Guideline on manufacturing site transfer requirements for immunobiological products

Background

Submissions are invited from those interested in new guidance for manufacturing site transfer requirements for immunobiological products. This guideline aims to provide clarity and consistency on specific data requirements for manufacturing site transfers of primary and secondary production steps for registered immunobiological products.

Consultation information

The APVMA is seeking feedback in relation to Guidance for guidance for manufacturing site transfer requirements for immunobiological products.

A registered veterinary chemical product can be varied via a number of different pathways. Further details are located on our website.

To vary the details for the sites of product manufacture a variation can be made by:

• prescribed variation (veterinary chemical products only)—Item 13A
• non-technical fixed fee application—Item 12
• technical modular application—Item 14.

Under the current guidance there are special considerations for immunobiological or peptide veterinary chemical products. The new guidance seeks to update and clarify the procedure and data requirements for the transfer of the site of manufacture for immunobiological products.

The new guidance will remove the requirements for a module for efficacy and target animal safety with bioequivalence of manufacture demonstrated under a chemistry module when required under an Item 14 variation application.

Making a submission

The consultation period is open until close of business on 28 February 2020.

Note that all submissions received are subject to legislation, including the Freedom of Information Act 1982, the Privacy Act 1988 and the Agvet Codes. In providing your submission to the APVMA, you agree to the APVMA publicly disclosing your submission in whole or summary form.

Electronic submissions are preferred, and may be sent to:

Registration Management
Martin.Ilott@apvma.gov.au
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001