Glossary
The Paul-Ehrlich-Institut has developed the definitions in this glossary to help users understand regulatory and biomedical terminology. Definitions may differ from those given in German and European Union legislation and medicine. Many definitions correspond to the glossary entries on the pages of the European Medicines Agency (EMA).
Parallel Distribution
In a parallel distribution, the imported product is a medicinal product that has been authorised simultaneously in one centralised procedure throughout the EU. Parallel marketing does not require a separate marketing authorisation.
Parallel Import
Pharmaceutical companies / manufacturers often market medicines both in Germany and in other Member States of the European Union (EU) or the European Economic Area (EEA) with national marketing authorisations. If a company, independently from the original marketing authorisation holder or manufacturer, acquires the product in another EU or EEA Member State and imports it to Germany for marketing in parallel with the original pharmaceutical operator, this would be a parallel import. It is based on the different drug prices in the different EU and EEA Member States.
PASS - Post-Authorisation Safety Study
A post-authorisation safety study (PASS) is carried out to obtain further information on the safety of a medicinal product or to investigate the effectiveness of risk management measures.
PDCO - Paediatric Committee
The Paediatric Committee (PDCO) of the European Medicines Agency (EMA) is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.
Performance Study
A study undertaken to establish or confirm the analytical or clinical performance of an in vitro diagnostic (IVD) medical device.
Pharmacovigilance
Pharmacovigilance covers all of the activities and scientific analyses for monitoring the safety of medicinal products. Such activities and analyses serve to observe, detect, assess and understand adverse effects of a medicinal product, including measures to prevent adverse effects.
Further Information:
Phase I Trial
A clinical trial in which a medicine is administered for the first time to a few (mostly healthy) people to test the tolerability of the medicine.
Phase II Trial
A clinical trial, often with 100 to 300 participants, to determine the appropriate dose and obtain initial information on the efficacy of the medicinal product against the disease.
Phase III Trial
A clinical trial, usually conducted on a large group of subjects, to gather information about the efficacy and safety of a medicinal product.
Phase IV Trial
A clinical trial to be conducted after authorisation of a medicinal product if necessary.
PIP - Paediatric Investigation Plan
Paediatric Investigation Plan (PIP): A development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children. All applications for a marketing authorisation for new medicines have to include the results of studies as described in an agreed paediatric investigation plan, unless the medicine is exempt because of a deferral or waiver.
Plasma Master File
Documentation providing detailed information on the characteristics of the human plasma used in a medicine or a medical device.
PRAC - Pharmacovigilance Risk Assessment Committee
Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is responsible for assessing all aspects of the risk management of medicines for human use.
Product-Specific Waiver
An exemption from the obligation to acquire data, through a paediatric investigation plan, in some or all subsets of the paediatric population for a given condition, route of administration and pharmaceutical form of a specified medicine. Product-specific waivers are adopted by the Paediatric Committee (PDCO).
PSUR - Periodic Safety Update Report
PSUR stands for Periodic Safety Update Report – a regularly updated safety report. The PSUR, which must be submitted at predefined intervals, is prescribed in the marketing authorisation and is used to update the risk-benefit assessment of a medicinal product. The pharmaceutical company (marketing authorisation holder) must submit the report to the bodies of the European Medicines Agency (EMA) and thus also to the national medicines authorities. The PSUR is subject to an evaluation by a medicines authority, which examines the content of the data submitted and evaluates the conclusions of the pharmaceutical company. Additional evaluations are initiated when necessary and the product information text is modified accordingly if required.
Further Information (German only)
PSUSA – PSUR Single Assessment
PSUR Single Assessment (PSUSA) refers to the periodic safety update report (PSUR) for all medicinal products containing the same active substance. The assessment is carried out by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).
PUMA - Paediatric-Use Marketing Authorisation
Paediatric-Use Marketing Authorisation (PUMA): A type of marketing authorisation covering the indication(s) and appropriate formulation(s) for the paediatric population, which was introduced by the Paediatric Regulation. Applicants can request paediatric-use marketing authorisations for medicines that are already authorised, are no longer covered by a supplementary protection certificate or a patent that qualifies as such and are developed exclusively for use in children.