The TGA has issued a Guidance for Sponsors and stakeholders regarding the management and reporting and communication of medicine shortages and discontinuations in Australia.
From January 1 2019 all medicine sponsors are required to report to the TGA medicine shortages and discontinuation as publication is now mandatory.
Some definitions as per TGA website:
“A medicine shortage is defined in the Act as:
a shortage of a medicine in Australia at a particular time if, at any time in the 6 months after that particular 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.
A shortage of a reportable medicine must be reported to the TGA within legislated timeframes.
The discontinuation of the supply of a medicine (a permanent shortage) must also be notified to the TGA as outlined in the legislation:
- if the discontinuation is likely to be of critical impact:
- at least 12 months before the discontinuation is proposed to occur; or
- if the person is unable to comply with subparagraph (i) – as soon as practicable after the decision is made; or
- in any other case:
- at least 6 months before the discontinuation is proposed to occur; or
- if the person is unable to comply with subparagraph (i) – as soon as practicable after the decision is made.
A discontinuation refers to a medicine no longer being available in the marketplace; it does not refer to the cancellation of the Australian Register of Therapeutic Goods (ARTG) entry from the Register. Information about discontinuations will be visible on the Medicines Shortage Information Initiative website for a limited time period (12 months from the deletion from market date provided by the sponsor).”