To make changes to details on a manufacturing licence – or to its conditions – holders must apply to the Australian Pesticides and Veterinary Medicines Authority (APVMA) for a licence variation.
Changes can include:
- a change to company name where the ACN remains the same (not a change to the legal entity)
- the addition of a product type within an already licensed manufacturing category (and applicable steps)
- a change to steps of manufacture covered by the licence (addition/deletion) or change to product types or categories
- the inclusion of a subcontractor under the provisions of Regulation 59A (analysis and testing, packaging or labelling only)
- any other change not already specified.
This is because licences to manufacture chemical products in Australia are issued with certain details and licence conditions which are specific to each holder. The licence will specify, among other things, precisely what steps of manufacture, at which sites and what products can be manufactured under it. Any change to a licence or its conditions must be approved by the APVMA, meaning holders must submit an application.
The process for receiving, assessing and deciding the outcome of a variation application is similar to the process for new licence applicants. It is undertaken in accordance with APVMA legislation.