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Compounded medicines and good manufacturing practice (GMP)

Guide to the interpretation of the PIC/S Guide to GMP for compounded medicinal products

29 May 2017

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Interpretation - licensing and regulatory/reporting requirements - schedule 5A item 5 condition (c)

Topic PIC/S clause Interpretation
Licensing and regulatory/reporting requirements Schedule 5A item 5 condition (c)

The licence holder is required to notify the Secretary every quarter (within 15 days from the end of that quarter) of the goods manufactured for that quarter and who they were for.

These reports are to be sent to the TGA Experimental Products Section eps@tga.gov.au.

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