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TGA presentations: Biotherapeutics Association of Australasia 2016 AGM, 13 October 2016
TGA workshop & education session
This workshop covered topics of biovigilance, epidemiological situations, TGA licensing and certification applications, update and variations to Biologicals, and the consultation on "Guidance on variations to biologicals included in the Register".
- Epidemiological situations: Compliance to to Therapeutic Goods Order No. 88 - Table 1 (s)
- TGA Licensing & Certification Applications: TGA Business Services Portal for biologicals
- Update and Variations to Biologicals
- Consultation on "Guidance on variations to biologicals included in the Register"
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.