Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1997No. 3991

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Therapeutic Goods Regulations2 (Amendment)

I, The Governor-General 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 18 December 1997.

 WILLIAM DEANE

 Governor-General

By His Excellency’s Command,

TRISH WORTH

Parliamentary Secretary to the

Minister for Health and Family Services for the

 Minister for Health and Family Services

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1.   Commencement

1.1   These Regulations, other than this regulation, subregulation 3.1 and regulations 9 and 10, commence on 1 January 1998.

[NOTE:  This regulation, subregulation 3.1, and regulations 9 and 10, commence on gazettal: see Acts Interpretation Act 1901, s 48.]

2.   Amendment

2.1   The Therapeutic Goods Regulations are amended as set out in these Regulations.

3.   Regulation 2 (Interpretation)

3.1   After the definition of “fungicide”, insert:

“‘gene therapy’ means the in vivo transfer of DNA or RNA into the cells of human recipients;”.

3.2   Insert the following definitions:

“‘active ingredient’ means the therapeutically active component in a drug’s final formulation that is responsible for its physiological or pharmacological action;

‘designated orphan drug’ means an orphan drug designated under subregulation 16J (2);

‘orphan drug’ means a drug, vaccine or in vivo diagnostic agent mentioned in regulation 16H;

‘rare disease’ means a disease, or condition, likely to affect not more than 2,000 individuals in Australia at any time;”.

4.   New Part 3B

4.1   After Part 3A, insert:

“PART 3B—ORPHAN DRUGS

Orphan drug

 “16H.(1) A drug, vaccine or in vivo diagnostic agent is an orphan drug if it complies with this regulation.

 “(2) It:

• (a)

  must be intended to treat, prevent or diagnose a rare disease; or

• (b)

  must not be commercially viable to supply to treat, prevent or diagnose another disease or condition.

 “(3) It is not an orphan drug if any of the following persons or bodies has refused to approve it for use for the disease for a reason related to the drug’s safety:

• (a)

  the Secretary;

• (b)

  the Food and Drug Administration of the United States of America;

• (c)

  the Medicines Control Agency of the United Kingdom;

• (d)

  the Bureau of Pharmaceutical Assessment of Canada;

• (e)

  the Medical Products Agency of Sweden;

• (f)

  the Medicines Evaluation Board of the Netherlands;

• (g)

  the European Agency for the Evaluation of Medicinal Products.

 “(4) It is not an orphan drug if it has been registered for use for the disease or condition before 1 January 1998.

 “(5) However, it may be registered before 1 January 1998 for another use or indication.

Application for orphan drug designation

 “16I.(1) The sponsor of an orphan drug may apply to the Secretary for the drug to be designated as an orphan drug.

 “(2) The application must be made using an application form approved by the Secretary.

 “(3) The application must show why the drug is an orphan drug.

 “(4) For a vaccine or in vivo diagnostic agent, the application must also state that the vaccine or agent will be administered in Australia to not more than 2,000 people in each year after it is registered for use for the disease or condition.

[NOTE:  There is no fee for making the application: see subregulation 45 (12).]

Orphan drug designation

 “16J.(1) The Secretary must consider the application.

 “(2) The Secretary must designate the drug, in writing, as an orphan drug if the Secretary is satisfied that the statements made in the application are correct.

 “(3) The Secretary must refuse to designate the drug as an orphan drug if the Secretary is not satisfied that all of the statements made in the application are correct.

 “(4) The Secretary must tell the applicant in writing, as soon as practicable after making the decision, whether the drug has been designated.

[NOTE:  There is no fee for making the Secretary’s decision: see subregulation 45 (12).]

 “(5) If the Secretary designates the drug, the Secretary must publish a notice in the Gazette, as soon as practicable after making the decision, giving the following information:

• (a)

  the sponsor’s name;

• (b)

  the drug’s dose form and indication;

• (c)

  a statement that the drug is a designated orphan drug.

5.   Regulation 45 (Waiver or reduction of fees)

5.1   Add at the end of the regulation:

 “(12) The Secretary must waive the following fees:

• (a)

  a fee that would have been payable, but for this subregulation, for applying to the Secretary under subregulation 16I (1) to have a drug designated as an orphan drug;

• (b)

  a fee that would have been payable, but for this subregulation, for the Secretary considering the application under regulation 16J;

• (c)

  a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug.”.

6.   Regulation 46 (Release of information)

6.1   Subregulation 46 (2):

Add at the end of the subregulation:

• “; (g)

  whether the goods are a designated orphan drug.”.

7.   Regulation 48 (Review of decisions)

7.1   Subregulation 48 (1) (definition of “initial decision”):

Omit the definition, substitute:

“‘initial decision’ means a decision of the Secretary under any of the following provisions:

• (a)

  regulation 7;

• (b)

  regulation 9;

• (c)

  subregulation 13 (7);

• (d)

  subregulation 14A (3), (4), (5) or (6);

• (e)

  subregulation 16J (3);

• (f)

  subregulation 22 (8);

• (g)

  regulation 45;

• (h)

  regulation 45AA;”.

8.   Schedule 3 (Therapeutic goods required to be included in the part of the Register for registered goods)

8.1   Items 1 and 2, Part 1:

Omit the items, substitute:

“1 drugs that:

• (a)

  are not mentioned in item 1 in Part 1 of Schedule 4; and

• (b)

  are not designated orphan drugs

2 drugs that:

• (a)

  are not mentioned in items 3 to 10 (inclusive) in Part 1 of Schedule 4; and

• (b)

  are not designated orphan drugs; and

• (c)

  are supplied as pharmaceutical benefits

2A drugs that:

• (a)

  are not mentioned in item 1, 2, 3, 4, 6, 8, 9 or 11 in Schedule 5; and

• (b)

  are not designated orphan drugs; and

• (c)

  are supplied as pharmaceutical benefits

2B drugs that:

• (a)

  are not mentioned in mentioned in item 1, 2 or 3 in Schedule 5A; and

• (b)

  are not designated orphan drugs; and

• (c)

  are supplied as pharmaceutical benefits”.

8.2   Add at the end of the Schedule:

“PART 3—THERAPEUTIC GOODS

ATTRACTING NO FEE

UNDER DIVISION 1 OR 2 OF PART 3

Item no. Therapeutic goods

1 Designated orphan drugs”.

9.   Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)

9.1   Item 6:

After “drugs”, insert “(other than drugs used for gene therapy)”.

10.   Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions)

10.1   Add at the end of the Schedule:

“8	Therapeutic goods imported by a member of a group of persons	(a) the group must be members of the military forces of another country, visiting Australia for military training; and (b) the goods must be for use in the treatment of a member or members of that group; and (c) the goods must not be supplied to, or used in the treatment of, a person other than a member of: (i) the visiting group; or (ii) the Australian Defence Force; and (d) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and (e) a member of the group to whom the goods have been issued must be responsible for the control and custody of the goods while the group is in Australia; and (f) the person mentioned in paragraph (e) must: (i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and (ii) for each of the goods that is not a therapeutic device—include in the list the generic name and strength of the active ingredient of the goods; and
(iii) keep a record of the use of the goods while the group is in Australia; and (iv) produce the list or the record for inspection at the request of a customs officer or a person who is an authorised officer for a provision of Part 5 of these Regulations”.

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 24 December 1997.

2. 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 in the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162 and 398.