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Specifications as made
This instrument specifies the kinds of therapeutic goods information that may be released to the public by the Secretary of the Department of Health under subsection 61(5C) of the Therapeutic Goods Act 1989 in relation to shortages and discontinuations of the supply of medicines.
Administered by: Health
Registered 12 Dec 2018
Tabling HistoryDate
Tabled HR12-Feb-2019
Tabled Senate12-Feb-2019
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Information relating to Shortages and Discontinuations of Supply of Medicines) Specification 2018

I, Jane Cook, as delegate of the Minister for Health, make the following specification.

Dated 10 December 2018

 

(signed by)

Jane Cook

First Assistant Secretary

Medicines Regulation Division

Health Products Regulation Group

Department of Health

 

 

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Repeals..................................................................................................................................... 2

6  Therapeutic goods information................................................................................................. 2

Schedule 1—Repeals                                                                                                     4

Therapeutic Goods Information (Medicine Shortages Information Initiative) Specification 2014                4

Schedule 2—Specified kinds of therapeutic goods information                               5

Part 1— Information relating to a shortage of a medicine that arises on or after 1 January 2019          5

Part 2— Information relating to a decision to permanently discontinue the supply of a medicine that is made on or after 1 January 2019                                                               8

Part 3—Information relating to a shortage of a medicine that arose before 1 January 2019      11

Part 4—Information relating to a decision to permanently discontinue the supply of a medicine that was made before 1 January 2019                                                                    14

 

 


1  Name

                   This instrument is the Therapeutic Goods (Information relating to Shortages and Discontinuations of Supply of Medicines) Specification 2018.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 January 2019.

1 January 2019

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989.

4  Definitions

Note:          A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a)    medicine;

(b)    Register;

(c)    registered goods;

(d)    registration number;

(e)    reportable medicine;

(f)    shortage;

(g)    sponsor.

                   In this instrument:

                   Act means the Therapeutic Goods Act 1989.

                   active ingredient has the same meaning as in the Regulations.

                   anticipated shortage, in relation to a medicine, means a shortage other than a current shortage.

                   ATC means anatomical therapeutic chemical.

                   ATC classification system means the Anatomical Therapeutic Chemical Classification System, an internationally accepted classification system for medicines that is maintained by the WHO and under which the WHO assigns ATC codes to all active ingredients contained in medicines based on the therapeutic indication for the medicine and classifies such ingredients into groups at 5 different levels according to the organ or system of the human body on which they act and the active ingredient’s therapeutic, pharmacological and chemical properties, as in force or existing at 1 December 2018.

Note:          The ATC classification system can be found (and viewed for free) on the internet at:  https://www.whocc.no/atc_ddd_index_and_guidelines/atc_ddd_index/  (while there is a cost to obtain an electronic (200€) or paper (60€) version of the whole system, this website contains a free index which can be used to search for a medicine and view its ATC code without charge).

                   critical impact, in relation to the discontinuation of the supply of a medicine, has the meaning given by subsections 30EG(2) and (3) of the Act.

                   critical impact, in relation to the shortage of a medicine, has the meaning given by subsections 30EF(2) and (3) of the Act.

                   current shortage, in relation to a medicine, means a shortage at a particular time if, at that time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.

                   discontinuation decision has the meaning given by subsection 30EG(1) of the Act.

MSII means the voluntary Medicines Shortage Information Initiative that was administered by the Therapeutic Goods Administration for the period 2014 to 2018.

Note:          The Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration can be found (and viewed for free) on the internet at: http://www.tga.gov.au

NIP means the National Immunisation Program Schedule as in force or existing at 1 December 2018.

Note:          The National Immunisation Program Schedule can be found (and viewed for free) on the internet at: http://beta.health.gov.au.  

Regulations means the Therapeutic Goods Regulations 1990.

substitute medicine, in relation to a medicine which is in shortage or the subject of a discontinuation decision, means a medicine that has the same active ingredient as that medicine.

                   therapeutic alternative, in relation to a medicine which is in shortage or the subject of a discontinuation decision, means other therapeutic options that a health professional may consider as an alternative treatment for a patient who may be affected by a shortage or discontinuation of supply of that medicine.

                   Therapeutic Goods Administration or TGA, has the same meaning as in the Regulations.

                   trade name has the same meaning as in the Regulations.

                   WHO means the World Health Organisation.

Repeals

                   Each instrument that is specified in Schedule 1 to this instrument is repealed as set out in that Schedule.

6  Therapeutic goods information

             (1)  The kinds of therapeutic goods information set out in Part 1 of Schedule 2 are specified for the purpose of subsection 61(5C) of the Act, in relation to a shortage of a reportable medicine in Australia that arises on or after 1 January 2019.

             (2)  The kinds of therapeutic goods information set out in Part 2 of Schedule 2 are specified for the purpose of subsection 61(5C) of the Act, in relation to a decision to permanently discontinue the supply of a reportable medicine in Australia that is made on or after 1 January 2019.

             (3)  The kinds of therapeutic goods information set out in Part 3 of Schedule 2 are specified for the purpose of subsection 61(5C) of the Act, in relation to a shortage of a medicine in Australia that arises before 1 January 2019.

             (4)  The kinds of therapeutic goods information set out in Part 4 of Schedule 2 are specified for the purpose of subsection 61(5C) of the Act, in relation to a decision to permanently discontinue the supply of a medicine in Australia that is made before 1 January 2019.

Note:          Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).


 

Schedule 1—Repeals

Note:       See section 5.

Therapeutic Goods Information (Medicine Shortages Information Initiative) Specification 2014

1  The whole of the instrument

Repeal the instrument

 


 

Schedule 2—Specified kinds of therapeutic goods information

Note:       See section 6.

Part 1— Information relating to a shortage of a reportable medicine that arises on or after 1 January 2019

 

For each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.

 

Kinds of  therapeutic goods information

Column 1

Item

Column 2

Information                           

Column 3

Description

Information about the medicine:

1

name of medicine

the trade name or brand name of the reportable medicine that is the subject of a notification to the Secretary under section 30EF of the Act (the relevant medicine)

2

active ingredient

the active ingredient, or active ingredients, of the relevant medicine

3

strength

the strength of the relevant medicine

4

dosage form

the dosage form of the relevant medicine

5

container

the type of container of the relevant medicine

6

registration number

the registration number of the relevant medicine

7

therapeutic class

the ATC code for the relevant medicine’s active ingredient under the ATC classification system

Information about the sponsor:

8

sponsor name

the name of the sponsor of the relevant medicine (the relevant sponsor)

9

sponsor's nominated public contact details

an Australian telephone number and/or email address nominated by the relevant sponsor for the purposes of responding to enquiries from the public seeking additional information about the relevant medicine

10

sponsor's nominated  website details

the website address (URL) nominated by the relevant sponsor for the purposes of providing the public with additional information about the relevant medicine

Information about the shortage:

11

status of the shortage

whether the relevant medicine is the subject of a shortage that:

(a)     is an anticipated shortage;

(b)     is a current shortage; or

(c)      has been resolved

12

reason for the shortage

the relevant sponsor’s advice as to the general  reason for the shortage of the relevant medicine, as follows:

(a)     commercial reasons;

(b)     manufacturing:

(c)      product recall;

(d)     unexpected increase in demand; or

(e)      other

13

commencement date of impact on supply

the relevant sponsor’s advice as to:

(a)     for a current shortage¾the date the shortage commenced;

(b)     for an anticipated shortage¾the date that it is anticipated that the supply of the relevant medicine in Australia will not, or will not be likely to, meet the demand for the relevant medicine for all of the patients in Australia who take, or who may need to take, the relevant medicine

14

anticipated date the shortage will be resolved

the relevant sponsor’s advice as to the date the supply of the relevant medicine in Australia will, or will be likely to, meet the demand for the relevant medicine for all of the patients in Australia who take, or who may need to take, the relevant medicine

15

availability level

the relevant sponsor’s advice as to the current availability level of the supply of the relevant medicine, as follows:

(a)     available¾there are no constraints or restrictions on supply;

(b)     limited availability¾the relevant medicine is available in limited quantities throughout the supply chain;

(c)      only available under government programs ¾ in relation to a medicine that is a vaccine, the relevant medicine is only available for Commonwealth (NIP) or State and Territory government immunisation programs and is not available in the private market;

(d)     emergency supply only¾the relevant sponsor is imposing controls on the supply of the relevant medicine; or

(e)      unavailable¾the relevant medicine is not available

16

patient impact

whether the impact of the shortage is:

(a)     critical;

(b)     medium; or

(c)      low

17

supply details and other information

any information, or links to any information, in relation to:

(a)     the supply arrangements in relation to the relevant medicine;

(b)     substitute medicines for the relevant medicine, including supply arrangements and use;

(c)      therapeutic alternatives  to the relevant medicine, including supply arrangements and use

18

TGA management action

details of action that has been or is being taken by the TGA in relation to managing the shortage

19

updated

date that the entry was last updated

 

In this Part:

                   low impact, in relation to a shortage of a reportable medicine that is not of critical impact, means a shortage that is assessed as low patient impact in accordance with the assessment framework set out in the Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies published in November 2018.

                   medium impact, in relation to a shortage of a reportable medicine that is not of critical impact, means a shortage that is assessed as medium patient impact in accordance with the assessment framework set out in the Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies published in November 2018.

Note:          The Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies can be found (and viewed for free) on the internet at: http://www.tga.gov.au.


 

Part 2— Information relating to a decision to permanently discontinue the supply of a reportable medicine that is made on or after 1 January 2019

 

For each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.

 

Kinds of  therapeutic goods information

Column 1

Item

Column 2

Information                           

Column 3

Description

Information about the medicines:

1

name of medicine

the trade or brand name of the reportable medicine that is the subject of a notification to the Secretary under section 30EG of the Act (the relevant medicine)

2

active ingredient(s)

the active ingredient, or active ingredients, of the relevant medicine

3

strength

the strength of the relevant medicine

4

dosage form

the dosage form of the relevant medicine

5

container

the container type of the relevant medicine

6

registration number

the registration number of the relevant medicine

7

therapeutic class

the ATC code for the relevant medicine’s active ingredient under the ATC classification system

Information about the sponsor:

8

sponsor name

the name of the sponsor of the relevant medicine (the relevant sponsor)

9

sponsor's nominated public contact details

an Australian telephone number and/or email address nominated by the relevant sponsor for the purposes of responding to enquiries from the public seeking additional information about the relevant medicine

10

sponsor's nominated  website details

the website address (URL) nominated by the relevant sponsor for the purposes of providing the public with additional information about the relevant medicine

Information about the discontinuation:

11

status of the discontinuation

whether the relevant medicine will be or has been permanently discontinued by the relevant sponsor

12

reason for the discontinuation 

the relevant sponsor’s advice as to the general reason for the discontinuation decision, as follows:

(a)     commercial reasons;

(b)     manufacturing:

(c)      product recall;

(d)     unexpected increase in demand; or

(e)    other

13

market deletion date

the sponsor’s advice as to the date from which the sponsor will cease, or has ceased, supply of the relevant medicine to the Australian market

14

availability level

the relevant sponsor’s advice as to the current availability level of the supply of the relevant medicine, as follows:

(a)     available¾there are no constraints or restrictions on supply;

(b)     limited availability¾the relevant medicine is available in limited quantities throughout the supply chain;

(c)      only available under government programs ¾ in relation to a medicine that is a vaccine, the medicine is only available for Commonwealth (NIP) or State and Territory government immunisation programs and is not available in the private market;

(d)     emergency supply only¾the relevant sponsor is imposing controls on the supply of the relevant medicine; or

(e)      unavailable¾the relevant medicine is not available

15

patient impact

whether the impact of the discontinuation is:

(a)     critical;

(b)     medium; or

(c)      low

16

supply details and other information

any information, or links to any information, in relation to:

(a)     the supply arrangements in relation to the relevant medicine;

(b)     substitute medicines for the relevant medicine, including supply arrangements and use;

(c)      therapeutic alternatives  to the relevant medicine, including supply arrangements and use

17

TGA management action

details of action that has been or is being taken by the TGA in relation to managing the discontinuation

18

updated

date that the entry was last updated

 

In this Part:

                   low impact, in relation to a discontinuation of the supply of a reportable medicine that is not of critical impact, means a discontinuation that is assessed as low patient impact in accordance with the assessment framework set out in the Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies published in November 2018.

                   medium impact, in relation to a discontinuation of the supply of a reportable medicine that is not of critical impact, means a discontinuation that is assessed as medium patient impact in accordance with the assessment framework set out in the Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies published in November 2018.

Note:          The Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies can be found (and viewed for free) on the internet at: http://www.tga.gov.au.


 

Part 3—Information relating to a shortage of a medicine that arose before 1 January 2019

 

For each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.

 

Kinds of  therapeutic goods information

Column 1

Item

Column 2

Information                           

Column 3

Description

Information about the medicine:

1

name of medicine

the trade name or brand name of the medicine that was the subject of a notification to the Secretary under the MSII (the relevant medicine)

2

active ingredient

the active ingredient, or active ingredients, of the relevant medicine

3

strength

the strength of the relevant medicine

4

dosage form

the dosage form of the relevant medicine

5

container

the type of container of the relevant medicine

6

registration number

the registration number of the relevant medicine

7

therapeutic class

the ATC code for the relevant medicine’s active ingredient under the ATC classification system

Information about the sponsor:

8

sponsor name

the name of the sponsor of the relevant medicine (the relevant sponsor)

9

sponsor's nominated public contact details

an Australian telephone number and/or email address nominated by the relevant sponsor for the purposes of responding to enquiries from the public seeking additional information about the relevant medicine

10

sponsor's nominated  website details

the website address (URL) nominated by the relevant sponsor for the purposes of providing the public with additional information about the relevant medicine

Information about the shortage:

11

status of the shortage

whether the relevant medicine is the subject of a shortage that:

(a)     is an anticipated shortage;

(b)     is a current shortage; or

(c)      has been resolved

12           

reason for the shortage

the relevant sponsor’s advice as to the general  reason for the shortage of the relevant medicine, as follows:

(a)     commercial reasons;

(b)     manufacturing:

(c)      product recall;

(d)     unexpected increase in demand; or

(e)      other

13

commencement date of impact on supply

the relevant sponsor’s advice as to:

(a)     for a current shortage¾the date the shortage commenced;

(b)     for an anticipated shortage¾the date that it is anticipated that the supply of the relevant medicine in Australia will not, or will not be likely to, meet the demand for the relevant medicine for all of the patients in Australia who take, or who may need to take, the relevant medicine

14

anticipated date the shortage will be resolved

the relevant sponsor’s advice as to the date the supply of the relevant medicine in Australia will, or will be likely to, meet the demand for the relevant medicine for all of the patients in Australia who take, or who may need to take, the relevant medicine

15

availability level

the relevant sponsor’s advice as to the current availability level of the supply of the relevant medicine, as follows:

(a)     available¾there are no constraints or restrictions on supply;

(b)     limited availability¾the relevant medicine is available in limited quantities throughout the supply chain;

(c)      only available under government programs ¾ in relation to a medicine that is a vaccine, the relevant medicine is only available for Commonwealth (NIP) or State and Territory government immunisation programs and is not available in the private market;

(d)     emergency supply only¾the relevant sponsor is imposing controls on the supply of the relevant medicine; or

(e)      unavailable¾the relevant medicine is not available

16

patient impact

whether the impact of the shortage is:

(a)     critical;

(b)     medium; or

(c)      low

17

supply details and other information

any information, or links to any information, in relation to:

(a)     the supply arrangements in relation to the relevant medicine;

(b)     substitute medicines for the relevant medicine, including supply arrangements and use;

(c)      therapeutic alternatives  to the relevant medicine, including supply arrangements and use

18

TGA management action

details of action that has been or is being taken by the TGA in relation to managing the shortage

19

updated

date that the entry was last updated

 

In this Part:

                   low impact, in relation to a shortage of a medicine that is not of critical impact, means a shortage that is assessed as low patient impact in accordance with the assessment framework set out in the Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration published in May 2014.

                   medium impact, in relation to a shortage of a medicine that is not of critical impact, means a shortage that is assessed as medium patient impact in accordance with the assessment framework set out in the Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration published in May 2014.

Note:          The Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration can be found on the internet (and viewed for free) on the internet at http://www.tga.gov.au.


 

Part 4—Information relating to a decision to permanently discontinue the supply of a medicine that was made before 1 January 2019

 

For each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.

 

Kinds of  therapeutic goods information

Column 1

Item

Column 2

Information                           

Column 3

Description

1

name of medicine

the trade name or brand name of the medicine, that was the subject of a notification to the Secretary under the MSII (the relevant medicine)

2

active ingredient(s)

the active ingredient, or active ingredients, of the relevant medicine

3

strength

the strength of the relevant medicine

4

dosage form

the dosage form of the relevant medicine

5

container

the type of container of the relevant medicine

6

registration number

the registration number of the relevant medicine

7

therapeutic class

the ATC code for the relevant medicine’s active ingredient under the ATC classification system

Information about the sponsor:

8

sponsor name

the name of the sponsor of the relevant medicine (the relevant sponsor)

9

sponsor's nominated public contact details

an Australian telephone number and/or email address nominated by the relevant sponsor for the purposes of responding to enquiries from the public seeking additional information about the relevant medicine

10

sponsor's nominated  website details

the website address (URL) nominated by the relevant sponsor for the purposes of providing the public with additional information about the relevant medicine

Information about the discontinuation:

11

status of the discontinuation

whether the relevant medicine will be or has been permanently discontinued by the relevant sponsor

12

reason for the discontinuation 

the relevant sponsor’s advice as to the general reason for the discontinuation decision, as follows:

(a)     commercial reasons;

(b)     manufacturing:

(c)      product recall;

(d)     unexpected increase in demand; or

(e)    other

13

market deletion date

the sponsor’s advice as to the date from which the sponsor will cease, or has ceased, supply of the relevant medicine to the Australian market

14

 

availability level

the relevant sponsor’s advice as to the current availability level of the supply of the relevant medicine, as follows:

(a)     available¾there are no constraints or restrictions on supply;

(b)     limited availability¾the relevant medicine is available in limited quantities throughout the supply chain;

(c)      only available under government programs ¾ in relation to a medicine that is a vaccine, the medicine is only available for Commonwealth (NIP) or State and Territory government immunisation programs and is not available in the private market;

(d)     emergency supply only¾the relevant sponsor is imposing controls on the supply of the relevant medicine; or

(e)      unavailable¾the relevant medicine is not available

15

patient impact

whether the impact of the discontinuation is:

(a)     critical;

(b)     medium; or

(c)      low

16

supply details and other information

any information, or links to any information, in relation to:

(a)     the supply arrangements in relation to the relevant medicine;

(b)     substitute medicines for the relevant medicine, including supply arrangements and use;

(c)      therapeutic alternatives  to the relevant medicine, including supply arrangements and use

17

TGA management action

details of action that has been or is being taken by the TGA in relation to managing the discontinuation

18

updated

date that the entry was last updated

 

                   In this Part:

                   low impact, in relation to a discontinuation of a supply of a medicine that is not of critical impact, means a discontinuation that is assessed as low patient impact in accordance with the assessment framework set out in the Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration published in May 2014.

                   medium impact, in relation to a discontinuation of a supply of a  medicine that is not of critical impact, means a discontinuation that is assessed as low patient impact in accordance with the assessment framework set out in the Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration published in May 2014.

Note:          The Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration can be found on the internet (and viewed for free) on the internet at: http://www.tga.gov.au.