The Australian Registry of Therapeutic Goods (ARTG) has made measures to help patients deal with the consequences of medication shortages, including the temporary import or supply of an internationally licensed pharmaceutical in place of one that is in limited supply. Australian drugs were previously covered by the ARTG, and the TGA Australia Drug Shortage Reports Database has undergone revisions to increase the accuracy of the data. These modifications make the criteria for updating and addressing shortages clearer by TGA Australia.
Changes in Import and Distribution of pharmaceuticals from outside
The Australian Registry of Therapeutic Products (ARTG) allows for the import or supply of an overseas drug in the best interest of public health. This is a stand-in for drugs that were previously registered in Australia and could be used to prolong patient access if the medicine is canceled or removed from the ARTG but is still therapeutically significant.
Notification of modifications to medicine shortage periods and resolution
- Sponsors must inform us when a drug shortage period changes and when the shortfall is resolved.
- TGA must be informed of any modifications to the length or termination date of the shortage and its resolution..
- All notifications of medication shortages in Australia must include the duration of the medication shortage.
- The reporting deadlines correspond to the initial impact rating. In the best interests of the affected patients, notification should take place as soon as feasible.
- Modifications to the shortage term or end date for important shortages must be notified within two working days after learning about them.
- Modifications to the period or end date for any other shortfalls must be notified within 10 working days of learning about the change.
The American Medical Association (AMA) has introduced regulations to help alleviate the effects of medicine shortages on patients and provide up-to-date information to patients and health professionals. The Medicine Shortage Reports Database is maintained to help health professionals and patients manage shortages by updating the shortage details and clarifying sponsor responsibilities.
Implementation
Important modifications to Section 19A of the Act’s framework for the import and supply of unapproved medicines:
Changes to the import or supply of medicines from overseas
| What | When |
| New application type – section 19A(2A) | Applies as of March 22, 2023 |
| New application type – section 19A(2B) | Applies as of 22 March 2023 |
Notify of any changes to the period or resolution of a drug shortage
| Period of shortage – section 3(1), 30EIA, 30EF(4)(a) | Applies to notifications of medication shortages made on or after September 22, 2023 |
| Reporting changes to the period of a medicine shortage – section 30 EFA | Applies to notices of medication shortages having an end date on or after September 22, 2023, regardless of when the shortfall was initially reported. |
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Source: TGA.gov
