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ACM meeting statement, Meeting 10, 2 August 2018
Advisory Committee on Medicines
Section A: Submissions for registration
The committee's advice was sought on seven new pre-market applications for prescription medicines, as tabulated below.
|Number of applications||Application type||Main consideration by ACM|
|7||Type A - New Chemical /Biological Entities/Biosimilar||For general consideration|
Further details of the ACM discussions and advice associated with pre-market items are released within the Australian Public Assessment Reports (AusPARs) for each new active. Please note that there is a delay from when an application was considered at ACM, and the publication of the AusPAR. Browse all AusPARs.
Section B: Post-Market items referred for advice
No pharmacovigilance items were discussed.