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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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This step-by-step guide is for:

  • Australian manufacturers of therapeutic goods (medicines, active pharmaceutical ingredients (APIs) and biologicals, human blood and blood components and haematopoietic progenitor cells) applying for a manufacturing licence for an Australian manufacturing site
  • Australian sponsors of therapeutic goods manufactured overseas applying for GMP certification of the overseas manufacturer
  • overseas manufacturers inspected by the TGA

This guidance is not intended for:

Only Australian manufacturing sites can obtain a manufacturing licence.

Overseas manufacturers can instead obtain GMP certification following a successful on-site inspection by the TGA.

GMP certification applications are required to be submitted by the Australian sponsor or an agent acting on the Australian sponsor's behalf.

GMP certification is usually only requested if it is not possible to obtain GMP clearance via the Mutual Recognition Agreement (MRA) or Compliance Verification (CV) pathways, for example due to lack of evidence. The TGA reserves the right to undertake an audit of an overseas manufacturing site, irrespective of any other evidence supplied. For example, this may be where TGA has other regulatory information, has concerns regarding compliance. Ensure that GMP clearance cannot be obtained via the MRA or CV pathways before applying for GMP certification.

Step 1 will help you determine if this process is appropriate for you.

Australian manufacturing licences and overseas GMP certification

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Contents

  • Responsibilities
  • Supplying manufactured goods to Australia
  • Confidentiality
  • Timeframes
  • APVMA–TGA cooperation
  • The licensing and certification process
  • 1: Determining whether licensing or certification is required
  • 2: Complying with the manufacturing principles
  • 3: Becoming a TGA client
  • 4: Compiling documentation
  • 5: Making a statutory declaration
  • 6: Drafting and submitting your application
  • 7: Application fees
  • 8: Determining whether your application is effective
  • 9: Scheduling the inspection
  • 10: Paying inspection invoices
  • 11: Preparing for inspection
  • 12: The onsite inspection
  • 13: The post-inspection letter (PIL)
  • 14: Addressing deficiencies
  • 15: Reviewing your response and closeout
  • 16: Issuing the inspection report
  • 17: Paying your final invoice
  • 18: Providing feedback
  • 19: Making a decision
  • 20: Granting licences and issuing certification
  • 21: Conducting follow-up inspections
  • 22: Keeping us up-to-date and making requests
  • Contacting the Manufacturing Quality Branch

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