Risk management plans for medicines and biologicals
How to tell us whether you'll be submitting an RMP with an application
Ensure you accurately indicate whether you will be submitting an RMP by completing the information relating to CTD Section 1.13 in the Pre‐submission Planning Form (PPF).
If an RMP is not mandatory
If it is not mandatory to submit an RMP, and you think an RMP is unnecessary, ensure you provide a brief justification.
Assessing the requirement for an RMP
We will assess the requirement to submit an RMP at the Pre‐submission Planning stage of the application process. This applies to applications for:
- a new combination of well‐known active ingredients commonly used together
- low-risk changes to indication, population, form, strength, dose and route of administration
Where we conclude that the change to the registration of a medicine does not demonstrate a new or increased level of risk to the consumer, we will advise you that you do not need to submit an RMP for evaluation with your application. However, we expect that the you will continue to maintain any existing RMP relating to the product(s).
If we conclude that the change to registration may result in a new risk or heightened level of risk, and you have indicated that an RMP will not be submitted in the PPF, we will notify you that an RMP must be submitted for evaluation.
We will assess the requirement for an RMP during any pre-submission process or during the screening of an application following receipt.