TGA International Harmonisation of Ingredient Names

The Australian Therapeutic Goods Administration (TGA) maintains a terminology for ingredients used in medicines. Over time, some of the ingredient names used in Australia have become inconsistent with internationally-accepted terminology. This can be confusing for Australian consumers who travel internationally, and healthcare professionals who were trained overseas.

A range of changes are required over a four-year transition period. Some will be relatively minor spelling updates to both excipient and active ingredient names. Other name changes will have a more-significant impact including:

  • Dual labelling requirements for affected medicinal products.
  • Updating of Consumer Medicine Information (CMI), Product Information (PI), and Product Summary Pracsoft documents.
  • Re-submission of relevant documents and labels for TGA approval.

MedicalDirector has made relevant changes to its Drug and Allergy listings to assist its users in identifying affected medicinal products. These changes were included with the February 2017 MDref update.

  • Patient Allergies/ADRs reference the new terminology.
  • Prescription prompts/alerts reference the new terminology.
  • The Prescribing or Medication lookup routines reference the new terminology.
  • Patients who had an Allergy/ADR for "Amoxycillin" prior to the Feb2017 MDref update, now display "Amoxicillin" once the update has been applied.
  • When prescribing "Frusemide Tablet", the medication will be listed as either of the following. Please note the prescription references the newer terminology of "Furosemide Tablet".
    • Frusemide (see Furosemide)
    • Furosemide Tablet

There can be some inconsistencies between the names that appear in browse/search results and the names displayed within Clinical:

  • The TGA has provided pharmaceutical manufacturers with a transition period of up to four years to amend all relevant packaging, labels, and documentation. Relevant updates to Clinical will only be applied once they have been made by the associated manufacturer first.
  • MedicalDirector will always represent the content of manufacturer authored documents as supplied.