This content is current only at the time of printing. This document was printed on 21 January 2021. A current copy is located at https://apvma.gov.au/node/72546
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Making changes to veterinary sites of manufacture
We’ve made some changes to the way holders can apply to vary their veterinary product’s site/s of manufacture.
Prescribed variations (Item 13A)
The Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019 has been updated to allow two new types of variation application to be made as prescribed variations (Item 13A applications).
Holders will now be able to add an overseas site of manufacture that performs secondary steps of manufacture through an Item 13A application. Secondary steps are defined as those steps which have no contact with the veterinary medicine, for example, secondary packaging, labelling, storage and quality control testing (excluding biological assays for immunobiological products).
In some circumstances, holders will also be able to add an overseas site of manufacture which performs primary steps of manufacture, where the site has already been approved for those steps of manufacture for another product for which they are the holder.
Changes to Item 12 (non-technical assessment)
Holders of veterinary products (excluding immunobiological products) are now able to vary an overseas site of manufacture that performs primary steps of manufacture via an Item 12 application, when the new site has not already been assessed for another product with the same holder.
Previously, this type of variation would require an Item 14 application. However, the Australian Pesticides and Veterinary Medicines Authority (APVMA) now considers a chemistry assessment is no longer required as, like an Australian manufacturing site change, we would be satisfied the product is manufactured to an equivalent standard required by the APVMA for Australian sites, through Good Manufacturing Practice (GMP) certification.
To make an application to vary a veterinary site of manufacture, please use the tailored guidance for applicants as the decision tree has not yet been updated to allow these application types.
It is a condition of registration that registered veterinary products are manufactured at sites that hold appropriate GMP certification, or the overseas equivalent recognised by the APVMA. This requirement is not changing.