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Risk management plans for medicines and biologicals

Australian requirements and recommendations

29 March 2019

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How to tell us if you will be submitting an RMP with an application

Medicines RMP submission

Ensure you accurately indicate whether you will be submitting an RMP by completing the information relating to CTD Module 1.8 in the Pre‐submission Planning Form (PPF).

Provide a justification if you think an RMP is not necessary. If we advised you that an RMP would not be required before you submitted the PPF, please state this in the PPF.

We recommend that you contact us for advice before submitting the PPF if you are unsure if an RMP will be required.

Assessing the requirement for an RMP

We will consider the information you provide in the PPF and tell you whether you need to submit an RMP in the planning letter (standard applications) or notification letter (PPF only applications).

If we conclude that you should submit an RMP with the application, but you have indicated in the PPF that you do not intend to submit an RMP, we will tell you that an RMP must be submitted for evaluation. If we previously advised that an RMP was not required, then we will work with you to develop an agreed timeframe for submission.

If you indicate you will be submitting an RMP, but we conclude that it is not a requirement, we will tell you that you do not need to submit an RMP.

If you submit an RMP with a 'PPF only' application, and we determine that it is not a requirement, we will tell you that your RMP will not be evaluated for the purposes of the application. If your product is already registered, we will ask you to consider whether you should submit your current RMP as a post-approval update. If so, you should complete and submit the 'Submission of an updated RMP' form (see Submitting RMP updates after regulatory approval).

For products approved with an RMP as a condition of registration, the RMP should be maintained throughout the remainder of that product's lifecycle (even if we do not request an RMP for evaluation with applications for extensions of indication or other changes).

Biologicals RMP submission

We will assess the requirement for an RMP during any pre-submission process or during the screening of an application following receipt.

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