Note that an Australian Register of Therapeutic Goods (ARTG) entry is not limited to the information visible in the public ARTG entry. It also includes any supporting information provided with the dossier or subsequent variations that are held by TGA and were considered to be relevant to the initial decision.
For matters that would have been relevant to the initial decision to include the biological in the ARTG:
- You need to request and receive our approval for any variations or changes to or in relation to the biological.
- This is to satisfy a condition imposed at the time of inclusion in the ARTG.
Guidance and resources
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User guideThis form is used to include a new biological or vary an existing biological on the ARTG