International Collaboration and Agreements
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The APVMA attends and participates in the OECD Working Group on Pesticides, the Task Force on Biocides and the Biopesticides Steering Group.
The authority has been the lead agency on several international workgroups dealing with minor use, efficacy guidelines for pool and spa sanitisers, and an international scientific advisory committee on residues and provision of pre-registration advice.
The Commonwealth of Australia has entered into two Mutual Recognition Agreements (MRAs) on conformity assessments that cover veterinary chemical products. One is with the European Union (EU) and another with the European Free Trade Association (EFTA) (which includes the countries of Iceland, Liechtenstein and Norway).
Please view the EU-Australia and EFTA-Australia MRA (external site).
What is the MRA?
The EU-MRA allows the parties to the Agreement that is the EU Member States and Australia, to recognise certificates of conformity (eg GMP certificates) issued by their respective competent authorities using their own conformity assessment or inspection rules and regulations. That is, the MRA provides for conformity assessment (ie GMP assessment) to be carried out in the country of manufacture.
In recognition that different legislative and regulatory requirements apply between MRA partners, the MRA does not create a direct equivalence between Australia and EU regulations. Rather, it allows for mutual recognition of test results and other conformity assessment documentation including certification.
Scope of the MRA
The MRA became operative on 1 January 1999 and covers various other industry sectors through an annex structure, including medical devices, machinery, pressure equipment, low voltage equipment, telecommunication terminal equipment, electromagnetic compatibility and automotive parts.
The full title of the annex relating to both veterinary chemical products and human medicinal products is "Medicinal Products GMP Inspection and Batch Certification", which is commonly referred to as the GMP Annex.
The GMP Annex covers all those medicinal products for veterinary and human use that are manufactured in Australia and the EU, and to which GMP requirements apply, including chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, and products derived from blood/plasma. The MRA has the provision to be applied (albeit on a voluntary basis) to products defined as "medicinal products" (and therefore requiring GMP) by the legislation of one Party but not the other.
It is important to note that the MRA only applies to GMP inspections of manufacturers of veterinary chemical products, and subsequent licensing of the manufacturer. It does not apply to the mutual recognition of veterinary chemical product registrations (ie Marketing Authorisations). Australian manufacturers or Registrants wishing to market veterinary chemical products in the EU will still need to apply for product Marketing Authorisation with an individual EU member country ("de-centralised" procedure) or the European Medicines Evaluation Agency (EMEA) ("centralised" procedure).
For further information on the procedures for lodging applications for product Marketing Authorisation, refer to the European Medicines Agency (EMEA) website (external site).
The main thrust of the GMP Annex is the recognition of GMP audits conducted by the other Party. This is facilitated by the exchange of a Certificate of GMP Compliance of a Manufacturer certifying that the manufacturer has been audited and found to comply with GMP for the manufacture of a specific product or a group of veterinary chemical products. This standard form of the certificate has been developed by the competent authorities of Australia and EU as part of the implementation of the MRA.
The exporter, importer or competent authority may request the Certificate of GMP Compliance of a Manufacturer. It is usual for a competent authority to request a Certificate of GMP Compliance of a Manufacturer during the assessment/evaluation of an application for registration/marketing approval of a product. The benefit of an exporter or importer requesting these certificates is that the certificate can be lodged as part of an application for marketing approval before assessment commences.
The Therapeutic Goods Administration (TGA) is the recognised Official Inspection Service (authorised auditors) in Australia for both veterinary chemical products and human medicinal products. Manufacturers wishing to export to the EU must be audited by a TGA auditor to the Australian human GMP Code (administered by the TGA) or the EU GMP Code. However, in the case of veterinary chemical products, the Certificate of GMP Compliance of a Manufacturer is issued by the APVMA, as the APVMA is the competent authority legally responsible for authorising veterinary chemical product manufacture in Australia.
For full details of the arrangements in place between the APVMA and TGA to accommodate the requirements of the MRA please refer to the APVMA work instruction:
- Issuing a Certificate of GMP Compliance of a Manufacturer under the Provisions of the Mutual Recognition Agreements between Australia and the European Community and the European Free Trade Association (PDF, 54kb) (KP80-W11).
Requests for Certificates
Any request for a Certificate of GMP Compliance of a Manufacturer pertaining to an Australian manufacturer of a veterinary chemical product should be made to the APVMA Manager, GMP Section, by completing form KP80_F39 (DOC, 92kb).To minimise regulatory burden and costs, those manufacturers wishing to export to the EU are strongly encouraged to have their facilities regularly audited against the human GMP Code or the EU GMP Code by APVMA-authorised TGA auditors for the purposes of APVMA licensing. The normal APVMA licence fees will apply. However, that will obviate the need for a separate audit for MRA purposes provided the APVMA can refer to a current and compliant TGA audit when issuing the Certificate of GMP Compliance of a Manufacturer.
EU legislation requires that each batch of veterinary chemical product imported into the EU must be accompanied by a manufacturer's Batch Certificate (PDF, 11kb) for medicinal products exported to countries under the scope of a MRA. A standard format has been developed by the competent authorities of Australia and EU as part of the MRA implementation process.
The need for a Batch Certificate is a specific requirement of the EU; there is no similar Australian requirement.
The Batch Certificate must be signed by the person in the exporting company responsible for releasing the batch of veterinary chemical product for sale/supply and must be held by the EU importer and be available upon request by the relevant authority in the EU.
Official Batch Release
Official batch release relates to the testing by competent authorities of batches of immunological products (vaccines) and blood products. The requirement applies only in some of the EU Member States. Whilst the MRA does not encompass the mutual recognition of official batch release, it does allow for the exchange of such certification to take place if required. Exporters are advised to make all inquiries regarding requirements for Official Batch Release with the competent authority of the country of product destination.
Country of Origin
The MRA applies to veterinary chemical products undergoing the final significant manufacturing step in Australia, or in an EU country. That is, the MRA cannot be applied to manufacturers located outside the EU or Australia.
Competent authorities for the EU-MRA
Competent authorities are those national authorities mutually recognised by the parties to the EU-MRA as the Official Inspection Service and/or those responsible for granting Manufacturing Authorisation (ie licence) and for issuing the Certificate of GMP Compliance of a Manufacturer under the provisions of the EU-MRA GMP Annex.
The EFTA- MRA is in principle identical to the EU-MRA. Manufacturers wishing to export to an EFTA country are advised to contact the APVMA at the early planning stage so that appropriate arrangements can be determined.