Clearance Application Assistance Tool

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TGA certificates issued as a result of a successful on-site inspection may be provided as evidence to obtain a GMP clearance if you were not using this manufacturer at the time the inspection was scheduled.

If you provide a TGA certificate as evidence, you will still be required to provide the following sponsor-specific evidence (where applicable):

• GMP, quality or technical agreements between the sponsor and manufacturer
• a list of products intended for supply (specific to the application)
• the latest product quality review (specific to the products in the application)
• an API declaration

We will not accept a TGA issued certificate as evidence for a GMP clearance application if you declined to contribute to the cost of the inspection without justification.

Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

If you wish to decrease the scope of your existing GMP clearance, please vary your existing clearance by submitting a variation application via the TGA Business Services portal.

Further information on varying a GMP clearance can be found in Step 11 (Maintaining your active GMP clearance) of the GMP clearance guidance. There are currently no fees for this application.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the evidence you have available, you may wish to apply for an application to obtain a clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP certificate or alternative
2. Most recent inspection report
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. GMP agreement or equivalent
7. List of authorised tests (for contract testing labs only).

Where a US FDA inspection report is available as evidence, the TGA ascertains the compliance status of the site in lieu of a GMP certificate. Please select 'TGA to obtain evidence' when filling out your clearance application. A fee is applicable for this service.

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the selections you have made, you can apply for a GMP clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP Certificate
2. Most recent inspection report
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. List of products intended for supply
7. GMP agreement or equivalent
8. Release procedure(s)
9. Validation master plan
10. Latest product quality review for all products intended for supply

Where a US FDA inspection report is provided as evidence, the TGA ascertains the compliance status of the site in lieu of a GMP certificate. Please select 'TGA to obtain GMP certificate' when filling out your GMP clearance application. A fee is applicable for this service.

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the selections you have made, you can apply for a GMP clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP Certificate
2. Most recent inspection report
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. List of products intended for supply
7. GMP agreement
8. Release procedure(s)

Where a US FDA inspection report is provided as evidence, the TGA ascertains the compliance status of the site in lieu of a GMP certificate. Please select 'TGA to obtain GMP certificate' when filling out your application. A fee is applicable for this service.

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the selections you have made, you can apply for an application to obtain a clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP Certificate
2. Most recent inspection report
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. List of products intended for supply
7. Validation master plan
8. Latest product quality review for API(s) intended for supply

Where a US FDA inspection report is provided as evidence, the TGA ascertains the compliance status of the site in lieu of a GMP certificate. Please select 'TGA to obtain GMP certificate' when filling out your application. A fee is applicable for this service.

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the selections you have made, you can apply for a GMP clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP Certificate
2. Most recent inspection report
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. List of products intended for supply

Where a US FDA inspection report is provided as evidence, the TGA ascertains the compliance status of the site in lieu of a GMP certificate. Please select 'TGA to obtain GMP certificate' when filling out your GMP clearance application. A fee Is applicable for this service.

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

If you wish to transfer your GMP clearance to another sponsor, please email GMPClearance@tga.gov.au with the subject heading 'Clearance transfer - MI clearance number' and provide the relevant documentation.

Further information on transferring a GMP clearance can be found in the 'Transferring your GMP clearance' section of the GMP clearance guidance.

For transfer of ARTG listings or registrations, please refer to the 'Notification of a change in sponsorship' page of the TGA website.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

If you wish to update the sponsor or applicant contact details in your GMP clearance, please vary your existing clearance by submitting an application via the TGA Business Services portal.

Further information on varying a GMP clearance, including evidence requirements, can be found in Step 11 (Maintaining your active GMP clearance) of the GMP clearance guidance. There are currently no fees for this application.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

If you wish to make administrative updates to the manufacturer details in your GMP clearance, please vary your existing clearance by submitting an application via the TGA Business Services portal.

Further information including evidence requirements for varying a GMP clearance can be found in Step 11 (Maintaining your active GMP clearance) of the GMP clearance guidance. There are currently no fees for this application.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the selections you have made, you can apply for a GMP clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP Certificate
2. Most recent inspection report (this can also be an EDQM inspection report where applicable, however the corresponding GMP certificate must be issued by the MRA regulatory agency)
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. List of products intended for supply
7. GMP agreement or equivalent
8. Release procedure(s)
9. Validation master plan
10. Latest product quality review for all products intended for supply

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the selections you have made, you can apply for a GMP clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP certificate or alternative
2. Most recent inspection report (this can also be an EDQM inspection report where applicable, however the corresponding GMP certificate must be issued by the MRA regulatory agency)
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. GMP agreement or equivalent
7. List of authorised tests (for contract testing labs only)

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the selections you have made, you can apply for a GMP clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP Certificate
2. Most recent inspection report (this can also be an EDQM inspection report where applicable, however the corresponding GMP certificate must be issued by the MRA regulatory agency)
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. List of products intended for supply
7. GMP agreement or equivalent
8. Release procedure(s)

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the selections you have made, you can apply for a GMP clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP Certificate
2. Most recent inspection report (this can also be an EDQM inspection report where applicable, however the corresponding GMP certificate must be issued by the MRA regulatory agency)
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. List of products intended for supply
7. Validation master plan
8. Latest product quality review for API(s) intended for supply

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Where current evidence from a recognised regulatory authority using an equivalent GMP standard is not available, sponsors may request a TGA on-site inspection.

For further guidance, refer to the Australian manufacturing licences and overseas GMP certification guidance or contact the Manufacturing Quality Branch.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Based on the selections you have made, you can apply for a GMP clearance via the CV assessment pathway. The evidence required for the application includes the following:

1. GMP Certificate
2. Most recent inspection report (this can also be an EDQM inspection report where applicable, however the corresponding GMP certificate must be issued by the MRA regulatory agency)
3. Regulatory inspection list
4. Regulatory action details
5. Site Master File, quality manual or equivalent
6. List of products for supply

Additional information may be requested. Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

If you have a GMP certificate from an MRA regulator (or alternative), you can submit an application to obtain a GMP clearance via the MRA pathway.

Alternatively, you may request the TGA to liaise with an MRA regulator to obtain the GMP certificate by selecting the option 'TGA to obtain GMP Certificate' in your application via the TGA Business Services portal. Please note an additional fee is applicable for this service.

Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges
• International agreements and arrangements

A manufacturer LoA to evidence grants a sponsor permission to use evidence that has been submitted by the manufacturer for another application.

A sponsor LoA to evidence grants a sponsor permission to use evidence that has been submitted by another sponsor for another application.

While the use of LoAs is intended to reduce the regulatory burden on industry, for the CV Pathway, certain sponsor-specific evidence is still required to be provided (where applicable) along with the relevant fees.

Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

A sponsor LoA to clearance grants a sponsor permission to use an existing GMP clearance as primary evidence for an additional clearance to be issued. The scope of the application must be identical or smaller to the existing clearance.

While the use of LoAs is intended to reduce the regulatory burden on industry, for the CV Pathway, certain sponsor-specific evidence is still required to be provided (where applicable) along with the relevant fees.

Further information on documentation requirements can be found in Step 3 (Identifying what documentation is required) of the GMP clearance guidance.

Useful links

• GMP clearance guidance
• Schedule of fees and charges

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Note: A good laboratory practice (GLP) certificate in lieu of a GMP certificate may be acceptable for some contract laboratories. GLP certificates for contract laboratories will only be accepted if they are accredited to ISO 17025 (General requirements for the competence of testing and calibration laboratories), relevant to the scope of the application. You should only accept this option as evidence if your GLP certificate meets the above criteria.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Note: A good laboratory practice (GLP) certificate in lieu of a GMP certificate may be acceptable for some contract laboratories. GLP certificates for contract laboratories will only be accepted if they are accredited to ISO 17025 (General requirements for the competence of testing and calibration laboratories), relevant to the scope of the application. You should only select GLP certificate as evidence if it meets the above criteria.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Note: An International Standards Organisation (ISO) certificate in lieu of a GMP certificate may be acceptable for some contract sterilisers. ISO certificates for contract sterilisers will only be accepted if they are issued to the specific site and accredited to the relevant sterilisation accreditation; for example, ISO 11137 (Sterilisation of healthcare products - radiation). You should only select this option as evidence if your ISO certificate meets the above criteria.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Note: An international Standards Organisation (ISO) certificate in lieu of a GMP certificate may be acceptable for some contract sterilisers. ISO certificates for contract sterilisers will only be acceptable if they are issued to the specific site and accredited to the relevant sterilisation accreditation; for example, ISO 11137 (Sterilisation of healthcare products - radiation). You should only select this option as evidence if your ISO certificate meets the above criteria.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

Select the evidence you have to support your GMP clearance application below. Further information about the requirements for each piece of evidence is outlined in the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

The TGA has entered into various international agreements and arrangements with other regulatory agencies to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulatory agencies for GMP clearance purposes.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important because this will determine the appropriate GMP clearance pathway.

Further information can be found in Step 2 (Identifying the appropriate GMP clearance pathway) of the GMP clearance guidance.

Where you need to vary your GMP clearance as a result of physical changes to the manufacturer details, the documentary evidence and fees incurred will be the same as submitting a new application.

There are specific evidence requirements for GMP clearance applications depending on the product type or manufacturing activity. An application might relate to:

• manufacture of an Active Pharmaceutical Ingredient (API) used in a medicine
• manufacture of a medicine as the finished product intended for supply in Australia
• manufacturing steps undertaken by a contract steriliser or contract testing laboratory

You will need to submit separate applications for API and finished products, even if the evidence is applicable to both.

Pay particular attention when selecting the scope of your GMP clearance application, as incorrect selection(s) may impact the evidence requirements and processing times.

If you are unsure of the options, refer to the GMP clearance guidance or contact the Manufacturing Quality Branch prior to submitting a GMP clearance application.

There are specific evidence requirements for GMP clearance applications depending on the product type or manufacturing activity. An application might relate to:

• manufacture of an Active Pharmaceutical Ingredient (API) used in a medicine
• manufacture of a medicine as the finished product intended for supply in Australia
• manufacturing steps undertaken by a contract steriliser or contract testing laboratory

You will need to submit separate applications for API and finished products, even if the evidence is applicable to both.

Pay particular attention when selecting the scope of your GMP clearance application, as incorrect selection may impact the evidence requirements and processing times.

If you are unsure of the options, refer to the GMP clearance guidance or contact the Manufacturing Quality Branch prior to submitting a GMP clearance application.

There are specific evidence requirements for GMP clearance applications depending on the product type or manufacturing activity. An application might relate to:

• manufacture of an Active Pharmaceutical Ingredient (API) used in a medicine
• manufacture of a medicine as the finished product intended for supply in Australia
• manufacturing steps undertaken by a contract steriliser or contract testing laboratory

You will need to submit separate applications for API and finished products, even if the evidence is applicable to both.

Pay particular attention when selecting the scope of your GMP clearance application, as incorrect selection may impact the evidence requirements and processing times.

If you are unsure of the options, refer to the GMP clearance guidance or contact the Manufacturing Quality Branch prior to submitting your GMP clearance application.

There are specific evidence requirements for GMP clearance applications depending on the product type or manufacturing activity. An application might relate to:

• manufacture of an Active Pharmaceutical Ingredient (API) used in a medicine
• manufacture of a medicine as the finished product intended for supply in Australia
• manufacturing steps undertaken by a contract steriliser or contract testing laboratory

You will need to submit separate applications for API and finished products, even if the evidence is applicable to both.

Pay particular attention when selecting the scope of your GMP clearance application, as incorrect selection may impact the evidence requirements and processing times.

If you are unsure of the options, refer to the GMP clearance guidance or contact the Manufacturing Quality Branch prior to submitting your GMP clearance application.

There are different evidence requirements depending on whether you want to

1. Obtain a new clearance
2. Vary an existing clearance (renew, change scope, change manufacturer details or applicant/sponsor details)
3. Transfer a GMP clearance

When you update an existing GMP clearance by submitting a variation application, this will allow you to keep the original GMP clearance number and avoid the need to update your ARTG entries. Where there has been a transfer of product sponsorship, transferring GMP clearances to the new sponsor will ensure continuity of the product listing or registration.