Risk management plans for medicines and biologicals

12 December 2017

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Australian-Specific Annex template

1. Introduction

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

Include:

  • a summary of previously submitted and approved, withdrawn or rejected Australian applications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

OR

  • 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

For biologicals, replace 'pharmacovigilance' with 'biovigilance'.

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)
[Hyperlink to study protocol]

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
Item 1

Routine activities
Include exact wording for EU SmPC statements proposed for this safety concern

Additional activities
Include details of  additional activities to be undertaken for this safety concern in the EU

Routine activities
Include exact wording for Australian PI statements proposed for this safety concern

dditional activities
Include details of additional activities to be undertaken for this safety concern in Australia

If routine and/or additional activities differ for Australia from that proposed in the EU RMP, provide justification for these differences

Item 2

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

Item 1

Routine activities
e.g. Routine pharmacovigilance targeted questionnaire
Additional activities
Include study title or identifier
[Less detail than the previous tables: summary only]

Routine activities
e.g. Section of the PI and/or CMI
Additional activities
e.g. Educational programme
[Less detail than the previous tables: summary only]

Item 2

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').

6. References

Provide a reference list, if required.

7. Appendices

This section allows for flexibility of submitting additional (relevant) documents as appendices to the RMP (e.g. Australian‐specific educational materials).

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