods become registered or listed goods; or

(b)

when the Minister varies the exemption by removing those goods from the exemption;

whichever first occurs.

(6)

If the Minister revokes the exemption as mentioned in paragraph (4)(b), or varies the exemption as mentioned in paragraph (5)(b), the revocation or variation takes effect:

(a)

if the Minister states in the revocation or variation that the revocation or variation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the revocation or variation is made; or

(b)

in any other case—on the day specified by the Minister in the revocation or variation.

The day specified under paragraph (b) of this subsection must not be earlier than 28 days after the day on which the revocation or variation is made.

Note: The revocation or variation must be made in writing, see subsection 33(3) of the Acts Interpretation Act 1901 .

Conditions for the exemption

(7)

The exemption is subject to conditions specified in the exemption about any of the following:

(a)

the period for which the exemption is to have effect;

(b)

the quantity of goods that are exempt;

(c)

the source of those goods;

(d)

the persons or class of persons who may import, manufacture, supply or export those goods;

(e)

the supply of those goods (including the persons or class of persons to whom goods may be supplied for use and the circumstances under which a stockpile of goods may be supplied for use);

(f)

the storage and security of those goods;

(g)

the keeping and disclosure of, and access to, records about those goods;

(h)

the disposal of those goods;

(i)

the manner in which any of those goods are to be dealt with if a condition of the exemption is breached;

(j)

any other matters that the Minister thinks appropriate.

Whether or not goods are exempt under this section is not affected by whether or not there is a breach of a condition of an exemption under this section in relation to those goods.

Note: A person may commit an offence by breaching a condition of an exemption under this section, see subsections 20(2A) and (2C), 22(7AB) and (7AD), and 30H(1) and (3).

(8)

The Minister may revoke or vary the conditions (including by imposing new conditions) after the exemption is made. The revocation or variation must be made in writing.

(9)

A revocation or variation under subsection (8) takes effect:

(a)

if the Minister states in the revocation or variation that the revocation or variation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the revocation or variation is made; or

(b)

in any other case—on the day specified by the Minister in the revocation or variation.

The day specified under paragraph (b) must not be earlier than 28 days after the day on which the revocation or variation is made.

Exemption etc. to be disallowable

(9A)

An exemption covered by paragraph (2)(a), and a revocation or variation under subsection (8) of an exemption covered by paragraph (2)(a), are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901 .

Notification

(10)

The Secretary must cause a document setting out particulars of:

(a)

an exemption covered by paragraph (2)(b); and

(b)

a revocation or variation under subsection (8) of an exemption covered by paragraph (2)(b);

to be published in the Gazette within 5 working days after the day on which the Minister makes the exemption, revocation or variation. However, an exemption, or a revocation or variation, is not invalid merely because of a failure to comply with this subsection.

Tabling

(11)

The Minister must cause a document setting out particulars of:

(a)

an exemption covered by paragraph (2)(b); and

(b)

a revocation or variation under subsection (8) of an exemption covered by paragraph (2)(b);

to be tabled before each House of the Parliament within 5 sitting days of that House after the day on which the Minister makes the exemption, revocation or variation. However, an exemption, or a revocation or variation, is not invalid merely because of a failure to comply with this subsection.

Exclusion of liability of the Commonwealth etc.

(12)

An exemption under this section does not render the Commonwealth, the Minister or a delegate of the Minister liable to a person for loss, damage or injury of any kind suffered by the person as a result of, or arising out of, the use of therapeutic goods by that person or another person.

Note: There are other requirements in other parts of this Act about goods exempt under this section:

(a) sections 20 and 22 (breach of a condition of the exemption);
(b) section 30F (goods not conforming to standards etc.);
(c) section 30G (disposal of unused goods);
(d) section 30H (record keeping);
(e) section 31AA (providing information to the Secretary);
(f) sections 35, 39 and 41 (manufacturing goods that are exempt under this section);
(g) section 46A (search of premises).

2 After subparagraph 20(1)(b)(ii)

Insert:

(iia)

the goods are exempt under section 18A;

3 At the end of subsection 20(1)

Add:

Note: A person may commit an offence against subsection (2A) or (2C) by importing into Australia therapeutic goods that are exempt under section 18A.

4 After subsection 20(2)

Insert:

(2A)

A person commits an offence if:

(a)

the person imports therapeutic goods into Australia; and

(b)

the goods are exempt under section 18A; and

(c)

the importation breaches a condition of the exemption.

Maximum penalty: Imprisonment for 4 years or 240 penalty units, or both.

(2B)

Strict liability applies to paragraph (2A)(b).

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

(2C)

A person commits an offence if:

(a)

the person imports therapeutic goods into Australia; and

(b)

the goods are exempt under section 18A; and

(c)

the importation breaches a condition of the exemption.

Maximum penalty: 60 penalty units.

(2D)

An offence under subsection (2C) is an offence of strict liability.

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

5 After paragraph 21(b)

Insert:

(ba)

the goods are exempt under section 18A; or

6 After paragraph 22(4)(b)

Insert:

(ba)

represent therapeutic goods that are not goods exempt under section 18A as being goods exempt under that section; or

7 Subsection 22(6)

After "exempt goods", insert "or goods exempt under section 18A".

8 After subsection 22(7AA)

Insert:

(7AB)

A person commits an offence if:

(a)

the person does an act or omits to do an act in relation to therapeutic goods; and

(b)

the goods are exempt under section 18A; and

(c)

the act or omission results in the breach of a condition of the exemption; and

(d)

the act or omission is likely to cause a serious risk to public health.

Maximum penalty: Imprisonment for 5 years or 300 penalty units, or both.

Note 1: A person may commit an offence against subsection 20(2A) or (2C) by breaching a condition of an exemption of therapeutic goods under section 18A that relates to the importation of the goods.

Note 2: A person may commit an offence against subsection 30H(1) or (3) by breaching a condition of an exemption of therapeutic goods under section 18A that relates to records about the goods.

(7AC)

Strict liability applies to paragraph (7AB)(b).

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

(7AD)

A person commits an offence if:

(a)

the person does an act or omits to do an act in relation to therapeutic goods; and

(b)

the goods are exempt under section 18A; and

(c)

the act or omission results in the breach of a condition of the exemption.

Maximum penalty: Imprisonment for 4 years or 240 penalty units, or both.

(7AE)

Strict liability applies to paragraph (7AD)(b).

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

9 Subsection 22(8)

After "registered goods", insert ", goods exempt under section 18A".

10 Paragraph 30A(1)(b)

After "exempt goods,", insert "goods exempt under section 18A,".

11 Before section 31

Insert in Division 3:

30F Goods exempt under section 18A not conforming to standards etc.

(1)

This section applies if:

(a)

therapeutic goods of a particular kind are exempt under section 18A; and

(b)

a person supplies a batch of goods of that kind; and

(c)

the Secretary is satisfied that the goods included in that batch:

(i)

do not conform to a standard applicable to goods of that kind; or

(ii)

are otherwise not fit to be used for their intended purposes.

(2)

The Secretary may, by written notice given to the person, require the person to take steps to recover the goods included in that batch (except any of those goods that cannot be recovered because they have been administered to, or applied in the treatment of, a person or animal).

(3)

The notice may specify one or more of the following requirements:

(a)

the steps to be taken to recover the goods;

(b)

the manner in which the steps are to be taken;

(c)

a reasonable period within which the steps are to be taken.

(4)

The Secretary must, as soon as practicable after giving the notice, cause particulars of it to be published in the Gazette .

(5)

A person commits an offence if:

(a)

the Secretary gives a notice to the person under subsection (2); and

(b)

the notice specifies a particular requirement mentioned in subsection (3); and

(c)

the person fails to comply with that requirement.

Maximum penalty: Imprisonment for 12 months or 60 penalty units, or both.

(6)

For the purposes of an offence against subsection (5), strict liability applies to the following physical elements of circumstances:

(a)

that the notice concerned is given under subsection (2);

(b)

that the particular requirement concerned is a requirement mentioned in subsection (3).

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

30G Disposal of unused goods exempt under section 18A

(1)

This section applies to particular therapeutic goods if:

(a)

an exemption in relation to those goods under section 18A ceases to have effect otherwise than because those goods have become registered goods or listed goods (see paragraph 18A(5)(a)); and

(b)

those goods have not been used before the exemption so ceases to have effect.

(2)

The Secretary may arrange for the disposal of any of those goods in accordance with the regulations.

(3)

Regulations made for the purposes of subsection (2) may set out the methods by which those goods are to be stored, supplied, destroyed, exported or otherwise disposed of.

(4)

A method set out in the regulations under subsection (3) must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of those goods.

30H Record for goods exempt under section 18A

(1)

A person commits an offence if:

(a)

there are therapeutic goods that are exempt under section 18A; and

(b)

a condition of the exemption:

(i)

requires the person to keep a record about those goods; or

(ii)

specifies the manner in which the person must keep the record; and

(c)

the person does an act or omits to do an act in relation to those goods; and

(d)

the act or omission results in the breach of that condition of the exemption.

Maximum penalty: 240 penalty units.

(2)

Strict liability applies to paragraph (1)(b).

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

(3)

A person commits an offence if:

(a)

there are therapeutic goods that are exempt under section 18A; and

(b)

a condition of the exemption:

(i)

requires the person to keep a record about those goods; or

(ii)

specifies the manner in which the person must keep the record; and

(c)

the person does an act or omits to do an act in relation to those goods; and

(d)

the act or omission results in the breach of that condition of the exemption.

Maximum penalty: 60 penalty units.

(4)

An offence under subsection (3) is an offence of strict liability.

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

12 After section 31A

Insert:

31AA Secretary may require information etc. about goods exempt under section 18A

(1)

This section applies to a person who is required to comply with a condition of an exemption of therapeutic goods under section 18A.

(2)

The Secretary may, by written notice given to the person, require the person to give to the Secretary specified information or documents relating to one or more of the following:

(a)

the supply of any of those goods;

(b)

the handling of any of those goods;

(c)

the monitoring of the supply of any of those goods;

(d)

the results of the supply of any of those goods;

(e)

any other matter prescribed by the regulations for the purposes of this paragraph.

Compliance period

(3)

The notice must specify a reasonable period within which the person must comply with it. The period must be at least 14 days starting on the day on which the notice is given.

Note: The heading to section 31A is replaced by the heading "Secretary may require information etc. about goods exempt under section 18".

13 Subsection 31C(1)

After "31A", insert ", 31AA".

Note: The heading to section 31C is altered by inserting ", 31AA" after "31A".

14 Subsection 31D(1)

After "31A", insert ", 31AA".

15 Subsection 35(1)

After "therapeutic goods", insert "(other than goods exempt under section 18A)".

16 At the end of section 35

Add:

(4)

A person commits an offence if:

(a)

the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods for supply for use in humans; and

(b)

the goods are exempt under section 18A; and

(c)

the person is not the holder of a licence that:

(i)

is in force; and

(ii)

authorises the carrying out of that step in relation to the goods at those premises.

Maximum penalty: Imprisonment for 4 years or 240 penalty units, or both.

(5)

Strict liability applies to paragraph (4)(b).

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

17 At the end of section 39

Add:

(2)

If:

(a)

the licence covers therapeutic goods that are exempt under section 18A; and

(b)

those goods cease to be exempt under that section before the licence is revoked;

the licence ceases to be in force in relation to those goods when those goods cease to be exempt under that section.

Note: An exemption under section 18A may cease to have effect only in relation to some of the goods covered by the exemption, see subsection 18A(5).

18 At the end of subsection 41(1)

Add:

; or (g) the goods are exempt under section 18A and the holder has breached a condition of the exemption in relation to those goods.

19 Before subparagraph 46A(4)(a)(i)

Insert:

(ia)

who is required to comply with a condition of an exemption of therapeutic goods under section 18A; or

20 Subsection 57(1)

After "(8)", insert "to (10)".

21 At the end of section 57

Add:

(10)

The power of the Minister under paragraph 18A(2)(a) may be delegated only to the Secretary.