Sponsor responsibilities related to GMP clearance and certification

Version 1.0, August 2017

4 August 2017

This guidance is for sponsors of medicines manufactured overseas. It applies when GMP clearance is obtained by any pathway, that is, the MRA pathway, the compliance verification (CV) pathway, or by GMP certification following a TGA inspection.

As a sponsor you may be asked to contribute financially to an on-site inspection by TGA.

You cannot cancel a TGA onsite inspection by submitting a desktop assessment via the MRA or CV pathways if we have confirmed the inspection dates with the manufacturer and begun arranging travel.

This guidance also applies to applicants who submit applications for certification or GMP clearance on behalf of sponsors. These applicants are subject to the same responsibilities as sponsors prior to submission and during processing.

Sponsors should maintain evidence of GMP compliance for all overseas manufacturing sites used in the manufacture of their registered or listed medicine and are responsible for these nominated sites at all times.

Failure to meet the required responsibilities may result in:

  • your GMP clearance not being issued
  • rejection of your GMP certification application
  • cancellation of any active GMP clearance

Prior to submission (draft applications)

Prior to submission, ensure that:

  • All information provided in the application is accurate, current and does not contradict the corresponding information contained within the evidence provided
  • The scope of the application is relevant to the activities carried out by the manufacturing site and is reflected in the evidence provided
  • All required evidence is attached when submitting the GMP certification or clearance application or provided to TGA directly by the manufacturer
  • For GMP clearance applications, that signed and effective GMP/Quality/Technical agreements are in place and meet the relevant requirements, if required

During processing (under review)

During processing, ensure that:

  • Any additional information or clarification requested by the TGA during the assessment of GMP certification or clearance applications is provided within the specified timeframe
  • Any updated evidence that becomes available while the application is under review is provided to the TGA

Post-approval (active GMP clearances)

Post-approval, ensure that:

  • You monitor regulatory actions by any competent overseas regulatory authority (for example, recalls, unacceptable inspection findings, warning letters, import alerts etc.) for manufacturing sites for which you hold an active GMP clearance
  • You maintain GMP / quality / technical agreements with your manufacturers
  • You notify the TGA of these regulatory actions and of any significant changes to the manufacturing site, quality management system (QMS), products or product range where the changes could potentially impact the GMP compliance of the site
  • You submit applications for renewal of a GMP clearance at least 6 months prior to the expiry of the current clearance, or alternatively, if evidence for a renewal is not available, request TGA certification
  • You submit a short term extension request, along with the accompanying reasons or evidence, if unable to submit a renewal GMP clearance or GMP Certification application in the above timeframe.
  • You contribute to the cost of an on-site inspection by TGA, where applicable, if requested.

Version history

Version Description of change Author Effective date
V1.0 Original publication following consultation with industry in January 2017 Manufacturing Quality Branch August 2017