Risk management plans for medicines and biologicals

12 December 2017

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Australian-specific annex to the EU RMP

The Australian‐specific annex (ASA) enables the EU RMP (or, if no current EU RMP exists, then a core or global RMP) to be adapted to the Australian context.
The ASA is required because global activities proposed in the EU RMP may differ from those planned for Australia. For example, the sponsor may propose different wording for the Australian PI than that proposed in the EU RMP for the SmPC.

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/activities)
  • the relevance of product vigilance and risk minimisation activities to Australia, and identify and explain the reasons for any differences from activities planned overseas (this includes product information statements)

If an RMP activity to be conducted overseas will not include Australian data, the ASA should address the applicability of that activity to the Australian context.

When is an ASA required?

Submit an ASA with the EU RMP, or an alternative RMP if no current EU RMP exists.

The only situation where an ASA is not routinely required is if:

  • the RMP submitted will be applied in its entirety to Australia

AND

  • there are no differences to its implementation (i.e. the pharmacovigilance and risk minimisation activities proposed for Australia are identical to that proposed in the RMP, including product information statements).

If this is the case, ensure this is specifically stated.

Format and content of the ASA

The ASA template provides guidance when drafting ASAs.

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