THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1994 NO. 150

THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1994 NO. 150

STATUTORY RULES 1994 No. 150

Issued by authority of the Minister for Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

Sections 17, 18, 34 and 63 of the Act enable the Governor-General to make regulations prescribing, among other things, matters necessary or convenient to be prescribed for carrying out or giving effect to the Act and setting the fees payable in respect of such matters. This includes:

Paragraphs 17(4)(a) and 17(4)(b), and Subsections 18(1) and 18(3)

•       prescribing the classes of therapeutic goods which are to be included in each part of the Australian Register of Therapeutic Goods, transferred from one part to the other, exempted from inclusion or included by revocation of an exemption;

Subsections 34(1) and 34(3)

•       prescribing the classes of therapeutic goods exempt from being manufactured by a licensed manufacturer and revoking such exemptions;

Paragraph 63(2)(c)

•       prescribing requirements for the advertising of therapeutic goods;

Paragraph 63(2)(d)

•       providing for procedures to be followed in the sampling and testing of therapeutic goods;

Paragraph 63(2)(h)

•       prescribing fees in respect of matters under the Act.

Accordingly, the regulations:

(a)       specify therapeutic goods which are to be transferred from that part of the Register for listed goods, to the part of the Register for registered goods (the herb Wall germander) and vice versa (certain drug infusion systems and intraocular lenses to become listable goods). These transfers result from reconsideration of the level of health risk posed by these classes of goods and the degree of control needed;

(b)       specify particular classes of goods to be exempted from registration or listing (allergen test patches, animal derived insulin imported by an arriving passenger for personal use, and therapeutic goods imported by certain visiting sports groups for use by the group), and revoke current exemptions for particular classes of goods (certain blood collection containers). These changes arise from reconsideration of the level of health risk posed by these classes of goods and the degree of control needed;

(c)       revise the conditions applying to the exemption from inclusion in the Register of goods which are to be used in clinical trials, in line with the recommendations of a review of the current system known as the 'Clinical Trial Notification Scheme,; and revise the fees payable for the notification of goods so exempted, in line with recommendations of the review;

(d)       revoke current manufacturing licence exemptions for sunscreen products and certain blood collection containers and require them to be manufactured by a licensed manufacturer, to ensure that these types of products are manufactured to an acceptable standard, and exempt allergen test patches from the licensing requirement;

(e)       provide that existing manufacturers of products included in a class of goods for which the manufacturing licence exemption has been revoked, may continue to manufacture while an application for a licence is under consideration, so that there is no disruption to the manufacturer's business during this period;

(f)       include additional professional bodies in Schedule 1 to the Regulations, and update the names of or remove other bodies now no longer in existence, so that advertising restrictions under Part 2 of the Regulations designed principally for control of advertising to consumers, will not affect members of the specified bodies;

(g)       revise the procedures for the sampling and testing of therapeutic goods so that they are more appropriate for current administrative practises; and

(h)       amend references to therapeutic goods kits, consequential to recent amendments to the Act effected by the Health and Community Services Legislation Amendment Act (No. 2) 1993.

In addition, the Regulations revise wording of some items in various schedules to clarify their meaning, particularly in respect of technical descriptions, and correct inaccurate references within and between schedules.

Further details of the amendments are set out in Attachments A and B.

The Regulations commence on Gazettal, with the exception of the revocations regarding the requirement for certain goods to be included in the Register or manufactured by a licensed manufacturer, which commence on 1 July 1994.

ATTACHMENT A

DETAILS OF REGULATIONS

Subregulation 2.1 has the effect of removing the interpretation of a 'kit' as an interpretation is now included in new section 7B of the Therapeutic Goods Act 1989

Subregulation 3.1 inserts new regulation 11A to enable the Secretary to approve guidelines which would specify the technical criteria applying to an intraocular lens to render it subject to inclusion in the part of the Register for listed goods, by the operation of new item 14 in Part 1 of Schedule 4. These criteria would specify parameters of the lens, manufacturing process, design, size, shape, dioptric power and mechanical properties which must apply, and specify the tests to be ,carried out to determine that they do apply. These guidelines would be developed on the recommendations of the Therapeutic Device Evaluation Committee, (TDEC), presently established under Regulation 35. The proposed guidelines as developed by TDEC are attached at B.

Subregulation 4.1 inserts a provision into Regulation 17, to enable an existing manufacturer of goods previously exempted under Regulation 17 from the requirement to be licensed, but for which the exemption has been revoked, to continue to manufacture the goods while a licence application is being determined, without committing an offence, and so prevent any disruption to the manufacturer's business.

Regulations 5 to 10 revise various provisions prescribing administrative procedures to be followed in relation to the sampling, testing and review of tests of therapeutic goods, in a way that provides for appropriate streamlining of these procedures:

•       Subregulation 5.1 inserts new definitions of the terms "responsible analyst" and "samples officer" in the Regulations.

•       Subregulation 6.1 inserts a provision detailing further powers and functions of an official analyst. These include: the power to ask an authorised officer to take samples of the goods; the power to decide what are the appropriate tests to be done on the sample and the power to nominate a "responsible analyst" who will arrange for the conduct of the tests on the sample.

•       Subregulations 7.1 and 7.2 amend Regulation 26 which details the procedures followed when samples of a therapeutic good are taken for testing. The proposed subregulations change wording necessary to make it clear that the sample taken will be sent to a relevant departmental laboratory for testing rather than a particular official analyst.

•       Subregulation 8.1 amends Regulation 27, which deals with the examination and testing of samples, to put in place appropriate administrative procedures to be followed on receipt of a sample or goods at a laboratory. It states that on receipt of a sample in laboratory, a "samples officer" (rather than an official analyst) will firstly, determine whether the sample is appropriately packaged, fastened and sealed and secondly, will stare the sample appropriately and securely. The "responsible analyst" will then collect the sample from the samples officer and arrange for the testing of the sample, as well as the examination of the goods, and of their labelling and packaging, in order to determine whether they comply with the relevant requirements.

•       Subregulations 9.1, 9.2 and 9.3 amend Regulation 29 which concerns the issue of a certificate on completion of analysis of the sample. They amend the regulation to make clear that it is the responsible analyst who was responsible for arranging the testing who undertakes these duties, not some other official analyst.

•       Subregulation 9.4 amends subregulation 29(4) regarding the requirement that the official analyst must advise the sponsor of a therapeutic good which has been sampled and tested, of the availability of a review of the results. The effect of the amendment is to make it clear that advice of availability of a review of results need only be provided when the goods do not conform to a specified standard applicable to the goods.

•       Subregulation 9.5 amends Paragraph 29(4)(a) to make it clear that any review of results will be in accordance with the procedures detailed in Regulation 30.

•       Subregulation 10.1 amends Regulation 32 to make clear that there may be more than one official analyst who may ask for information from a person about testing done on therapeutic goods.

Regulation 11 amends the list of professional bodies contained in Schedule 1 of the Regulations. Advertisements directed exclusively to members of professional bodies specified in Schedule 1 are not subject to the controls over advertising contained in Part 2 of the Therapeutic Goods Regulations. Subregulations 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, and 11.9 either add to, remove or amend the names of various professional bodies in Schedule 1, because either a new body has formed, or a body no longer exists, or a name change has occurred.

Subregulation 12.1 removes "Vitamin B3' as a synonym for nicotinic acid from Part 3, Item 4, Column 3 of Schedule 2. Part 3 of Schedule 2 lists vitamins referred to in Part 1 of Schedule 2. Item 3 of Part 1 prohibits representations that goods are, or contain, a vitamin, other than in accordance with the descriptions listed in Part 3. This means that, in line with international practise, the expression "Vitamin B3" is no longer an acceptable description of the substance nicotinic acid which is included in a therapeutic good.

Subregulation 13.1 amends Part 1 of Schedule 3 and has the effect of making certain types of implantable intraocular lenses (those now included in Item 13, Part 1 of Schedule 4), which were formerly subject to inclusion in the Australian Register of Therapeutic Goods as registered goods, now subject to inclusion as listed goods.

Subregulation 13.2 amends Part 1 of Schedule 3. It has the effect of making non-implantable powered drug infusion systems where the rate of flow is set by the calibre of the tubing on the system and may not be further adjusted, no longer subject to the requirement to be included in the Australian Register of Therapeutic Goods as registered devices and makes them now subject to inclusion as listed devices.

Subregulation 13.3 amends Part 2 of Schedule 3. In effect, it makes bedside or ambulatory bedside infusion pumps where the rate of flow is set by the calibre of the tubing on the system and may not be further adjusted, no longer subject to the requirement to be included in the Australian Register of Therapeutic Goods as registered devices and makes them now subject to inclusion as listed devices.

Subregulations 14.1 and 14.2 correct an incorrect reference to items in Schedule 3 which arose as a consequence of previous regulations which divided Schedule 3 into two parts.

Subregulation 14.3 amends Item 4, Part 1 of Schedule 4 to make it clear that certain concentrated homoeopathic preparations are registrable substances. These are preparations that are, or have as a component, a preparation of a Schedule 4, Part 4 herb other than as a dilution greater than one thousand-fold of a mother tincture. very dilute homoeopathic preparations containing the same herbs continue to be exempt from the requirement to be included in the Australian Register of Therapeutic Goods and other more concentrated preparations are listable.

Subregulation 14.4 amends the reference to the sunscreen standard to the latest edition.

Subregulation 14.5 makes it clear that device kits are not required to be listed unless at least one of the items in the kit is subject to registration or listing requirements.

Subregulation 14.6 makes it clear that drug kits are not required to be listed unless at least one of the items in the kit is subject to registration or listing requirements.

Subregulation 14.7 amends Schedule 4 to enable certain types of implantable intraocular lenses to be listed in the Australian Register of Therapeutic Goods rather than registered. New regulation 11A (inserted by subregulation 3.1) provides for the criteria which are to be applied to determine whether certain 'derived' lenses are eligible for listing.

Subregulation 14.8 amends Part 4 of Schedule 4 to add the herb 'Teucrium chamaedrys', (common name - Wall germander) to the list of herbs, which, if supplied in therapeutic goods alone or in combination, are required to be evaluated as registrable goods.

Subregulation 15.1 makes necessary amendments to Item 1 of Schedule 5 to the Therapeutic Goods Regulations to enable insulin of animal origin to be imported by an arriving passenger for the use of that person or that person's immediate family without the need for the approval of the Secretary.

Subregulation 15.2 places additional restrictions on the exemption regarding personal imports of therapeutic goods in Item 1 of Schedule 5 by limiting the annual amount of such imports to no more than fifteen months supply of a product at the maximum dose recommended by the manufacturer.

Subregulation 15.3 clarifies the existing regulation exempting therapeutic goods produced for use by a particular person. The expression "custommade" is substituted in place of the previous expression used to describe such goods which are therapeutic devices, in an effort to make the regulation clearer.

Subregulation 15.4 amends Item 7(b) of Schedule 5 to make clear that although the containers of therapeutic goods that are made subject to Part 3 (registration and listing requirements) of the Act in Item 7(1) of Schedule 5, could be described in some circumstances as diagnostic goods for in vitro use under Item 7(b) (and therefore be exempted), such containers are still subject to the requirements under Part 3 of the Act.

Subregulation 15.5 amends Paragraph 7(f) of Schedule 5 which details the types of dental devices that are not required to be included in the Australian Register of Therapeutic Goods. The purpose of the amendment is to reduce confusion presently arising from the complex wording of the paragraph. The new paragraph 7(f) clearly exempts goods such as orthodontic devices, false teeth, dental impression materials and mouthguards from the requirement to be included in the Register. Other dental devices such as dental implants, dental restorative materials and any devices covered by Schedules 3 and 4 are still required to be included in the Australian Register of Therapeutic Goods.

Subregulation 15.6 amends paragraph 7(1) of Schedule 5 which describes containers for goods for therapeutic use which are not exempted from the requirement to be included in the Australian Register of Therapeutic Goods. The amendment changes the wording of the description of various containers to clarify their meaning and make it consistent with other Schedules (particularly Schedule 7 covering goods exempted from manufacture by a licensed manufacturer), and adds a further type of container (certain blood collection containers for diagnostic testing) to the list.

Subregulation 15.7 rewords the current item which exempts certain sunscreens (stated or tested as having a sun protection factor of below 4) from the operation of Part 3 of the Act (registration and listing requirements), in order to clarify the meaning and update the reference to the standard.

Subregulation 15.8 adds a new item to Schedule 5 to exempt allergens for skin patch testing on unbroken skin from the requirement for inclusion in the Australian Register of Therapeutic Goods.

Subregulation 16.1 makes two changes to Schedule 5A:

•       it amends Item 3 which details the conditions applicable to therapeutic goods which are exempted from the Register because they are used in clinical trials. The conditions are amended to make it clear that the clinical trial may be conducted by the sponsor or by another type of body or organisation on the sponsor's behalf. They require that the approval for use of the goods in the trial be given in line with advice received from the ethics committee which will be monitoring the conduct of the trial, and make it clear that the goods may not be used in the trial if at any stage the ethics committee or the Secretary recommends to the contrary. The sponsor is required to notify the Secretary of the proposed use of the goods, in line with the Secretary's requirements regarding the form of notification, and to pay the prescribed notification fee; and

•       it inserts a new item 4 in Schedule 5A to incorporate an exemption from the requirement to be included in the Register of therapeutic goods imported by an arriving sporting group, visiting Australia for the purpose of participation in national or international sporting events, for use in the treatment of members of that group, subject to a number of requirements about the use of the goods and information to be held about the goods.

Subregulation 17.1 amends a reference to certain dental goods in Item 3(b) of Schedule 6 to describe the goods consistently with references to the same dental goods in Schedule 5, described there as "dental restorative materials".

Subregulation 17.2 amends the references in Item 4 of Schedule 6 to containers for therapeutic goods that are not exempted from the operation of Part 3 of the Act regarding assessment of the standard of manufacture of imported therapeutic devices, so that these containers are the same as those included in Item 5 of Schedule 7 which are required to be made in Australia by a licensed manufacturer, and which now includes an additional type of container; certain blood collection containers for diagnostic testing.

Subregulation 18.1 amends a reference to dental goods in Item 4(b) of Schedule 6 to describe the goods consistently with references to the same dental goods in Item 7(f) of Schedule 5, described there as "dental restorative materials".

Subregulation 18.2 amends references to containers for therapeutic goods not exempted from the operation of Part 4 of the Act (licensing requirements), in Item 5 of Schedule 7, so as to describe each item in consistent manner with Item 7(1) of Schedule 5 and to make certain blood collection containers for diagnostic testing subject to licensing requirements.

Subregulation 18.3 has the effect of revoking the exemption previously given by Item 14 of Schedule 7 to all sunscreens in respect of the requirement that they be manufactured by a licensed manufacturer. The amendment specifies that the exemption now only applies to those sunscreens with a sun protection factor of below 4.

Subregulation 18.4 adds a new item to Schedule 7 to exempt allergens for skin patch testing on unbroken skin from the requirement to be manufactured by a licensed manufacturer.

Subregulation 19.1 adds practitioners of traditional Chinese medicine to the list of persons exempted from the operation of Part 4 of the Act (licensing controls over manufacturers) contained in Schedule 8. This amendment eliminates the anomaly which existed between Regulation 4(1)(c) which exempted such practitioners with respect to controls over advertising, and Schedule 8 which excluded practitioners of traditional Chinese medicine from the list of professions manufacturing herbal, homoeopathic or nutritional supplements exempted from the requirements of Part 4.

Subregulation 20.1 amends the wording of Item 1(a) of Schedule 9 which sets the fee payable for the evaluation of pharmaceutical chemistry information submitted in support of an application for the use of therapeutic goods in a clinical trial. The wording is amended to describe the information required more accurately.

Subregulation 20.2 corrects a reference to an item in Schedule 3 which arose from previous regulation amendments which divided Schedule 3 into two parts.

Subregulation 20.3 amends the wording of Item 10 of Schedule 9 to reflect changes to the Act prescribing that a fee is now payable in respect of an application for a certification, instead of in respect of the issue of a certification.

Subregulation 20.4 amends Item 14 of Schedule 9 which details fees for notification of intention to sponsor a clinical trial using a specified drug or therapeutic device. The amendments provide for the payment of a notification fee for each occasion of the notification of the intention to sponsor a clinical trial conducted by one or more bodies or organisations.

Subregulation 21.1 amends Schedule 10 to clarify that Item 1 refers only to drugs containing chemical and biological entities that are not present in drugs included in the Register, for supply in Australia, as being evaluated by the Drug Evaluation Branch of the Department and to clarify that herbal substances are excluded from the meaning of "biological entities", as these are evaluated by the Compliance Branch.

Subregulation 21.2 amends Item 5 in Schedule 10 to make it clear that allergens other than allergens for skin patch testing on unbroken skin (which are exempted from registration by new Item 12 of Schedule 5) are among the drugs evaluated by the Drug Evaluation Branch of the Department.

Subregulation 22.1 sets 1 July 1994 as the date of revocation of exemptions made by subregulations 15.6, 17.2, 18.2 and 18.3.

ATTACHMENT B omitted - please see printed copy.

(Note: Explanatory Statements are scanned from the original paper copy, and some as ATTACHMENT B - are unreadable.)