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Decision tree
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Disclaimer
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This GMP decision tree aims to assist applicants to determine what type of GMP application may be required. If you require assistance navigating the tool or understanding your outcome, you may wish to contact the Manufacturing Quality Branch or consider engaging a regulatory affairs consultant.
If you have any doubts about manufacturing requirements, it is recommended that you contact the Manufacturing Quality Branch or seek independent legal advice.
The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials. It should be noted that this is general information only.
Question
Do you accept the above terms?