## Overview

This data package covers all EudraGMDP including API sites registration certificates for EEA and Non-EEA sites, Good Distribution Practices Certificates (GDP), Good Manufacturing Practice Certificates (GMP) for EEA and Non-EEA sites, Manufacturing and Importation Authorizations (MIA) and Wholesale Distributor Authorizations (WDA) delivered by The European Medicines Agency (EMA). All EudraGMDP data in this data package is updated regularly. The data package also includes other databases related to the European Agency like rare disease designation and withdrawn applications initiated by pharmaceutical companies.

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## License Information

The use of John Snow Labs datasets is free for personal and research purposes. For commercial use please subscribe to the [Data Library](https://aws.amazon.com/marketplace/pp/prodview-ou2apz7asjdai?sr=0-13&ref_=beagle&applicationId=AWSMPContessa#offers) on AWS. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.

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## Metadata

Description | Value

----|-----

Data Package Complexity | Simple

Available Enrichments | N/A

Keywords | EEA Active Substance, Pharmaceutical Substance, Active Substance Inspection, EEA Good Distribution Practices, Good Distribution Practices Certificates, European GDP, Centralized GDP, European GMP, GMP Inspection, EMA Orphan

Other Titles | European Medicines Agency Authorizations, European Medicines Agency Certificates, EudraGMPD Authorizations and Certificates

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## Included Datasets

1. EMA API Registration Certificates of EEA Sites

The European Medicines Agency (EMA) API Registration Certificates of EEA Sites dataset includes API sites registration certificates delivered by EMA or national competent authorities to European Economic Area countries API manufacturers.

2. EMA API Registration Certificates of Non-EEA Sites

The European Medicines Agency (EMA) API Registration Certificates of Non-EEA Sites dataset includes API sites registration certificates delivered by EMA or national competent authorities to European Economic Area countries API manufacturers.

3. EMA Good Distribution Practices Certificates

The European Medicines Agency (EMA) Good Distribution Practices Certificates (GDP) dataset lists GDP Certificates delivered by EMA or national competent authorities to European Economic Area countries Wholesale distributors of pharmaceutical products.

4. EMA Good Manufacturing Practice Certificates of EEA Countries

Good manufacturing practice (GMP) describes the minimum standard that a medicine manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonizing GMP activities at European Union (EU) level.

5. EMA Good Manufacturing Practice Certificates of Non-EEA Countries

Good manufacturing practice (GMP) describes the minimum standard that a medicine manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonizing GMP activities at European Union (EU) level including inspection of Non-EEA countries sites.

6. EMA Manufacturing and Importation Authorizations

The European Medicines Agency (EMA) Manufacturing and Importation Authorizations dataset includes manufacturing and importation authorizations delivered by EMA or national competent authorities to European Economic Area countries manufacturers and importers of pharmaceutical products.

7. EMA Opinions And Decisions On Paediatric Investigation Plans

The European Medicines Agency (EMA) Opinions And Decisions On Paediatric Investigation Plans dataset includes information on opinions and decisions adopted by the European Medicines Agency's (EMA) Paediatric Committee (PDCO) on Paediatric Investigation Plans (PIPs) including deferrals and waivers.

8. EMA Rare Disease Designations

The European Medicines Agency (EMA) Rare Disease Designations dataset includes information on rare disease (orphan) designations based on applications that have been assessed by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP).

9. EMA Wholesale Distributor Authorizations

The European Medicines Agency (EMA) Wholesale Distributor Authorizations dataset lists Wholesale distributors authorizations delivered by EMA or national competent authorities to European Economic Area countries Wholesale distributors of pharmaceutical products.

10. EMA Withdrawn Applications

The European Medicines Agency (EMA) Withdrawn Applications dataset includes information on the decision by a pharmaceutical company to withdraw an application made to the European Medicines Agency for a human medicine. It includes withdrawals of new marketing authorization applications or for changes to existing marketing authorizations, which are evaluated by the Committee for Medicinal Products for Human Use (CHMP).

11. European Public Assessment Reports

The European Medicines Agency (EMA) publishes a European Public Assessment Report (EPAR) for every medicine granted a central marketing authorisation by the European Commission following an assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). EPARs are full scientific assessment reports of medicines authorized at a European Union level.

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## Data Engineering Overview

#### We deliver high-quality data

* Each dataset goes through 3 levels of quality review

* 2 Manual reviews are done by domain experts

* Then, an automated set of 60+ validations enforces every datum matches metadata & defined constraints

* Data is normalized into one unified type system

* All dates, unites, codes, currencies look the same

* All null values are normalized to the same value

* All dataset and field names are SQL and Hive compliant

* Data and Metadata

* Data is available in both CSV and Apache Parquet format, optimized for high read performance on distributed Hadoop, Spark & MPP clusters

* Metadata is provided in the open Frictionless Data standard, and its every field is normalized & validated

* Data Updates

* Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted

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#### Our data is curated and enriched by domain experts

Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:

* Field names, descriptions, and normalized values are chosen by people who actually understand their meaning

* Healthcare & life science experts add categories, search keywords, descriptions and more to each dataset

* Both manual and automated data enrichment supported for clinical codes, providers, drugs, and geo-locations

* The data is always kept up to date – even when the source requires manual effort to get updates

* Support for data subscribers is provided directly by the domain experts who curated the data sets

* Every data source’s license is manually verified to allow for royalty-free commercial use and redistribution.

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## Need Help?

* If you have questions about our products, contact us at <info@johnsnowlabs.com>.

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## About Us

[John Snow Labs](https://www.johnsnowlabs.com/), an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.