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Table column headings explained
The tables below identify the data to be collected within each tab and how it will be used. The column headings are:
- Field title - how the field is described on the notification form.
- Explanation - explanation on why this data is required and what it will be used for.
- Mandatory - is the field required to be completed prior to the notification form being submitted to the TGA. This is further split between information for initial critical notifications only and information for all other notifications.
- Copied - indicates which fields are duplicated when an existing draft notification is copied to create a new draft notification form.
- Published - identifies the fields that will be published on the TGA website.
- Variation - identifies the fields that can be edited when a variation to an existing completed notification is created by a sponsor.
New Medicine Shortage Notification
(Pop-up box – for initial notification only)
| Field title | Explanation | Mandatory | Copied | Published | Variation | |
|---|---|---|---|---|---|---|
| Critical | All others | |||||
| Impact of shortage | As determined by the Sponsor – refer to the Management and communication of medicine shortages in Australia – Guidance for sponsors and other stakeholder bodies. | Yes | Yes | No pop-up box for a copied notification | Yes | No pop-up box for a variation |
| Nature of shortage | As determined by the Sponsor – refer to the Management and communication of medicine shortages in Australia – Guidance for sponsors and other stakeholder bodies. | Yes | Yes | No pop-up box for a copied notification | Yes | No pop-up box for a variation |
Tab 1 - Notifier
| Field title | Explanation | Mandatory | Copied | Published | Variation | |
|---|---|---|---|---|---|---|
| Critical | All others | |||||
| Sponsor Name: | This is prepopulated based on the TBS logon ID used. | Yes | Yes | Yes | Yes | No |
| Sponsor Address: | Select from addresses recorded in TBS for this sponsor. | Yes | Yes | Yes | No | No |
| Australian telephone number for public contact purposes: | This number will be used by the public if further information is sought. | Yes | Yes | Yes | Yes | Yes |
| Medical information email for public contact purposes: | This email will be used by the public if further information is sought. | Yes | Yes | Yes | No | Yes |
| Primary Contact | This will be the point of contact for communications with the TGA – Prepopulated from TBS login. If a different representative from the sponsor is responsible for varying the notification to provide an update these fields will automatically populate with their details. | |||||
| Name: | Prepopulated from TBS login | Yes | Yes | Yes | No | No |
| Phone Number: | Prepopulated from TBS login | Yes | Yes | Yes | No | No |
| Email Address: | Prepopulated from TBS login | Yes | Yes | Yes | No | No |
| Secondary Contact | This will be the point of contact for communications with the TGA if the Primary contact is unavailable. | |||||
| Name: | Chosen from drop-down list | No | No | Yes | No | Yes |
| Phone Number: | Prepopulated with chosen secondary contact name details | No | No | Yes | No | Yes |
| Email Address: | Prepopulated with chosen secondary contact name details | No | No | Yes | No | Yes |
Tab 2 - ARTG entry
| Field title | Explanation | Mandatory | Copied | Published | Variation | |
|---|---|---|---|---|---|---|
| Critical | All others | |||||
| ARTG number of the product that has a supply disruption: | Only those ARTG entries that belong with the TBS logon ID can be accessed. A search using the ARTG number returns the following ARTG entry details:
| Yes | Yes | No | Yes | No |
| ATC Descriptor: | To enable a user of the medicine shortages website to sort by therapeutic class an ATC descriptor needs to accompany the report of the medicine undergoing a shortage. These ATC descriptors are at level 1. | No | Yes | Yes | Yes | Yes |
| Are all pack sizes for this ARTG entry affected? | Approximately 50% of all ARTG entries have multiple packs sizes listed. As all pack sizes under a single ARTG may not have a supply issue this question is used to distinguish these. | No | Yes | No | No | Yes |
| What are the affected pack sizes? | Appears when 'No' radio button is selected for question above. Please describe the pack sizes that are affected by the shortage here. | No | Yes | No | No | Yes |
| Is this ARTG entry listed in the PBS? | If this ARTG entry is listed on the PBS, the Technology Assessment and Access Division will be made aware of the shortage. | No | Yes | No | No | Yes |
| Please provide the PBS number for this listing: | Appears when 'Yes' radio button is selected for question above. The Technology Assessment and Access Division will be made aware of the information | No | Yes | No | No | Yes |
| Do you have the contact details of sponsor's nominated PBS contact? | Appears when 'Yes' radio button is selected for question above. This person will be the point of contact in your company if the Technology Assessment and Access Division needs to contact your company. | No | Yes | Yes | No | Yes |
| PBS Contact Details | Appears when 'Yes' radio button is selected for question above. Used if the Technology Assessment and Access Division needs to contact the responsible person in your company. | |||||
| Name: | Appears when 'Yes' radio button is selected for question above. | No | Yes | Yes | No | Yes |
| Phone Number: | Appears when 'Yes' radio button is selected for question above. | No | Yes | Yes | No | Yes |
| Email Address: | Appears when 'Yes' radio button is selected for question above. | No | Yes | Yes | No | Yes |
Tab 3 - Details
| Field title | Explanation | Mandatory | Copied | Published | Variation | |
|---|---|---|---|---|---|---|
| Critical | All others | |||||
| When was the shortage known to the sponsor? | This is the date on which the sponsor became aware that there was, or will be, a shortage of the medicine in Australia. This date cannot be a future date. | Yes | Yes | Yes | No | No |
| Nature of the shortage: | Has the shortage started, ended or yet to begin? Is the product discontinued? This will have prepopulated based on the decision made in the first New Medicine Shortage Notification pop-up screen. This can be changed here but be aware that changes may result in changes to the nature of fields displayed and the number of mandatory fields in the notification. | Yes | Yes | Yes | Yes | Yes |
| Shortage reason: | Most enquires to the TGA on medicine shortages ask for a reason for the shortage. This is published on the TGA website. Selecting 'Other' brings up a free text box. The free text is not published. Selecting 'Manufacturing' brings up a drop-down list of manufacturing reasons and if other is chosen here there is another free text box to be completed. Only 'Manufacturing' is published as the reason on the TGA website. | No | Yes | Yes | Yes | Yes |
Estimated period supply will be affected at wholesaler points: From: | The 'From date' is the date from which supply of the medicine is affected. The date entered into this field cannot be a date in the past for an anticipated shortage. For both current and anticipated shortages this date cannot be later than the 'To' date below. | Yes | Yes | Yes | Yes | Yes |
Estimated period supply will be affected at wholesaler points: To: | The 'To date' is the date by which the period of shortage is estimated to be over. 'To date' field is not displayed if 'Discontinued' is selected as Nature of the shortage. | Yes | Yes | Yes | Yes | Yes |
| Availability | For Anticipated shortages and resolved shortages 'available' is prepopulated and cannot be changed. For current shortages and discontinuations a drop-down list of levels of availability are available to best represent the current situation of the product. Sponsors should ensure that this is kept current as this is published on the TGA website. Definitions of Availability Levels:
| Yes | No | Yes | Yes | Yes |
| Deletion from market date: | Appears only if 'Discontinued' is selected as Nature of shortage. This is the date at which there is no stock remaining at the sponsor level. This is NOT the date the product is cancelled from the ARTG. | Yes | Yes | Yes | Yes | Yes |
| Do you consent to this notification being published in the interest of public health? | Please note that if you choose 'No' the notification may still be published by the TGA under section 61 of the Therapeutic Goods Act 1989. If this were to happen the TGA would notify the sponsor prior to the notification being published. | N/A | Yes | Yes | No | Yes |
| Proposed date of publication on the TGA Medicine Shortages website: | This is the date you choose to publish the publishable information within this notification form onto the medicine shortages website. Note: the actual publication may be delayed by a couple of days if there is a high volume of notifications to be processed. | Yes | Yes | Yes | No | Yes |
| Is this shortage related to other medicines within the same Therapeutic class? | Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | No | Yes | Yes | No | Yes |
| Please enter the details for the other medicines: | Appears when 'Yes' radio button is selected for question above. Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | No | Yes | Yes | No | Yes |
| Is this shortage specific to Australia? | Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | No | Yes | Yes | No | Yes |
| Estimated normal demand volumes for Australia: | Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | No | Yes | Yes | No | Yes |
| Estimated percentage share of the Australian market: | This refers to the share within the market of products containing the actual therapeutic ingredient not the share of the therapeutic class off the ingredient, for example specific vs NSAIDs. Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | No | Yes | Yes | No | Yes |
| Estimated current stock at sponsor / manufacturing level in Australia: | Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. One unit is defined by the sponsor below. | No | Yes | Yes | No | Yes |
| Estimated current stock at wholesaler / distributor level in Australia: | Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. One unit is defined by the sponsor below. | No | Yes | Yes | No | Yes |
| Please explain what is meant by 1 unit in this context: | By defining what you mean by 1 unit you assist the TGA in understanding the exact situation with respect to product quantities available. This assist TGA in understanding the overall situation as different sponsor use different definitions. | No | Yes | Yes | No | Yes |
Tab 4 - Impact
| Field title | Explanation | Mandatory | Copied | Published | Variation | |
|---|---|---|---|---|---|---|
| Critical | All others | |||||
| Are there therapeutic alternatives on the Australian market? | Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | No | Yes | Yes | No | Yes |
| What is the status of substitute options for this product in Australia? | Appears when 'Yes' radio button is selected for question above. Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. Definitions of the status:
OR
| No | Yes | Yes | No | Yes |
| Are they available in adequate supplies to meet demand? | Appears when 'Yes' radio button is selected for question above. Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | No | Yes | Yes | No | Yes |
| Provide details: | Appears when 'Yes' radio button is selected for question above. Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | No | No | Yes | No | Yes |
| Do any specific population groups use this product? | Examples may be oncology patients, patients with dermatological conditions, paediatric population, etc. Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | Yes | Yes | Yes | No | Yes |
| Provide details of the group and the impact on that group: | Appears when 'Yes' radio button is selected for question above. Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. | No | Yes | Yes | No | Yes |
| Based on your answers to the above and your understanding of the Assessment Framework what ranking would you assign to the product experiencing a supply disruption? | This will have prepopulated based on the decision made in the first New Medicine Shortage Notification pop-up screen. This can be changed here but be aware that changes may result in changes to the nature of fields displayed and the number of mandatory fields in the notification. | Yes | Yes | Yes | Yes | Yes |
Tab 5 - Shortage action
| Field title | Explanation | Mandatory | Copied | Published | Variation | |
|---|---|---|---|---|---|---|
| Critical | All others | |||||
| What communication activities have happened or are planned? | Can select up to 5 options that will assist the TGA in coordinating communications and shortage management in parallel with the sponsor. They are letters to:
The date of communication is the date that you intend to send the letter to the group. If the letters are to be sent out in batches, then the date should reflect the first date that the communication is released. | No | Yes | Yes | No | Yes |
| Are you attaching the letter in the supporting information tab? | This is a reminder to attach the letter on the following tab. If you answer yes here, the notification will not validate without an attachment being present. It is mandatory to answer this question but not mandatory to attach a letter. | Yes | Yes | Yes | No | Yes |
| Further comments on communications: | Will assist the TGA in coordinating communications and shortage management in parallel with the sponsor. This is a free text field to communicate information to the Medicine Shortages Section around communications. | No | No | Yes | No | Yes |
| What supply management actions have happened or are planned? | Can select up to eight options that will assist the TGA in coordinating communications and shortage management in parallel with the sponsor. They are:
| No | Yes | Yes | No | Yes |
| Further comments on management actions: | Will assist the TGA in coordinating communications and shortage management in parallel with the sponsor. This is a free text field to communicate information to the Medicine Shortages Section around sponsor supply management actions. | No | No | Yes | No | Yes |
Tab 6 - Supporting information
| Field title | Explanation | Mandatory | Copied | Published | Variation | |
|---|---|---|---|---|---|---|
| Critical | All others | |||||
| Supporting data will be: | Support information such as a Dear Healthcare Professional Letter can be attached to this notification form or sent to the TGA by other electronic media. If supporting information is to be sent by other electronic media please provide an estimation of the date the support information will be sent to the TGA | No | No | Yes | No | Yes |
Sponsor website: (ONLY where medicine shortage information is available) | This URL will be a link on the medicine shortages website that will take the user to the sponsor's webpage where the sponsor has provided information relating to the medicine shortage or its management. Please note: This website will be published IF AND ONLY IF the sponsor website has information relating to the management of the shortage. | No | No | Yes | Yes, but only if the website relates to the management of the medicine shortage | Yes |