Early Access Programs

New or novel therapies are often made available by global manufactures that are supplied on Managed Access Mechanisms. These mechanisms are often also referred to as Early Access Programs or Named Patient Programs.

Orspec offers a comprehensive service to ethically support pharmaceutical companies, patients, and physicians to access products with a high unmet clinical need where products are not available in the respective markets.

The mechanisms can also include:

• Post trials supplies
• Charged for managed access programs
• Companionate managed access programs

Orspec currently supports with various exclusive Early Access Programs across Australia, New Zealand, Singapore, South Korea, Malaysia, Hong Kong and Macao on behalf of partners from the United States, United Kingdom, Canada, Japan and Europe.

Medicine Shortages

 Medicine shortages are a growing and complex global challenge. Shortages of essential drugs are becoming increasingly frequent, placing additional costs on health systems and putting patients at risk when they cannot access the medicines they need.

Orspec Pharma works closely with regulators and pharmaceutical companies across our territories to reduce the impact of medicine shortages on patients. Each country and territory has specific management actions in place to minimise the effect on public health.

For information about our products approved in Australia by the TGA under Section 19A, visit the TGA website here. 

Contact us to request an alternative to a registered product currently in shortage in your territory.

Named Patient Supply

 Orspec Pharma provides access to products not commercially available to hospitals, healthcare professionals, or patients in our territories. This includes medicines, medical devices, or biologicals that are unregistered, affected by shortages, discontinued, or otherwise unavailable.

As a leading supplier of unlicensed medicines, we work with hospitals, pharmacists, and physicians, leveraging a global supplier network to ensure reliable and efficient delivery. Our team has the necessary licenses, regulatory expertise, and local market knowledge to navigate complex regulatory pathways and provide secure supply routes.

Orspec also holds stock of products listed on the TGA SAS Category C list with an established history of use in Australia.

For information on the TGA Special Access Scheme or to access products under Named Patient Supply in other territories, please visit the TGA website
or contact us.