Variation to an overseas site of manufacture for veterinary products (excluding immunobiological products), where the change involves the addition of an overseas site involved in a primary step of product manufacture is processed as either:
- a prescribed variation (Item 13A)
- a non-technical variation (Item 12).
A primary step includes all steps that result in direct contact with the veterinary chemical product, and excludes:
- labelling or relabelling or secondary/supplementary labelling
- secondary packaging
- release for supply
- analysis and testing: any form of physical or chemical testing.
Is a prescribed variation (Item 13A) or a non-technical assessment (Item 12) required for my site change?
The addition of an overseas site of primary steps of manufacture will usually be processed as a non-technical application (Item 12). The proposed new site must hold acceptable evidence of overseas GMP compliance, and this will be assessed as part of the Item 12 application.
In limited circumstances, the addition of an overseas site of primary steps of manufacture can be made as a prescribed variation (Item 13A). A prescribed variation can be submitted when the proposed site of manufacture is already recorded as a site of manufacture for another veterinary product with the same holder. The proposed site must have appropriate GMP certification.
I want to add an overseas site for primary steps of manufacture and: