1

Therapeutic goods imported into Australia, if:

(a) the goods are not any of the following:

(i) disposable therapeutic vapes (other than disposable therapeutic vapes that are, or include, medicinal cannabis products);

(ii) therapeutic vaping substances (other than therapeutic vaping substances that are medicinal cannabis products);

(iii) therapeutic vaping substance accessories (other than therapeutic vaping substance accessories that are, or include, medicinal cannabis products);

(iv) a therapeutic vaping kit (other than a therapeutic vaping kit where each good in the kit is, or includes, a medicinal cannabis product);

(v) goods in a therapeutic vaping pack; and

(b) the goods are held under the direct control of the sponsor, until the goods are:

(i) the subject of a notification under item   3; or

(ii) approved for importation into Australia under subsection   19(1), section   19A, subsection   32CK(1) or section   32CO of the Act; or

(iii) authorised for supply under subsection   19(5) or 32CM(1) of the Act; or

(iv) authorised for supply under rules made under subsection   19(7A) or 32CM(7A) of the Act; or

(v) dispensed as a medicine or biological prescribed for a Category A patient within the meaning of subregulation   12A(5); or

(vi) exported from Australia

(a) the supply of the goods must be in accordance with the relevant notification, approval, authorisation or prescription; and

(b) the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and

(c) the sponsor must:

(i) keep records relating to the source and supply of the goods; and

(ii) if requested by the Secretary, give the records to the Secretary

1A

Therapeutic goods imported into Australia and held under the direct control of the sponsor, until a decision is made under section   25, 26, 26A, 26AE, 32DB, 32DC, 32DF or 32DG of the Act about the goods

(a) the sponsor must:

(i) keep records about the source of the goods; and

(ii) if requested by the Secretary, give the records to the Secretary; and

(iii) have lodged an application under section   23, 32DA or 32DD of the Act for the goods before their importation; and

(b) if the goods are not registered, listed, or included   in the Register under Part   3 - 2A of the Act:

(i) in the case of therapeutic goods other than biologicals--the goods must be destroyed; or

(ii) in the case of biologicals--the biologicals must be destroyed or returned to the consignor of the biologicals within 1 month of the decision not to include the biologicals

1B

Therapeutic goods imported into Australia that are needed for dispensing as a medicine prescribed for persons who are seriously ill with a condition from which premature death is reasonably likely to occur in the absence of early treatment

(a) the goods must be supplied to a person covered by column 2 in circumstances where subparagraphs   12A(2)(a)(ii) and (iii) and paragraph   12A(2)(b) of these Regulations are satisfied; and

(b) until the goods need to be so supplied, either or both of the following apply:

(i) the goods are kept in a warehouse or a properly secured area under the control of the sponsor;

(ii) the goods are kept at a hospital or other healthcare facility after being delivered to the hospital or facility by, or on behalf of, the sponsor; and

(c) the sponsor must:

(i) keep records relating to the source, and delivery, of the goods; and

(ii) if requested by the Secretary, give the records to the Secretary

2

Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part   3 - 3 of the Act and are held under the direct control of the sponsor, until the goods are:

(a) the subject of a notification under item   3; or

(b) approved for supply in Australia under subsection   19(1) or section   19A of the Act; or

(c) authorised for supply under subsection   19(5) of the Act; or

(d) authorised for supply under rules made under subsection   19(7A) of the Act

(a) the supply of the goods must be in accordance with the relevant notification, approval or authorisation; and

(b) the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and

(c) the sponsor must:

(i) keep records relating to the source and supply of the goods; and

(ii) if requested by the Secretary, give the records to the Secretary

2A

Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part   3 - 3 of the Act and are held under the direct control of the sponsor, until a decision is made under section   25 or 26 of the Act about the goods

the sponsor must:

(a) keep records about the source of the goods; and

(b) if requested by the Secretary, give the records to the Secretary; and

(c) have lodged an application under section   23 of the Act for the goods before their manufacture

3

Therapeutic goods to be used in a clinical trial solely for experimental purposes in humans

(a) the sponsor must notify the Secretary:

(i) in a form approved by the Secretary; and

(ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;

  about the trial and the therapeutic goods covered by the trial and must do so before:

(iii) the goods begin to be used in the trial, unless subparagraph   (iv) applies; or

(iv) if the sponsor seeks the Secretary's agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this--the end of that nominated period; and

  that the sponsor intends to sponsor a clinical trial using specified goods; and

(b) the notification referred to in paragraph   (a) must be accompanied by the relevant notification fee referred to in paragraph   (a) of column 2 of item   14 in the table in clause   3 of Schedule   9 or paragraph   (a) of the column headed "Matter" in item   17 of the table in Part   2 of Schedule   9A; and

(c) the approval of the goods for this purpose must be given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee that has, or will assume, responsibility for monitoring the conduct of the trial; and

(d) the terms of the approval by the sponsor, body or organisation referred to in paragraph   (c) must be no less restrictive than the terms advised by the ethics committee; and

(e) the Secretary must not, at any time:

(i) have become aware that to conduct or continue the trial would be contrary to the public interest; and

(ii) have directed that the trial not be conducted, or be stopped; and

(f) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must not receive, or have received, advice from the ethics committee that is inconsistent with the continuation of the trial; and

(g) the conditions set out in regulation   12AD must be complied with, as if that regulation applied to a person using therapeutic goods under this item; and

(h) the goods are not either or both of the following:

(i) a Class 4 biological that has not received clinical trial approval for an equivalent indication from a national regulatory agency with comparable regulatory requirements;

(ii) a Class 4 biological that does not have a history of previous usage that is supported by clinical evidence received by the TGA; and

(ha) the sponsor must notify the Secretary:

(i) in a form approved by the Secretary; and

(ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;

  about any trial site not covered by the notification referred to in paragraph   (a) and must do so before:

(iii) the goods begin to be used at that site, unless subparagraph   (iv) applies; or

(iv) if the sponsor seeks the Secretary's agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this--the end of that nominated period; and

(hb) the notification referred to in paragraph   (ha) must be accompanied by the relevant notification fee referred to in paragraph   (b) of column 2 of item   14 in the table in clause   3 of Schedule   9 or paragraph   (b) of the column headed "Matter" in item   17 of the table in Part   2 of Schedule   9A; and

(i) the sponsor must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial (whether or not the sponsor is conducting the trial); and

(j) if a body or organisation is conducting the trial for the sponsor, that body or organisation must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and

(k) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must allow an authorised officer to do the things mentioned in regulation   12AC

4

Therapeutic goods that are imported by a member of a group of persons

(a) the group must be visiting Australia to participate in a national or an international sporting event; and

(b) the goods must be for use in the treatment of a member or members of that group; and

(c) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations   1956 ; and

(d) the goods must not be supplied to, or used in the treatment of, a person who is not a member of the visiting group; and

(e) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and

(f) a member of the group must be responsible for the control and custody of the goods while the group is in Australia; and

(g) the person referred to in paragraph   (f) must:

(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and

(ii) for each of the goods that is not a biological--include in the list the generic name and strength of the active ingredient of the goods; and

(iii) keep a record of the use of the goods while the group is in Australia; and

(iv) produce the list or the record for inspection at the request of a customs officer or a person who is an authorised officer for the purposes of a provision of Part   5 of these Regulations

5

Therapeutic goods, if:

(a) the goods are not:

(i) biologicals; or

(ii) goods referred to in item   3; and

(b) the goods are manufactured by a person under a contract between the person and a private hospital, a public hospital in a State or Territory or a public institution (the relevant institution ); and

(c) the manufacture is in accordance with a formulation specified by the relevant institution; and

(d) the goods are for use by, or in connection with, a patient of:

(i) the relevant institution; or

(ii) if the relevant institution is a public hospital in a State or Territory--another public hospital in the State or Territory

(a) there are no listed goods or registered goods that, in all relevant respects, are substantially similar to the goods; and

(b) the person:

(i) manufactures the goods at premises in Australia; and

(ii) holds a licence, required by the Act, that authorises the manufacture, or a step in the manufacture, of the goods at those premises; and

(c) the person notifies the Secretary, in accordance with a form approved by the Secretary and within 15   days of the end of a quarter, of:

(i) the goods manufactured under the contract during that quarter; and

(ii) the relevant institution that entered the contract

7

Therapeutic goods, or parts of therapeutic goods, that form part of a medicine delivery system in which the medicine is supplied in a device that acts as a container

(a) none of the goods, or any part of the goods are separately supplied in Australia; and

(b) if the component and kit manufacturer are the same manufacturer and the components are not separately supplied outside the kit by the kit sponsor; and

(c) if the kit sponsor or the manufacturer obtains components from other manufacturers and the kit manufacturer's licence covers quality control of those components

8

Therapeutic goods imported by a member of a group of persons

(a) the group must be members of the military forces of another country, visiting Australia for military training; and

(b) the goods must be for use in the treatment of a member or members of that group; and

(c) the goods must not be supplied to, or used in the treatment of, a person other than a member of:

(i) the visiting group; or

(ii) the Australian Defence Force; and

(d) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and

(e) a member of the group to whom the goods have been issued must be responsible for the control and custody of the goods while the group is in Australia; and

(f) the person mentioned in paragraph   (e) must:

(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and

(ii) for each of the goods that is not a biological--include in the list the generic name and strength of the active ingredient of the goods; and

(iii) keep a record of the use of the goods while the group is in Australia; and

(iv) produce the list or the record for inspection at the request of a customs officer or a person who is an authorised officer for a provision of Part   5 of these Regulations

9

Unused emergency goods or unused emergency biologicals directed by the Secretary, under clause   7 of Schedule   5B, to be exported

the provisions of Schedule   5B continue to apply to the goods or biologicals, as if the goods or biologicals were not exempt from the operation of section   30G or   32CG of the Act

10

Therapeutic goods imported into Australia by a medical practitioner or a member of a medical team (being 1 or more persons under the professional supervision of a medical practitioner)

(a) the medical practitioner or medical team must be accompanying a person to Australia who:

(i) has a critical illness; and

(ii) is under the direct care and supervision of the practitioner or team; and

(b) the goods must be for use in the treatment of the person who has the critical illness; and

(c) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations   1956 ; and

(d) the quantity of the goods must be consistent with the quantity required for the treatment of the person mentioned in paragraph   (b); and

(e) the goods must not be supplied to, or used in the treatment of, a person other than the person mentioned in paragraph   (b); and

(f) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and

(g) the medical practitioner, or a member of the medical team, must be responsible for the control and custody of the goods while the practitioner or team is in Australia; and

(h) the person mentioned in paragraph   (g) must:

(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and

(ii) for each of the goods that is not a biological--include in the list the generic name and strength of the active ingredient of the goods; and

(iii) keep a record of the use of the goods while the medical practitioner or medical team is in Australia; and

(iv) produce the list or record for inspection at the request of a customs officer or a person who is an authorised officer for the purposes of a provision of Part   5 of these Regulations.

11

Therapeutic goods imported into Australia by a member of a group of persons

(a) the group must include a person who is the Head of State or Head of Government of a foreign country and senior Government officials of that country, who are visiting Australia on official business; and

(b) the goods must be for use in the treatment of a member or members of the visiting group; and

(c) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations   1956 ; and

(d) the goods must not be supplied to, or used in the treatment of, a person other than a member of the visiting group; and

(e) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and

(f) a member of the visiting group must be responsible for the control and custody of the goods while the group is in Australia; and

(g) the person mentioned in paragraph   (f) must:

(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and

(ii) for each of the goods that is not a biological--include in the list the generic name and strength of the active ingredient of the goods; and

(iii) keep a record of the use of the goods while the group is in Australia; and

(iv) produce the list or record for inspection at the request of a customs officer or a person who is an authorised officer for the purposes of a provision of Part   5 of these Regulations.

12

Therapeutic goods that are part of the medical supplies of a ship (including a yacht or other marine vessel) or aircraft visiting Australia

(a) the goods must be for use in the treatment of a passenger or a member of the crew travelling on the ship or aircraft; and

(b) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations   1956 ; and

(c) the quantity of the goods must be consistent with the quantity required for the treatment of passengers and members of the crew travelling on the ship or aircraft; and

(d) the goods must not be supplied to, or used in the treatment of, a person other than a passenger or a member of the crew travelling on the ship or aircraft; and

(e) the goods must not be removed from the ship or aircraft while the ship or aircraft is in Australia; and

(f) the master of the ship or the pilot of the aircraft must be responsible for the control and custody of the goods while the ship or aircraft is in Australia; and

(g) the person mentioned in paragraph   (f) must:

(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and

(ii) for each of the goods that is not a biological--include in the list the generic name and strength of the active ingredient of the goods; and

(iii) keep a record of the use of the goods while the ship or aircraft is in Australia; and

(iv) produce the list or record for inspection at the request of a customs officer or a person who is an authorised officer for the purposes of a provision of Part   5 of these Regulations.

13

Therapeutic goods in relation to which all of the following paragraphs apply:

(a) the goods comprise, contain or are derived from human cells or human tissues collected from a patient who is under the clinical care of a medical or dental practitioner;

(b) the goods were manufactured by, or under the professional supervision of, the practitioner;

(c) the single indication of the goods is homologous use:

(i) on that patient; and

(ii) in a single clinical procedure; and

(iii) by, or under the professional supervision of, that practitioner;

(d) the goods have been subjected to only minimal manipulation;

(e) the practitioner is registered in a State or internal Territory

if the sponsor knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation   16AB

14

Therapeutic goods in packs, if:

(a) the packs contain tampons or menstrual cups; and

(b) any other therapeutic goods in the packs are included in the Register; and

(c) the packaging of any individually packaged medical devices or medicines in the pack is intact; and

(d) the packs do not contain any of the following:

(i) a biological;

(ii) a medicine mentioned in Part   1 of Schedule   10;

(iii) a medical device (other than an IVD medical device) that is classified under the Therapeutic Goods (Medical Devices) Regulations   2002 as Class IIa or higher;

(iv) an IVD medical device or in - house IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations   2002 as Class 2 or higher

the packs must not be supplied:

(a) by persons other than charities; or

(b) for a charge; or

(c) to persons other than homeless or disadvantaged women

15

Therapeutic goods, if:

(a) the goods are:

(i) therapeutic vaping substances; or

(ii) therapeutic vaping substance accessories; or

(iii) a therapeutic vaping kit; or

(iv) goods in a therapeutic vaping pack; and

(b) the goods are not, or do not include, any medicinal cannabis products; and

(c) the only indications of the goods are use for smoking cessation or the management of nicotine dependence; and

(d) for goods other than therapeutic vaping devices, or therapeutic vaping device accessories, in a therapeutic vaping pack--the sponsor of the goods, and any other person involved in the wholesale or retail supply of the goods, intend the goods to be supplied to the ultimate consumer of the goods in accordance with an approval or authority under section   19 of the Act

(a) the sponsor must give the Secretary a notice (the sponsor notice ), in a form approved in writing by the Secretary, stating that:

(i) the goods conform with any standard applicable to the goods, or are imported or supplied (as the case may be) with the consent of the Secretary under section   14 or 14A of the Act; and

(ii) the only indications of the goods are use for smoking cessation or the management of nicotine dependence; and

(b) the sponsor notice must be given as follows:

(i) for goods imported into Australia on or after 1   March 2024--before the goods are imported;

(ii) for goods imported into Australia before 1   March 2024--before the earlier of the time the goods are supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule   1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations   2024 commences; and

(iii) for goods manufactured in Australia on or after 1   March 2024--before the goods are first supplied in Australia; and

(iv) for goods manufactured in Australia before 1   March 2024--before the earlier of the time the goods are supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule   1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations   2024 commences; and

(c) the sponsor holds information or evidence to support the statements made in the sponsor notice; and

(d) neither of the statements made in the sponsor notice is incorrect; and

(e) the goods are not the subject of a determination, by the Secretary and published on the Department's website, that the supply of the goods be stopped or should cease because:

(i) the Secretary is satisfied that the supply compromises public health and safety; or

(ii) the Secretary is satisfied that the goods do not conform with a standard applicable to the goods; and

(f) the sponsor must:

(i) if requested by the Secretary, give the Secretary the information or evidence referred to in paragraph   (c); and

(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made); and

(fa) the sponsor must:

(i) if requested by the Secretary, give the Secretary a reasonable number of samples of the goods; and

(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made); and

(fb) the sponsor must allow an authorised officer:

(i) to enter, at any reasonable time, any premises (including premises outside Australia) at which the sponsor or any other person deals with the goods; and

(ii) while on those premises, to inspect those premises and the goods and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of the goods or any thing on those premises that relates to the goods; and

(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

(fc) the sponsor must, if requested to do so by an authorised officer, produce to the authorised officer such documents relating to the goods as the authorised officer requires and allow the authorised officer to copy the documents; and

(fd) if the sponsor is not the manufacturer of the goods, the sponsor must have procedures in place to ensure that the manufacturer of the goods allows an authorised officer:

(i) to enter, at any reasonable time, any premises (including premises outside Australia) at which the manufacturer or any other person deals with the goods; and

(ii) while on those premises, to inspect those premises and the goods and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of the goods or any thing on those premises that relates to the goods; and

(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

(fe) if the sponsor is not the manufacturer of the goods, the sponsor must have procedures in place to ensure that the manufacturer of the goods, if the manufacturer is requested to do so by an authorised officer, produces to the authorised officer such documents relating to the goods as the authorised officer requires and allow the authorised officer to copy the documents; and

(g) for goods manufactured in Australia--either of the following apply:

(i) the goods are manufactured by a person who is the holder of a licence in force under Part   3 - 3 of the Act that authorises the manufacture of the goods, or the carrying out of the step in the manufacture of the goods, at the manufacturing site where the manufacture, or the step, is carried out;

(ii) the goods are manufactured by a person who is exempt in accordance with subsection   34(2) of the Act from the operation of Part   3 - 3 of the Act in relation to the manufacture of the goods and the Secretary has given the person a consent under subsection   41RC(1) of the Act to manufacture the goods, or carry out the step in the manufacture of the goods, and the manufacture, or the step, is carried out in accordance with the consent; and

(h) the goods may be supplied to a person who is not the ultimate consumer of the goods only if:

(i) the person (the recipient) to whom the goods are supplied is the holder of a licence in force under Part   3 - 3 of the Act that authorises a step in the manufacture of the goods; or

(ii) the recipient is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule   3 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; or

(iii) the Secretary has given the recipient a consent under subsection   41RC(1) of the Act to supply the goods; or

(iv) in the case of goods that are covered by a determination made by the Minister under section   41R of the Act--the recipient is specified in the determination, or is included in a class of persons specified in the determination, in relation to those goods; and

(i) the goods may be supplied to the ultimate consumer of the goods only if:

(i) the goods are supplied as a finished product; and

(ii) the supply is by a pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule   3 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; and

(iii) for goods other than therapeutic vaping devices, or therapeutic vaping device accessories, in a therapeutic vaping pack--the supply is in accordance with an approval or authority under section   19 of the Act; and

(iv) if the supply is by a person authorised as described in subparagraph   (ii), the supply is in accordance with that authorisation; and

(j) the sponsor must:

(i) keep records relating to the source and supply of the goods; and

(ii) if requested by the Secretary, give the records to the Secretary within the period requested by the Secretary (which must be at least 5   working days starting on the day on which the Secretary's request is made); and

(k) the sponsor must provide information of a kind mentioned in subsection   29A(2) or 29AA(2) of the Act relating to the goods to the Secretary within the following periods:

(i) if the information relates to an event or other occurrence that represents a serious threat to public health--48 hours after the sponsor becomes aware of the event or occurrence;

(ii) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the goods, or another person--10 days after the sponsor becomes aware of the event or occurrence;

(iii) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the goods, or another person--30 days after the sponsor becomes aware of the event or occurrence;

(iv) in any other case--60 days after the sponsor becomes aware of the information

16

Therapeutic goods imported into Australia, if:

(a) the goods are nicotine in solution as a starting material for use in the manufacture of a therapeutic vaping substance, a therapeutic vaping substance accessory or any other therapeutic good; or

(b) the goods are any other starting materials that are ingredients or components for use in the manufacture of a therapeutic vaping substance or a therapeutic vaping substance accessory

(a) the sponsor must give the Secretary a notice (the sponsor notice ), in a form approved in writing by the Secretary, stating that the goods are for use in the manufacture, in accordance with the requirements of the Act, of another therapeutic good by a manufacturer that holds all relevant licences or approvals (however described) required under the following:

(i) Part   3 - 3 of the Act;

(ii) the law of the State or Territory in which the manufacture is to occur; and

(b) the sponsor notice must be given before importing the goods; and

(ba) the sponsor must:

(i) if requested by the Secretary, give the Secretary a reasonable number of samples of the goods; and

(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made); and

(c) the goods may be supplied only for use in manufacture as referred to in paragraph   (a)