Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 5A

Therapeutic goods exempt from operation of Parts 3-2 and 3-2A of Act subject to conditions

(subregulations 12(2) and (3))

   

 

Column 1
Item

Column 2
Therapeutic goods

Column 3
Conditions

1

Therapeutic goods imported into Australia that 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 importation into Australia under subsection 19(1), section 19A, subsection 32CK(1) or section 32CO of the Act; or

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

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

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

(e) 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

(d) the sponsor must:

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

(iii) 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 used solely for experimental purposes in humans

(a) before starting to use the goods, 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;

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

(b) the notification must be accompanied by the relevant notification fee referred to in item 14 in Part 2 of Schedule 9 or item 17 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 any 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

(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; 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




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