TGA in bid to force drug companies to report medicines shortages

Those who don’t comply may face fines or even jail

Mandatory reporting of all medicines shortages could be introduced in January 2019, according to a TGA consultation paper.

rule book

And the Federal Government is considering legislation to force manufacturers and sponsors to comply.
The TGA has released options for classifying a medicine shortage and a draft of list medicines that would be subject to mandatory reporting.

Options include:

  • Manufacturers have to report the shortage as soon as they are aware of it or within two days of being queried by the TGA about a possible shortage.
  • Naming and