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

2020-10-02

Version

2020-10-02

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 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_NI_04_GDP_2020_001720101WholesaleDE_NI_04_WDA_2020_0012 / 41403-16/32GDPWDAB. Braun Gesundheitsservice GmbHGewerbepark Ebbendorf 14Hilter49176Germany41403-16/322020-10-272020-10-012020-10-27T11:31:00+00:00
402-25/2020-420038Wholesale801-14/2015-11GDPWDAVIVALIS, proizvodnja in storitve, d.o.o. - warehouse at Kemofarmacija, veletrgovina za oskrbo zdravstva, d.d.Cesta na Brdo 100Ljubljana1000SloveniaVIVALISWDA12020-10-162020-09-242020-10-16T05:51:00+00:00
DE_NI_04_GDP_2020_001620104WholesaleDE_NI_04_WDA_2020_0011/ 41403-15/43GDPWDAWittrock + Uhlenwinkel GmbH & Co. KGCarl-Lüer-Str. 11Osnabrück49084Germany41403-15/542020-10-152020-09-232020-10-27T12:25:00+00:00
UK WDA(H) 43542 Insp GMP/GDP 43542/12302391-000519930WholesaleUK WDA(H) 43542GDPWDAEURO-LINK PHARMA LIMITED110 BUTTERFIELDGREAT MARLINGSLUTONLU2 8DLUnited Kingdom12302391-EURO-LINK PHARMA LIMITED2020-09-222020-09-222020-09-23T18:34:00+00:00
DE_NW_02_GDP_2020_0017/24.05.02-06119988WholesaleDE_NW_02_WDA_2020_0010/24.05.02-061GDPWDAÖkonomed GmbHDieselstraße 9Rödinghausen32289GermanyDE_NW_02_WDA_2020_0010/24.05.02-0612020-10-052020-09-222020-10-05T13:27:00+00:00
NL/G 20/202502619898Wholesale8091 GGDPWDAVTS Logistics B.V.Ingenieur Wagterstraat 8BOXMEER5831AZNetherlandsFUSY/494302020-09-182020-09-182020-09-18T11:01:00+00:00
UK WDA(H) 46078 Insp GDP 46078/19392332-000119931WholesaleUK WDA(H) 46078GDPWDACHLORACO HEALTHCARESYKESIDE VIEWBURNLEY ROAD, ALTHAMACCRINGTONBB5 5UHUnited Kingdom19392332-CHLORACO HEALTHCARE2020-09-222020-09-172020-09-23T18:34:00+00:00
OGYÉI/49373-7/202020059WholesaleHU-D-TEVAGDPWDATEVA Gyógyszergyár Zrt.Vasút u. 11. (Shark Park) SPH4 és SPH5 Raktárépület, 2-14. kapukBudaörs2040HungaryHU-D-TEVA092020-10-212020-09-172020-10-20T12:22:00+00:00
402-22/2020-420100Wholesale801-26/2018-15GDPWDAABAKUS TRADING, Proizvodnja, servis in trgovina, d.o.o. - warehouse at Farmadent, trgovina, proizvodnja in storitve, d.o.o.Minařikova ulica 6Maribor2000SloveniaABAKUSTRADINGWDA12020-10-272020-09-162020-10-27T10:54:00+00:00
DE_HE_01_GDP_2020_189119961WholesaleDE_HE_01_WDA_2020_0044GDPWDADipharma Arzneimittel GmbHOffheimer Weg 33Limburg a.d. Lahn65549Germany2020_00442020-09-292020-09-112020-09-30T13:37:00+00:00