Therapeutic Goods Amendment Regulations 2003 (No. 1) (Cth)

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Therapeutic Goods Amendment Regulations 2003 (No. 1)1

Statutory Rules 2003 No. 1112

I, GUY STEPHEN MONTAGUE GREEN, Administrator of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 12 June 2003

G. S. M. GREEN

Administrator

By His Excellency’s Command

TRISH WORTH

Parliamentary Secretary to the Minister for Health and Ageing

1Name of Regulations

These Regulations are the Therapeutic Goods Amendment Regulations 2003 (No. 1).

2Commencement

These Regulations commence on gazettal.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1Amendments

(regulation 3)

  

[1]Regulation 2, after definition of tuberculocide

insert

unused emergency goods means goods to which section 30G of the Act applies.

[2]After regulation 12A

insert

12AAAEmergency goods — early cessation of exemption

  1. (1)

    This regulation applies to:

    1. (a)

      a revocation, under paragraph 18A (4) (b) of the Act, of an exemption of therapeutic goods under subsection 18A (1) of the Act; and

    2. (b)

      a variation, under paragraph 18A (5) (b) of the Act, of an exemption under subsection 18A (1) of the Act, that removes particular therapeutic goods from the exemption.

  2. (2)

    The Secretary must give notice of the revocation or variation to persons who, under the exemption, have been importing, manufacturing, supplying or exporting the goods by:

    1. (a)

      writing to the person; or

    2. (b)

      publication in the Gazette.

  3. (3)

    A notice given under subregulation (2) must:

    1. (a)

      identify the goods covered by the revocation or variation; and

    2. (b)

      state the date that the exemption ceases to have effect for the goods.

12AABDisposal of unused emergency goods

  1. (1)

    For subsection 30G (2) of the Act, Schedule 5B sets out the requirements of, and in relation to, an arrangement for disposal of unused emergency goods.

  2. (2)

    Nothing in this regulation or in Schedule 5B is taken to prevent a disposal of unused emergency goods if:

    1. (a)

      the goods have 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):

      1. (i)

        registered goods or listed goods; or

      2. (ii)

        exempt goods under section 18 of the Act; or

      3. (iii)

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

      4. (iv)

        goods that are the subject of an approval under section 19A of the Act; and

    2. (b)

      the disposal is in accordance with other provisions of the Act and these Regulations relevant to the goods.

[3]Subregulation 42C (1)

omit

12 members

insert

13 members

[4]Paragraph 42C (1) (e)

substitute

  1. (e)

    1 government member and 1 other member, both nominated by the Therapeutic Goods Administration.

[5]Subregulation 42E (2)

omit

the CHCA or ASMI.

insert

the Therapeutic Goods Administration.

[6]Paragraph 42K (e)

substitute

  1. (e)

    a member nominated by the Therapeutic Goods Administration.

[7]Subregulation 42Y (2)

substitute

  1. (2)

    A quorum for a meeting convened to consider a complaint does not include a member of the Panel mentioned in subregulation (1) if the complaint was made by:

    1. (a)

      the member; or

    2. (b)

      the body that nominated the member.

[8]Subregulation 42ZCAD (3)

substitute

  1. (3)

    A member of the Panel must not participate in the Panel’s consideration of a complaint if the complaint was made by:

    1. (a)

      the member; or

    2. (b)

      the body that nominated the member.

[9]Schedule 5A, after item 8

insert

9

Unused emergency goods directed by the Secretary, under clause 7 of Schedule 5B, to be exported

the provisions of Schedule 5B continue to apply to the goods, as if the goods were not exempt from the operation of section 30G of the Act

[10]After Schedule 5A

insert

Schedule 5BDisposal of unused emergency goods

(regulation 12AAB)

1Early cessation of exemption — notice of goods held

  1. (1)

    A person who is given notice under subregulation 12AAA (2) must give to the Secretary:

    1. (a)

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

    2. (b)

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

  2. (2)

    Subclause (1) must be complied with:

    1. (a)

      if the notice under subregulation 12AAA (2) is given before the exemption ceases to have effect for the goods — within 7 days after the exemption so ceases; or

    2. (b)

      in any other case — within 7 days after the notice is given.

2Expiration 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:

  1. (a)

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

  2. (b)

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

3Storage and disposal of unused emergency goods

  1. (1)

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

    1. (a)

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

    2. (b)

      the security of the goods is appropriate to the level of risk that the goods could pose to the public and the environment; and

    3. (c)

      the integrity of the condition of the goods is maintained.

  2. (2)

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

4Direction for disposal of unused emergency goods

  1. (1)

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

  2. (2)

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

  3. (3)

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

5Relocation of unused emergency goods

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

6Disposal of unused emergency goods — destruction

  1. (1)

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

    1. (a)

      the goods have passed their expiry date;

    2. (b)

      the goods no longer conform to a standard that applies to the goods;

    3. (c)

      use of the goods poses, or would pose, a risk to public health;

    4. (d)

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

    5. (e)

      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):

      1. (i)

        registered goods or listed goods; or

      2. (ii)

        exempt goods under section 18 of the Act; or

      3. (iii)

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

      4. (iv)

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

    6. (f)

      the person who has control over the goods requests that the goods be destroyed.

  2. (2)

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

7Disposal of unused emergency goods — export

  1. (1)

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

  2. (2)

    The Secretary may direct that the goods be exported to a country, instead of directing that they be destroyed, if a relevant authority of the country has confirmed its willingness to accept the goods.

  3. (3)

    A person directed to export the goods must ensure that, during exportation:

    1. (a)

      the goods are only accessible for purposes relating to the export; and

    2. (b)

      the security of the goods is appropriate to the level of risk that the goods could pose to the public and the environment; and

    3. (c)

      the integrity of the condition of the goods is maintained.

8Disposal of unused emergency goods — supply

  1. (1)

    This clause applies to unused emergency goods that have 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):

    1. (a)

      registered goods or listed goods; or

    2. (b)

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

    3. (c)

      goods that are the subject of an approval under section 19A of the Act.

  2. (2)

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

  3. (3)

    In this clause:

authorised person means, as appropriate, a person:

  1. (a)

    in relation to whom the registered goods or listed goods are registered or listed; or

  2. (b)

    to whom the approval or authority under section 19 of the Act is given; or

  3. (c)

    to whom the approval under section 19A of the Act is given.

9Owner to be paid for goods supplied

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

10Records about unused emergency goods

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

  1. (a)

    ensure that records are kept that include the following information:

    1. (i)

      the quantities of the goods under the person’s control;

    2. (ii)

      how the goods are stored before being disposed of;

    3. (iii)

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

    4. (iv)

      if the goods have been exported or supplied — to whom they were exported or supplied and in what quantity; and

  2. (b)

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

  3. (c)

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

    1. (i)

      within 14 days after being notified of the Secretary’s request; or

    2. (ii)

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

11Failure to comply with this Schedule

If a person who has control over any unused emergency goods has not complied with a provision of this Schedule, the Secretary may destroy the goods.

Notes

1. These Regulations amend Statutory Rules 1990 No. 394, as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998); 1998 Nos. 227, 247 and 369; 1999 Nos. 62, 209 and 324; 2000 Nos. 29, 48, 70, 123, 124, 267 and 358; 2001 Nos. 159, 160, 252 and 343; 2002 Nos. 9, 84, 114, 143, 234, 315 and 345.

2. Notified in the Commonwealth of Australia Gazette

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