GMP clearance: Bulgaria added to MRA pathway

GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway. Australian sponsors who submit GMP clearance applications via the MRA pathway will have shorter processing timeframes due to reduced evidence requirements and reduced fees. 

This follows the addition of other European countries to be assessed via the MRA pathway in March 2023 and ensures the Australia-European Union (EU) MRA is operational for all current EU members.

We have assessed the regulatory authority for Bulgaria and has added them to those countries listed under the Australia-EU MRA for GMP clearance.  

Effective immediately, GMP clearance applications using Bulgarian Drug Agency (BDA) evidence should be submitted via the TGA eBusiness portal as follows:

• If the inspection was performed by BDA within Bulgaria, the MRA pathway can be used.
• If the inspection was performed by BDA outside Bulgaria, the Compliance Verification pathway can be used.

Submitted GMP clearance applications

For any applications using evidence issued by BDA that were submitted but not yet assessed prior to this web statement, we will:

• process them as a ‘MRA’ application type
• contact you regarding any fees paid and if the required evidence for the MRA pathway has not been provided.

Draft GMP clearance applications

For draft applications not yet submitted to us for assessment, please review and update the ‘Application Type’ and re-select the manufacturer details before submitting:

1. Go to TGA Business Services - external site

2. On the left-hand menu, choose ‘Login to Business Services’.

   

3. On your homepage, click on ‘Work on drafts’.

   
4. Search for the relevant clearance application and edit your draft.

5. Under ‘Application Details’ section, choose the appropriate ‘Application Type’.

   
6. On the ‘Client Details’ tab, under ‘Existing Manufacturer’ section, re-select your manufacturer details.

7. Once you have updated the ‘Application Type’ and manufacturer details, click ‘Validate’ and ‘Save’.

   

Contact us

For enquiries regarding the above changes, contact GMPclearance@health.gov.au.

For information on submitting GMP clearance applications, refer to the GMP Clearance guidance.