Closed ATM View - Health/17-18/03532/1
Request for Tender for the Establishment of a Therapeutic Goods Evaluation Panel
The Therapeutic Goods Administration (TGA), a part of the Department of Health, is seeking to establish a Therapeutic Goods Evaluation Panel to provide medical and scientific evaluation services.
The Therapeutic Goods Evaluation Panel is expected to deliver evaluation services for technical streams as follows:
1. Clinical medicines and clinical technologies
2. Nonclinical sciences (pharmacology/toxicology)
3. Quality of pharmaceutical therapeutic goods (synthetic pharmaceuticals, biological sciences)
Evaluation services are in the form of a written evaluation report comprising review and critical evaluation of quality, safety and efficacy data on medicines, as submitted by pharmaceutical companies. The evaluation reports are prepared in a format prescribed by the TGA, and following procedures determined by the TGA.
Information sessions (industry briefings) for potential Tenderers will be held in selected major cities in November 2017. Registration for the information sessions is via the TGA website (www.tga.gov.au) (Please note: The registration information will be available from Tuesday 17 October)
The TGA’s Conditions for Participation (as stated in clause 11 of the RFT):
•The Tenderer must not have had any judicial decisions against it (excluding decisions under appeal) relating to employee entitlements and have not paid the claim.
•The Tenderer, its personnel, and any Subcontractors proposed in the Tender must not, at the Closing Time, be listed as terrorists under section 15 of the Charter of the United Nations Act 1945 (Cth).
•The Tenderer (and any Subcontractor proposed in its Tender) must not be named in the Consolidated List referred to in Regulation 40 the Charter of United Nations (Dealing with Assets) Regulations 2008 (Cth).
The Panel will commence on 1 July 2018 and will be in place for 3 years, with the possibility of extension.