EMA Good Distribution Practices Certificates

$179 / year

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.

Complexity

Active substances and medicinal products shall be distributed in accordance with good distribution practices. Member States shall enter the certificates of good distribution practices which they issue in the Union database (EudraGMDP) in accordance with Art. 111(6) of the Directive 2001/83/EC as amended.

Member States should appoint inspectors to inspect wholesale distributor sites concerned by Directive 2001/83/EC and 2001/82/EC. There should be sufficient resources at all levels to meet, effectively and efficiently, the EU requirements of verifying compliance with the legal requirements relating to the wholesale distribution of medicinal products.
The inspectors shall be officials of or appointed by the competent authorities of the Member States in accordance with national regulations and follow the provisions for the national competent authority.
GDP inspections may be performed before granting or modifying a wholesale distribution authorization. Routine GDP inspections cover the assessment of GDP compliance of a site.
Nonroutine inspection may be conducted to check specific aspects of GDP compliance, for example investigation of complaints, recalls, quality defects, previous non-compliance or suspected falsified products.
The wide diversity of facilities together with the variety of products supplied and handled by a site means that assessment by inspectors on site of the degree of compliance with GDP is essential. A consistent approach to the evaluation of the GDP standard is required.

Date Created

2011

Last Modified

2019-07-02

Version

2019-07-02

Update Frequency

Daily

Temporal Coverage

N/A

Spatial Coverage

European Economic Area Countries

Source

John Snow Labs; European Medicines Agency (EMA), EudraGMP;

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

EEA Good Distribution Practices, Good Distribution Practices Certificates, European GDP, Centralized GDP

Other Titles

EMA GDP Certificates of EEA Countries, GDP Certificates of EEA Countries, EMA Centralized GDP

NameDescriptionTypeConstraints
Certificate_NumberGDP compliance certificate numberstringrequired : 1
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerrequired : 1 level : Nominal
Distribution_OperationDistribution activitystringenum : Array required : 1
WDA_No_Or_API_Reg_NoEMA Wholesale Distributor or API site registration Numberstring-
Document_TypeDelivered document typestringenum : Array required : 1
Site_NameInspected site name.stringrequired : 1
Address_Line_1Inspected site addressstring-
Address_Line_2Inspected site addressstring-
Address_Line_3Inspected site addressstring-
Address_Line_4Inspected site addressstring-
CityInspected site city.string-
PostcodeInspected site Postcode.string-
CountryInspected site Country.stringrequired : 1
DUNS_NumberData Universal Numbering System Numberstring-
NCA_RefSite National Competent Authorities reference.stringrequired : 1
Issue_DateIssue datedaterequired : 1
Inspection_End_DateInspection end datedaterequired : 1
Last_Updated_DateLast updated datedatetimerequired : 1
Certificate NumberEudraGMDP Document Reference NumberDistribution OperationWDA No Or API Reg NoDocument TypeSite NameAddress Line 1Address Line 2Address Line 3Address Line 4CityPostcodeCountryDUNS NumberNCA RefIssue DateInspection End DateLast Updated Date
UK WDA(H) 39307 Insp GMP/GDP 39307/303632-003616447WholesaleUK WDA(H) 35184GDPWDAB & S GROUPUNIT 4BRADFIELD ROADRUISLIPHA4 0NUUnited Kingdom303632-B & S GROUP2019-06-272019-06-272019-07-01T14:12:00+00:00
DE_HB_01_GDP_2019_001916511WholesaleDE_HB_01_WDA_2019_0019GDPWDAaescuLog GmbHReiherstraße 223Bremen28239GermanyGH-2019-00192019-07-052019-06-272019-07-05T07:26:00+00:00
BPD/022/2019/CAN16652Wholesale022-CANGDPWDALogisters LogísticaCalle Trasera Monseñor Oscar Romero nº3, Parque empresarial MelenaraTelde35200Spain1101-0042019-07-192019-06-272019-07-19T12:10:00+00:00
DE_HE_01_GDP_2019_145216508WholesaleDE_HE_01_WDA_2017_0052GDPWDANOWEDA Apothekergenossenschaft eGPerchstetten 7Langgöns35428Germany2017_00522019-07-022019-06-262019-07-04T13:30:00+00:00
UK WDA(H) 48527 Insp GDP 48527/17387899-000216619WholesaleUK WDA(H) 48527GDPWDASTRATHARD PHARMACY LIMITEDMAIN STREETABERFOYLESTIRLINGFK8 3UGUnited Kingdom17387899-STRATHARD PHARMACY LIMITED2019-07-112019-06-262019-07-12T18:30:00+00:00
G3 - 5423/Vivisol/01/12.07.2019/CE_0116614WholesaleG3 - 5423/Vivisol/01/12.07.2019GDPWDAVIVISOL Deutschland GmbHAm Hasensprung 2Mühlenbecker Land16567GermanyG3 - 5423/Vivisol/01/12.07.20192019-07-122019-06-252019-07-12T12:40:00+00:00
MT/027/HW/201916386WholesaleWL028GDPWDACherubino Ltd (variation 1)Delf Building (Site 1)Sliema Road14, Stadium Street,(Site 2)GziraGZR1637 (Site 1) GZR1302 (Site 2)MaltaWL 0282019-06-242019-06-242019-06-26T13:23:00+00:00
UK WDA(H) 50659 Insp GDP 50659/18636463-000216342WholesaleUK WDA(H) 50659GDPWDATAURUS HEALTHCARE LIMITEDSUITE 1, BERROWS BUSINESS CENTREBATH STREETHEREFORDHR1 2HEUnited Kingdom18636463-TAURUS HEALTHCARE LIMITED2019-06-202019-06-202019-06-20T18:50:00+00:00
UK WDA(H) 11764 Insp GDP 11764/17972749-000216363WholesaleUK WDA(H) 11764GDPWDACATALENT UK SUPPLY CHAIN LIMITED8 ORCHARD PLACENOTTINGHAM BUSINESS PARKNOTTINGHAMNG8 6PXUnited Kingdom50-437-961117972749-CATALENT UK SUPPLY CHAIN LIMITED2019-06-202019-06-202019-06-24T18:40:00+00:00
UK WDA(H) 34434 Insp GDP 34434/8294012-000116451WholesaleUK WDA(H) 34434GDPWDAESTUARY VIEW PHARMACYUNIT 25, ESTUARY VIEW BUSINESS PARKBOORMAN WAYWHITSTABLECT5 3SEUnited Kingdom8294012-ESTUARY VIEW PHARMACY2019-06-262019-06-192019-07-01T19:00:00+00:00