WE ARE EXPERTS IN UNLICENSED MEDICINE
In some cases, patients with specific illnesses may encounter a challenge when seeking treatment due to the unavailability of commercially approved products in Australia that can address their clinical needs.
At Pro Pharmaceuticals Group, we understand the importance of providing solutions to such unmet clinical needs. Our primary focus is to bridge the gap and ensure patients have access to the necessary treatments, even when commercially available options are limited or non-existent in Australia.
Unlicensed Medicines and Managed Access Programs
In the world of pharmaceuticals, not all medicines receive approval in every country. This can pose a challenge for patients who require access to medications that are not approved in their respective countries.
In Australia, an Unlicensed Medicine (UL) refers to a medication that does not currently hold Registration or Marketing Approval (MA) from our Australian regulatory body, the Therapeutic Goods Administration (TGA). However, it's important to note that this specific medicine may possess valid Registration or Marketing Approval in other regions such as the UK, USA, Europe, or elsewhere in the world.
To facilitate the provision of these medicines, we have established a Managed Access Program (MAP). This term refers to a more formalised arrangement with a Sponsor, where the supply and distribution of a particular product are tailored to the Sponsor's specific requests. This program can be particularly beneficial during the pre-approval life-cycle stage of a medication, allowing patients to access necessary treatments while regulatory processes are still ongoing.
At Pro Pharmaceuticals Group, we understand the importance of ensuring patients' access to vital medicines, even if they are not yet approved in their countries. Through our Unlicensed Medicine offerings and Managed Access Programs, we strive to bridge the gap and provide solutions that meet the specific needs of patients and their healthcare providers.
Why is it not available in my region?
There are several reasons why a particular product may not be available in your region:
Clinical Development Status: The product may still be in the clinical development stage and awaiting approval. Timing plays a crucial role in determining when a product will be available for commercial use.
Lack of Approval: After completing clinical trials, the product may not proceed to approval in certain regions, meaning it will not be commercialised there.
Approval in Other Countries: The product may have obtained approval in other countries such as the USA, Europe, or Japan, but not in your specific region.
Shortages: Availability issues can arise due to market shortages within Australia, impacting the availability of certain products.
How does Pro Pharmaceuticals Group find the products?
At Pro Pharmaceuticals Group, we leverage our validated global network to source drugs from around the world. We assist hospitals, doctors, and institutions in obtaining the necessary authorizations to import these products. Through the Special Access Scheme (SAS) or S19A pathways, we become the sponsor and directly supply hospitals. Our in-house pharmacists, along with our experienced team, provide comprehensive support throughout the process.
Suppliers Interested in Joining Our Global Network
If you are a supplier looking to join our validated global network, we invite you to complete our Account Opening Form. We value collaborations that expand our reach and enhance the availability of essential medications.
Sponsors wanting to consider Australia
Pro Pharmaceuticals Group partners with sponsors to establish Managed Access Programs (MAPs). We tailor our services to meet sponsors' specific needs, including offering warehousing, GMP over-labelling, and distribution solutions.
MAPs provide hospitals, doctors, and institutions with access to pre-approval investigational drugs outside of the clinical trial setting. Sponsors interested in exploring MAP opportunities in Australia are encouraged to contact us for further discussions.
MAP allows Hospital / Doctor / Institutions access to pre-approval, investigational drugs outside of the clinical trial setting. Sponsors please contact us for further discussions.
Unlicensed Medicines (UL) Managed Access Programs(MAP)
Why work with Pro PG?
Bespoke service to help you meet the needs of your patient.
24/7 Support, 365 days per year
Rapid Response times
Range of products in stock and available from our Global Network.
100% Privately owned Australian company
Corporate and Social Responsibility
Direct Relationships with Manufacturers
Exclusive Supply Agreements
Partners with Validated Licensed Global Wholesalers
Work with us
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.