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GMP clearance for overseas manufacturers

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16 May 2011

Appendix I - Target timeframes

The following targets for dealing with GMP Clearance applications enable orderly processing and assessment. The TGA is usually able to meet these targets unless the level of compliance demonstrated in the evidence supplied is low or there are delays in receiving any additional documentation as requested. The relevant period starts when the TGA has received the application, supporting data and fees.

TGA's target timeframes for GMP Clearance applications
Application Type Outcomes (and major task outputs) Target Timeframe
Overseas Clearance - based on GMP certificate from an MRA country < 15 working days
Overseas Clearance - compliance verification (lower risk products) < 30 working days
Overseas Clearance - compliance verification (higher risk products) < 90 working days
Certificate of GMP Compliance - based on TGA Initial Audit < 6 months
Certificate of GMP Compliance - based on TGA Re-audit < 6 months
Issue of Certificate of GMP or notarised copy of certificate < 15 working days
  • All timeframes are subject to the co-operation of manufacturers and sponsors, and in some cases, international regulatory authorities. Certification(s) will be withheld until satisfactory resolution of any deficiencies or non-conformities identified.
  • The TGA's processing time excludes any delay where a sponsor has requested the TGA to obtain the GMP Certificate.
  • MRA agreements provide each party with 30 calendar days to supply a GMP Certificate, or 60 days if an inspection is required.

On-Site Audits

Where a TGA on-site audit is required, the TGA will initiate an application for a separate GMP Clearance for each of the sponsors paying for the TGA audit. GMP Clearances will be issued to each relevant sponsor after the audit has been completed and acceptable compliance has been found.

Overseas TGA on-site audits involve considerable lead-time in planning to ensure efficient audit visits. The usual lead time for an initial overseas on-site audit or a renewal of a GMP Certification for a site that was previously audited by the TGA is 6 months from the date of an effective GMP Certification application. Subject to the time required to receive and assess any deficiencies at an audit, a GMP certificate will usually be processed within 15 working days of despatch of the audit close-out letter.

The timeframes provided are correct at the time of publication but are subject to review. Modifications to these timeframes will be updated as required.

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