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ACM meeting statement, Meeting 10, 2 August 2018

Advisory Committee on Medicines

4 September 2018

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.

Further information

For further information on the ACM, please visit Advisory Committee on Medicines or contact the ACM Secretary by email .