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

2019-03-04

Version

2019-03-04

Update Frequency

Daily

Temporal Coverage

N/A

Spatial Coverage

European Economic Area Countries

Source

Source License URL

John Snow Labs Standard License

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
IN-2-15/14/31712Wholesale276GDPWDAZoovetvaruUusaru 5Saue76505Estonia75012014-06-052014-03-142014-06-18T10:06:00+00:00
482290-0001286WholesaleGDPWDAHal-allergyJohnstraße 4Wien1150Austria4822902012-01-102011-06-072013-08-20T13:22:00+00:00
IN-2-15/17/1110483Wholesale83GDPWDAKBM PharmaTähtvere 4Tartu51007Estonia72092017-10-162017-05-312017-10-18T10:54:00+00:00
15/04262-64757Wholesale8328GDPWDA2care4Tømrervej 9ESBJERG VDK-6710Norway83282015-10-052015-04-212015-10-05T11:53:00+00:00
IN-2-15/14/11421Wholesale464GDPWDAOribalt TallinnKungla 2Saue76505Estonia40042014-04-282014-01-292014-05-05T10:34:00+00:00
482346-0001312WholesaleGDPWDAAbbVie GmbHLemböckgasse 61Wien1230Austria4823462012-06-282012-05-232013-08-21T08:34:00+00:00
IN-2-15/19/314993Wholesale464GDPWDAOribalt TallinnKungla 2Saue76505Estonia40042019-02-012018-11-292019-02-04T10:38:00+00:00
DK GDP 000879179363Wholesale33450GDPWDALEMANVentrupvej 6Greve2670Denmark2759542017-06-222017-03-072017-06-22T13:00:00+00:00
VEN/01/20153452Wholesale101GDPWDAVENIFAR LTD3 Imvrou StreetLatsia2234Cyprus1012015-03-112014-06-042015-03-11T11:39:00+00:00
IN-2-15/17/109781Wholesale494GDPWDAPharmac MSRiia road 17Pärnu80019Estonia71282017-08-012017-06-122017-08-03T12:33:00+00:00