Eudravigilance medicinal product dictionary
The Eudravigilance Medicinal Product Dictionary (XEVMPD) is a vital tool used by the European Medicines Agency (EMA) for collecting and managing data on medicinal products authorized in the European Union (EU). It plays a crucial role in pharmacovigilance by facilitating the reporting and analysis of adverse drug reactions (ADRs).
Here are some key features of the XEVMPD:
1. Comprehensive data:
- Covers all authorized medicinal products in the EU, including both centrally and nationally authorized products.
- Stores detailed information on each product, including:
- Product name and marketing authorization holder (MAH).
- Active ingredients and their quantities.
- Anatomical Therapeutic Chemical (ATC) classification.
- Dosage forms and routes of administration.
- Summary of product characteristics (SmPC).
2. Standardized data entry:
- Uses a structured format called the XEVPRM (eXtended EudraVigilance product report message) to ensure consistency and accuracy of data.
- This format allows for efficient data analysis and exchange between different national authorities and the EMA.
3. Facilitates ADR reporting:
- Provides a platform for healthcare professionals and patients to report suspected ADRs for any authorized medicinal product in the EU.
- This data is then analyzed by the EMA to identify potential safety concerns and take appropriate regulatory action if necessary.
4. Benefits of the XEVMPD:
- Improved patient safety: Enables early detection and management of potential safety risks associated with medicinal products.
- Enhanced transparency: Provides public access to information about authorized medicinal products and reported ADRs.
- Streamlined data analysis: Facilitates efficient analysis of pharmacovigilance data across the EU.
- Harmonized data exchange: Enables efficient communication and collaboration between EU member states and the EMA.
5. Accessing the XEVMPD:
- Limited access is granted to healthcare professionals and regulatory authorities involved in pharmacovigilance activities.
- Public access to certain information is available through the EMA’s website and EudraVigilance database.
Overall, the Eudravigilance Medicinal Product Dictionary plays a critical role in ensuring the safety of medicinal products in the EU. It facilitates ADR reporting, data analysis, and regulatory action, ultimately protecting the health of EU citizens.
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