Today's member alert contains clarifying information for members who are involved in the sale, labelling, or advertising of listed medicines with substances derived from seafood (fish, crustacea or mollusc). These warning statements have been in a state of change to modernise warning statements and changes are still occurring.
Today’s alert includes a summary overview of current regulatory status relating to seafood warnings (both current and likely forthcoming due to existing consultations) and recently revised eBS Code Table warnings and listed medicine validation rules for sponsors.
A selection of sponsors may notice ARTG changes on some listings, affected sponsors will be contacted by the TGA about changes and opportunities to update ARTG records without charge in the near future. Sponsors who are not contacted may also choose to update ARTG records with updated warnings described in this alert as per normal processes (Noting that the ARTG record does not affect legislative requirements, which continue to apply irrespective of the ARTG record).