Package Leaflet (PL)

Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes into the public domain via a number of routes.

Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.

GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and distribution of medicines. GxP rules and guidelines ensure that all aspects of the medicines development process are conducted according to the best methods for safety, efficacy, and quality.

The medicines development process' ultimate goal is an approval for marketing the new medicinal product – a Marketing Authorisation. This should be an integral part of all steps throughout the life-cycle of the medicinal product. A Marketing Authorisation Application contains information on quality, and non-clinical and clinical studies.