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Risk management plans for medicines and biologicals
Australian requirements and recommendations
Australia-specific annex to the EU RMP
The Australia‐specific annex (ASA) provides details not included in the EU RMP that enables the EU RMP (or, core or global RMP if no current EU RMP exists) to be adapted to the Australian context.
The ASA is required:
- to document any differences in safety concerns between the EU and Australia (which may include differences in the frequency, severity or nature of safety concerns resulting from differences in the epidemiology of the indication and target population) and ensure that these are taken into account in determining an adequate risk management system
- to document any risk management activities not reflected in the EU RMP that are required to adequately address the safety concerns in Australia (such as differences between the EU SmPC and Australian PI in the wording of precautions or contraindications, or additional pharmacovigilance activities required by the TGA)
- to record details of the dissemination and evaluation of effectiveness of risk minimisation activities in Australia (which would be determined at a national level in the EU and are not reflected in the EU RMP)
- to record milestones and timelines for reporting on additional pharmacovigilance and risk minimisation activities to the TGA
Information needed in the ASA
The ASA should provide Australian‐specific information that is important in assessing:
- the risk in Australia (and therefore appropriateness of proposed plans and activities)
- whether there are any safety concerns that may be unique to Australia
- the relevance of international product vigilance and risk minimisation activities to Australia, and reasons for any differences from activities planned overseas
When is an ASA required?
You must submit an ASA with the EU RMP (or alternative RMP where no current EU RMP exists).
Are there any exceptions to this requirement?
The only situation where an ASA is not routinely required is if the RMP has been prepared specifically for Australia (because there is no EU RMP, core RMP or global RMP).
Format and content of the ASA
You should prepare the ASA using the template (which includes guidance for drafting the ASA). If you choose not to use the template provided, then you must ensure all the information required in the template, is included in your ASA.
The latest version of the template was published in March 2019.
New ASAs submitted with applications after 31 March 2020 should contain the information required in the updated version of the template.
ASAs first submitted prior to 31 March 2020 may be maintained in the format described in v3.1 (November 2017) of Risk management plans for medicines and biologicals: Australian requirements and recommendations.
You should include, as appendices to the ASA:
- additional risk minimisation materials to be implemented in Australia,
- targeted follow-up forms to be used in Australia, if they are not attached to the EU RMP, and
- protocols for any additional pharmacovigilance activities that appear only in the ASA.