Unlicenced Medicines (UL) Managed Access Programs(MAP)

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Bespoke service to help you meet the needs of your patient. 

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Work with us to solve your needs

Pro PG works with Health Care Professionals (HCP) to solve unmet medical needs.

We work with you to provide information on products (SmPC, CMI, CoA's) , logistic lead times, marketing authorisation, pack photos to assist the Quality Use of Medicines (QUM)

Pro PG imports and acts as the Sponsor of the product and we deliver direct to Hospitals providing products through the various TGA allowed pathways. 

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The Space Between the Lines..... 

  • Clinical demand is often there prior to a product obtaining its registration and offical launch to the market. 

  • Clinical demand may also not be met through product shortages.

  • Clinical demand may exist after a product is discontinued in a region. 

Its these areas that Pro PG works with our customers to Solve Unmet Medical Needs. 

Unmet Clinical Need

For a patient with an illness needing a particular treatment there may not be a commercially available product in Australia available to treat their clinical needs. 

Unlicensed Medicines and Managed Access Programs

Not all medicines are approved in every country, and there may be patients needing to access medicines not approved in their countries.

A Unlicensed Medicine (UL) in Australia means it is not currently holding Registration / Marketing Approval (MA) from our regulator the Therapeutics Goods Administration (TGA). The particular Medicine however, may have current Registration / Marketing Approval in another region of the world such as the UK or USA or Europe or another region. 

Managed Access Program (MAP) is a term we use to define a more formalised arrangement with a Sponsor. The particular product supply and distribution would be tailored to the Sponsors requests.  This may suit a pre-approval life-cycle stage for example. 

Why is it not available in my region?

  • Product maybe in clinical development not yet approved (timing)

  • Post clinical trial however not proceeding to approval (not proceeding to commercialisation in the region)

  • It may be approved in another country for example USA or Europe or Japan.

  • There may be a shortage in Australia

How does Pro Pharmaceuticals Group find the products?
We use our validated global network to source drugs from around the world and help Hospital / Doctor / Institution obtain the authorisations needed to import, become the Sponsor (via Special Access Scheme or S19A pathways) and supply directly to any hospital. We have in-house pharmacists supported by an experienced team to support the Hospital / Doctor / Institution. 

Suppliers wishing to join our validated global network please complete our Account Opening Form

Sponsors wanting to consider Australia

Pro Pharmaceuticals Group partners with sponsors to set up Managed Access Programs (MAP). We can work around the Sponsors needs including offering warehousing, GMP over labelling, Distribution.  

 

​MAP allows Hospital / Doctor / Institutions access to pre-approval, investigational drugs outside of the clinical trial setting. ​Sponsors please contact us for further discussions.

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