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TGA - Therapeutic Goods Administration

03/29/2019 | News release | Distributed by Public on 03/29/2019 03:15

Submission of an updated RMP

These forms are available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

Use this form when submitting an updated RMP after regulatory approval. This form should be submitted in module 1.0.1 and the updated RMP in module 1.8.2.

Submit your updated RMP/ASA as a NeeS/eCTD sequence.

See 'Risk management plans for medicines and biologicals: Australian requirements and recommendations' for information about when to submit updated RMPs.

How to access a pdf or Word document