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Consultation: Guidance on variations to biologicals included in the Register
This consultation closed on 25 November 2016.
The TGA sought comments from interested parties on draft guidance for varying a biological included in the Register. The document outlines
- the types of changes that require submission to and approval by the TGA, and
- the business processes for making an application to the TGA.
- Consultation: Guidance on variations to biologicals included in the Register (pdf,334kb)
- Consultation: Guidance on variations to biologicals included in the Register (docx,146kb)
Document released for consultation on Friday 30 September 2016.
Interested parties should respond by close of business on Friday 25 November 2016.
Feedback will be released following consideration of submissions. (see 'What will happen').
About the consultation
This document represents draft guidance to assist sponsors of biologicals included in the ARTG to meet their legislative obligations where a change to the goods is introduced. This includes where the change:
- has the potential to impact quality, safety or efficacy
- corrects an ARTG entry
- creates a separate and distinct good
- meets the criteria for a safety-related variation.
Biologicals available for general marketing in Australia have been included in the Australian Register for Therapeutic Goods (ARTG) since June 2013. The legislative basis for variations to included biologicals is in place and is equivalent to that for registered medicines. However, there is currently no guidance available to sponsors of biologicals explaining the types of changes that require submission to and approval by the TGA and outlining the business processes for varying a biological included in the Register.
Submissions may be provided on any aspect of the policies or processes outlined in the consultation document (Guidance on variations to biologicals included in the Register).
Any questions relating to submissions should be directed to the Biological Science Section by email to email@example.com or by telephone to 1800 678 799.
What will happen
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- seek feedback about how the consultation was undertaken.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
- More information on consultations and privacy is included in the submission form and on our website.