Feedback sought: Export of therapeutic goods from Australia and adoption of EU guidelines


The TGA is seeking feedback on two consultations, into the guidelines for the export of therapeutic goods from Australia, and the proposed adoption or non-adoption of a multitude of EU and ICH guidelines.

Export of therapeutic goods from Australia – closing 3 February

The updated guidance provides clarification on the TGA’s export policy for medicines and export certification for medical devices, and the TGA is seeking feedback.

To export therapeutic goods from Australia, certain regulatory requirements set out in Australia's therapeutic goods legislation, in addition to other relevant Commonwealth and state or territory legislation, must be met.

The TGA invites feedback on:

  1. Is it beneficial to allow submission of electronic schedules to accompany a Certificate of Pharmaceutical Product (CPP) or a Certificate of Listed Product (CLP) application?
    Export documents currently need to be provided to the TGA in hard copy, as this was a requirement of importing countries over 15 years ago. Would the option to submit electronic documents (where acceptable to the importing country) be beneficial?
  2. Is it beneficial for the TGA to provide a traceable post for all hard copy certificates? This may incur an appropriate fee increase.

Read more about the consultation.

Consultations on Adoption of European Union guidelines in Australia – closing 7 February

The TGA is seeking feedback on a proposed 18 guidelines for adoption and one for non-adoption.

Read more about the consultation.

Feedback can be proivded direct to the TGA or to AusBioetch via Andrew Mosley, Director Policy and Programmes.