I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council and under section 4 of the Acts Interpretation Act 1901, hereby make the following Regulations under the Therapeutic Goods Act 1989.
Dated 1 May 1990.
BILL HAYDEN
Governor-General
By His Excellency's Command,
B. HOWE
Minister of State for Community Services and Health
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CHAPTER 1—PRELIMINARY
Citation
These Regulations may be cited as the Therapeutic Goods Regulations.
Interpretation
In these Regulations, unless the contrary intention appears:
"analysis" includes examination and testing;
"antiseptic" means a substance that is intended for application on the body or the mucous membranes of a person or an animal
to kill or prevent the growth of a broad range of micro organisms, and that is:
(a) not represented to be suitable for internal use; and
(b) not capable of inducing resistance in micro organisms to other anti-infective agents;
"diagnostic goods for in vitro use" means a reagent, instrument or system that is intended to be used in the examination of specimens taken from the body of a person or animal in connection with the diagnosis of a disease, ailment or defect in, or injury to, a person or animal or the monitoring of a condition in a person or animal;
"disinfectant" means a substance that is intended for application to inanimate objects to kill a broad range of micro organisms, and that is:
(a) not represented to be suitable for the internal use in, or dermal use on, a person or an animal; and
(b) not capable of inducing resistance in micro organisms to other anti-infective agents;
"drugs" means:
(a) therapeutic goods that are represented to achieve, or are likely to achieve, any of the principal purposes of their use as a result of chemical action in or on the body of a person or animal; and
(b) any other therapeutic goods declared by the Secretary, by notice published in the Gazette, not to be therapeutic devices;
"herbal substance" means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):
(a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, glycerin or aqueous ethanol; and
(b) that is not subjected to any treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form;
"homoeopathic preparation" means a preparation:
(a) formulated on the principle of medication by extremely small doses of a substance of plant, animal or mineral origin that has the property of producing in a healthy person or animal the symptoms or conditions manifested by a disease; and
(b) made using the methods of serial dilution and succussion;
"immediate family", in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person;
"implantable", in relation to a therapeutic device, means designed to be implanted into the tissues or body cavities of a person or animal, other than the teeth, for a period of 30 days or more;
"mother tincture" means a preparation prepared by the process of solution, extraction or trituration for dilution in powers of 10 to prepare homoeopathic preparations;
"official analyst" means a person approved by the Secretary under regulation 25;
"pharmaceutical benefit" means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans' Entitlements Act 1986;
"poison" means a substance or preparation that is included in a Schedule to the Poisons Standard;
"Poisons Standard" means the current edition of the Standard for the uniform scheduling of drugs and poisons published by the National Health and Medical Research Council;
"prohibited representation" means a representation referred to in subregulation 8(1);
"required representation" means a representation referred to in subregulation 8 (2);
"sample" includes part of a sample;
"the Act" means the Therapeutic Goods Act 1989.
State or Territory laws that continue to apply
For the purposes of subsection 6 (3) of the Act, the following laws are identified:
(a) laws of the State of New South Wales:
(i) the Therapeutic Goods and Cosmetics Act 1972;
(ii) the Therapeutic Goods and Cosmetics Regulations;
(iii) the Poisons Act 1966;
(iv) the Poisons Regulations;
(b) laws of the State of Victoria:
(i) the Health Act 1958;
(ii) the Health (Proprietary Medicines) Regulations 1984;
(iii) the Drugs, Poisons and Controlled Substances Act 1981;
(iv) the Drugs, Poisons and Controlled Substances Regulations 1985;
(c) laws of the State of Queensland:
(i) the Health Act of 1937-1989;
(ii) the Poisons Regulations of 1973;
(iii) the Therapeutic Goods and Other Drugs Regulations 1982;
(d) laws of the State of South Australia:
(i) the Drugs Act, 1908;
(ii) the Controlled Substances Act, 1984;
(e) laws of the State of Western Australia:
(i) the Health Act 1911;
(ii) the Health (Drugs and Allied Substances) Regulations 1987;
(iii) the Poisons Act 1964;
(iv) the Poisons Regulations 1965;
(f) laws of the State of Tasmania:
(i) the Poisons Act 1971;
(ii) the Poisons Regulations;
(iii) the Poisons List Order 1984;
(g) the Therapeutic Goods and Cosmetics Act 1986 of the Northern Territory of Australia;
(h) laws of the Australian Capital Territory:
(i) the Public Health (Prohibited Drugs) Act 1957;
(ii) the Public Health (Sale of Food and Drugs) Regulations.
CHAPTER 2—ADVERTISEMENTS
This Chapter not to apply to advertisements directed at health professionals etc.
This Chapter does not apply to advertisements directed exclusively to:
(a) medical practitioners, dentists, veterinary surgeons, pharmacists, physiotherapists or nurses; or
(b) persons who are engaged in the business of wholesaling therapeutic goods.
This Chapter not to apply to advertisements for goods not for human use
This chapter does not apply to advertisements in respect of goods that are not for use in humans.
Advertising offences
A person must not publish an advertisement about therapeutic goods:
(a) that contains a prohibited representation about those goods; or
(b) that does not contain a required representation about those goods; or
(c) that is in contravention of a notice referred to in regulation 7 or 9:
(i) that was served on that person; or
(ii) of which the person was aware when the advertisement was published; or
(d) that contains:
(i) a reference to the Act, other than in relation to the registration number or listing number of the goods; or
(ii) a statement suggesting or implying that the goods have been recommended or approved by or on behalf of a government or government authority, other than a statement of their availability as a pharmaceutical benefit; or
(e) that refers to goods included in Schedule 3,4 or 8 to the Poisons Standard; or
(f) that are not registered or listed, unless the goods are exempt goods.
Certain representations not to be published
If a representation in an advertisement about therapeutic goods is false or misleading, the Secretary may, by notice given to the person apparently responsible for publishing the advertisement, prevent that person from publishing, or causing to be published an advertisement containing that representation (whether express or implied) about those goods.
Prohibited and required representations
(1) For the purposes of paragraph 6 (a), the representations specified in column 2 of an item in Part 1 of Schedule 1 are prohibited representations about the therapeutic goods specified in column 3 of that item.
(2) For the purposes of paragraph 6 (b), a representation specified in column 2 of an item in Part 2 of Schedule 1 is a required representation about the therapeutic goods specified in column 3 of that item.
Use of prohibited representations
The Secretary may, by notice published in the Gazette, permit a prohibited representation to be included on the label of therapeutic goods, or in information included in the package in which therapeutic goods are contained, if the representation is necessary for the appropriate use of the goods.
CHAPTER 3—REGISTRATION, LISTING AND EXEMPTION OF THERAPEUTIC GOODS
Registered Goods
For the purpose of paragraph 17 (4) (a) of the Act, the therapeutic goods, or classes of therapeutic goods, specified in Schedule 2 must be included in the part of the Register for registered goods.
Listed Goods
For the purposes of paragraph 17 (4) (a) of the Act, the therapeutic goods, or classes of therapeutic goods, specified in Part 1 of Schedule 3 must be included in the part of the Register for listed goods.
Exempt Goods
For the purposes of subsection 18 (1) of the Act, the therapeutic goods or classes of therapeutic goods specified in Schedule 4 are exempt from the operation of Part 3 of the Act.
Change of name in which goods are registered or listed
13. (1) If a person in relation to whom therapeutic goods are registered or listed dies, the legal personal representative of the dead person:
(a) is to be taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the death.
(2) If a person in relation to whom therapeutic goods are registered or listed becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:
(a) is to be taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the bankruptcy.
(3) If a body corporate in relation to which therapeutic goods are registered or listed is being wound up, the liquidator of the body corporate:
(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the winding up.
(4) If:
(a) a person agrees to dispose of a business relating to the manufacture, distribution or sale of therapeutic goods; and
(b) it is agreed that the disposal of that business is to include a transfer of the registration or listing of therapeutic goods;
then:
(c) the person who acquires that business is to be taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(d) that person must, as soon as practicable after the transfer, inform the Secretary that the person has, by reason of that agreement, become the person in relation to whom the goods are to be registered or listed.
(5) When a person notifies the Secretary of an event referred to in paragraph (1) (b), (2) (b), (3) (b) or (4) (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
(6) If the Secretary is informed of the transfer of registration or listing of any therapeutic goods in accordance with this regulation, the Secretary must amend the Register accordingly.
(7) If, at any time, the Secretary becomes aware that he or she has not been informed of the transfer of registration or listing in respect of any therapeutic goods in accordance with this regulation, the Secretary may cancel the registration or listing of those goods.
(8) As soon as practicable after the Secretary has amended the Register in accordance with subregulation (6), the Secretary must give to the person in whose name the goods are registered or listed a certificate of registration or listing of the goods.
(9) If the Secretary:
(a) amends the Register in accordance with subregulation (6); or
(b) cancels the registration or listing of goods under subregulation (7);
the person who has the certificate issued under subsection 25 (4) or 26 (4) of the Act or subregulation (8) must return it as soon as practicable to the Secretary.
Penalty: $100.
Transfers within the Register
14. (1) If goods that are included in the part of the Register for listed goods become subject to inclusion in the part of the Register for registered goods, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry in relation to the goods to the part of the Register for registered goods.
(2) An application under subregulation (1) must be made:
(a) if the Secretary notifies the person in whose name the goods
are entered in the Register of a period within which the application must be made—within that period; or
(b) in any other case—not later than 15 months after the day on which the goods became subject to inclusion in the part of the Register for registered goods.
(3) In determining a period of notice for the purposes of paragraph (2) (a) the Secretary is to have regard to:
(a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and
(b) the reasons for the transfer in relation to the protection of the public.
(4) It is not an offence for the sponsor of goods to which subregulation (1) applies to import, export, supply or manufacture the goods as listed goods until the time for making the application under subregulation (2) has expired or, if an application is made, until it is determined, whichever is the later.
(5) If goods that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:
(a) to transfer the entry in relation to the goods to the part of the Register for listed goods; or
(b) to retain the entry in the part of the Register for registered goods.
(6) An application to transfer an entry in relation to goods from one part of the Register to the other is to be treated as an application for registration or listing of the goods, as the case requires.
Application of registration or listing number to goods
For the purposes of paragraph 20 (2) (d) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:
(a) in the case of a therapeutic device included in the part of the Register for registered goods—by writing the number so that it is clearly visible to the user:
(i) on the label on the device; or
(ii) on the label on the outermost level of packaging in which the device is to be supplied to its user;
and, where more than one device is packaged for supply together, on the label on the outermost surface of the outermost package; and
(b) in the case of drugs—by writing the number on the label on
the container of the drugs, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and
(c) in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:
(i) "AUST R" in the case of registered goods; and
(ii) "AUST L" in the case of listed goods;
the numbers and letters in each case being not less than 1 millimetre in height.
Listing of certain therapeutic devices
For the purposes of paragraph 26 (1) (g) of the Act, the therapeutic devices specified in Schedule 5 are prescribed.
CHAPTER 4—LICENSING OF MANUFACTURERS
Exempt goods for the purposes of subsection 34 (1) of the Act
For the purposes of subsection 34 (1) of the Act, the therapeutic goods specified in Schedule 6 are exempt from the operation of Part 4 of the Act unless the goods are supplied as pharmaceutical benefits.
Exempt Persons
For the purposes of subsection 34 (2) of the Act, the persons specified in column 2 of an item in Schedule 7 are exempt from the operation of Part 4 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.
Requirements for licence holders
For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:
(a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and
(b) details of persons nominated by the licence holder as having control of:
(i) the production of the goods; and
(ii) the quality control measures that are to be employed in the manufacture of the goods.
Conditions of licences
For the purposes of section 40 of the Act, the following are conditions to which each licence is subject:
(a) a copy of the licence and of any document issued by the
Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;
(b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:
(i) keep records showing:
(A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and
(B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and
(C) details of the tests performed on the goods and the results of those tests; and
(D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and
(ii) where the goods to which the licence relates are produced in identifiable batches:
(A) assign a batch number to each batch of the goods; and
(B) if it is not unreasonable in the circumstances— retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and
(iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and
(iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control;
(c) the licence holder must comply with the provisions of Chapter 5 in relation to the taking of samples by authorised officers.
Persons having control of production etc. to be named
If:
(a) an applicant for a licence to manufacture therapeutic goods
nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and
(b) the licence is granted; and
(c) the applicant wishes to replace the nominated person with another person;
then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.
Transfer of licences
22. (1) If a person who was the holder of a licence dies the legal personal representative of the dead person:
(a) is to be taken to be the holder of the licence; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the death.
(2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:
(a) is to be taken to be the holder of the licence; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the bankruptcy.
(3) If a body corporate that is the holder of a licence is being wound up, the liquidator of the body corporate:
(a) is taken to be the holder of the licence; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the winding up.
(4) If:
(a) a person agrees to dispose of a business relating to the manufacture, distribution or sale of therapeutic goods; and
(b) it is agreed that the disposal of that business is to include a transfer of a licence held by that person;
then:
(c) the person who acquires that business is to be taken to be the holder of the licence; and
(d) that person must, as soon as practicable after the transfer, inform the Secretary that the person has, by reason of that agreement, become an applicant for the licence.
(5) When a person notifies the Secretary of an event referred to in paragraph (1) (b), (2) (b), (3) (b) or (4) (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
(6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as
an applicant for the licence and may deal with the notification referred to in paragraph (1) (b), (2) (b), 3 (b) or (4) (b) as if it were an application for a licence.
(7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.
(8) If, at any time, the Secretary becomes aware that he or she has not been informed of an event referred to in paragraph (1) (b), (2) (b), (3) (b) or (4) (b) in accordance with this regulation, the Secretary may cancel the licence to which the event relates.
CHAPTER 5—EXAMINATION, TESTING AND ANALYSIS OF GOODS
Interpretation
In this Chapter, unless the contrary intention appears:
"authorised officer", in relation to a provision in this Chapter, means:
(a) an officer of the Department, of another Department or of an authority of the Commonwealth; or
(b) an officer of:
(i) a Department of State of a State; or
(ii) a Department or administrative unit of the Public Service of a Territory; or
(iii) an authority of a State or of a Territory;
that is a Department, unit or authority the functions of which relate to health matters;
who is authorised in writing by the Secretary to exercise powers under that provision;
"relevant test", in relation to the analysis of therapeutic goods, means a test that, under regulation 28, is a relevant test for the purposes of determining whether goods of a class in which the first-mentioned goods are included are goods of a particular standard.
Authorised officer—powers and duties
24. (1) An authorised officer may, during normal business hours:
(a) enter the premises of a licence holder on which therapeutic goods are kept for supply; and
(b) inspect the place at which those goods are kept; and
(c) take samples of those goods; and
(d) request the owner of therapeutic goods, or the person apparently
in charge of those goods, for information relevant to the manufacture and testing of those goods.
(2) If the registration or listing of goods is subject to the condition that the sponsor of the goods comply with this regulation, the powers of an authorised officer referred to in subregulation (1) extend to the sponsor as if the sponsor were a licence holder.
Appointment of official analysts
25. (1) The Secretary may, in writing, appoint a person who has appropriate qualifications and experience to be an official analyst for the purposes of these Regulations.
(2) The Secretary is to maintain a register of the names of official analysts and is to cause those names to be published in the Gazette from time to time.
Taking of samples for testing
26. (1) Where an authorised officer takes a sample of therapeutic goods, the authorised officer:
(a) must notify the person from whom the sample was taken that the authorised officer is going to send the sample to an official analyst for analysis; and
(b) must give the person from whom the sample was taken a notice setting out details of the goods taken and, if the person from whom the sample was taken was not the sponsor of the goods, send a copy of that notice to the sponsor of the goods; and
(c) must forward the whole or part of the sample to an official analyst.
(2) The authorised officer must ensure the sample is appropriately packaged, fastened and sealed and is to cause the sample to be stored and transported in accordance with the conditions (if any) specified on the label of the goods.
(3) For the purposes of subregulation (2), a sample is to be fastened and sealed:
(a) in a vessel or package that is marked with the name and address of the person from whom the sample was taken; and
(b) so as to prevent the opening of the vessel or package, or the removal of the name and address, without breaking the seal.
Examination and testing by official analyst
27. An official analyst must, as soon as practicable after receiving a sample of goods determine whether the sample is or has been appropriately packaged, fastened and sealed in accordance with subregulation 26 (3) and, if so:
(a) arrange for and supervise the analysis of the sample by means
of relevant tests to the extent that the analyst considers necessary to establish:
(i) the quantity and quality of the goods comprising the sample; and
(ii) any other matter relevant to determining whether the goods from which the sample was taken comply with any standard applicable to them or with conditions relating to matters referred to in paragraph 28 (2) (d) of the Act; and
(b) arrange for the examination of the goods, the label (if any) relating to the goods and the 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.
Relevant tests
Each of the following is a relevant test for determining whether particular therapeutic goods are of a particular standard:
(a) a test specified by the Minister in an order under section 10 of the Act for those goods in relation to that standard; and
(b) a test specified in a monograph in the British Pharmacopoeia in relation to that standard if:
(i) those goods are for use in humans; and
(ii) the Minister has not specified a test in an order under section 10 of the Act for those goods in relation to that standard; and
(c) a test specified in a monograph in the British Pharmacopoeia (Veterinary) in relation to that standard if:
(i) those goods are for veterinary use; and
(ii) the Minister has not specified a test in an order under section 10 of the Act for those goods in relation to that standard; and
(d) a test accepted for the purposes of registration of the goods under Part 3 of the Act; and
(e) any other suitable test that the Secretary requires to be carried out in respect of those goods in relation to that standard.
Certificate of official analyst
29. (1) An official analyst who has arranged and supervised the analysis of a sample of goods must send to the sponsor of the goods, a certificate signed by the official analyst setting out the results of the examination and analysis.
(2) The official analyst must forward a copy of the certificate signed by the official analyst to:
(a) the Secretary; and
(b) the person from whom the sample was taken if that person was not the sponsor of the goods.
(3) The certificate and copies of the certificate of the official analyst must be sent to the persons referred to in subregulations (1) and (2) within a reasonable time of the completion of the analysis.
(4) In proceedings under the Act or these Regulations, a certificate of an official analyst issued under subregulation (1), or a copy of that certificate, is, in the absence of evidence to the contrary, conclusive proof of the matters set out or stated in it.
(5) A document purporting to be:
(a) a certificate of an official analyst issued under subregulation (1); or
(b) a copy of that certificate;
and purporting to be signed by an official analyst is, in the absence of evidence to the contrary, to be taken to be the certificate or a copy of the certificate and to have been issued under subregulation (1) or (2), as the case requires.
Review of findings of official analyst
30. (1) Where:
(a) an official analyst has issued a certificate under subregulation 29 (1) stating that goods do not conform to a specified standard, or requirement, that is applicable to the goods within the meaning of regulation 27; and
(b) a person to whom the certificate, or a copy of the certificate, was issued, sends to the Secretary evidence in writing establishing that the goods do conform to that standard or requirement;
the person may ask for the results of the analysis to be reviewed.
(2) A request for review of the results of the analysis is to be made not later than 21 days after the person receives the certificate, or the copy of the certificate, as the case may be.
(3) The Secretary must extend the period of 21 days if it is not reasonable to expect the person to provide the evidence within the period referred to in subregulation (2).
(4) A person is not to be regarded as having sent the Secretary evidence establishing that goods conform to a particular standard unless that person has sent to the Secretary a certificate of an analyst who has appropriate qualifications and experience setting out:
(a) a statement that the analyst has analysed a part of the same sample, or a similar sample from the same batch (if any), of those goods; and
(b) the results of that analysis; and
(c) details of the tests used in the analysis.
(5) If the certificate referred to in subregulation (4) shows that an analysis of goods for the purpose of establishing that the goods conform to the standard was carried out in accordance with the relevant tests in relation to the goods, subregulation (6) applies to those goods.
(6) Unless the results of the analysis of a sample of goods to which this subregulation applies, or other information available to the Secretary in relation to those goods, shows lack of homogeneity in the sample, the Secretary, at the request of the sponsor of the goods, must direct:
(a) if part of the sample remains unimpaired—the official analyst to send so much of the sample as remains unimpaired; or
(b) if no part of the sample remains unimpaired—that a further sample be taken by an authorised person from the same batch as the original sample and that that further sample be sent;
to an analyst agreed upon by the person who requested the review and the official analyst, or, in the absence of agreement, to an analyst nominated by the Secretary.
(7) If a sample is forwarded to an analyst referred to in subregulation (6), the analyst is to:
(a) analyse the sample of the goods in accordance with any relevant tests;
(b) send to the Secretary a certificate, signed by the analyst, setting out the results of the analysis; and
(c) send a copy of that certificate, signed by the analyst to the sponsor of the goods.
(8) A certificate under regulation 29 setting out the results of the analysis of a sample of goods ceases to have effect when the Secretary receives the certificate in relation to those goods under subregulation (7).
(9) If the findings of the official analyst are upheld, the sponsor must pay any charges payable to the analyst referred to in subregulation (6) in respect of the analysis of the sample.
(10) In proceedings under the Act or these Regulations, a certificate of an analyst issued under subregulation (7) or a copy of that certificate is, in the absence of evidence to the contrary, conclusive proof of the matters stated in it.
(11) A document purporting to be:
(a) a certificate of an analyst issued under subregulation (7); or
(b) a copy of that certificate, and purporting to be signed by the analyst is, in the absence of evidence to the contrary, to be regarded as the certificate, or a copy of the certificate, and to have been issued under that subregulation.
Payment for samples
31. (1) If a sample of therapeutic goods is taken by an authorised officer, the Commonwealth is liable to pay the owner of the goods from which the sample was taken an amount equal to the value of any part of the sample removed by the authorised officer.
(2) The amount the Commonwealth is liable to pay is to be worked out on the basis of the market value of the sample when the sample was taken.
Offences relating to analysis etc.
32. (1) A person must not:
(a) molest, obstruct or try to intimidate or influence an authorised officer in the execution of his or her powers or the performance of his or her duties under these Regulations; or
(b) on being asked by an authorised officer, refuse or fail, without reasonable excuse:
(i) to show the authorised officer the place where any therapeutic goods are kept; or
(ii) to admit the authorised officer to a place where therapeutic goods are kept; or
(iii) to show the authorised officer, or let the authorised officer inspect, therapeutic goods kept by the person; or
(iv) to allow a sample of therapeutic goods to be taken in accordance with these Regulations; or
(v) to give an authorised officer information required by the authorised officer, being information relevant to the manufacture and testing of therapeutic goods that the person is able to provide; or
(vi) to assist the authorised officer in the execution of his or her powers or the performance of his or her duties under these Regulations; or
(c) on being asked by the official analyst, refuse or fail, without reasonable excuse, to give any information required by the official analyst, being information relevant to the testing of therapeutic goods, that that person is able to provide.
(2) It is a reasonable excuse for a person to refuse or fail to comply with a request for information under paragraph (l) (b) or (c) if compliance with that request would tend to incriminate that person.
Identity cards
33. (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.
(2) Where the authorised officer enters premises in the course of his or her duties under this Chapter, the authorised officer must, if requested to do so by any person at those premises, produce his or her identity card for inspection by that person.
(3) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person's identity card to the Secretary.
Penalty for an offence against this subregulation: $100.
CHAPTER 6—COMMITTEES
Therapeutic Goods Committee
34. (1) The Therapeutic Goods Committee is established.
(a) to consider any matters referred to it by the Minister relating to the administration of the Act; and
(b) to consider and inquire into:
(i) the standards applicable to any therapeutic goods and any matter relating to those standards; and
(ii) the requirements with respect to labelling and packaging of goods; and
(iii) principles to be observed in the manufacture of therapeutic goods for use in humans;
and to advise the Minister about those matters, standards, requirements and principles.
(3) The Committee consists of not fewer than 8 persons and not more than 11 persons, each of whom is to be appointed in writing by the Minister.
(4) The Committee is to consist of:
(a) persons, each of whom has expertise in one or more of the following fields:
(i) pharmaceutics;
(ii) pharmaceutical chemistry;
(iii) pharmacology;
(iv) microbiology;
(v) virology;
(vi) therapeutic devices;
(vii) veterinary science;
(viii) pharmacognosy; and
(b) at least one person who has experience of each of the following kinds:
(i) scientific experience in the manufacture of drugs;
(ii) scientific experience in the manufacture of therapeutic devices;
(iii) consumer affairs experience in respect of therapeutic goods; and
(c) a person nominated by the Secretary to the Department of Primary Industries and Energy.
(5) The Minister is to appoint, in writing, a member of the Committee to be its chairperson.
(6) The Committee may appoint sub-committees, consisting of members of the Committee and other persons to inquire into, and report to the Committee on, any matter that is within the functions of the Committee.
Therapeutic Device Evaluation Committee
35. (1) The Therapeutic Device Evaluation Committee is established.
(a) to make medical and scientific evaluations of therapeutic devices that the Minister or the Secretary refers to it for evaluation; and
(b) to make medical and scientific evaluations of other therapeutic devices if, in the opinion of the Committee, it is desirable that it should do so; and
(c) to make medical and scientific evaluations of drugs that the Minister or the Secretary refers to it for evaluation; and
(d) to give such advice to the Minister or the Secretary about the importation into, the exportation from and the production and distribution within, Australia of therapeutic goods that have been the subject of evaluation by the Committee; and
(e) to give advice that has been given to the Minister or the Secretary under paragraph (d) to such persons or bodies as the Minister directs.
(3) The Committee consists of not less than 6 and not more than 9 persons appointed in writing by the Minister from persons at least 6 of whom are expert in one or more of the following disciplines:
(i) anaesthetics;
(ii) bioengineering;
(iii) biomaterials;
(iv) dentistry;
(v) epidemiology;
(vi) intensive care;
(vii) medicine;
(viii) microbiology;
(ix) ophthalmology;
(x) pharmaceutics;
(xi) surgery;
(xii) nursing.
(4) The Minister is to appoint, in writing, a member of the Committee to be its chairperson.
(5) The Committee may appoint sub-committees, consisting of members of the Committee and other persons, to inquire into, and report to the Committee on, any matter that is within the functions of the Committee.
Australian Drug Evaluation Committee
36. (1) The Australian Drug Evaluation Committee is established.
(a) to make medical and scientific evaluations of any drugs that the Minister or the Secretary refers to it for evaluation; and
(b) to make medical and scientific evaluations of other drugs if, in the opinion of the Committee, it is desirable that it should do so; and
(c) to make medical and scientific evaluations of such therapeutic devices that the Minister or the Secretary refers to it for evaluation; and
(d) to give advice to the Minister or the Secretary about the importation into, the exportation from and the production and distribution within, Australia of therapeutic goods that have been the subject of evaluation by the Committee; and
(e) to give advice that has been given to the Minister or the Secretary under paragraph (d) to persons or bodies as the Minister may direct.
(3) The Committee consists of not less than 6 and not more than 9 members, who are to be appointed, in writing, by the Minister.
(4) In appointing members of the Committee, the Minister is to ensure that the members include:
(a) not less than 4 persons each of whom is a medical practitioner eminent in his or her profession and of whom at least 3 are specialists in clinical medicine; and
(b) not less than 2 persons, each of whom is a pharmacologist or a person who has been admitted to a degree in science or a branch of science by a university and has specialised in pharmaceutical science.
(5) The Minister is to appoint, in writing, a member of the Committee to be its chairperson.
(6) The Committee may appoint sub-committees, consisting of members of the Committee and other persons, to inquire into, and report to the Committee on, any matter that is within the functions of the Committee.
Minister or Secretary may seek further advice
Where a Committee established under this Chapter gives advice to the Minister or the Secretary, the Minister or the Secretary may send a copy of that advice to another Committee established under this Chapter and that other Committee may make comments to the Minister or the Secretary in relation to that advice as it thinks fit.
Tenure of office of members
A member of a Committee established under this Chapter holds office for not more than 3 years unless the member is removed from office before the end of that period.
(2) A member is eligible for re-appointment.
(3) The Minister may, by instrument, remove a member from office at any time.
Disclosure of Interests
39. (1) A member of a Committee established under this Chapter who has a direct or indirect pecuniary interest in a matter being considered or about to be considered at a meeting of the Committee must, as soon as possible after the relevant facts have come to the member's knowledge, disclose the nature of the interest at a meeting of the Committee.
(2) The disclosure is to be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines:
(a) be present during any deliberation of the Committee with respect to the matter; or
(b) take part in any decision of the Committee with respect to that matter.
(3) For the purpose of the making of a determination in relation to the member who has made the disclosure, any member who has a direct or indirect pecuniary interest in the matter to which the disclosure relates must not:
(a) be present during any deliberation of the Committee for the purpose of making the determination; or
(b) take part in the making of the determination by the Committee.
Acting Members
40. (1) The chairperson may appoint a person to act as a member:
(a) during a vacancy in the office, whether or not an appointment has previously been made to the office; or
(b) during any period, or during all periods, when the holder of the office is absent from duty or from Australia or is, for any other reason, unable to perform the duties of the office.
(2) A person appointed to act during a vacancy in the office of a member must not continue so to act for more than 12 months.
(3) Anything done by a person purporting to act as a member is not invalid merely because:
(a) the occasion for the appointment had not arisen; or
(b) there is a defect or irregularity in connection with the person's appointment; or
(c) the appointment had ceased to have effect; or
(d) the occasion for the person to act had not arisen or had ceased.
Meetings of Committees
41. (1) Meetings of a Committee established under this Chapter are to be held at the times and places that the chairperson of the Committee directs.
(2) At a meeting of a Committee:
(a) in the case of the Therapeutic Goods Committee—5 members constitute a quorum; and
(b) in the case of the Australian Drug Evaluation Committee:
(i) if fewer than 7 members of the Committee are in Australia when a meeting is held—3 members constitute a quorum; or
(ii) in any other case—4 members constitute a quorum; and
(c) in the case of the Therapeutic Device Evaluation Committee— 4 members constitute a quorum.
(3) The chairperson of a Committee is to preside at all meetings of the Committee at which he or she is present.
(4) If the chairperson of a Committee is absent from a meeting of a Committee, the members of the Committee present are to appoint one of their number to preside at that meeting.
(5) A question arising at a meeting of a Committee is to be determined by a majority of votes of the members present and voting.
(6) The member presiding at a meeting of a Committee has a deliberative vote and, in the event of an equality of votes, also has a casting vote.
Effect of vacancy on Committee
The exercise of a power or the performance of a function of a Committee established under this Chapter is not affected by a vacancy or vacancies in the membership of that Committee.
CHAPTER 7—FEES AND COSTS
Fees
43. (1) The fees specified in column 3 of an item in Schedule 8 are prescribed in respect of the matters specified in column 2 of that item.
(2) If, but for this subregulation, more than one fee referred to in item 9 of Schedule 8 would otherwise apply in relation to:
(a) an application to carry out steps in the manufacture of therapeutic goods at particular premises; or
(b) the inspection of licensed manufacturing premises for the purposes of section 40 of the Act;
the fee that is the greatest applicable fee is the only fee that applies in respect of that application or inspection.
Testing of samples—recovery of costs
If a person asks the Department to analyse a sample of goods, the costs incurred by the Department in carrying out that analysis are recoverable from that person as a debt due to the Commonwealth.
Waiver or reduction of fees
45. (1) The Secretary may waive or reduce any fees specified in Schedule 8 payable in relation to the supply of therapeutic goods if the supply of those therapeutic goods, in the opinion of the Secretary:
(a) is in the interest of public health; and
(b) would not be commercially viable for the sponsor of the goods if the fee were paid.
(2) The Secretary may waive or reduce any fees specified in Schedule 8 payable in relation to therapeutic goods if a person submits more than one application for registration of the goods at the same time and:
(a) the goods in each application contain the same therapeutically active ingredient; and
(b) in the opinion of the Secretary, the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made.
CHAPTER 8—MISCELLANEOUS
Release of information
46. (1) In this regulation, "therapeutic goods information" has the same meaning as in section 61 of the Act.
(2) For the purposes of subsection 61 (6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information relating to:
(a) whether the goods are included in the Register, and, where included, the registration or listing number of the goods and the class in which the goods are included;
(b) the name of the goods and the name and address of the sponsor of the goods;
(c) if any ingredient in, or component of, the goods is derived from an animal, the species of the animal;
(d) if the goods are supplied in a sterile state, the technique of sterilisation used;
(e) if the goods are drugs:
(i) the quantity of goods in the primary pack; and
(ii) the entry relating to the drugs in the Poisons Schedule; and
(iii) the indications for the drugs; and
(iv) the dosage form of the drugs and their physical appearance; and
(v) the names and quantities of therapeutically active substances in the drugs; and
(vi) the presence or absence of any specific excipient in the drugs; and
(vii) the routes of administration of the drugs;
(f) if the goods are therapeutic devices, a description of the devices, including the name and code (if any) by which the devices are classified.
Delegation
The Secretary may, by signed instrument, delegate to an officer of the Department all or any of the Secretary's powers and functions under these Regulations other than the power of delegation.
Review of decisions
48. (1) In this regulation:
"decision" has the same meaning as in the Administrative Appeals Tribunal Act 1975;
"initial decision" means a decision of the Secretary under regulation 7 or 9 or subregulation 13 (7) or 22 (8);
"reviewable decision" means a decision of the Minister under subsection (3) of the Act.
(2) A person whose interests are affected by an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person's notice.
(3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:
(a) confirm the initial decision; or
(b) revoke the initial decision, or revoke that decision and make a decision in substitution for the initial decision.
(4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.
(5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 28 (4) of the Administrative Appeals Tribunal Act 1975 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Appeals Tribunal for review of that decision.
(6) If written notice of the making of an initial decision is given to a person whose interests are affected by the decision, the notice is to include a statement to the effect that a person whose interests are affected by the decision may:
(a) seek a reconsideration of the decision under this regulation; and
(b) subject to the Administrative Appeals Tribunal Act 1975, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Appeals Tribunal for review of that decision.
(7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.
(8) An application may be made to the Administrative Appeals Tribunal for review of a reviewable decision.
—————
SCHEDULE 1 Regulation 8
PROHIBITED AND REQUIRED REPRESENTATIONS FOR THE PURPOSES OF PARAGRAPHS 6 (a) AND (b)
PART 1
PROHIBITED REPRESENTATIONS
Column 1
Column 2
Column 3
Item No.
Representation
Therapeutic Goods
1
a representation in respect of the use of goods in relation to:abortifacient actionalcoholismanaemiaarthritis (all forms, including rheumatoid arthritis), other than temporary relief of pain asthmabaldness, including hair growth or hair loss blindnessboils, other than treatment by topical applicationbronchitis, other than relief of cough bust developmentcarbuncles, other than treatment by topical applicationcardio-vascular system diseases, ailments or defects (including high or low blood pressure) other than:(a) the advertising of blood pressure appliances where the advertisement includes a statement to the effect that a medical practitioner is the only person qualified to evaluate the meanings of recorded blood pressure; and(b) the advertising of cholesterol measurement services or appliances where that advertising includes a statement to the effect that a medical practitioner is the only qualified person to evaluate the meanings of recorded cholesterol levelscataractcatarrh, other than temporary reliefchilblains, other than temporary relief of symptoms colds, other than temporary reliefcoughs, other than temporary reliefcroup
all therapeutic goods
Column 1
Column 2
Column 3
Item No.
Representation
Therapeutic Goods
deafness, other than relief by an appliance diphtheriaeczema, other then temporary relief of symptomsendocrine system diseases, ailments, defects or injuries (including diabetes and goitre), other than the advertising of blood glucose monitoring productserysipelasfertilityfungus infections including tinea (athlete's foot), other than for relief or treatment by topical applicationgallbladder diseases, ailments, defects or injuriesgastric, peptic or duodenal ulcergenito-urinary system diseases, ailments, defects or injuriesglandular diseases, ailments, defects or injuries (including glandular enlargement)glaucomagouthaemorrhoids, other than:(a) temporary relief of discomfort by local application and where the directions for use include the statement that sufferers should consult a doctor if the symptoms persist; or(b) reference to bulk-producing laxatives being of indirect benefit to people suffering from haemorrhoidsheadaches, other than temporary reliefheight increasehernia or rupture, other than advertising of hernia appliancesherpes virus infections other than:(a) the relief of the symptoms of cold sores; or(b) the reduction of risk of the transmission of genital herpes by the use of condomshormonal diseases, ailments, defects or injuries immune system diseases, ailments, defects or injuries, including acquired immune deficiency syndrome (A.I.D.S.), other than reduction of the risk transmission of disease by the use of condomsimpetigo, other than treatment by topical applicationimpotenceindigestion, other than temporary relief
Column 1
Column 2
Column 3
Item No.
Representation
Therapeutic Goods
infertilityinfluenza, other than temporary relief of symptomsliver diseases, ailments, defects or injuries lupusmenopausal diseases, ailments, defects or conditionsmenstrual cycle diseases, ailments, defects or injuries, other than the temporary relief of menstrual pain and pre-menstrual symptoms where the advertisement includes the following statement:"Use only as directed and consult your doctor if pain or symptoms persist" mental diseases, disorders or illness mouth ulcers, other than temporary relief muscular aches and pains, other than temporary reliefneoplastic diseases (including cancer and leukemia), other than the use of sun-screening preparations as an aid in the prevention of skin cancer, but without implying that long hours of exposure in the sun are desirablenervous system diseases, ailments, defects or injuries (including convulsions, epilepsy, fits, or paralysis)obesity including the reduction of subcutaneous fat also referred to as "cellulite"overweight, other than suppression of appetite in conjunction with a balanced low joule (calorie) dietphlebitisprostate gland disease, ailments, defects or injuriespsoriasis except for the relief or treatment of the effect of psoriasis on the skin:(a) where the advertisement carries the warning:"do not use for prolonged periods without consulting a medical practitioner"; and(b) if the advertisement is an advertisement for products that contain coal tar—where the advertisement carries the additional warning:"do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a medical practitioner"
Column 1
Column 2
Column 3
Item No.
Representation
Therapeutic Goods
psychiatric disease, disorders or illnesspurpurapyorrhoearheumatism, other than temporary relief of pain scabies, other than relief by topical application sexual intercourse and diseases arising from sexual intercourse other than:(a) reduction in the possibility of conception; or(b) reduction of the risk of transmission of sexually transmissible diseases by the use of condomssexual function, potency or virility short staturesinus infection, other than temporary relief of sinusitissleeplessness, other than temporary reliefthrombosistuberculosisvaricose ulcers or varicose veins other than the temporary relief by the use of elastic hosiery whooping cough
2
a representation with respect to the use of goods that:(a) depicts excessive pain or suffering; or(b) induces or is likely to induce persons to believe that they are suffering from a serious ailment; or(c) induces or is likely to induce persons to believe that harmful consequences will result if those goods are not used or consumed, except where the representation is approved in writing by the Secretary; or(d) disparages any physical or mental affliction or disformity; or(e) makes any reference to a dose of a drug in excess of a therapeutic dose; or(f) claims or implies that those goods are recommended or used generally by medical practitioners, pharmacists, dentists, nurses or physiotherapists or by persons having or purporting to have a qualification in a health care field; or(g) states that the goods are safe or that their use cannot cause harm, except where the representation is approved in writing by the Secretary
all therapeutic goods
Column 1
Column 2
Column 3
Item No.
Representation
Therapeutic Goods
3
a representation with respect to the use of goods in which it is stated or implied that those goods:(a) are a universal panacea; or(b) possess infallible, unfailing, sure, magical or miraculous curing properties; or(c) possess unique or absolute properties except where the Secretary, after considering all the circumstances, considers that the representation is substantiated; or(d) are immediately or rapidly acting except where the Secretary, after considering all the circumstances, considers that the representation is substantiated; or(e) are a natural remedy or nature's remedy; or(f) possess stimulant properties; or(g) promote vitality; or(h) must be used for the relief of symptoms of a disease, ailment, defect or injury; or(i) are, or contain, a vitamin—unless those goods are composed of, or contain, a substance specified in column 2 of an item in Part 3 or a salt or derivative of a substance and that substance is described either by the name referred to in column 2 of that item, or by the name of its salt or derivative, or by the name specified in column 3 of that item and not otherwise; or(j) are, or contain, a substance described as a vitamin otherwise than by a description specified in Column 2 or 3 of Part 3; or(k) will effect rejuvenation, regeneration or revitalisation of the human body or any part of it or, except for broad-spectrum sunscreen preparations, in any way arrest or reverse the ageing process
all therapeutic goods
4
a representation that:(a) analgesic consumption is safe; or(b) analgesic preparations will relieve tension, relax, sedate or stimulate; or
analgesics
Column 1
Column 2
Column 3
Item No.
Representation
Therapeutic Goods
-
(c) an analgesic is appreciably less irritating to the stomach, more rapidly absorbed or less harmful than any other analgesic except where the representation is approved in writing by the Secretary
5
a representation containing a reference to bacteriostatic activity, except where it is made in conjunction with a reference to bactericidal activity
disinfectants
6
a representation:(a) containing reference to the Rideal-Walker test or to the Phenol Coefficient; or(b) on any label, containing a reference to the results of laboratory tests on micro-organisms; or(c) containing a reference to the achievement of sterility except where the representation is approved in writing by the Secretary
disinfectants and antiseptics
7
a representation that antiseptics promote healing
liquid antiseptics
8
a representation that:(a) the use of vitamin supplements can be justified by claims that soil depletion reduces nutritional values of food or that processed foods lack nutritional value; or(b) differentiates between the respective values of natural and synthetic vitamins; or(c) vitamins are of benefit in cases of irritability, nervousness, stress or sexual inadequacy; or(d) vitamins stimulate the appetite or growth; or(e) vitamins occasion good looks, good health or long life; or(f) vitamins provide nutritional insurance
vitamins
9
a representation that:(a) purports to show the recommended daily or dietary intake or allowance of a vitamin or a mineral unless the amount shown is that recommended by the National Health and Medical Research Council; or
vitamins and minerals
Column 1
Column 2
Column 3
Item No.
Representation
Therapeutic Goods
(b) expresses the quantity of a vitamin or a mineral contained in a preparation as a percentage or proportion of the recommended daily or dietary intake or allowance
PART 2
REQUIRED REPRESENTATIONS
Column 1
Column 2
Column 3
Item No.
Representation
Therapeutic Goods
1
a statement that vitamins can only be of assistance if the dietary vitamin intake is inadequate
Vitamin preparations supplied in Australia
PART 3
VITAMINS REFERRED TO IN ITEM 3 OF PART 1
Column 1
Column 2
Column 3
Item No.
Substance
Name
1
Vitamin A
—
2
Thiamine
Vitamin B1
3
Riboflavine
Vitamin B2
4
Nicotinic Acid
Vitamin B3
5
Pantothenic Acid
Vitamin B5
6
Pyridoxine
Vitamin B6
7
Cyanocobalamin
Vitamin B12
8
Ascorbic Acid
Vitamin C
9
Ergocalciferol
Vitamin D2
10
Cholecalciferol
Vitamin D3
11
alpha-Tocopherol
Vitamin E
12
Biotin
Vitamin H
13
Phytomenadione
Vitamin K1
14
Menaphthone
Vitamin K3
15
Folic Acid
SCHEDULE 2 Regulation 10
THERAPEUTIC GOODS REQUIRED TO BE INCLUDED IN THE PART OF THE REGISTER FOR REGISTERED GOODS
Item No.
Therapeutic goods
1
drugs referred to in item 1 in Schedule 3
2
drugs, other than drugs:(a) referred to in items 3 to 10 (inclusive) in Schedule 3 unless:(i) the intended action or purpose of the drugs is in the treatment of a condition referred to in item 1 of Part 1 of Schedule 1; or(ii) the drugs are supplied as pharmaceutical benefits; or(b) referred to in item 1, 2, 3, 4, 5, 6, 8 or 9 in Schedule 4 unless those drugs are supplied as pharmaceutical benefits
3
therapeutic devices that are:(a) implantable intra-ocular lenses; or(b) intra-uterine contraceptive devices; or(c) implantable cardiac pacemakers and their accessories; or(d) implantable defibrillators and their accessories; or(e) implantable cardioverters and their accessories; or(f) prosthetic heart valves; or(g) intra-ocular visco-elastic fluids; or(h) powered drug infusion systems which regulate the flow of infusate; or(i) devices of human or animal origin for use on or in the body of a person
SCHEDULE 3 Regulation 11
THERAPEUTIC GOODS REQUIRED TO BE INCLUDED IN THE PART OF THE REGISTER FOR LISTED GOODS
PART 1
LISTABLE THERAPEUTIC GOODS
Item No.
Therapeutic goods
1
therapeutic goods manufactured in Australia for export only other than goods exempt under regulation 12
2
therapeutic devices other than devices to which:(a) item 3 of Schedule 2 applies; or(b) item 1, 2, 3, 4, 5, 6 or 7 of Schedule 4 applies
3
preparations containing as their therapeutically active ingredients only vitamins, minerals or herbal substances and other substances specified in Part 5 or combination of those substances where:(a) the preparation is not included in a Schedule to the Poisons Standard or is not of a kind required to be sterile; and(b) the vitamins consist only of vitamins or their salts specified in Part 2; and(c) the minerals consist only of minerals or their salts specified in Part 3; and(d) the herbal substances are not derived from herbs specified in Part 4unless the intended action or purpose of the preparation is in the treatment of a condition referred to in item 1 of Part 1 of Schedule 1
4
mother tinctures:(a) not included in a Schedule to the Poisons Standard; and(b) where the intended action or purpose of the mother tincture is not in the treatment of a condition referred to in item 1 of Part 1 of Schedule 1
5
dilutions of mother tinctures in water, ethanol, aqueous ethanol or lactose for use as homoeopathic preparations:(a) where each dilution:(i) does not exceed a one thousand fold dilution; and(ii) is not required to be sterile; and(iii) is not included in a Schedule to the Poisons Standard; and(b) where the intended action or purpose of the dilution is not in the treatment of a condition referred to in item 1 of Part 1 of Schedule 1
Item No.
Therapeutic goods
6
medicated throat lozenges where the medication consists only of volatile oils and their constituents alone or in combination with ac-sorbic acid or its salts and unless the intended action or purpose of the lozenges is in the treatment of a condition referred to in item 1 of Part 1 of Schedule 1
7
sunscreen preparations for dermal use that, when tested as described in Australian Standard AS2604-1986 as amended and in force from time to time, are established to have, and claim on their labels, a sun protection factor of 4 or greater (or the equivalent category description) unless the intended action or purpose of the preparation is in the treatment of a condition referred to in item 1 of Part 1 of Schedule 1
8
uncompounded drug substances packed for retail sale:(a) being substances that comply with a monograph of the British Pharmacopoeia for those substances and that are not included in a Schedule to the Poisons Standard; and(b) where the intended action or purpose of the substances is not in the treatment of a condition referred to in item 1 of Part 1 of Schedule 1
9
pressurised aerosol, medicated space sprays where the medication consists only of volatile oils and their constituents
10
drugs containing amino acids for therapeutic use singly or in combination with other substances unless:(a) the amino acids are tryptophan, arginine, ornithine, phenylalanine, methionine, tyrosine, lysine, carnitine, taurine, aspartic acid or glutamic acid; or(b) the other substances are included in Schedule 2; or(c) the goods are included in a Schedule to the Poisons Standard; or(d) the goods are in a form required to be sterile; or(e) the intended action or purpose of the goods is in the treatment of a condition referred to in item 1 of Part 1 of Schedule 1
PART 2
VITAMINS AND THEIR SALTS TO WHICH PARAGRAPH (b) OF ITEM 3 OF PART 1 APPLIES
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 3 OF THE ACT
Column 1
Column 2
Item No.
Therapeutic goods
1
therapeutic goods that are imported for use in the treatment of the importer or the importer's immediate family where:(a) the goods do not contain a substance the importation of which is prohibited under the Customs Act 1901; and(b) in the case of injections—the goods are the subject of an approval under section 19 of the Act; and(c) in the case of other drugs—the quantity imported represents not more than 3 month's supply at the maximum dose recommended by the manufacturer; and(d) the goods:(i) are subject to Schedule 4 to the Poisons Standard; and(ii) are the subject of a written authority issued by a medical practitioner registered under a law of a State or Territory;except where the goods are carried by the importer as a passenger on a ship or aeroplane
2
therapeutic goods that are exported and that:(a) are not for commercial supply; and(b) do not contain a substance the exportation of which is prohibited under the Customs Act 1901
3
samples of therapeutic goods supplied for:(a) submission to a regulatory authority; or(b) subjection to developmental or quality control procedures; or(c) examination, demonstration or display; or(d) subjection to analysis or laboratory testing procedures;but not for supply for therapeutic use in humans
4
goods imported solely for the purpose of export that remain subject to the control of the Customs and that are not subject to manufacture in Australia
5
goods imported into Australia that are held under the direct control of the sponsor pending approval for registration or listing
Column 1
Column 2
Item No.
Therapeutic goods
6
therapeutic goods that are manufactured or dispensed or extemporaneously compounded for a particular person for therapeutic application to that person (other than electronic devices that must be programmed for each patient using them)
7
the following therapeutic devices and parts of therapeutic devices:(a) components and parts of therapeutic devices intended for use in the manufacture, installation, repair or maintenance of devices that are not provided separately to the consumer as an accessory or consumable component;(b) diagnostic goods for in vitro use other than:(i) goods that are represented in any way to be, or that are for any reason, likely to be taken to be for use by a person not otherwise trained:(A) in the use of diagnostic equipment; or(B) in the diagnosis or monitoring of a disease, ailment, defect, injury or condition in that person; or(ii) goods that incorporate material of human origin; or(iii) goods supplied as a pharmaceutical benefit; or(iv) goods for use in the diagnosis of infection with Human Immunodeficiency Virus;(c) non implantable, non powered diagnostic tools and instruments that are not supplied in a sterile state;(d) non powered surgical or dental instruments that are not supplied in a sterile state, other than flexible tubing catheters, cannulae, fluid and gas lines and other instruments that introduce substances to, or remove substances from, the body;(e) manufacturing, laboratory and dispensary equipment used in the preparation of therapeutic goods other than equipment specifically designed to process a patient's blood or other tissues for reintroduction to that patient;
Column 1
Column 2
Item No.
Therapeutic goods
(f) therapeutic devices for dental use that are specified in the most recent notice published in the Australian Dental Journal as products certified or approved by the Australian Dental Association's Therapeutics, Instruments, Materials and Equipment Committee (other than toothpastes to which a Schedule of the Poisons Standard applies);(g) non-powered equipment used in general patient care being equipment that does not constitute or contribute to a specific diagnosis, monitoring or treatment of a medical condition;(h) furniture other than powered appliances for use in diagnosis or treatment of a medical condition;(i) linen and bedding other than linen and bedding supplied in a sterile state;(j) protective clothing for patients or health workers other than:(i) clothing supplied in a sterile state; or(ii) surgeon's gloves and patient examination gloves; or(iii) patient nuclear radiation shielding apparel;(k) communications equipment;(l) containers other than syringes
8
the following drugs unless their intended action or purpose is in the treatment of a condition referred to in item 1 of Part 1 of Schedule 1:(a) homoeopathic preparations more dilute than a one thousand fold dilution of a mother tincture in water, ethanol, aqueous ethanol or lactose and which are not required to be sterile or are not included in a Schedule to the Poisons Standard;(b) antiperspirant preparations that derive their antiperspirant properties from inorganic salts of aluminium, zinc or zirconium only;(c) unmedicated anti-acne preparations having only a cleansing action or purpose;(d) medicated insect repellants for dermal use except those that are included in a Schedule to the Poisons Standard;
Column 1
Column 2
Item No.
Therapeutic goods
(e) lotions, shampoos or hairdressings for the prevention or treatment of dandruff except those that are included in a Schedule to the Poisons Standard;(f) disinfectants;(g) sunscreen preparations for dermal use that when tested as described in Australian Standard AS2604-1986 as amended from time to time, are established to have, and claim on their labels, a sun protection factor below 4 or the equivalent category description
9
the following drugs:(a) starting materials used in the manufacture of therapeutic goods, except when:(i) prepackaged for sale for other therapeutic purposes; or(ii) formulated as a dosage form;(b) blood and blood components manufactured by the Australian Red Cross Society
SCHEDULE 5 Regulation 16
THERAPEUTIC DEVICES PRESCRIBED FOR THE PURPOSES OF PARAGRAPH 26 (1) (g) OF THE ACT
Column 1
Column 2
Item No.
Device
1
therapeutic devices supplied as pharmaceutical benefits
2
therapeutic devices that are required to be, or that are represented to be, sterile
3
therapeutic devices that are not sterile and do not contain or include any sterile component or portion and that are:(a) devices for use in contraception or in the prevention of transmission of disease between persons; or(b) materials for the restoration or replacement of teeth or other matter intended to be implanted in the human body; or(c) bandages (excluding casting bandages), dressings, gauzes and undercast padding; or(d) soft contact lenses; or(e) lubricants for insertion into body cavities or orifices; or(f) diagnostic goods for in vitro use that are:(i) goods that are represented in any way to be, or that are, for any reason, likely to be taken to be for use by a person not otherwise trained:(A) in the use of diagnostic equipment; or(B) in the diagnosis or monitoring of a disease, ailment, defect, injury or condition in that person; or(ii) goods that incorporate material of human origin; or(iii) goods for use in the diagnosis of infection with Human Immunodeficiency Virus
4
containers (not being glass containers) that are:(i) designed to contain blood or blood components; or(ii) intended for use with goods for par-enteral administration
SCHEDULE 6 Regulation 17
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 4 OF THE ACT UNLESS SUPPLIED AS PHARMACEUTICAL BENEFITS
Column 1
Column 2
Item No.
Therapeutic goods
1
goods prepared for the initial experimental studies in human volunteers
2
ingredients, except water, used in the manufacture of therapeutic goods where those ingredients do not have a therapeutic action
3
components for therapeutic devices that are intended to be inserted into the human body, except for those components that come into direct contact with body tissue or body fluids
4
therapeutic devices that are not sterile and do not contain or include any sterile component or portion, other than:(a) devices for use in contraception or prevention of transmission of disease between persons; or(b) materials for restoration or replacement of teeth or other matters intended to be implanted in the human body; or(c) bandages (excluding casting bandages), dressings, gauzes and undercast padding; or(d) soft contact lenses; or(e) lubricants for insertion into body cavities or orifices; or(f) any other devices included in Schedule 2; or(g) diagnostic goods for in vitro use that are:(i) goods that are represented in any way to be, or that are, for any reason, likely to be taken to be for use by person not otherwise trained:(A) in the use of diagnostic equipment; or(B) in the diagnosis or monitoring of a disease, ailment, defect, injury or condition in that person; or(ii) goods that incorporate material of human origin;(iii) goods for use in the diagnosis of infection with Human Immunodeficiency Virus
5
containers (other than glass containers) that are not:
SCHEDULE 6—continued
Column 1
Column 2
Item No.
Therapeutic goods
(a) designed to contain blood or blood components; or(b) intended for use with goods for parenteral administration
6
toothpastes
7
homoeopathic preparations more dilute than a one thousand fold dilution of a mother tincture in ethanol, aqueous ethanol or lactose and that are not required to be sterile
8
antiperspirant preparations that derive their antiperspirant properties from inorganic salts of aluminium, zinc or zirconium only
9
unmedicated anti-acne preparations having only a cleansing action or purpose
10
medicated insect repellents for dermal use
11
lotions, shampoos or hairdressings for the prevention or treatment of dandruff
12
medicated soaps other than liquid medicated soaps
13
disinfectants
14
sunscreen preparations for dermal use
15
medicated throat lozenges, where the medication consists only of volatile oils and their constituents either alone or in combination with ascorbic acid or its salts
16
pressurised aerosol, medicated space sprays where the medication consists only of volatile oils and their constituents
SCHEDULE 7 Regulation 18
PERSONS EXEMPT FROM THE OPERATION OF PART 4 OF THE ACT
Column 1
Column 2
Column 3
Item No.
Persons
Matter in relation to which person exempted
1
medical practitioners, dentists and health care workers registered under a law of a State or Territory
the manufacture of:(a) a drug by a medical practitioner or a dentist specifically for a patient under his or her care; or(b) a therapeutic device by a health care worker specifically for a patient under his or her care
2
pharmacists
the manufacture of therapeutic goods produced by the pharmacist:(a) in a pharmacy where the pharmacist practices and the pharmacy is open to the public; or(b) on the premises of a dispensary conducted by a Friendly Society; or(c) on the premises of a private hospital;for supply (other than by wholesale) on or from those premises
3
biomedical engineers, radio-chemists and pharmacists in public hospitals
the manufacture of therapeutic goods by the person when employed by a public hospital or a public institution and produced by that person for supply in hospitals or public institutions in the same State or Territory
4
persons engaged in the manufacture of any herbal or homoeopathic preparation
where the preparation is for use in the course of his or her business and:(a) the preparations are manufactured on premises that the person carrying on the business occupies and that he or she is able to close so as to exclude the public; and(b) the person carrying on the business supplies the preparation for administration to a particular person after being requested by or on behalf of that particular person and in that particular person's presence to use his or her own judgment as to the treatment required
SCHEDULE 7—continued
Column 1
Column 2
Column 3
Item No.
Persons
Matter in relation to which person exempted
5
a person who applies supplementary labelling to a manufactured product
the application of supplementary labelling, where the supplementary label contains only a name and address or the registration or listing number of goods
6
persons who operate blood collection centres
the operation of human blood collection centres except those that supply plasma for the manufacture of blood components
SCHEDULE 8 Regulation 43
FEES
Column 1
Column 2
Column 3
Item
Matter
Fee
$
1
Evaluation fee for the purposes of subparagraph 19 (2) (b) (iii) of the Act:
(a) if the goods are drugs for use solely for experimental purposes in humans and the evaluation is based on a check list of chemistry and quality control information and guidelines relating to clinical usage
800
(b) if the goods are drugs for use solely for experimental purposes in humans (other than drugs to which paragraph (a) applies)—for each drug
10,100
(c) if the goods are therapeutic devices and they are evaluated on the basis that they are substantially similar to other devices
800
(d) if the goods are therapeutic devices to which paragraph (c) does not apply
7,000
2
Application fee for the purposes of paragraph 23 (c) of the Act for registration of therapeutic goods:
(a) if the application is an application to which item 5 or 6 applies
300
(b) if the application is an application to which item 4 (c) (ii) applies
nil
(c) in any other case
2,000
3
Application fee for the purposes of paragraph 23 (c) of the Act for listing of therapeutic goods:
60
4
Evaluation fee for the purposes of subsection 24 (1) of the Act in respect of a drug evaluated by the Drug Evaluation Branch of the Department involving the evaluation of:
(a) human clinical information
34,700
(b) animal toxicological information
17,400
(c) chemistry, quality control and manufacturing information:
(i) major evaluation
6,400
(ii) minor evaluation
2,900
5
Evaluation fee in respect of a drug to which item 4 does not apply
1,700
6
Evaluation fee for the purposes of subsection 24 (1) of the Act in respect of a therapeutic device where the device is evaluated on the basis that it is substantially equivalent to another device:
(a) if the evaluation involves human clinical information
7,000
SCHEDULE 8—continued
Column 1
Column 2
Column 3
Item
Matter
Fee
$
(b) if the evaluation does not involve human clinical information
1,700
7
Evaluation fee in respect of a therapeutic device to which item 6 does not apply:
(a) involving extensive human clinical information
23,000
(b) involving minimal clinical information
11,600
8
Application fee for the purposes of paragraph 37 (1) (g) of the Act
300
9
Inspection fee for the purposes of paragraph 38 (1) (c), 41 (1) (f) or 58 (3) (b) of the Act:(a) if the fee is in relation to the manufacture of a single type of therapeutic device that is required, or is represented, to be sterile(b) if the fee is in relation to the manufacture of therapeutic goods to which paragraph (a) does not apply that are required, or represented, to be sterile(c) if the fee is in relation to the manufacture of therapeutic goods that are neither required to be, nor represented as being sterile(d) if the fee is in relation to a single step in the manufacture of therapeutic goods(e) if the fee is in relation to the manufacture of ingredients or components for use in the manufacture of therapeutic goods and paragraph (d) does not apply
2,6005,2003,5001,7501,750
10
Fee for the issue to a person of a certification under paragraph 58 (3) (a) of the Act in respect of therapeutic goods where a certification has not been issued in the current financial year to the person in relation to goods that are the same as the goods to which the fee relates
300
11
Fee for the inspection of manufacturing operations other than for the purposes of Part 4 of the Act
The fee applicable under item 9 for that step of manufacture
12
Fee for an evaluation of data concerning therapeutic goods by the Department other than for the purposes of Part 3 of the Act
The fee applicable under item 1, 4, 5, 6 or 7 for an evaluation of that nature
SCHEDULE 8—continued
Column 1
Column 2
Column 3
Item
Matter
Fee
$
13
Fee for an evaluation under subsection 66 (4) of the Act
The fee applicable under item 1, 4, 5, 6 or 7 for an evaluation of that nature
NOTE
1. Notified in the Commonwealth of Australia Gazette on 4 May 1990.