RMP format

You should submit the most up-to-date version of the EU RMP relevant to the submission, accompanied by an Australia-specific annex (ASA) to document the differences between the plan for Australia and the EU RMP. An EU RMP that is under consideration by the EMA is acceptable if there is no approved version of the EU RMP.

If no EU RMP exists, then you may submit an alternative RMP, such as a global or core RMP. However, it must:

• cover all of the modules of the EU RMP,
• be presented in the current EU RMP format, and
• be accompanied by an ASA

The format for the EU RMP is described in the following guidance:

• EMA/838713/2011 Guideline on good pharmacovigilance practices: Module V ‐ Risk management systems, and
• Guidance on format of the risk management plan (RMP) in the EU — in integrated format. It is acceptable to submit RMPs in the format consistent with either the first revision of the template (EMA/465932/2013 Rev 1) or the second revision of the template (EMA/PRAC/613102/2015 Rev 2).

It is acceptable to submit an 'Australia-specific RMP' if no EU, core or global RMP exists. This is the only situation in which an ASA is not required.

Risk management plans for biologicals should include additional sections about possible risks specific to a biological. Refer to Requirements for RMPs for biologicals for further information.

Risk management plans for generics should follow either the integrated format or abridged format for generics. Refer to Requirements for RMPs for generics for further information.

You should contact us for advice if you are uncertain about which RMP you should submit.

Requirements for RMPs for biologicals

In an RMP for a biological (human cell or tissue product), include discussion of possible risks specific to biologicals that may not apply to other therapeutic products. Refer to:

• EMA/838713/2011 Guideline on good pharmacovigilance practices (GVP) Module V — Risk management systems
• EMEA/149995/2008 Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products, which contains guidance about:
  • the possible risks specific to biologicals
  • biovigilance, efficacy follow-up and risk minimisation activities of particular relevance to biologicals

The concepts and information in these EMA guidelines are applicable to biologicals, despite being focused on medicines and advanced therapy medicinal products (ATMPs), which include a narrower group of products than those regulated under the Australian biologicals framework.

The following information is required for RMPs for biologicals. These additions may be included in the EU RMP or included as an attachment to the Australia-specific annex.

If an RMP section is not applicable to a particular product, do not omit the section, but instead state this in the RMP and provide a justification.

How to access a pdf document

1. consider the specific risks of biologicals. This can be in the safety specification in the EU RMP or in a separate attachment to the Australia-specific annex. For guidance on risks to address refer to:
   • EMEA/149995/2008 (pdf,207kb) Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products, Section 8.1 Safety specifications
2. include a section 'Evaluation of the need for efficacy follow-up' in either RMP Part II or attached to the Australia-specific annex. When a need for efficacy follow-up is identified, the efficacy follow-up plan should be included as an attachment to the Australia-specific annex. Refer to:
   • EMEA/149995/2008 (pdf,207kb) Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products, Section 8.4 Evaluation of the need for efficacy follow-up
3. provide a detailed description of the sponsor's biovigilance system in Australia either in the Australia-specific annex (where an EU, global or core RMP is provided) or in RMP Part III Pharmacovigilance plan (when an Australian RMP is provided). Refer to:

   • Biovigilance responsibilities of sponsors of biologicals: Australian requirements and recommendations

     The description of the biovigilance system should include:

     • 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
4. in the biovigilance plan described in RMP Part III or in the Australia-specific annex, include consideration of safety follow-up issues relevant to biologicals. Refer to:
   • EMEA/149995/2008 (pdf,207kb) Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products, Section 8.3 Pharmacovigilance plan (incorporating safety follow-up)
5. when developing the risk minimisation plan, consider the guidance provided on reducing particular risks of a biological product. Refer to:
   • EMEA/149995/2008 (pdf,207kb) Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products, Section 8.5 Risk Minimisation plan

Requirements for RMPs for generics

RMPs for generics should be submitted in the integrated format (see Guidance on the format of the risk management plan in the EU - in integrated format (Rev 2)).

You should submit the most recent EU RMP, with an ASA, unless there is no EU RMP available, in which case you should submit a core or global RMP with an ASA, or an Australia-specific RMP if no core or global RMP is available.

There is specific guidance regarding the content of the Australia-specific annex for generics. See the Template for the Australia-specific annex to the risk management plan for details.

You should refer to the guidance in Guideline on good pharmacovigilance practices (GVP) Module V, section V.C.1.1.1 about parts of the RMP to be included for generics.

Safety specification

Align the summary of safety concerns for the generic with that of the originator, by referring to sources such as:

• the Australian Public Assessment Report (AusPAR)
• the European Public Assessment Report (EPAR)
• the list of safety concerns per approved RMP of active substances per product, published by the Co-ordination Group for Mutual recognition and Decentralised Procedures — Human

Consider whether there are any safety concerns associated with the generic product, for example:

• if introduction of a generic in a different administration device could increase the risk of medication error with a significant impact on public health or for the individual (for example, lack of efficacy for a life-threatening condition or an increased risk of adverse effects)
• if introduction of a generic without presentations suitable for use by particular patient populations, such as children or people with particular conditions, may require additional education of health professionals

Pharmacovigilance plan

If there are specific adverse-event follow-up forms implemented for the originator, these should also be implemented for the generic.

Risk minimisation plan

An RMP will generally only be required for a generic:

• when the originator has been required to undertake additional risk minimisation activities, or
• where there may be a need for additional risk minimisation activities to address a safety concern specific to the generic

Therefore, in the risk minimisation plan in the RMP/ASA you should:

• describe the proposed additional risk minimisation activities for the generic
• where known, state whether these differ from the additional risk minimisation activities implemented for the originator, and if so
  • provide a justification for each difference

We evaluate the need for additional risk minimisation activities to be undertaken for generic medicines on a case-by-case basis, taking into account factors such as:

• the nature and purpose of the additional risk minimisation activities required for the originator
• whether the additional risk minimisation activities required for the originator are ongoing
• whether the relevant safety concerns are adequately mitigated by routine clinical practice
• any safety concerns specific to the generic

Additional risk minimisation materials for generics should cover the same key safety messages as those for the originator, and any safety concerns specific to the generic. The key safety messages should be included in the Australia-specific annex.

As the risk minimisation in place in Europe is generally similar to that in Australia, risk minimisation materials implemented in the United Kingdom on the electronic Medicines Compendium website (eMC) website can be a useful source of information relating to the additional risk minimisation activities in place for the originator.