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GMP clearance guidance
Version 18.1, January 2019
Step 9 - Application assessment
Once your application has progressed past the receipt process, it will enter the assessment queue. When your application is selected, the supporting evidence you have provided will be assessed against the scope you have applied for. Assessment times vary depending on the:
- risk of the substances or products manufactured
- complexity of the manufacturing steps involved
- number of documents provided for assessment
- level of compliance identified during our assessment.
Once we perform the MRA or CV assessment, taking into account the information and evidence provided with the application, we will make a determination (step 10).
To ensure we maintain consistent processing times and do not disadvantage applicants who provide the correct information, we will make a determination on the information provided and will not seek clarification from you unless in specific circumstances.
If we require further information or clarification during the CV assessment, you will be sent one request with a specified due date to provide this information.
Where deficiencies have been identified during assessment, these will be included in the request. We may also use this request as a notice of intent to not issue the GMP clearance unless the deficiencies can be addressed satisfactorily.
Applications that have been sent a request for information or a proposal to not issue will be placed on hold and the application status will change to "with manufacturer".
Your response should address each deficiency raised from the assessment.
Where new or updated information is provided as part of your response, you should include specific reference as to how it addresses the deficiency.
After the due date has passed, a determination will be made (step 10) based on the information provided.