Operational Notice:
Provision of registration advice by the APVMA

April 2005

One of the principal roles of the APMVA is to make regulatory decisions on applications for approval of active constituents, registration of products, approvals of labels, and variations to these approvals and registrations.

The APVMA has a responsibility to provide information to applicants on the procedures for making an application, the category under which application must be made, and data requirements for each category of application.

The Ag and Vet Requirements Series are the principal documents which provide this information (these documents are currently being extensively revised). The Ag and Vet Requirements Series are supplemented by a number of specific guidelines, most of which are available on the APVMA website.

The APVMA also has a responsibility to respond to inquiries about the process and procedures for making applications and APVMA officers spend a great deal of time in responding to these inquiries. The most frequent inquiries are:

• does the product require registration?
• what category best suits the application?
• what types of data/studies should be provided as part of the application?

In responding to these inquiries the APVMA will provide a reasonable amount of information and assistance. The APVMA will spend a reasonable amount of time in responding to telephone inquiries and for registration of new products will participate in meetings with applicants to discuss matters such as data requirements and application category.

However, provision of this information and assistance cannot become ‘open-ended’. Apart from the matter of limitations on staff time, the APVMA must avoid conflict between being advisor and also regulator.

If an applicant is seeking extensive assistance on how to make an application, or a request for registration advice, the following avenues are open to the applicant:

Type of inquiry	General advice on the class of product	Specific advice on specific products
Does the product require registration?	Refer to information on the APVMA website.	Obtain advice from a registration consultant.
What category best suits the application?	Refer to the Ag and Vet Manuals.	Submit an application for registration or variation and nominate an application category. The registration category will be determined as part of the screening process.
What types of data/studies should be provided as part of the application?	Refer to website guidelines relevant to the product.	Obtain advice from a registration consultant.For a specific data requirement (eg efficacy, or residues) make an application for a trial protocol evaluation under Category 50.

For any of the above inquiries, applicants might also find answers or links to answers thought the APVMA’s new ‘Ask client services’ facility which is accessible thought the APVMA website.