EudraGMP
EudraGMP
EudraGMP (pronounced: yoo-dra-jee-em-pee) is a database maintained by the European Medicines Agency (EMA) that contains information about Good Manufacturing Practice (GMP) compliance and non-compliance, as well as manufacturing and importation authorizations.
Etymology
The term "EudraGMP" is an acronym derived from "European Union Drug Regulatory Authorities Good Manufacturing Practice".
Definition
EudraGMP is a publicly accessible, free-to-use database that provides information about the GMP compliance status of manufacturing sites within the European Economic Area (EEA). It also includes information about manufacturing and importation authorizations. The database is updated regularly with information provided by the competent authorities of the EEA Member States.
Related Terms
- Good Manufacturing Practice (GMP): A system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
- European Medicines Agency (EMA): A decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
- European Economic Area (EEA): The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EU’s single market.
- Manufacturing Authorization: A legal requirement in many countries for the manufacturer of a product to have government approval of the facilities and processes used to produce the product.
- Importation Authorization: A legal requirement in many countries for the importer of a product to have government approval of the facilities and processes used to import the product.
External links
- Medical encyclopedia article on EudraGMP
- Wikipedia's article - EudraGMP
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