Others titles

  • EMA GDP Certificates of EEA Countries
  • GDP Certificates of EEA Countries
  • EMA Centralized GDP

Keywords

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

EMA Good Distribution Practices Certificates

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.

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Description

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.

About this Dataset

Data Info

Date Created

2011

Last Modified

2023-08-18

Version

2023-08-18

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

Data Fields

Name Description Type Constraints
Certificate_NumberGDP compliance certificate numberstringrequired : 1
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerlevel : Nominalrequired : 1
Distribution_OperationDistribution activitystringenum : Array ( [0] => Wholesale [1] => API ) required : 1
WDA_No_Or_API_Reg_NoEMA Wholesale Distributor or API site registration Numberstring-
Document_TypeDelivered document typestringenum : Array ( [0] => GDPWDA [1] => GDPAPI ) 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

Data Preview

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_NW_01_GDP_2023/24.05.07-018-00227752WholesaleDE_NW_01_WDA_2023/24.05.07-018-002GDPWDAPOA Pharma GmbHLangenbruchstrasse 20aHiddinghausenSprockhoevel45549Germany16917450824422023-08-112023-07-132023-08-15T13:12:00+00:00
455-19/2023-127647Wholesale801-16/2023-12GDPWDAMAGNAPHARM SI trgovina in marketing d.o.o.Gornje Lepovce 114Ribnica1310Slovenia16908747143152023-08-012023-07-122023-08-01T08:55:00+00:00
DE_NI_05_GDP_2023_004027758WholesaleDE_NI_05_WDA_2019_0013GDPWDAWir Leben - Apotheken Inh. D. Duvel e.K. Additional Details: The GDP certificate is issued for "wir leben-Apotheke in Marschacht" - wholesale -, Elbuferstraße 86 a, 21436 Marschacht, based on the findings from the last inspection.Das GDP-Zertifikat wird für die "wir leben-Apotheke in Marschacht" - Großhandel -, Elbuferstraße 86 a, 21436 Marschacht, aufgrund der aus der letzten Inspektion gewonnenen Erkenntnisse ausgestellt.Elbuferstrasse 86 AObermarschachtMarschacht21436Germany13492023-08-162023-07-062023-08-16T09:19:00+00:00
3377627648WholesaleGDPWDAAvec Logistics (Ireland) LimitedUnit 2Harbour Gate Business Park Little IslandCorkT45 T286Ireland16908812682642023-08-012023-06-292023-08-01T09:14:00+00:00
DK GDP H 1000076527769Wholesale102898GDPWDAChemvet Dk A/SA.c.illums Vej 6Silkeborg8600Denmark1859002023-08-172023-06-282023-08-17T13:02:00+00:00
DK GDP H 1000076527770Wholesale102898GDPWDAChemvet Dk A/SA.c.illums Vej 6Silkeborg8600Denmark1859002023-08-172023-06-282023-08-17T13:09:00+00:00
DE_HH_01_GDP/517-02.13/1,0363-227671WholesaleDE_HH_01_WDA/517-02.13/01,0363GDPWDAEris Pharma GmbHDorotheenstrasse 48WinterhudeHamburg22301GermanyDE_HH_01_WDA/517-02.13/01,03632023-08-022023-06-262023-08-03T09:50:00+00:00
DK GDP H 1000078227514Wholesale40377GDPWDAAmgen Denmark (filial af Amgen AB, Sverige)Borupvang 9Ballerup2750Denmark3215822023-07-182023-06-212023-07-18T08:17:00+00:00
DE_NI_02_GDP_2023_001127584WholesaleDE_NI_02_WDA_2023_0003GDPWDAYASIN Pharma GmbHHorst-Niebuhr-Ring 42Seelze30926Germany16901831039142023-07-042023-06-212023-07-26T06:03:00+00:00
DE_ST_01_GDP_2023_02027710WholesaleDE_ST_01_WDA_2023_020GDPWDAAIR LIQUIDE Medical GmbHMoellensdorfer Strasse 13 DPiesteritzLutherstadt Wittenberg06886Germany504.41504.1.A.1412023-08-032023-06-212023-08-07T09:33:00+00:00