Using the TGA Business Services Portal to apply for manufacturing licences and variations for biologicals.

1. TGA Licensing & Certification Applications
TGA Business Services Portal for TGA manufacturing
licences and variations – biologicals
Paul Oosterwyk – Director, Manufacturers Assessment Support
Nicola Carr – A/g Assistant Director, Licensing & Certification
Manufacturing Quality Branch, Medical Devices and Product Quality Division
Biotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session

2. Agenda
• Introduction
• About the Manufacturing Quality Branch
• TGA Business Services Portal
• Fees & Charges
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3. About the Manufacturing Quality Branch (MQB)
• MQB is part of the Medical Device and Product Quality Division (MD&PQD) in the TGA.
• MQB is responsible for ensuring manufacturers of medicines as well as blood, tissue and cellular therapies,
meet appropriate quality standards. This involves both the physical inspection of manufacturing facilities in
Australia and abroad as well as provision of clearances for facilities where suitable inspections have been
carried out by comparable overseas regulators.
• The branch also coordinates product recalls when necessary and provides technical advice to support
Medicines Regulation Division decisions, particularly on matters relating to manufacturing practice and quality
management.
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4. Licensing & certification applications
Background Information
• All Australian sites participating in the manufacture of the therapeutic goods, unless exempt, must have a
licence to manufacture therapeutic goods issued by the TGA that permits the manufacturing steps and
dosage forms relevant to the goods being supplied, under the Therapeutic Goods Act 1989 and the
Therapeutic Goods Regulations 1990.
• For sites located overseas, a Good Manufacturing Practice (GMP) clearance for the site that permits the
manufacturing steps for the required dosage forms to be undertaken may be required.
• You need to be a TGA client with access to TGA Business Services (TBS) to make an application. Only
Australian manufacturers, sponsors and agents can lodge applications for Licences and / or Certification.
• To lodge applications, log into https://www.ebs.tga.gov.au/
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5. TBS Portal - landing page
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6. Lodging manufacturing applications
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7. Submitting a new licence application
1. Select licence application
2. Complete all mandatory fields in all tabs of the application form
3. Attach the required supporting documents
– For new TGA licences, make a declaration on Certificate 38(1)(g)
– A Site Master File, Quality Manual or equivalent must be prepared and submitted as part of the application.
4. Select ‘Validate’
5. Select ‘Submit’.
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8. Submitting a licence variation application
1. Click on Your TGA -> Manufacturer Information
2. When you locate your licence, double click on it to open the application
3. Click on the 'vary application' button at the top of the application
4. Vary the required details (eg: licence nominees)
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9. Submitting a licence variation application
5. In the Type of Change tab, please enter a description of the type of change requested
6. Select ‘Validate’
7. Select ‘Submit’.
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10. Useful links
TGA Business Services
https://www.ebs.tga.gov.au/
https://www.tga.gov.au/tga-business-services-getting-started-tga
https://www.tga.gov.au/tga-business-services-how-use-site
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11. Fees & charges
Domestic manufacturing of biologicals
• There is no annual charge for a manufacturer who only manufactures biologicals, sub regulation 3(2)(m)
Therapeutic Goods (Charges) Regulations 1990.
• There are additional fees for overseas manufacturing sites not shown. Refer to Schedule 9A of the
Therapeutic Goods Regulations 1990.
Item Fee
Australian manufacturing sites - application fee for a manufacturing
licence
$1,050
Initial manufacturing audit - inspection fee for Australian and
overseas manufacturing sites
$20,800
Subsequent manufacturing audit - inspection fee for Australian and
overseas manufacturing sites
$15,700
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12. Fees & charges
• TGA has identified a billing issue in our online systems. The issue affects Australian manufacturers who only
undertake the manufacture of biologicals.
• The issue concerns the invoicing of the correct application fee of $1,050.00 though the tBS Portal, for a
manufacturing licence application under 37(1)(g) of the Therapeutic Goods Act 1989.
• An interim process to ensure invoicing of the correct amount has been developed and will be in place this
week to resolve the issue. Details of this process will be available on TGA’s Notices for Manufacturers page
on our website.
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13. Useful links
Fees & Charges
https://www.tga.gov.au/schedule-fees-and-charges
https://www.tga.gov.au/payment-options
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14. Contact TGA
Email General & Australian manufacturing enquiries: gmp@tga.gov.au
Overseas manufacturing enquiries: gmpclearance@tga.gov.au
Phone 1800 446 443 (freecall within Australia)
+61 2 6221 6881
Users who are deaf or have a hearing or speech impairment can call through the National Relay
Service:
TTY or computer with modem users: phone 1800 555 677 then ask for 1800 446 443
Speak and listen (speech to speech relay) users: phone 1800 555 727 then ask for 1800 446 443
Fax +61 2 6232 8426
Postal Manufacturing Quality Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia
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15. TGA Licensing & Certification Applications
Contact TGA
Address Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia
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