Fixed combination prescription medicines

Information on registration of fixed combination prescription medicines.

Last updated

26 May 2014

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A 'fixed combination' medicine contains more than one active ingredient.

The active ingredients may be present as:

separate entities
a mixture
in a chemical combination which is intended to degrade into the active components in vivo.

They may be either:

in the same dose form (for example, tablet)
in separate dose forms packaged in a manner which indicates they are to be taken together.

The benefits of these include:

the simplification of therapy (leading to improved medical compliance)
one active substance counteracting an adverse reaction produced by another active substance within that combination medicine.

Steps to register a new fixed combination medicine

Prior to lodging a Pre-submission Planning Form with us, prepare a 'Justification for fixed combination'*.

This should usually be less than 2 pages in length and prepared according to the EU guidelines adopted in Australia.

Ensure you justify:

the particular combination
the type (and extent) of data to be submitted with the application.

* This requirement does not apply to vaccines.

Submit your justification to us in an electronic format (i.e. via email with attachments, or on a CD/DVD):
- Applications via email should be sent to streamlinedsubmission@tga.gov.au
  (Ensure you include the words 'Justification for fixed combination' in the title)
- Applications submitted on a disc (CD-R or DVD-R, see General dossier requirements for prescription medicines) should be sent to:
  - Postal address:
    Office of Medicines Authorisation
    Therapeutic Goods Administration
    PO Box 100
    Woden ACT 2606
    Australia
  - Street address:
    (for deliveries)
    Office of Medicines Authorisation
    Therapeutic Goods Administration
    27 Scherger Drive
    Fairbairn ACT 2609
    Australia
We will review the applicant's justification and advise them whether the justification for the fixed dose combination is acceptable.
If your justification is accepted, ensure you attach a copy of our letter advising this to the Pre-submission Planning Form when lodging the application.

Active ingredients not currently included on the ARTG 'in combination'

If the component active ingredients are registered but not currently included 'in combination' on the ARTG, either:

submit quality, nonclinical, and clinical studies of the combination
provide a justification for the absence of any of these studies.

Active ingredients not currently included on the ARTG

If one or more of the component active ingredients is/are not registered, ensure the justification includes the dossier lodgement dates for the unregistered components and the fixed combination product.

If you propose to submit concurrent applications to register a new chemical entity and a new combination (where the combination product contains the new chemical entity), ensure you lodge complete applications (at the same time) for both:

the new chemical entity
the new combination.

If you propose to submit an application to register a new combination prior to a component active ingredient being registered*, ensure the combination application is a 'stand-alone' application which includes a full dossier for: