We are currently experiencing extremely high volumes of GMP clearance applications resulting in delayed processing. The tables below provide an overview of current processing times and applications on hand for GMP Clearances.
The data will be updated monthly to ensure it remains current.
GMP clearance current processing timeframes
Currently it takes us the following number of working days to assess 90 percent of applications.
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28
MRA
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457
CV: Non-Sterile API
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441
CV: Non-Sterile Finished Product
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420
CV: Sterile API
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395
CV Sterile Finished Product
GMP clearance workload volumes
We have the following numbers of applications at various stages of assessment.
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1699
Desktop assessment applications - awaiting assessment
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532
Extension applications awaiting assessment
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118
Applications awaiting receipt
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173
Incomplete queue
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194
Administrative applications
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123
Applications awaiting payment
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327
Assessment in progress
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54
Applications on hold
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1121
Applications completed in last 90 days
Prioritisation requests
We will continue to process effective applications as quickly as possible. Medicine shortage remain a high priority for us, and we will continue to process these when sponsors have provided the required information.
For any request for prioritisation, you must provide the required information outlined below:
- The product name and existing ARTG number (where applicable)
- The category of medicine (Complementary, OTC, Prescription etc.)
- The product submission type and submission number and any applicable milestone dates (for example, priority review pathway or NCE, PM-XXXX-XXXXX-X-X etc.)
- For variations, you need to provide information about the change as certain changes made by manufacturers may require additional GMP assessment.
- The medicines shortage notification number (for example MS-XXXX-XX-XXXXX-X)
- Any other information to help us understand the urgency of the situation. For example, existing stock levels or supply dates, negative effect on patients or business etc.
Featured notices
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NoticesUpdate on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.
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NoticesMRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.
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NoticesFind out about how GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway.
Related guidance
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PageFind out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
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User guideThis user guide is for sponsors wanting to submit GMP clearance application by the TGA Business services (TBS) portal.
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User guideCheck out our user guide to assist sponsors when using the code tables for GMP Clearance applications.