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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2002 (NO. 1) 2002 NO. 84
EXPLANATORY STATEMENTSTATUTORY RULES 2002 No. 84
Issued by authority of the Parliamentary Secretary to the Minister for Health and Ageing
Therapeutic Goods Act 1989
Therapeutic Goods Regulations
Therapeutic Goods Amendment Regulations 2002 (No. 1)
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 (TGA) is responsible for administering the Act.
Section 63 of the Act provides that the Governor-General may 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.
Therapeutic goods, or classes of goods, are required to be included in the Australian Register of Therapeutic Goods (the Register) as "listed goods" (that is, low risk products meeting the criteria for inclusion in the Register without prior evaluation of the product by the TGA) or "registered goods" (that is, higher risk products included in the Register following evaluation by the TGA and approval by the Secretary). Goods required to be included in the part of the Register for listed goods are set out in Schedule 4 of the Regulations while goods required to be included in the part of the Register for registered goods are set out in Schedule 3.
Certain prescribed therapeutic goods, or classes of goods, are exempt from inclusion in the Register (section 18(1) of the Act) including certain goods imported for personal use, dilute homoeopathic medicines, certain antiperspirants, sunscreen preparations with a sun protection factor less than 4, blood and blood products manufactured by the Australian Red Cross Blood Service. Medicines exempt from inclusion in the Register are set out in Schedules 5 and 5A of the Regulations.
The main purpose of the Regulations is to amend Schedule 4 of the Therapeutic Goods Regulations 1990 (the Principal Regulations), to include changes to warning statements on listed goods, the removal of common names of herbal substances and the inclusion of new substances in Schedule 4.
The Regulations also update the Principal Regulations to:
• clarify that certain medicines that are not included in Schedule 5A are required to be included in the part of the Register for registered goods (Item 2 refers);
• amend Schedule 3 so that devices containing biologically derived substances for use in or on the body of a person are evaluated for efficacy as well as safety (Item 3 refers); and
• correct minor errors and remove entries no longer required, for example Items 27, 28 and 29.
Details of the Regulations are set out in the Attachment.
The Regulations commenced on gazettal.
ATTACHMENT 1
Therapeutic Goods Amendment Regulations 2002 (No. 1)
Regulation 1 states that the title of these regulations will be the Therapeutic Goods
Amendment Regulations 2002 (No. 1)
Regulation 2 provides that these regulations will commence on gazettal.
Regulation 3 provides that Schedule 1 amends the Therapeutic Goods Regulations 1990.
SCHEDULE 1 -AMENDMENTS
Item 1
Deletes sub-regulation 12(1 B) as this subregulation refers to a specific exemption that ceased to apply at the end of August 1996.
Item 2
The amendment corrects omissions to make it clear that medicines which are not included in Schedule 5A are required to be included in the part of the Australian Register of Therapeutic Goods (the Register) for registered goods.
Item 3
Amends Schedule 3, Part 1, item 3(g) so that all devices containing biologically derived substances (ie products of animal, bacterial or recombinant origin) for use in or on the body of a person are evaluated for both safety and efficacy. This corrects an anomaly that allowed substances derived from sources such as bacterial fermentation or other recombinant techniques being considered only from the aspect of safety whilst substances of human and animal origin were evaluated for safety and efficacy.
Item 4
Amends the heading to Schedule 3, Part 3 to clarify that the reference in the heading is to the Therapeutic Goods Act 1989.
Item 5
Changes the heading of Schedule 4, Part 1 from 'Listable therapeutic goods' to 'Listable goods' to be consistent with the terminology used in the Act since the insertion of a definition for 'Listable goods' in the Act by Act No. 14 of 200 1.
Item 6
Corrects an error in Schedule 4, Part 1, item 2(b) which is intended to refer to devices only. Item 6 in Schedule 5, which is to be deleted by the amendment, refers to medicines, not devices.
Item 7
Corrects an error whereby some only of the devices in Schedule 5A, which are exempt from the operation of Part 3 of the Act (subject to certain conditions), were referred to in Schedule 4, item 2(c).
Item 8
Amends the wording of Schedule 4, Part 1, item 3, subparagraph (d)(ii) which refers to preparations containing herbal substances as a consequence of changes to the format of the table in Schedule 4, Part 4, Division 2 which details the herbal substances that are listable goods only with qualifications.
Item 9
Amends the wording of Schedule 4, Part 1, item 3, subparagraph (g)(ii) to allow flexibility to the wording of the warning statements required for substances in Schedule 4, Part 5, Division 3. The exact wording of the warning is no longer prescribed, however, the wording has to be to the same effect as the statement in column 3 of Division 3.
Item 10
Amends the entry for ascorbyl palmitate so that it reflects the intended restriction when Schedule 4, Part 2 was amended in 1995 to restrict the use of ascorbyl palmitate in listable goods. The change followed a review of the safety of ascorbyl palmitate taken orally. At the time of the review, the available data indicated that ascorbyl palmitate was relatively safe for oral ingestion in doses of up to 100 mg per day but there appeared to be little data to support its use at higher doses.
At the time of this change, the intention was to restrict only the oral use of ascorbyl palmitate to 100 mg daily. However, the change that was made to Schedule 4 at that time did not accurately reflect what had been intended.
Items 11 and 12
Includes in Schedule 4, Part 3 the mineralscolloidal anhydrous silica and silicon dioxide. These two substances were permitted for use as active ingredients in listable goods, by publication of Therapeutic Goods (Listing) Notice 2000 (No.1) provided that they are not used in goods that have a powdered dosage form. The intention of this restriction was to minimise the risk of accidental inhalation of the substances, given that inhalation of some forms of silica may be associated with the development of silicosis. This recommendation was based on a theoretical concern rather than on any evidence that powdered therapeutic goods could present any hazard.
The restriction was subsequently reviewed based on common usage of these substances and it was agreed that the existing restriction be revoked and replaced with a restriction on the route of administration, inhalation.
Items 13 and 14
Replaces the heading Schedule 4, Part 4, Division 1 with a heading to reflect more accurately the purpose of the table - to list plant materials from which herbal substances in listable goods must not be derived.
Item 15
Deletes the common name entries in Schedule 4, Part 4, Division 1. This Part includes common names as well as botanical names for herbs to which restrictions apply. The use of common names was presumably originally intended to assist sponsors but in fact the list of common names is not comprehensive and gives rise to further confusion as to the exact herbal substance that is the subject of the restriction. For example, the common name 'mustard seed' is currently included in the table in relation to the item Brassica. However, this common name is applicable to only one species in the Brassica genus.
Item 16
Replaces the current table in Schedule 4, Part 4, Division 2 by a table that sets out clearly the herbal substances that may be used in listable goods subject to certain qualifications. Qualifications are placed on a number of parameters including dose, plant part or preparation, route of administration and labelling or any combination of parameters. The current layout of the table in this Division is confusing as it specifies that the identified herbs can only be used either if they are present in minute doses or if other specified conditions are met. In fact in some cases both dose limits and other conditions are required.
The current wording of some of these restrictions is confusing and does not reflect the intent of the original decision to restrict them. An expert review of these restrictions recommended a number of changes. Also, for some of the herbal substances included in this Division, the botanical name has recently been amended. The revised Division incorporates updated botanical nomenclature.
In addition to the format and wording changes for the current entries, this amendment incorporates a number of new entries to the restricted herbal substance table as follows:
• St John's Wort - medicines containing St John's Wort (Hypericum perforatum) and intended for oral administration must carry a statement warning about the possibility of interactions with prescription medicines.
• Kava and kunzea oil - In 1998, restrictions were placed on the use of kava (Piper methysticum) in listable goods. In 1999 a new herbal substance, Kunzea ambigua essential oil, was approved for use in listable goods, with certain restrictions. In both cases, these herbal substances were included in Schedule 4, Part 5 when they should more correctly have been placed in Schedule 4, Part 4, Division 2. The purpose of the amendment is therefore to move the entry for these substances from Part 5 to Part 4.
• In 2000 and 2001, Schedule 4 was amended by the publication of a series of notices issued under section 17(5) of the Act in the Commonwealth Gazette in order to allow the use of a number of new herbal substances as active ingredients in listed goods with restrictions. However, there were some minor errors in the section 17(5) gazette notices which have been corrected in these amendment regulations. While the section 17(5) gazette notices included herbal substances included in Schedule 4, Part 4, Division 2, the errors pertain to substances incorporated into Schedule 4, Part 5. The herbal substances permitted under section 17(5) gazette notices that are included in Schedule 4, Part 4, Division 2 are:
- Backhousia citriodora oil
- Morinda citrifolia fruit juice
- Pseudowintera colorata leaf
- Santalum spicatum oil
Item 17
Removes restrictions that are no longer warranted on safety grounds. The use of fish oils as active ingredients in listable goods is currently restricted in Schedule 4, Part 5, Division 1.
Item 18
Amend a typographical error in Schedule 4, Part 5. Sodium beta-hydroxy-betamethylbutyrate was recommended for use in listed medicines by the Complementary Medicines Evaluation Committee in 1999 and was included as a listable good by virtue of a section 17(5) gazette notice in 1999. When was previously updated to include this substance, the name was entered incorrectly as 'Sodium betahydroxy-beta-methylbutyra'.
Item 19
To amend some minor errors in some of the section 17(5) gazette notices which have been corrected in these amendment regulations. In 2000 and 2001, Schedule 4, Part 5 Division 1 was amended by the publication of a series of notices issued under section 17(5) of the Act in the Commonwealth Gazette in order to allow the use of a number of new substances as active ingredients in listed goods. The substances permitted under section 17(5) gazette notices that are included in Schedule 4, Part 5, Division 1 are:
- Acetyllevocarnitine hydrochloride (included in the 17(5) notice as Acetyllevocamitine, not the hydrochloride salt)
- Black boned chicken powder
- Bromelains (included in the 17(5) notice as 'Bromelain')
- Conifer phytosterol complex
- Demineralised fish proteoglycan extract
- Glucosamine sulfate potassium chloride complex
- Glucosamine sulfate sodium chloride complex
- Levocarnitine
- Levocarnitine furnarate
- Levocarnitine hydrochloride
- Levocarnitine magnesium citrate
- Levocarnitine tartrate
- Phosphatidylserine-enriched soy lecithin
- Propionyllevocarnitine hydrochloride
- R-alpha lipoic acid
- R,S-alpha lipoic acid (included in the 17(5) notice as 'Thioctic acid', a synonym for the Australian Approved Name 'alpha lipoic acid')
- Streptococcus thermophilis
Items 20 and 23
Two herbal substances included in Schedule 4, Part 5, Division 2, Subdivision 2 (item 6) and Division 3 (item 5), namely Piper methysticum and Kunzea ambigua, have been removed from this Part and inserted in Part 4 which specifically pertains to herbal substances.
Items 21, 24 and 26
The qualification 'Words to the following effect' in relation to warnings has been removed wherever it occurs in column 3 of the table in Schedule 4, Part 5, Division 3 because the wording of Schedule 4, Part 1, item 3 (g)(ii), once amended as per item [10] in the Amendment Regulations includes the provision for the wording of these warnings to be varied by the inclusion of the qualification 'or words to the same effect' therein.
Items 22 and 25
Adds the new listable goods, bovine lactoferrin and sodium selenate, as substances that require a warning statement on the product label.
Item 27
Removes a superfluous entry. Devices of human, animal, bacterial or recombinant origin fall within Item 7(f)(vii) of Schedule 5.
Item 28
Deletes item 6 of Schedule 5A as this exemption ceased to apply at the end of August 1996.
Item 29
Inserts the correct abbreviation for "gram".