Access Generic Medicines work-sharing initiative

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:

1. 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. 

   Access Consortium - Generics Operational Procedures (OP) [PDF, 378.92 KB]
   Access Consortium - Generics Operational Procedures (OP) [DOCX, 443.55 KB]

2. Download and complete the Expression of Interest (EOI) form below to express interest in participating in a work-sharing submission 

   Access Consortium – Generics Expression Of Interest (EOI) Form [PDF, 284.28 KB]
   Access Consortium – Generics Expression Of Interest (EOI) Form [DOCX, 107.97 KB]
3. 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.

• Australia: PCSInbox@tga.gov.au / international@tga.gov.au,
• Canada:  collaboration@hc-sc.gc.ca,
• Singapore: HSA_TP_Enquiry@hsa.gov.sg
• Switzerland: Networking@swissmedic.ch
• United Kingdom: access-mhra@mhra.gov.uk