Active Constituent Approvals

An active constituent is the component(s) in a chemical preparation or formulation that is responsible for bringing about a biological or therapeutic effect. For example, bio-allethrin is an active constituent used in fly spray formulations.

Registered products must contain active constituent(s) approved by the APVMA. Only active constituents from APVMA approved sites of manufacture may be used in the formulation of registered end-use-products (EUP).

Thus, to achieve registration in Australia of a commercial product can involve a 2-step process :

> Approval of a new active constituent, or approval of a new site of manufacture of an active constituent;
> Registration of any end-use-product (EUP) and its label.

These applications may be submitted to the APVMA concurrently or separately.

During the approval process of a new active constituent , the APVMA assesses the chemistry, health and safety (toxicology) and metabolism (pharmacokinetics) of the active constituent , to ensure the chemical complies with an appropriate standard and does not contain unacceptable levels of potentially harmful impurities.

The APVMA also has a process of evaluating new sources or sites of manufacture of active constituents which have already been approved in Australia. Only active constituents from approved sites of manufacture may be used in the formulation of registered end-use-products (EUP). Additionally, the APVMA has a process of evaluating variations to manufacturing processes of active constituents or new analytical methods.

The regulatory consultants at De Groot Technical Services are experienced in the preparation and submission of applications for APVMA active constituent approval. This includes new active constituents, new sources or variations to existing approvals. We provide advice on data requirements, review the suitability of existing data, and we collate all the necessary information in the format required.