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

2019-11-19

Version

2019-11-19

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_05_GDP_2019_001217563WholesaleDE_NI_05_WDA_2019_0014GDPWDAPunkt-Apotheke GroßhandelSchützenplatz 5aSalzgitter38259Germany03552019-11-072019-11-072019-11-07T12:09:00+00:00
DE_NI_02_GDP_2019_001717630WholesaleDE_NI_02_WDA_2019_0017GDPWDAWEECO GmbHBismarckplatz 10-11Hildesheim31135GermanyDE_NI_02_WDA_2019_00172019-11-142019-11-062019-11-14T13:51:00+00:00
DE_NI_05_GDP_2019_001017539WholesaleDE_NI_05_WDA_2019_0011GDPWDASt. Laurentius-Apotheke - Großhandel -Weberstr. 1Hohenhameln31249Germany02622019-11-042019-11-042019-11-04T14:08:00+00:00
UK WDA(H) 18799 Insp GDP 17481/303632-004217525WholesaleUK WDA(H) 35184GDPWDAB & S GROUPUNIT 4BRADFIELD ROADRUISLIPHA4 0NUUnited Kingdom303632-B & S GROUP2019-10-302019-10-302019-11-01T19:37:00+00:00
UK WDA(H) 6735 Insp GDP 6735/18976717-000117677WholesaleUK WDA(H) 6735GDPWDADAY LEWIS MEDICAL LIMITEDUNIT 4, BEDDINGTON TRADING PARKBATH HOUSE ROADCROYDONCR0 4TTUnited Kingdom18976717-DAY LEWIS MEDICAL LIMITED2019-11-062019-10-232019-11-20T19:34:00+00:00
DE_HE_01_WDA_2019_007417505Wholesale2019_0074GDPWDAHassan OsmanSprendlinger Landstraße 76aOffenbach am Main63069Germany2019-00742019-10-282019-10-182019-10-31T07:26:00+00:00
DE_HE_01_GDP_2019_186417615WholesaleDE_HE_01_WDA_2019_0075GDPWDAbava medical GmbHGräfenhäuser Straße 36Darmstadt64293Germany2019_00752019-11-112019-10-182019-11-13T07:54:00+00:00
BE/GDP/2019/04917666Wholesale1788 HGDPWDAMoriau Gas BVBAPijnbroekstraat 5Sint-Pieters-Leeuw1600Belgium0473 211 6292019-11-192019-10-182019-11-19T12:48:00+00:00
UK WDA(H) 51817 Insp GDP 51817/18980609-000117491WholesaleUK WDA(H) 51817GDPWDAGLOBOCEUTICS LTDGROUND FLOOR, OFFICE 3, BUILDING 4, HILLE BUSINESS CENTRE132A ST ALBANS ROADWATFORDWD24 4AEUnited Kingdom18980609-GLOBOCEUTICS LTD2019-10-242019-10-162019-10-29T19:34:00+00:00
UK WDA(H) 43557 Insp GDP 43557/16147675-000317578WholesaleUK WDA(H) 43557GDPWDADCS GROUP (UK) LIMITEDOCEAN HOUSENORAL WAYBANBURYOX16 2AAUnited Kingdom16147675-DCS GROUP (UK) LIMITED2019-11-052019-10-102019-11-07T19:33:00+00:00