Therapeutic Goods Amendment Regulations 2001 (No. 3) 2001 No. 252
EXPLANATORY STATEMENT
STATUTORY RULES 2001 No. 252
Issued by authority of the Parliamentary Secretary to the Minister for Health and Aged Care
Therapeutic Goods Act 1989
Therapeutic Goods Amendment Regulations 2001 (No. 3)
The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
The Governor-General may, under section 63 of the Act, make regulations required or permitted to be prescribed by the Act, or that are necessary or convenient to be prescribed for carrying out or giving effect to the Act. In particular, the Governor-General may make regulations to:
• Prescribe therapeutic goods, or classes of goods, that are required to be included in the Australian Register of Therapeutic Goods (the Register) as "listed" or "registered" goods (paragraph 17(4)(a) of the Act);
• Provide for the transfer of therapeutic goods from the part of the Register for "registered goods" to the part for "listed goods" (paragraph 17(4)(b) of the Act);
• Prescribe other different characteristics that make medicines that are listable goods (other than export only medicines) separate and distinct from other therapeutic goods (ss. 16(1A) of the Act);
• Prescribe the process for, and safeguards associated with, obtaining samples requested by the Secretary in relation to medicines that are listable goods (ss.28(5A) of the Act); and
• Prescribe requirements for the advertising of therapeutic goods (paragraph 63(2)(c) of the Act).
The purpose of the Regulations is to extend the list of listable goods in Schedule 4 of the Therapeutic Goods Regulations, amend provisions relating to the listing and advertising of therapeutic goods, and insert new procedures for the handling of samples of therapeutic goods sent by sponsors.
The Regulations:
(e) prescribe in the Regulations additional characteristics that make medicines that are listable goods (except export only medicines) separate and distinct from other therapeutic goods (Item 1);
(f) provide for the same procedures and requirements set out in subregulations 26(2) and 26(3) of the Regulations to be adopted for the purposes of ss. 28(5A) of the Act to ensure the integrity of samples of therapeutic goods delivered to the Secretary under this section of the Act (Items 2, 3, 4, 5, 6, 7, 8, 9 and 10);
(g) update references in the Regulations to the Therapeutic Goods Advertising Code to reflect changes made to that Code (items 11 and 12); and
(h) update Schedule 4 of the Regulations to reflect the fact that additional therapeutic goods or substances have been included in the "listable" part of the Register through notices gazetted by the Minister's delegate under ss. 17(5) of the Act (Items 13, 14, 15, 16, 17, 18, 19 and 20).
Details of the Regulations are set out in the Attachment.
The Regulations will commence on the date of commencement of the Therapeutic Goods Amendment Act 2001, ie by 23 September 2001.
ATTACHMENT 1
Therapeutic Goods Amendment Regulations 2001 (No. 3)
Regulation 1 states that the title of these regulations will be the Therapeutic Goods Amendment Regulations 2001 (No. 3)
Regulation 2 provides that these regulations commence on the commencement of the Therapeutic Goods Amendment Act 2001.
Regulation 3 provides that Schedule 1 amends the Therapeutic Goods Regulations 1990.
SCHEDULE 1 -AMENDMENTS
Item 1
Inserts new regulation 10A which lists additional characteristics that separate and distinguish certain medicines, specifically medicines that are listable goods (except export only medicines), from other therapeutic goods.
The Therapeutic Goods Amendment Act 2001 amends section 16 of the Therapeutic Goods Act 1989 ("the Act") to provide a different set of criteria for determining when medicines that are listable goods (other than export only medicines) are deemed to be "separate and distinct" from each other, for the purposes of being required to be listed in the Australian Register of Therapeutic Goods ('the Register'). Criteria for distinguishing separate and different listable medicines include "such other different characteristics as the regulations prescribe" (new paragraph 16(1A)(d) of the Act). The purpose of this amendment is to prescribe the following other characteristics as defined in the model for a new system for listing medicines in the Register:
- a different name; or
- different indications; or
- a different excipient; or
- a different quantity of an excipient that is a restricted ingredient; or
- a different quantity of any restricted ingredient where the restriction is based on concentration; or
- for medicines containing restricted ingredients and the restriction is based on recommended single or daily dose, different directions for use, if the difference in the directions is a different recommended single or daily dose.
The amendment also adds definitions for "restricted ingredient" and "relevant medicine".
"Restricted ingredient" is defined as an ingredient in a relevant medicine and, for the medicine to' be eligible for listing, the permissible quantity or concentration of the ingredient in the medicine is restricted by operation of Schedule 4 of the Regulations, the Poisons Standard, a condition imposed under section 28 of the Act, a standard under section 10 of the Act or any other provision in the Act or the Regulations that deals with the eligibility of medicines for listing.
"Relevant medicine" is defined as a medicine that is listable or listed and that is not an export only medicine.
Item 2
Divides Regulation 23 "Interpretation" into two subregulations (subregulation 23(1) and 23(2)) to accommodate new subregulation 23(2), inserted by Item 3.
Item 3
Has the effect of providing how a sample should be fastened and sealed, for the purposes of Part 5 of the Regulations and for the purposes of new subsection 28(5) of the Act. Part 5 of the Regulations deals with the procedure for an authorised officer to take samples of any therapeutic goods that are in supply or testing, to establish compliance of the goods with applicable standards and other statutory requirements. Samples can be taken at any time from any place where the therapeutic goods are being supplied or kept for supply. Subsection 28(5) is a new provision inserted into the Act by the Therapeutic Goods Amendment Act 2001 that allows the Secretary to require a person who has listed therapeutic goods in the Register through section 26A of the Act to send samples of the listed goods. The samples sent by the sponsor can then be tested for compliance with statutory requirements, including any standards. The amendments effected by Items 2 to 10 inclusive are designed to establish the procedures to be followed to ensure the integrity of samples collected for the purposes of new subsection 28(5) of the Act. To the extent possible, these procedures have been integrated with those currently applying under Part 5 of the Regulations.
Item 4
Amends paragraphs 25(3)(b) and (c) to clarify that the Official Analyst may determine tests that are to be performed for the purposes of either Part 5 of the Regulations or new subsection 28(5) of the Act. Also, the Official Analyst may nominate another official analyst to be the "responsible analyst" for the purposes of either Part 5 of the Regulations or new subsection 28(5) of the Act. The responsible analyst arranges for an analysis of the sample by relevant tests to establish the quantity and quality of the goods and to determine whether the goods comply with applicable standards. The responsible analyst also arranges for an examination of the goods and the label (if any) and packaging of the goods to determine whether the goods comply with the labelling, packaging and other requirements (including requirements relating to advertising) applicable to the goods.
Item 5
Clarifies that the notification requirements placed upon an authorised officer to give certain details to the person from whom a sample is taken for testing for the purposes of Part 5 of the Regulations, need not be repeated when a further sample is taken from the same person, in the event that a further sample is needed for testing by an independent analyst for the purposes of paragraph 30(6)(b) of the Regulations.
Item 6
Makes consequential changes to reflect that the requirement relating to proper packaging of samples has been moved from subregulation 26(3) to new subregulation 23(2), where the requirement will have general application for the purposes of both Part 5 of the Regulations as well as subsection 28(5) of the Act.
Item 7
Describes the actions to be taken by the Secretary on receiving a sample delivered for the purposes of subsection 28(5A) of the Act to ensure the integrity of that sample. The Secretary is to determine, as soon as practicable after receiving the sample, whether it is appropriately packaged, fastened and sealed. If the sample is appropriately packaged, fastened and sealed, the Secretary is to send the sample to a relevant laboratory for analysis. If the sample is not appropriately packaged, fastened and sealed, the Secretary is to return the sample to the sponsor with an explanation of why it is not appropriately packaged, fastened and sealed.
Item 8
Clarifies that where a sample is taken by an authorised officer under subregulation 25(3) of the Regulations, and not subsection 28(5) of the Act, the responsible analyst must send a copy of the certificate setting out the results of the analysis to the person from whom the official analyst took the samples. In the case of samples sent by a sponsor to the Secretary under subsection 28(5) of the Act, the responsible analyst has an obligation under subregulation 29(1) to send the original certificate setting out the results of the examination and analysis to that sponsor.
Items 9 and 10
Adds a provision for the Commonwealth to be liable to pay for a sample delivered to the Secretary under subsection 28(5A) of the Act and defines the amount the Commonwealth is liable to pay. These amendments are consistent with the existing provisions under subregulations 31(1) and 31(2) for payment for samples taken by authorised officers.
Item 11
Changes the wording in Column 2 of Schedule 2, Part 1, Item 1 of the Regulations from "a representation about a disease, condition, ailment or defect specified in Part 1 of Appendix 6 to the Therapeutic Goods Advertising Code" to "a representation specified in Part 1 of Appendix 6 to the Therapeutic Goods Advertising Code". This amendment has the effect of limiting "prohibited representations" to those representations outlined in Part 1 of Appendix 6 to the Advertising Code, which include representations about the treatment of diseases such as neoplastic, HIV, AIDS or mental illness. "Prohibited representations" are claims that may not be used in advertisements for therapeutic goods that are directed at the public.
The amendment will have the effect of permitting claims to be made in advertisements about the use of therapeutic goods for the prevention of neoplastic, HIV, Aids or mental illness, such as claims used in advertising sunscreens for the prevention of skin cancer. However, these claims would still be restricted representations under the provisions of the Advertising Code and approval of the use of such claims in advertising would be subject to a public interest test.
Item 12
Updates references to the Therapeutic Goods Advertising Code to reflect changes in paragraphing made to that Code.
Items 13, 14, 15, 16, 17, 18, 19, 20
These Items insert the changes already made to Schedule 4 of the Regulations following the exercise of the Minister's powers under subsection 17(5) of the Act. The purpose of these Items is to update Schedule 4 to incorporate the gazetted changes. A description of the changes is set out below.
Amend Schedule 4 of the Regulations to include the following therapeutic goods or substances:
Schedule 4, Part 2
Thiamine phosphoric acid ester chloride
Schedule 4, Part 3
Calcium lactate gluconate
Schedule 4, Part 5, Division 1
Chondroitin sulfate - bovine
Chondroitin sulfate - shark
Lycopene
Papain
Tocotrienols complex - palm
Schedule 4, Part 5, Division 2, Subdivision 2
Sugar cane wax alcohols (with appropriate maximum daily dose)
Schedule 4, Part 5, Division 3
Ademetionine in the form of sulphate salts, tosylate salts or mixed sulphate and tosylate salts (with appropriate warning) (S)-(S)-Adenosylmethionine in the form of sulphate salts, tosylate salts or mixed sulphate and tosylate salts (with appropriate warning) Sugar cane wax alcohols (with appropriate warning)
Replace the entry in Schedule 4, Part 3 of the Regulations for "ferrous lactate" with "Ferrous lactate" for the sake of consistency. All other entries in this part of Schedule 4 commence with an upper-case letter.