The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use

In the early 1990’s, occasional incidents of transmission of enveloped viruses (hepatitis B (HBV) and C viruses (HCV)) and other blood-borne viruses, including hepatitis A virus (HAV) occurred with plasma-derived medicinal products. As a result, the effectiveness of processes for inactivation/ removal of enveloped viruses was increased. In addition, the Committee on Proprietary Medicinal Products (CPMP) encouraged the development and introduction of effective steps for non-enveloped viruses including hepatitis A and parvovirus B19 (CPMP Note for Guidance on Plasma-Derived Medicinal Products, CPMP/BWP/269/95).