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This left pharmaceuticalcompanies in Europe with no European API supply source, and only a few suppliers in Asia. The recent update to the EC Urban Waste Directive, part of the environment package ‘Towards Zero Pollution,’ 4 has a disproportionate producer responsibility principle that will incur considerable extra costs.
This is due to the regulatory requirements imposed on parallel imported medicinal products in various Member States, the fulfilment of which often requires repackaging. Repackaging a medicinal product… means that the trademark is reapplied by an entity other than the trademark proprietor.”
Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceuticalcompanies developing medicines, change is also happening. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and genericmedicines.
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