The Generic Medicines Work-Sharing Initiative is an innovative work-sharing model for the coordinated assessment of a generic applications that are filed with multiple Access Consortium agencies. The initiative has worked through the practicalities of undertaking a coordinated assessment that will complement the regulatory decision-making within each jurisdiction.
Approved medicines through Generic Medicines work-sharing include:
How to submit an application for Generic Medicines work-sharing
Access Generic Medicines work-sharing is actively exploring opportunities for work-sharing with industry and is seeking applications for this initiative. Applicants who are interested in taking part in this initiative should:
Review the Operational Procedures (OP) document below which outlines the operational steps, target milestones and recommendations for the planning and the filing of an application.
Submit your completed EOI form to at least two of the Access Consortium members listed below via email. To be considered as a suitable candidate for this work-sharing initiative, submit your applications simultaneously to participating members.
Please include 'Access Consortium - Generic Medicines work-sharing' in the subject line of your email.
Public Statement for the ACSS Generics Working Group face to face meetings, Strasbourg, France, 6-7 May 2016
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.