Proposed changes to the overseas GMP compliance assessment fee process

This consultation closed on 18 August 2022

Consultation period

18 May 2022 to 18 August 2022

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is seeking input from registered holders and other stakeholders regarding the change to the overseas good manufacturing practice (GMP) compliance assessment fee process.

Regulation 71A(2) of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Regulations) provides that the overseas GMP compliance assessment fee is payable for each site outside Australia at which either:

  • the product is manufactured
  • a step in the manufacture of the product occurs.

The overseas GMP compliance assessment fee is required to be paid under Regulation 71A(4) – Fees for continued registration of chemical product. The amount is $1,000 for each financial year the registration is in force.

In April 2022, the APVMA advised registered holders that from the commencement of financial year 2023–24 they would be required to pay an Overseas GMP compliance assessment fee for each site of manufacture listed on their registration on 1 July (unless a fee has already been paid for another chemical product under Regulation 71A(3)).

Holders were advised that there will no longer be an option to submit a statutory declaration regarding unused site/s of manufacture.

If a site of manufacture is no longer in use, registration holders have been advised to lodge a variation application to remove the site from their registration. If an unused site remains on the registration the $1,000 fee will be payable.

Preparing your submission 

The APVMA invites written submissions about the Overseas GMP compliance assessment fee process change, which may include (but not be limited to):

  • business impact
  • concerns or issues
  • general feedback.

When preparing your submission, the APVMA prefers you to:

  • clearly identify the issue and clearly state your point of view
  • give reasons for your comments, supporting them with relevant information.

Making a submission

Electronic submissions are preferred and all electronic submissions to the APVMA will be acknowledged via email.

When making a submission please include:

  • contact name
  • company or group name (if relevant)
  • postal address
  • email address
  • the date you made the submission.

Please note: Submissions will be published on the APVMA’s website unless you have asked for the submission to remain confidential (see public submission coversheet).

Please lodge your submission with a public submission coversheet, which provides options for how your submission will be published.

Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.

The closing date for submissions is 18 August 2022.

Submissions can be sent to:

Manufacturing Quality and Licensing (MQL)
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001

Email: mls@apvma.gov.au

For information on how the APVMA manages personal information when making a submission, see our privacy policy.

Submissions received

The APVMA sought comments from registered holders and other stakeholders regarding the change to the overseas GMP compliance assessment fee process, in a consultation that closed on 18 August 2022. Four submissions were received from industry stakeholders. A copy of the published submissions, where consent to publish was provided, is available on our website.

Consultation feedback

The APVMA is currently considering all submissions as part of this consultation.

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