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GMP clearance for overseas manufacturers

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16 May 2011

1. Responsibilities of Australian sponsors of medicines manufactured overseas

The key responsibilities of Australian sponsors of medicines that use overseas manufacturers in relation to GMP Clearances are listed below. Please note this list is not exhaustive and sponsors should satisfy themselves that they have done all that the relevant legislation and guidelines require.

A sponsor who proposes to seek market authorisation for supply in Australia through the registration or listing of the product on the ARTG or who has a product registered or listed on the ARTG is responsible for:

  • Providing to the TGA relevant evidence of GMP compliance for the purposes of obtaining the marketing authorisation to supply medicinal products in Australia;
  • Maintaining evidence of GMP compliance of all overseas manufacturing sites used in the manufacture of the registered or listed medicine, and notifying the TGA immediately of any changes in circumstances or regulatory compliance of the overseas manufacturer.6
    • Sponsors are responsible for all overseas manufacturing sites nominated in their Clearance applications at all times.
    • Sponsors are required to advise the TGA of any 'significant changes' to the manufacturing site, quality management system (QMS), products or product range (these are changes that could potentially affect GMP compliance) – changes may also require a variation application for the sponsor's listing or registration on the ARTG.
    • Sponsors should monitor regulatory actions by any competent overseas regulatory agency (i.e. recalls, unacceptable inspection findings, warning letters) that involves any overseas manufacturer used by the sponsor.
    • Sponsors must notify the TGA as soon as the overseas manufacturing site is no longer used and is not intended to be maintained as an alternative manufacturer.
  • Establishing and maintaining GMP agreements with manufacturers with which the sponsor has a direct relationship. Where the manufacturer is a wholly owned subsidiary of the same parent company as the sponsor, the roles and responsibilities of the parties should be documented in the absence of a agreement. Sponsors are not expected to have a GMP agreement with a manufacturer's sub-contractors7.
  • Ensuring that all required documents are submitted electronically with applications for GMP Clearance.
    • Incomplete applications may be rejected.
  • Remitting all application fees at the time of lodging an application for GMP Clearance (refer to Schedule of fees at Schedule of fees and charges).
    • Initial processing of an application will not commence until payment of the application fee has been received.
    • Any applicable assessment fee invoiced to the sponsor must also be paid before assessment of an application can commence.
  • Submitting applications for renewal of a GMP Clearance at least six months prior to the expiry of the current Clearance. This allows time:
    1. to submit an extension of a Clearance where evidence is not yet available. See 3.1; or
    2. to determine the need for a request that the TGA attempt to obtain evidence from the relevant MRA regulator See 3.2; or
    3. for scheduling an overseas audit should it appear during the assessment that such an audit is required.
  • Promptly submitting any additional information requested by the TGA during an assessment.
    • Failure to provide required documents in the time requested by the TGA may result in the application being rejected without a refund of fees paid.
  • A separate application is required for each overseas manufacturing site used in relation to dosage forms for registered or listed medicines.

Clearance extensions may be granted if some documents (eg audit report) for the clearance application are not yet available.


Footnotes

  1. The TGA is introducing a Periodic Manufacturer Update form to assist sponsors in meeting this responsibility. This form allows sponsors to inform the Office of Manufacturing Quality of non-critical changes such as changes in production and products, which ensures the information the TGA holds of the manufacturer remains current. The form will be accessible from the TGA website. Any critical events should be notified immediately to GMP@tga.gov.au.
  2. GMP contracts between principal manufacturers and sub-contractors are required by the code of GMP

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