Closed ATM View - RFT TGA 15/0910
Provision of Committee Secretariat Services for the Therapeutic Goods Advertising Code Council (TGACC) and Complaints Resolution Panel (CRP), and technical education seminars on the regulatory requirements for advertisements for therapeutic goods
The Therapeutic Goods Administration (TGA) is seeking the provision of committee secretariat services for the Therapeutic Goods Advertising Code Council (TGACC) and Complaints Resolution Panel (CRP); and technical education seminars for stakeholder groups on the regulatory requirements for advertisements for therapeutic goods.
The TGA administers the Therapeutic Goods Act 1989 (“the Act”) and the Therapeutic Goods Regulations (“the Regulations”); and is responsible for the regulation of therapeutic goods in Australia. The TGA develops and implements appropriate national policies and controls for medicines, medical devices, blood, blood products and tissues. The objective of regulation is to ensure that products available in Australia meet standards of safety, quality and efficacy at least equal to those of comparable countries.
One aim is to ensure that the products are made available in a timely manner and that the regulatory impact on business is kept to the minimum necessary to meet the standards. This is achieved through a risk management approach to pre-market evaluation and approval of therapeutic products intended for supply in Australia, licensing of manufacturers, and post market monitoring and surveillance.
The legislation also establishes controls relating to advertisements for therapeutic goods (see Part 5 of the Act and Part 2 of the Regulations). These controls are administered under a system of co-regulation and the TGACC and CRP are established as statutory committees in the Regulations (see Division 2 and 3, Part 6 of the Regulations).
(a) the tenderer and any subcontractors proposed in the Tender must not be named as not complying with the Equal Opportunity for Women in the Workplace Act 1999 (Cth);
(b) there is currently no judicial decision against the tenderer or its subcontractor (not including decisions under appeal) in relation to employee entitlements where the tenderer or its subcontractor has not paid the claim; and
(c) the Tenderer complies with the Fair Work Act 2009 (Cth).