Risk management plans for medicines and biologicals
Australian-Specific Annex template
1.1 Purpose of Australian Specific Annex for this Risk Management Plan
The Australian‐specific annex (ASA) should:
- provide Australian‐specific information that is important in assessing and managing the risk in Australia (and therefore appropriateness of proposed plans/activities) and the relevance of pharmacovigilance and risk management activities in Australia
- identify and explain the reasons for any differences from activities planned overseas
- address the applicability of global activities to the Australian environment, if no specific Australian data will be collected
1.2 Registration history
Provide the Australian registration history including:
- current and previous application types (e.g. New Chemical Entity, line‐extension etc.)
- orphan status
- pertinent dates
- ARTG number(s) as appropriate
- a summary of previously submitted and approved, withdrawn or rejected Australian applications
- a summary of any submissions currently under evaluation (include relevant application numbers)
- a table comparing the approved and/or proposed indications in Australia and the EU, identifying and explaining the reasons for any differences
1.3 History of RMPs submitted in Australia
Provide information on the RMPs previously submitted for evaluation in Australia for the product.
Include a tabulated history of all RMPs submitted in Australia pertaining to the product (with summary of changes between versions, unless this is clearly included in the EU RMP).
1.4 Epidemiology of the population to be treated in Australia
Provide Australian epidemiological information on the population to be treated:
- information relating to the size of the target population
- any specifics that need to be known in assessing use in Australia
For each indication, discuss:
- incidence and prevalence
- demographics of the target population (age, sex, race/ethnic origin)
- risk factors for the disease
- main treatment options
- mortality and morbidity (natural history)
2. Pharmacovigilance Plan
2.1 Pharmacovigilance Organisation in Australia
Include confirmation that the local pharmacovigilance organisation is operating in accordance with current TGA guidelines for responsibilities of sponsors.
2.2 Routine Pharmacovigilance Activities
Describe routine activities carried out in Australia (including targeted questionnaires).
Include justifications for any routine activities included in the EU RMP that are not to be implemented in Australia.
For biologicals, a detailed description of the biovigilance system in Australia should be provided, including:
- a summary of the sponsor's routine biovigilance activities
- details of the elements of the biovigilance system needed to support the additional biovigilance activities included in the RMP
- details of procedures for traceability of products from donor to recipient, and recipient to donor, to investigate and act on possible disease transmission
2.3 Pharmacovigilance activities for safety concerns specific to Australia
This section should include details of any safety concerns for Australia that are additional to those proposed in the EU RMP.
Relevant information includes:
- why the additional safety concern is included in the ASA (e.g. TGA requirement)
- the Australian pharmacovigilance plan for each additional safety concern
If the pharmacovigilance plan for the specific safety concern includes additional activities then provide details.
If there are no additional safety concerns for Australia then state this.
2.4 Studies Referenced in the Pharmacovigilance Plan of the RMP
Outline the differences, if any, between the additional pharmacovigilance activities proposed in the EU RMP and those proposed for Australia.
Ensure you consider the following when completing this section:
- Whether Australia is involved in each pharmacovigilance study outlined in the EU RMP. If not, provide a brief justification for how each study is still considered applicable and/or relevant to Australia. If an EU RMP pharmacovigilance activity is not considered applicable or relevant to the Australian environment, provide a justification for this.
- Include details of any Australian‐specific studies that are not detailed in the EU RMP, but are part of the pharmacovigilance plan for Australia. Such activities should be clearly assigned to an existing safety concern (suggested table format below). If Australian‐specific studies are referenced in the ASA, provide (as a minimum) copies of draft protocols for these studies.
- If dates for submission of study results in Australia differ from the dates proposed in the EU RMP, provide a summary table setting out the anticipated dates for their submission in Australia.
Studies Referenced in the Pharmacovigilance Plan of the RMP – suggested format
|Additional activity||Assigned Safety Concerns or Missing Information||Actions/ outcome proposed||Australian involvement||Planned submission of data in Australia|
Additional activity (with unique title and protocol ID)
|List of Assigned Safety Concerns or Missing Information||Summary of proposed actions and/or outcomes||Yes/No||Include interim and final dates|
3. Risk Minimisation Plan
3.1 How risk minimisation activities will be implemented in Australia
If relevant, describe and provide detail about any additional risk minimisation activities to be undertaken in Australia. If applicable, provide (as a minimum) copies of draft Australian educational materials.
Identify and justify the differences between risk minimisation activities in the EU (as detailed in the EU RMP) compared to those proposed for Australia.
Provide a table comparing all planned risk minimisation measures for Australia with those proposed in the EU (suggested format below). Include in the table wording relating to all the specified Safety Concerns and Missing Information items in the proposed Australian PI and CMI.
How risk minimisation activities will be implemented in Australia – suggested format
|Safety Concerns or Missing Information||Risk minimisation activities (routine and additional) proposed in the EU RMP||Risk minimisation activities (routine and additional) proposed for Australia||Differences between EU and Australian activities with justification|
If routine and/or additional activities differ for Australia from that proposed in the EU RMP, provide justification for these differences
3.2 Potential for medication errors or other risks if applicable
Include Australian information (if available) on the potential for medication errors or other risks, for example, if an extension of indication or new dosage form is proposed.
3.3 How risk minimisation activities will be evaluated in Australia.
Provide detail about how and when evaluation of additional risk minimisation activities, including educational activities, will be undertaken and reported to the TGA.
You must demonstrate that the measures used to mitigate risk are working and, if not, what actions will be taken to ensure effectiveness.
4. Summary of the RMP
Provide a table briefly summarising the pharmacovigilance and risk minimisation activities proposed for Australia (suggested format below).
Summary of the RMP
|Safety Concerns or Missing Information||Pharmacovigilance activities (routine and additional) proposed for Australia||Risk minimisation activities (routine and additional) proposed for Australia|
5. Person responsible for this RMP and contact details
This should be the person responsible for the implementation of activities in the RMP within the sponsor company, and will usually be the Australian Contact Person for Pharmacovigilance ('the nominated contact person').
Provide a reference list, if required.
This section allows for flexibility of submitting additional (relevant) documents as appendices to the RMP (e.g. Australian‐specific educational materials).