EudraPharm
EudraPharm, or the European Union Drug Regulating Authorities Pharmaceutical Database, serves as the centralized database for medicinal products that have received authorization within the European Union. Its comprehensive collection incorporates critical information related to the Summary of Product Characteristics, patient or user package leaflets, and data exhibited on the medicinal labelling.
Overview[edit | edit source]
The primary objective of the EudraPharm database is to provide transparent and accessible data to the public. In order to ensure the information is both beneficial and easily understood by all users, the database is constructed in a manner that is both comprehensive and user-friendly.
Regulatory Framework[edit | edit source]
The establishment and functioning of EudraPharm are rooted in EU Regulation 726/2004. This regulation outlines the procedures and criteria for granting medicinal product licenses within the European Union, and it mandates the maintenance of an accessible database of authorized products.
Content and Scope[edit | edit source]
EudraPharm's focus is largely on products that have undergone the Centralised procedure for licensing. This means that for human medicines, EudraPharm primarily acts as a revamped interface, presenting information previously available via the EPARs (European Public Assessment Reports) section at the European Medicines Agency (EMEA).
Accessibility and Usage[edit | edit source]
EudraPharm is open to the general public, ensuring that individuals, healthcare professionals, researchers, and policymakers can readily access information about authorized medicinal products within the EU. Given its transparency and comprehensiveness, it plays an integral role in promoting informed decisions related to medicinal usage and policy formulation.
See Also[edit | edit source]
- European Union
- European Medicines Agency (EMEA)
- Medicinal product licensing
- European Medicines Agency
- EUDRANET
- EudraCT
- EudraGMP
- EudraVigilance
External links[edit | edit source]
- EudraPharm
- EUDRANET
- Projects of Common Interest for Administrations (EU)
- European Medicines Agency Implementation of the New EU Pharmaceutical Legislation
- EPAR section at European Medicines Agency
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Contributors: Prab R. Tumpati, MD
