Where can additional information on a biological or biosimilar medicine be found

At the time of marketing authorisation, informative documents are approved and published to ensure the safe and effective use of the medicinal product i.e. The Summary of Product Characteristics (SmPC), the Package Leaflet and the Labelling. The MAH is obliged to follow scientific and technical progress and keep the product information up to date. In certain cases, however, additional measures are required to reduce the risks associated with medicinal products. This can be with the Patient Alert Card, Information for Healthcare Professionals, Patient Information or other types of educational brochures. More detailed information, which presents the quality aspects of the medicinal product, pre-clinical and clinical studies of the safety and efficacy, can be found in the European Public Assessment Report (EPAR) prepared by the CHMP and is available on the website of the European Medicines Agency (EMA) under the “Assessment history” tab.

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