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

2020-08-03

Version

2020-08-03

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 numberintegerlevel : Nominal required : 1
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
DE_HE_01_GDP_2020_187819591WholesaleDE_HE_01_WDA_2020_0038GDPWDAApomedica Deutschland GmbHHessenring 144Bad Homburg v. d. Höhe61352Germany2020_00382020-07-282020-07-092020-07-31T07:46:00+00:00
DE_NI_04_GDP_2020_000919565WholesaleDE_NI_04_WDA_2020_0005/41403-15/57GDPWDAOnko Trade GmbH & Co. KGMöserstr. 46Osnabrück49074Germany41403-15/572020-07-212020-07-082020-07-24T08:25:00+00:00
sukls129028/202019578Wholesalesukls93726/2016GDPWDAPerfect Distribution a.s.warehouse is in FROL a.s., Farského 1117Olomouc779 00Czechia47675934-12020-07-232020-07-032020-07-28T11:51:00+00:00
DE_BB_01_GDP_2020/G3 - 5423/ DRK-Brandenburg/01/03.08.2020/CE_0119601WholesaleDE_BB_01_WDA_2020/G3 - 5423/ DRK/08/03.08.2020GDPWDADRK-Bluspendedienst Nord-Ost gemeinnützige GmbHKlinikum der Stadt BrandenburgHochstraße 29Haus 6Brandenburg14770GermanyDE_BB_01_5423/DRK_Brandenburg/01/30.06.20162020-08-032020-07-032020-08-04T08:59:00+00:00
DE_BB_01_GDP_2020/G3 - 5423/ DRK-Cottbus/01/03.08.2020/CE_0119602WholesaleDE_BB_01_WDA_2020/G3 - 5423/ DRK/08/03.08.2020GDPWDADRK-Blutspendedienst Nord-Ost gemeinnützige GmbHInstitut für Transfusionsmedizin CottbusThiemstraße 105Cottbus03050GermanyDE_BB_01_5423/DRK_Cottbus/01/30.06.20162020-08-032020-07-022020-08-04T09:14:00+00:00
UK WDA(H) 52500 Insp GDP 52500/19195937-000119624WholesaleUK WDA(H) 52500GDPWDABIRCHWOOD MEDICAL PRACTICEPARK LANENORTH WALSHAMNR28 0BQUnited Kingdom19195937-BIRCHWOOD MEDICAL PRACTICE2020-08-032020-07-022020-08-05T18:34:00+00:00
DK GDP 0013412019466Wholesale39019GDPWDAAir Liquide Danmark A/SEnergivej 7-9, PÃ¥rupEngesvang7442Denmark2777292020-07-082020-07-012020-07-08T13:29:00+00:00
sukls150748/202019579Wholesalesukls132217/2019GDPWDAJB Pharma, s.r.o.warehouse is in PHARMOS, a.s.Kladská 1192/65aHradec Králové500 03Czechia275 00 1102020-07-232020-07-012020-07-28T12:09:00+00:00
DE_BB_01_GDP_2020/G3 - 5423/ DRK-Schwedt/01/03.08.2020/CE_0119604WholesaleDE_BB_01_WDA_2020/G3 - 5423/ DRK/08/03.08.2020GDPWDADRK-Blutspendedienst Nord-Ost gemeinnützige GmbHAsklepios Klinikum UckermarkAuguststraße 23Schwedt/ Oder16303GermanyDE_BB_01_5423/DRK_Schwedt/01/25.01.20182020-08-032020-07-012020-08-04T09:19:00+00:00
DK API-GDP 0013442019612API39067GDPAPIFREJA Transport og Logistics A/SLitauen Allé 6Taastrup2630Denmark2552782020-08-042020-07-012020-08-04T13:41:00+00:00