TGA Licensing & Certification ApplicationsTGA Business Services Portal for TGA manufacturing licences and variations – biologicals

Paul Oosterwyk – Director, Manufacturers Assessment SupportNicola Carr – A/g Assistant Director, Licensing & CertificationManufacturing Quality Branch, Medical Devices and Product Quality DivisionBiotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session

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

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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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Licensing & certification applicationsBackground 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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TBS Portal - landing page

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Lodging manufacturing applications

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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’.

Adobe Acrobat Document

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Submitting a licence variation application1. 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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Submitting a licence variation application5. 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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Useful linksTGA 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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Fees & chargesDomestic 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 FeeAustralian 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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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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Useful linksFees & Chargeshttps://www.tga.gov.au/schedule-fees-and-charges https://www.tga.gov.au/payment-options

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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 8426Postal Manufacturing Quality Branch

Therapeutic Goods AdministrationPO Box 100Woden ACT 2606Australia

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Contact TGA

Address Therapeutic Goods Administration136 Narrabundah LaneSymonston ACT 2609Australia