Commonwealth Consolidated Regulations

[Index] [Table] [Search] [Search this Regulation] [Notes] [Noteup] [Previous] [Next] [Download] [Help]

THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 5B

Disposal of unused emergency goods and unused emergency biologicals

(regulation   12AAB)

 

 

1   Early end of exemption--notice of goods held

  (1)   This clause applies if:

  (a)   the Minister makes an exemption under subsection   18A(1) of the Act in relation to specified therapeutic goods or therapeutic goods in a specified class; and

  (b)   a person is given a copy of a revocation or variation of the exemption under paragraph   18A(9B)(b) of the Act.

  (2)   The person must give the Secretary:

  (a)   notice, in writing, of the quantity and location of:

  (i)   for a revocation--the goods over which the person has control that have not been used; or

  (ii)   for a variation--the goods mentioned in the variation over which the person has control that have not been used; and

  (b)   a copy of any records about the goods that the person is required to keep under a condition of the exemption.

  (3)   The person must comply with subclause   (2) in relation to the goods within 7 days after the day the exemption ends for the goods.

1A   Early cessation of exemption--notice of biologicals held

  (1)   A person who is given notice under paragraph   32CE(b) of the Act must give to the Secretary:

  (a)   notice, in writing, of the quantity and location of any unused emergency biologicals over which the person has control; and

  (b)   a copy of any records about the biologicals that, under a condition of the exemption, the person is required to keep.

  (2)   Subclause   (1) must be complied with:

  (a)   if the notice under paragraph   32CE(b) of the Act is given before the exemption ceases to have effect for the biologicals--within 7 days after the exemption ceases; or

  (b)   in any other case--within 7 days after the notice is given.

2   Expiration of period of exemption--notice of goods held

    A person who has been importing, manufacturing, supplying or exporting therapeutic goods under an exemption under subsection   18A(1) of the Act must, within 7 days after the exemption ceases to have effect under paragraph   18A(4)(a) of the Act, give to the Secretary:

  (a)   notice, in writing, of the quantity and location of any unused emergency goods over which the person has control; and

  (b)   a copy of any records about the goods that, under a condition of the exemption, the person is required to keep.

2A   Expiration of period of exemption--notice of biologicals held

    A person who has been importing, manufacturing, supplying or   exporting biologicals under an exemption under subsection   32CB(1) of the Act must, within 7 days after the end of the period specified in the exemption under subsection   32CB(4), give to the Secretary:

  (a)   notice, in writing, of the quantity and location of any unused emergency biologicals over which the person has control; and

  (b)   a copy of any records about the biologicals that, under a condition of the exemption, the person is required to keep.

3   Storage and disposal of unused emergency goods and unused emergency biologicals

  (1)   A person who has control over unused emergency goods or unused emergency biologicals must ensure that those unused emergency goods or unused emergency biologicals are stored in a way that ensures that:

  (a)   the goods or biologicals are only accessible for supply, export, use or disposal in accordance with the Act and these Regulations; and

  (b)   the security of the goods or biologicals is appropriate to the level of risk that the goods or biologicals could pose to the public and the environment; and

  (c)   the integrity of the condition of the goods or biologicals is maintained.

  (2)   A person may dispose of unused emergency goods or unused emergency biologicals only in accordance with a direction given by the Secretary under subclause   4(1).

4   Direction for disposal of unused emergency goods and unused emergency biologicals

  (1)   The Secretary may direct, in writing, any person who has control over unused emergency goods or unused emergency biologicals to dispose of the unused emergency goods or unused emergency biologicals in the manner directed.

  (2)   A direction given under subclause   (1) must be in accordance with clause   5, 6, 7 or 8.

  (3)   A person who has been given a direction under subclause   (1) must comply with the direction.

5   Relocation of unused emergency goods and unused emergency biologicals

    If storage of particular unused emergency goods or unused emergency biologicals at a particular location poses, or would pose, a risk to the public or the environment, the Secretary may direct that the goods or biologicals be stored at a specified location that will ensure compliance with subclause   3(1).

6   Disposal of unused emergency goods and unused emergency biologicals--destruction

  (1)   The Secretary may direct that unused emergency goods or unused emergency biologicals be destroyed within the time specified in the direction if any of the following applies:

  (a)   the goods or biologicals have passed their expiry date;

  (b)   the goods or biologicals no longer conform to a standard that applies to the goods or biologicals;

  (c)   use of the goods or biologicals poses, or would pose, a risk to public health;

  (d)   storage of the goods or biologicals at their current location and any other location poses, or would pose, a risk to the public or the environment;

  (e)   for unused emergency goods--within 12   months after the exemption ceases to have effect in relation to the goods, the goods have not become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):

  (i)   registered goods or listed goods; or

  (ii)   exempt goods under section   18 of the Act; or

  (iii)   goods that are the subject of an approval or authority under section   19 of the Act; or

  (iv)   goods that are the subject of an approval under section   19A of the Act;

  (ea)   for unused emergency biologicals--within 12 months after the exemption ceases to have effect in relation to the biologicals, the biologicals have not become (whether in relation to an indication for which the biologicals could have been used under the exemption or in relation to a different indication):

  (i)   included in the Register under Part   3 - 2A of the Act; or

  (ii)   exempt biologicals under section   32CA of the Act; or

  (iii)   biologicals that are the subject of an approval or authority under section   32CK or 32CM of the Act; or

  (iv)   biologicals that are the subject of an approval under section   32CO of the Act;

  (f)   the person who has control over the goods or biologicals requests that the goods or biologicals be destroyed.

  (2)   A person directed to destroy the goods or biologicals may destroy the goods or biologicals only in a way, approved by the Secretary, that ensures that the destruction avoids or minimises harm to the public and the environment.

7   Disposal of unused emergency goods and unused emergency biologicals--export

  (1)   This clause applies to unused emergency goods or unused emergency biologicals to which any of paragraphs   6(1)(a) to (e) applies.

  (2)   The Secretary may direct that the goods or biologicals be exported to a country, instead of directing that they be destroyed, if a relevant authority of the country has confirmed, in writing or by electronic communication, its willingness to accept the goods or biologicals.

  (3)   A person directed to export the goods or biologicals must ensure that, during exportation:

  (a)   the goods or biologicals are only accessible for purposes relating to the export; and

  (b)   the security of the goods or biologicals is appropriate to the level of risk that the goods or biologicals could pose to the public and the environment; and

  (c)   the integrity of the condition of the goods or biologicals is maintained.

  (4)   In this clause:

"electronic communication" has the meaning given by subsection   5(1) of the Electronic Transactions Act 1999 .

8   Disposal of unused emergency goods and unused emergency biologicals--supply

  (1)   This clause applies to unused emergency goods or unused emergency biologicals that have become (whether in relation to an indication for which the unused emergency goods or unused emergency biologicals could have been used under the exemption or in relation to a different indication):

  (a)   registered goods or listed goods; or

  (aa)   biologicals included in the Register under Part   3 - 2A of the Act; or

  (b)   goods that are the subject of an approval or authority under section   19 of the Act; or

  (ba)   biologicals that are the subject of an approval or authority under section   32CK or 32CM of the Act; or

  (c)   goods that are the subject of an approval under section   19A of the Act; or

  (d)   biologicals that are the subject of an approval under section   32CO of the Act.

  (2)   The Secretary may direct that the goods or biologicals be supplied to an authorised person (otherwise than by way of administration to, or application in the treatment of, the person).

  (3)   In this clause:

"authorised person" means, as appropriate, a person:

  (a)   in relation to whom the registered goods or listed goods are registered or listed; or

  (aa)   in relation to whom the biologicals are included in the Register under Part   3 - 2A of the Act; or

  (b)   to whom the approval under subsection   19(1) or section   32CK of the Act, or the authority under subsection   19(5) or 32CM(1) of the Act, is given; or

  (ba)   who is included in a class of health practitioners specified in rules made under subsection   19(7A) or 32CM(7A) of the Act; or

  (c)   to whom the approval under section   19A or 32CO of the Act is given.

9   Owner to be paid for goods or biologicals supplied

    A direction given under clause   7 or 8 does not affect a person's liability to pay the owner of the goods or biologicals for the export or supply of the goods or biologicals to the person.

10   Records about unused emergency goods and unused emergency biologicals

    A person who has, or has had, control over unused emergency goods or unused emergency biologicals must:

  (a)   ensure that records are kept that include the following information:

  (i)   the quantities of the goods or biologicals under the person's control;

  (ii)   how the goods or biologicals are stored before being disposed of;

  (iii)   if a direction under subclause   4(1) has been received--what actions have been taken to dispose of the goods or biologicals as directed and when the actions were taken;

  (iv)   if the goods or biologicals have been exported or supplied--to whom they were exported or supplied and in what quantity; and

  (b)   retain the records for 7 years after the last entry is made; and

  (c)   if the Secretary so requests in writing--give to the Secretary a copy of a record mentioned in paragraph   (a):

  (i)   within 14 days after being notified of the Secretary's request; or

  (ii)   if the information is required to establish whether the goods or biologicals pose imminent risk to the public or the environment--within 24 hours, or any shorter period, specified by the Secretary.

11   Failure to comply with this Schedule

    If a person who has control over any unused emergency goods or unused emergency biologicals has not complied with a provision of this Schedule, the Secretary may direct, in writing, that the unused emergency goods or unused emergency biologicals be destroyed by another person.


AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback