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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1998 NO. 227
EXPLANATORY STATEMENTSTATUTORY RULES 1998 NO. 227
Issued by Authority of the Minister for Health and Family Services
Therapeutic Goods Act 1989
Therapeutic Goods Regulations (Amendment)
The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or are exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Subsection 63(1) of the Act provides that the Governor-General may make Regulations prescribing, among other things, matters necessary or convenient for carrying out or giving effect to the Act.
Subsection 17(4) of the Act provides that the regulations may prescribe, among other things, the therapeutic goods, or classes of therapeutic goods, that are required to be included in either of the two parts of the Australian Register of Therapeutic Goods, one of which is to contain a list of "registrable" goods and the other a list of "listable" goods. Very generally, "registrable goods" undergo more stringent scrutiny for safety, quality and efficacy, whereas "listable goods" are granted general marketing approval unless the Secretary is satisfied the goods am not safe for the purposes for which they are to be used, or the quality of the goods is not acceptable.
Subsection 24D(1) of the Art enables regulations to be made to prescribe time limits for the evaluation of certain classes of therapeutic goods.
Subsection 34(1) provides that regulations may exempt therapeutic goods or a class of therapeutic goods identified in the Regulations from the requirement to be licenced under a manufacturing licence issued under Part 4 of the Act.
Paragraph 63(2)(c) of the Act prescribes requirements for the advertising of therapeutic goods.
The need for most of the proposed amendments arose following a review of how complementary medicines are to be evaluated for the purposes of granting marketing approval for use of such products by the general public.
Further refinements in the approach to the general regulation of these products have included the establishment of specialist groups. including an expert Complementary Medicines Evaluation Committee, to evaluate complementary medicines. This in turn requires amendments to the Regulations to clarify what constitutes a "complementary medicine" and to identify products that may be subject to evaluation processes that may differ from those adopted for other more orthodox medicines, although the criteria for granting marketing approval will remain the same for both orthodox and complementary medicines.
In addition, one proposed amendment exempts manufacturers which "transfill" "cascade fill" or "decant fill" medicinal oxygen cylinders for patients own use from the licencing requirements of Part 4 of the Art. This is because it is considered that this type of filling presents a very low risk of contamination, as opposed to manufacturers which fill cylinders for commercial use, and which will continue to be licensed. '
An amendment is also proposed which would allow for the advertising to consumers of certain medicines which are currently only available for supply by pharmacists. These are medicines which are listed in Schedule 3 to the Poisons Standard and are suitable for self administration by consumers on the advice of health care professionals,
Accordingly, the Regulations:
(a) clarify certain definitions and insert others relating to "complementary medicine" (regs 3.1, 3.2, 3.3);
(b) better characterise the classes of goods included in Schedule 14 of the Regulations, which sets out the list of "designated active ingredients". "Designated active ingredients" are relevant in identifying what "complementary medicine" means in Regulation 5B of the Regulations (reg 12);
(c) clarify whether particular drugs or classes of drugs are registrable or listable, and identify whether such drugs will not be required to be evaluated within a prescribed time limit (regs 5, 6, 7, 8, 11);
(d) exempt a class of therapeutic goods from the requirement to be manufactured under a manufacturing licence issued under Part 4 of the Act (reg 10);
(e) enable the advertising to consumers of certain pharmacist supplied medicines listed in Schedule 3 of the Poisons Standard (reg 4); and
(f) make additions to lists of substances which may comprise "listable" goods, subject to conditions in some cases (regs 9.1, 9.2, 9.3, 9.4, 9.5, 9.6),
Further details of the Regulations are set out in the Attachment.
The Regulations commence on the date of Gazettal.
DETAILS OF THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
1. Commencement
Regulation 1 states that the commencement date for the regulations is to be the date of gazettal.
2. Amendment
Regulation 2 states the Therapeutic Goods Regulations are amended as set out in these amending Regulations.
3. Regulation 5B (Interpretation)
Subregulation 3.1 replaces the current definition of "complementary medicine" with a new definition, to refer to goods containing one or more designated active ingredients, each of which has a complementary or traditional use
Subregulation 3.2 replaces the current definition of "designated active ingredient" with a new definition which refers to active ingredients mentioned in Schedule 14.
Subregulation 3.3 inserts two new definitions - for "complementary use" and "traditional use" in relation to designated active ingredients. "Complementary use" is referred to as use in the prevention or alleviation of a disease or ailment that does not necessarily rely on evidence of effectiveness as set out in an NHMRC Clinical Guidelines Document. "Traditional use" is referred to as use where the designated active ingredient has a clearly established identity, the use is well documented or established according to the accumulated experience of traditional health care practitioners (for example Chinese traditional medicine) and the use accords with well established procedures for preparation, application and dosage for the purpose for which it is used.
4. Regulation 6 (Advertising offences)
Regulation 4 amends the current paragraph 6(1)(e) to allow for the advertising of certain pharmacist supplied medicines listed in Schedule 3 to the Standard for the uniform scheduling of drugs poisons (the Poisons Standard). The Poisons Standard is the recommended classification of drugs and poisons in Australia. Schedule 3 substances can he supplied to the public only by pharmacists. They include treatments for common conditions that patients can administer safely themselves with advice from health professionals, for example, antifungals, antihistamines and nicotine patches
The purpose of allowing brand advertising of some Schedule 3 products is to give consumers more information and choice about the less dangerous medicines they can access without a prescription. This is done by allowing the substances that my be advertised to be listed in Appendix H of the Poisons Standard.
The National Drugs and Poisons Scheduling Committee (NDPSC) which is established by the Australian Health Ministers Advisory Council (AHMAC) wig provide the necessary expertise to consider and recommend which drugs may be advertised. This will ensure the advertising to consumers of only those products for which such advertising is appropriate.
5. Regulations 16C, 16D, 16F and 16G
Regulations 5, 6, 7 and 8 make consequential amendments to take into account the proposed changes to be made in relation to Schedule 10, which is to be divided into 3 Parts. Only Part 1 of Schedule 10 will contain a list of therapeutic goods that are subject to the time frames prescribed in each of the provisions identified in proposed regulations 5, 6, 7 and 8 and allows for more flexible evaluation of low risk products.
6. Schedule 4 (Therapeutic goods required to be included in the part of the Register for listed goods)
Regulation 9 makes technical amendments and adds a list of new substances that may be included as "listable therapeutic goods" in the Australian Register of Therapeutic Goods".
Subregulation 9.1 makes a technical amendment to the heading of the Schedule to more correctly identify both regulations under which the list of "listable" goods has been created. The technical amendment adds a reference to regulation 11A.
Subregulation 9.2 inserts new paragraph (f) to item 3 of Part 1 of Schedule 4. This provides that, in addition to all the other qualifications that apply to the preparations listed under this item, before they are eligible to be treated as "listable" goods, they must also, if they happen to be a substance mentioned in Division 2 of Part 5 of Schedule 4, comply with any conditions applying in relation to that substance that are specified in that Division.
Subregulation 9.3 adds 3 other vitamins to the list set out in Part 2 of Schedule 4. This Part lists vitamins and their salts to which paragraph (b) of item 3 of part 1 of Schedule 4 applies namely those vitamins that are eligible to be treated as 'listable' goods.
Subregulation 9.4 adds two other minerals salts to the fist set out in Part 3 of Schedule 4. This Part fists minerals and their salts to which paragraph (c) of item 3 of part 1 of Schedule 4 applies - namely those minerals that are eligible to be treated as "listable goods".
Subregulation 9.5 inserts the heading "Division 1" as Part 5 of Schedule 4 will now have 2 Divisions. Part 5 identifies the "substances" that may be eligible to be treated as "listable" goods for the purposes of Item 3 of Part 1 of Schedule 4. The requirement for having two Divisions is to separate those goods that may qualify as listable substances outright, from those that may only qualify as such if they meet certain conditions.
Subregulation 9.6 adds to the list of substances that may be eligible to be treated as listable goods for the purposes of Item 3 of Part 1 of Schedule 4. The substances listed under "Division 1" may qualify as "listable" goods outright. The substances listed under "Division 2" will only qualify as "listable" goods if the conditions specified in column 2 are complied with. The conditions specified all refer to a maximum daily allowable dose.
7. Schedule 7 (Therapeutic Goods exempt from the operation of Part 4 of the Act unless supplied as pharmaceutical benefit)
Regulation 10 inserts new Item 23 to Schedule 7 to exempt certain therapeutic goods from being manufactured under a licenced manufacturing process. These goods are medicinal oxygen cylinders that have been decant filled, transfilled or cascade filled by an organisation for use on patents under the direct care of that organisation.
8. Schedule 10 (Drugs evaluated by the Drug Safety and Evaluation Branch of the Department)
Regulation 11 substitutes a new Schedule 10, entitled "Therapeutic Goods for Evaluation" and divided into 3 separate Pans. Part 1 lists those therapeutic goods that are to be evaluated by the Drug Safety and Evaluation Branch of the Department of Health and Family Services, to which prescribed time limits for completing evaluations apply.
Parts 2 and 3 list those therapeutic goods which are eligible to undergo more flexible evaluation and are therefore not subject to the same time Emits applying to therapeutic goods evaluated by the Drug Safety and Evaluation Branch of the Department. The goods listed in Part 2 are complementary medicines and related products and will be evaluated by the Complementary Medicines Section of the Department. The goods listed in Part 3 include products such as sunscreens and antiseptics and will be evaluated by the Scheduling and Over the-counter drug Evaluation Section (SOTCDES) of the Department of Health and Family Services.
9. Schedule 14 (Designated active ingredients)
Regulation 12 substitutes a new Schedule 14 which updates the list of designated active ingredients permitted in complementary medicines.