Commercial – In – Confidence
Client Details
Therapeutic Goods Act 1989
(Sponsor/Manufacturer/Agent)
This form should be completed by or for each Client involved with the supply of the therapeutic goods in Australia for
which the TGA requires address details. Please read all notes carefully to help in completing this form.
Note:



Manufacturers need only complete Sections A and B.
Sponsors and Agents need only complete Sections A and B. Sections C and D need to be completed only if
advising of additional Client representatives or Agents.
If you require access to the eBusinessServices website to electronically view data and submit applications or
variations complete the E-Business Access form, which is available from the eBusinessServices Website at
www.ebs.tga.gov.au by opening the ‘eBS Access Forms’ link.
This form collects information about the legal entity making applications under the Therapeutic Goods Act 1989 and
the authority granted by that entity to others to make applications on its behalf.
Client Business Name
This is the name of the person or corporation/organisation for which particulars are being supplied. It may include a
trading name, but for Australian Clients must include either the registered Company name under the Corporation Act
2001 if a corporation, or the full name of the person, or each partner, who conducts the business.
Give the name of Australian Client as:
 The registered Company name; or
 The full name of the person/each partner conducting the business.
ROLE OF THE CLIENT:
Sponsor - in relation to therapeutic goods, can be a person or corporation who:
 exports, or arranges the export of therapeutic goods from Australia; or
 imports, or arranges the importation of therapeutic goods into Australia; or
 in Australia, manufactures therapeutic goods, or arranges for another person to manufacture therapeutic
goods for supply.
Manufacturer - means a person, corporation or organisation in Australia or elsewhere who:
 produces therapeutic goods, or
 engages in any part of the process of producing the goods or bringing the goods to their final state,
including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or
releasing for sale of the goods or of any component or ingredient of the goods or of any component or
ingredient of the goods as part of that process.
Agent - means any consultant, corporation or other organisation or person who is duly appointed by the sponsor
or Australian Manufacturer to represent them in consultations with TGA. The agent cannot be a
member of the particular Sponsor/Manufacturer Client. Agent does not mean a Sponsor who is the
‘Australian Agent’/distributor of an overseas manufacturer.
If sent separately, please send this form to the address below,
Attention The Information Technology Support Unit, TGA
If you encounter any problems, the contact details of the Information Technology Support Unit are:
Telephone: 1800 010 624
Facsimile: (02) 6232 8581
Email: [email protected]
Fax: (02) 6232 8581
Address: PO Box 100 Woden ACT 2606 Website: www.tga.gov.au
Telephone: 02 6232 8444 Facsimile: 02 6232 8605 ABN 40 939 406 804
Client Details
Section A – Client Information
Client ID
(if known)
Client Role – tick one or more boxes (Australian Agents & Manufacturers may also be Sponsors)
Sponsor
Agent
Manufacturer
PI Supplier
Business Activity of the Client – choose at least one activity
Prescription Medicines
Listed Medicines
Medical Devices
Other, please specify
Export Only
OTC Medicines
Client Business Name
Other Trading Names
(if applicable)
ABN
ACN
(if applicable)
(if applicable)
Street Address
Postcode
Postal Address
(if different)
Telephone
Postcode
(
)
(
)
Facsimile
(
)
(
)
Email Address
Telephone for Billing
(if different)
Facsimile
(if different)
Email Address for
Billing (if different)
Section B - Declaration
Note - The following declaration must be signed in the case of a corporation, by a company director or company
secretary; in the case of other clients, by the owner, partner or individual.
I declare that the above information is correct:
Printed Name
Position
Signature
Date
/
/
Fax (02) 6232 8581
Section C(1) – Client Representative - ADD
Client ID
(if known)
Complete the authorisation below for each person you have appointed to make submissions to the TGA for:
 Registration/variation;
 Listing/variation;
 Inclusion of medical devices;
 Manufacturer licence/evidence;
 To advise of cancellation of therapeutic goods or when applying for exemption from payment of annual charges;
 Seeking information on Client’s registrations or listings
A new authorisation must be completed for all new authorised persons.
Please make additional copies of this Section of the form if more than two representatives are to be nominated.
I,
being a sponsor, or partner, or owner, or Company
Director, or Company Secretary of therapeutic goods in Australia, hereby appoint the person(s) listed below to
provide information and make declarations/cancellations etc, as required under the Therapeutic Goods Act
1989 and the Therapeutic (Charges) Act 1989.
Full Name
Position
Email Address
Telephone No
(
)
Mobile No
Facsimile No
(
)
(
)
Signature
Full Name
Position
Email Address
Telephone No
Mobile No
(
)
Facsimile No
Signature
Declaration – to be made by Partner, Owner, Company Director/Secretary
Position in Company
Company Name
Signature
Date
/
/
Section C(2) – Client Representative - REMOVE
Client ID
(if known)
Complete the authorisation below for each person you wish to remove as a client contact from your company’s details:
Please make additional copies of this Section of the form if more than four representatives are to be nominated.
I,
being a sponsor, or partner, or owner, or Company
Director, or Company Secretary of therapeutic goods in Australia, hereby revoke the person(s) listed below to
provide information and make declarations/cancellations etc, as required under the Therapeutic Goods Act
1989 and the Therapeutic (Charges) Act 1989.
Full Name
Position
Full Name
Position
Full Name
Position
Full Name
Position
Declaration – to be made by Partner, Owner, Company Director/Secretary
Position in Company
Company Name
Signature
Date
/
/
Section D(1) – Agent Authorisation - ADD
Client ID
(if known)
Complete the authorisation below for each agent you have appointed to make submissions to the TGA for:
 Registration/variation;
 Listing/variation;
 Inclusion of medical devices;
 Manufacturer licence/evidence;
 To apply for exemption from payment of annual charges;
 Seeking information on Client’s registrations or listings
I,
being a partner, or owner, or Company Director, or
Company Secretary or a sponsor of therapeutic goods in Australia, hereby appoint:
Agent’s Information
Name of Agency
Client ID of Agency
Telephone No
(
)
Facsimile No
(
)
Agent’s Email Address
Agent’s Signature
As my duly appointed agent to provide information and make declarations etc as required under the Therapeutic
Goods Act 1989 and the Therapeutic (Charges) Act 1989
Client’s Information – to be signed by Partner, Owner, Company Director/Secretary
Printed Name
Company Name
Position in Company
Client’s Email Address
Signature
Date
/
/
Section D(2) – Agent Authorisation - REMOVE
Client ID
(if known)
Complete the authorisation below for each agent you wish to remove as an agent:
I,
being a partner, or owner, or Company Director, or
Company Secretary or a sponsor of therapeutic goods in Australia, hereby remove:
First Agent’s Information
Name of Agency
Client ID of Agency
Second Agent’s Information
Name of Agency
Client ID of Agency
As my duly appointed agent to provide information and make declarations etc as required under the
Therapeutic Goods Act 1989 and the Therapeutic (Charges) Act 1989
Client’s Information – to be signed by Partner, Owner, Company Director/Secretary
Printed Name
Company Name
Position in Company
Client’s Email Address
Signature
Date
/
/