TGA use only

This form, whencompleted, willbeclassified as 'For official use only'.
For guidance on how your information willbetreated by the TGA see: Treatment of information provided to the TGA at <

Application for

certificate of free sale

export certificate

for a therapeutic device/medical device

Export certification for therapeutic goods can only be issued for a product that has been registered, listed, included or is exempt from the requirement to be on the Australian Register of Therapeutic Goods (ARTG) under the Therapeutic Goods Act and Regulations.

Section 1. Client details

1.Sponsor business name
2.Sponsor postal address
Postcode
3.Sponsor business address
Postcode
4.Email address
5.Contact person
6.Contact numbers / Phone / Facsimile

7.Have you previously submitted a ‘Client Details’ form?Yes No

If yes, give your Client Identification number: / If no, please submit a ‘Client Details’ form (available from TGA website
8.Country(ies) requesting export certification / 1. / 4. / 7.
2. / 5. / 8.
3. / 6. / 9.

(Each country will require a separate certificate)

9.Number of identical certificates required
(5 copies per country maximum) / X / Processing fee for each = / Aust $

Please make cheques payable to Therapeutic Goods Administration. For credit card payment, please use the credit card authorisation form which is located on the TGA website

For fee amounts, see the summary of fees and charges on the TGA website

Section 2. Manufacturer details

(This is the manufacturer who is responsible for ‘Release for Supply’ — i.e. the manufacturer that determines if all manufacturing & Quality Assurance requirements have been met)

10.Manufacturer name
11.Manufacturer’s full site address
Post code:
12.Manufacturer Client Identification Code
13.Manufacturer’s Australian GMP Licence Number
(if applicable)

Section 3. Product details

14.The product requiring certification is:

Exempt from Registration/Listing on the ARTG

A Listed Therapeutic Device on the ARTG

A Registered Therapeutic Device on the ARTG

A Listed Therapeutic Device/Included Medical Device on the ARTG for EXPORT ONLY

An Included Medical Device on the ARTG

Product name / Trade name / GMDNS codes (if applicable)

More than one product can be included on the certificate if same manufacturer applies.

15.AUST R/AUST L or Inclusion number(s)

16.Is this product to be exported with a different name to that given in question 14?

YesNo

If yes, give the export name to be used

Section 4. Product material supplied with application

17.Please indicate if a schedule is to be attached to the certificate:Yes: No:
(See below for further explanation on attaching schedules)

Section 5. Schedules

Information such as labelling, product information and product formulation need only be supplied if required by the intended Country of import. This information will be attached to the certificate as a schedule and should be provided on the Sponsor’s company letterhead.

The top of any schedule should be headed: Schedule 1, 2 etc to Certificate Number……(leaving enough space for a certificate number to be added). A sub heading should also be included indicating the contents of the Schedule. If any schedule requires more than one page, subsequent pages should have the same heading followed by ‘page 2’ etc.

For those applicants who quote an Inclusion Number with several product names/models (>5 products), it is recommended that a schedule is provided indicating the products covered by the nominated GMDNS Codes(s). Certificates will only illustrate the GMDNS Code unless product names/models are indicated on the application (question 14).

Section 6. Sponsor declaration

Sponsors should note that the Crimes Act 1914 provides penalties for false or misleading Representations to the Commonwealth.

  • I declare that the product identified in this application is identical with that supplied, or approved for supply, for use in humans in Australia and that this supply is made in accordance with any conditions of approval to which the supply of the product is the subject under a law of the Commonwealth or of a State or Territory, and that the information contained in this application is current and correct.

It is the sponsor’s responsibility to ensure this application is accompanied by all relevant documentation. This includes the appropriate application fee(s).

Applications which are incomplete or contain incorrect information are liable to be rejected under either Section 23(2) or 41FC(2) of the Therapeutic Goods Act 1989, as applicable to the type of goods.

Name (please print)
Your position/title/office in
relation to the sponsor
Signatureof authorised person / Date

Send the completed original application form & fee to:

Financial Services Group
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia

Application for certificate of free sale or export certificate for a therapeuticdevice/medicaldevice(July 2014)

For official use onlyPage 1 of 4