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You require this licence to manufacture Schedule 4 medicines (restricted drugs), including for veterinary use.
A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.
Before applying for a licence you must ensure your premises meets stringent construction requirements.
This licence remains in effect for 12 months from the day it is granted. A renewal notice will be issued to you annually.
This licence cannot be transferred.
Contact the Therapeutic Goods Administration in Canberra on 1800 020 653 for additional information on Commonwealth requirements.
Chief Health Officer Branch
Medicines Regulation and Quality
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