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 2 Commencement 3 Authority 4 Definitions 5 Repeals 6 Therapeutic goods information Schedule 1—Repeals Therapeutic Goods Information (Medicine Shortages Information Initiative) Specification 2014 Schedule 2—Specified kinds of therapeutic goods information Part 1— Information relating to a shortage of a medicine that arises on or after 1 January 2019 Part 2— Information relating to a decision to permanently discontinue the supply of a medicine that is made on or after 1 January 2019 Part 3—Information relating to a shortage of a medicine that arose before 1 January 2019 Part 4—Information relating to a decision to permanently discontinue the supply of a medicine that was made before 1 January 2019 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of this instrument 1 January 2019. 1 January 2019 Note: This table relates only to the provisions of this instrument as originally made.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. 5 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 Column 2 Column 3 Item Information 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 shortagethe date the shortage commenced; (b) for an anticipated shortagethe 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) availablethere are no constraints or restrictions on supply; (b) limited availabilitythe relevant medicine is available in limited quantities throughout the supply chain; (c) only available under government programs  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 onlythe relevant sponsor is imposing controls on the supply of the relevant medicine; or (e) unavailablethe 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 Column 2 Column 3 Item Information 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) availablethere are no constraints or restrictions on supply; (b) limited availabilitythe relevant medicine is available in limited quantities throughout the supply chain; (c) only available under government programs  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 onlythe relevant sponsor is imposing controls on the supply of the relevant medicine; or (e) unavailablethe 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 Column 2 Column 3 Item Information 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 shortagethe date the shortage commenced; (b) for an anticipated shortagethe 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) availablethere are no constraints or restrictions on supply; (b) limited availabilitythe relevant medicine is available in limited quantities throughout the supply chain; (c) only available under government programs  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 onlythe relevant sponsor is imposing controls on the supply of the relevant medicine; or (e) unavailablethe 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 Column 2 Column 3 Item Information 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) availablethere are no constraints or restrictions on supply; (b) limited availabilitythe relevant medicine is available in limited quantities throughout the supply chain; (c) only available under government programs  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 onlythe relevant sponsor is imposing controls on the supply of the relevant medicine; or (e) unavailablethe 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.