• European Medicines Agency Authorizations
  • European Medicines Agency Certificates
  • EudraGMPD Authorizations and Certificates

Keywords

  • EEA Active substance
  • Pharmaceutical substance
  • Active substance inspection
  • EEA Good Distribution Practices
  • Good Distribution Practices Certificates
  • European GDP
  • Centralized GDP
  • European GMP
  • 3rd country inspection
  • GMP inspection
  • EMA Orphan

EMA Authorizations and Certificates Data Package

$869 $599 / YEAR

This data package allows access to all updated data of EudraGMDP databases including API sites registration certificates, Good Distribution Practices Certificates (GDP), Good Manufacturing Practice Certificates (GMP), Manufacturing and Importation Authorizations (MIA) and Wholesale Distributor Authorizations(WDA) delivered by The European Medicines Agency (EMA). Its includes also other data related to the European Agency like rare disease designation and withdrawn applications.

Benefits
Access to updated EudraGMPD data; Access to all certificates delivered by EMA to European and non European Companies; Access to rare disease designation and withdrawn applications databases;
Specification
Update Frequency: Daily
Data Complexity: Simple
Number of Datasets: 11
INCLUDED DATASETS
1. EMA API Registration Certificates of EEA Sites ($79)
2. EMA API Registration Certificates of Non-EEA Sites ($79)
3. EMA Good Distribution Practices Certificates ($79)
4. EMA Good Manufacturing Practice Certificates of EEA Countries ($79)
5. EMA Good Manufacturing Practice Certificates of Non-EEA Countries ($79)
6. EMA Manufacturing and Importation Authorizations ($79)
7. EMA Opinions And Decisions On Paediatric Investigation Plans ($79)
8. EMA Rare Disease Designations ($79)
9. EMA Wholesale Distributor Authorizations ($79)
10. EMA Withdrawn Applications ($79)
11. European Public Assessment Reports ($79)