This content is current only at the time of printing. This document was printed on 28 March 2017. A current copy is located at http://apvma.gov.au/node/150
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Overseas manufacturers producing intermediate or finished veterinary chemical products for the Australian market need to comply with equivalent standards to manufacturers in Australia.
This means overseas manufacturers need to provide acceptable evidence of overseas GMP compliance to the APVMA before the product can be registered—and supplied—in Australia. This applies to manufacturers involved in any step of manufacture.
Applications to change manufacturer should also include evidence of GMP compliance.
The APVMA recognises some overseas authorities and their documentation—if it considers their regulatory system is equivalent to Australia’s.
Australia recognises some overseas authorities and their documentation through mutual recognition agreements (MRAs) on conformity assessment, memoranda of understanding and similar arrangements. These are agreed after the APVMA establishes that the other country’s code of GMP—or equivalent—and regulatory inspection and enforcement practices are comparable to Australia’s.
If the APVMA does not recognise an overseas manufacturing site’s local authority and there is no evidence available from another recognised authority, the site must undergo an audit by an APVMA-authorised GMP auditor.
1. Post-registration reviews
To ensure continued compliance post-product registration, the APVMA periodically reviews evidence of overseas GMP compliance.
This means the APVMA selects a group of veterinary chemical products based on risk to confirm the registration holder’s evidence that the overseas site’s compliance is still current. Once a product and its site of manufacture have been identified, the APVMA may also request information about GMP compliance for other APVMA-registered products manufactured for the holder at the same site.
2. Overseas GMP compliance assessment fee
Registrants of veterinary chemical products fully or partially manufactured overseas are required to pay an annual overseas GMP compliance assessment fee for every overseas site used to manufacture those products.
|Annual overseas GMP compliance assessment fee per overseas site of manufacture used per registration holder||$1,000*|
*Fee applicable to product registration.
3. Product registration requirements
Registration holders who use overseas manufacturers to produce veterinary chemical products may have their product registrations suspended or cancelled if the conditions of registration that relate to the manufacture of the product are not met or if relevant fees are not paid. If a product manufactured overseas is supplied in contravention of a condition, we can commence a compliance investigation into people or organisations in Australia responsible for the product.
4. Excluded nutritional and digestive products (END products)
Under the Animal Feed Reforms of 2015, a number of additional nutritional and digestive products no longer require APVMA registration. Provided the exclusion criteria continue to be satisfied, provision of evidence of GMP compliance to the APVMA will no longer be required for these excluded products.