Transmissible spongiform encephalopathies (TSEs) questionnaire for sponsors
TSE questionnaire for sponsors (rtf, 228kb)
Introduction and explanation for Sponsors, how to use this questionnaire
This questionnaire has been designed by the TGA in consultation with Australian industry bodies to facilitate the collection of data to enable Sponsors to self-certify their therapeutic goods against the TGA's 'Supplementary requirements for therapeutic goods for minimising the risk of transmitting transmissible spongiform encephalopathies (TSEs)' <http://www.tga.gov.au/docs/html/tsesupp.htm>. This questionnaire should be sent to suppliers and manufacturers to obtain information about materials of ruminant origin used in the manufacture of raw materials, active, excipients, device components, reagents and finished products. The TGA Supplementary Requirements is available on this website which includes a TGA list of countries based on BSE risk.
The Supplementary Requirements document specifically concern ruminant Category C materials that will be subject to self-assessment by sponsors. Self-assessment is not applicable to Therapeutic Goods that are injectable, implantable or for intra-tracheal or opthalmic use.
For the purpose of this questionnaire, materials of ruminant origin should be reported. These include materials of bovine (cattle), ovine (sheep), caprine (goat) and cervid (elk, deer) origin.
Any materials of human origin are not self-assessable and require viral and prion safety evaluation by the TGA. Ruminant materials classified as Category A or B are not self-assessable. If materials originating from a ruminant source are classified as Category A or B, the manufacturer or supplier should inform the Sponsor. These ruminant materials should be evaluated for viral and prion safety by the TGA. Note that ruminant blood is specifically excluded from the scope of the Supplementary Requirements and does not undergo self-assessment. Blood and blood derivatives require viral and prion safety evaluation by the TGA.
Please make as many copies of this questionnaire as you need. A separate form should be used for each ruminant material used in the manufacture of the product(s). Respondents may make additional copies and may copy parts B, C and D separately to record information on additional exposures to ruminant materials in a single product or range of products. The questionnaire is available on the TGA website in rich text format so Sponsors may make modifications as necessary. The first section of the Questionnaire is designed for Sponsors to insert their details for return of the documentation. Sponsors may wish to add additional questions but are advised not to delete the basic questions provided.