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The same regulations and standards for quality apply to all parallel importers as they do to original producers.
Parallel importers are required to hold FDCA and GMP licenses, as well as an EU/EEA wholesale distribution license, and to submit to periodical inspections and audits.
Global challenges related to pharmaceutical shortages are becoming more complex. Globally, there are more and more frequent shortages of important medicines, it places additional financial strain on health systems and puts patients' health at risk if they do not receive the medications they require. More than 85% of hospitals in the EU indicate there is a serious challenge with pharmaceutical shortages.
Shortages of frequently prescribed hospital pharmaceuticals have a serious detrimental impact on patient care. A hospital can only find a solution by using unlicensed drug pathways to acquire and import an alternative treatment when there are medication shortages and no locally accessible, licensed replacement therapies commercially available in another country.
Alpha Pharmaceuticals provides a safe, continuous supply of products as an alternative to those that are in short supply to healthcare providers (or medical providers/individuals) around the world. The Group's network and geographic reach provide broader access choices for the pharmaceuticals as it is a favoured supplier of unlicensed pharmaceuticals to thousands of HCPs throughout the world seeking moral access to commercially unavailable pharmaceuticals in their markets.
Pharmaceutical corporations may choose to remove a pharmaceutical from the market as a viable strategic option, but doing so may leave patients with unmet medical needs if they are unable to locate appropriate substitute treatments. The best way for pharmaceutical companies to lessen the effects on patients is to implement a managed access programme that gives patients access to the needed medication after the product is removed on an unlicensed basis.