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Consultation: Export of therapeutic goods from Australia

9 December 2019

This consultation closes on 3 February 2020

Invitation to comment

The TGA is seeking comments from interested parties on an update to guidance for:

  • Export of medicines from Australia
  • Export certification for medical devices

Consultation documents

How to access a pdf or Word document

Export of medicines from Australia

Export certification for medical devices

Consultation questions

We are inviting feedback regarding the following proposals:

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

Timetable

Document released for consultation on 9 December 2019

Interested parties should respond by close of business 3 February 2020.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

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 Therapeutic Goods Administration (TGA) is responsible for administering the therapeutic goods legislation.

This updated guidance provides clarification of TGA export policy.

Content of submissions

Submissions may address any, or all, of the guidance content, proposals or identified issues.

How to submit

Complete the Consultation submission form to upload your submission in either pdf or word format:

Consultation submission form

Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:

Application Entry, Support and Export Section
Prescription Medicines Authorisation Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Enquiries

Any questions relating to submissions should be directed to the Prescription Medicines Authorisation Branch, by email to tga.exports@health.gov.au.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Once finalised, the updated guidance will be published on the TGA website.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.