Mandatory Drug Shortage Reporting In Australia Starts In January 2019
Drug sponsors will face penalties in Australia if they fail to comply with new rules on the mandatory reporting of medicines shortages that come into effect at the beginning of 2019 to replace the current "ineffective" voluntary system.
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The introduction of mandatory reporting of medicine shortages in Australia has caused a sharp increase in the number of notifications. Most of them related to manufacturing problems, although commercial issues and changes in demand patterns also played a part.
Sponsors are being encouraged to develop effective procedures to ensure compliance with the new requirements, including strict reporting timeframes.
Legislation that would introduce the proposed mandatory scheme for reporting medicines shortages has come before the Australian parliament. Among other things it specifies which shortages would have a "critical impact" on patient health.