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Presentation: TGA Licensing & Certification Applications: TGA Business Services Portal for biologicals

TGA presentations: Biotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session, Canberra

1 November 2016

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These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Paul Oosterwyk and Nicola Carr, Manufacturing Quality Branch, Medical Devices and Product Quality Division, Therapeutic Goods Administration
  • Presented at: Biotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session, Canberra
  • Presentation date: 13 October 2016
  • Presentation summary: Using the TGA Business Services Portal to apply for manufacturing licences and variations for biologicals.

Transcript

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

Slide 1 - Agenda

  • Introduction
  • About the Manufacturing Quality Branch
  • TGA Business Services Portal
  • Fees & Charges

Slide 2 - 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.

Slide 3 - 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/

Slide 4 - TBS Portal - landing page

Screenshot of TBS Portal - landing page

Slide 5 - Lodging manufacturing applications

Screenshot of Lodging manufacturing applications

Slide 6 - 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'.
    Screenshot of TGA eBusiness Services menu. The Validate and Submit buttons are highlighted.

Slide 7 - 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
    Screenshot of TGA eBusiness Services - Vary application button highlighted.
  4. Vary the required details (eg: licence nominees)

Slide 8 - Submitting a licence variation application

  1. In the Type of Change tab, please enter a description of the type of change requested
    Screenshot: TGA eBusiness Services. Type of Change tab.
  2. Select 'Validate'
  3. Select 'Submit'.

Slide 9 - Useful links

TGA Business Services

Slide 10 - Fees & charges

Domestic manufacturing of biologicals
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
  • 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.

Slide 11 - 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.

Slide 12 - Useful links

Fees & Charges

Slide 13 - Contact TGA

Contact TGA
Email

General & Australian manufacturing enquiries:

Overseas manufacturing enquiries:

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

Slice 13 - Contact TGA

Contact TGA
Address Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia

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