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

2019-09-16

Version

2019-09-16

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 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
DE_HE_01_GDP_2019_172016913WholesaleDE_HE_01_WDA_2019_0045GDPWDAFarmako GmbHTaunustor 1-3Frankfurt am Main60310Germany2019_00452019-08-222019-08-212019-08-22T14:04:00+00:00
DE_NW_04_GDP_2019/003217027WholesaleDE_NW_04_WDA_2019-0160GDPWDAWestfalen Medical GmbHZeißstr. 4Kerpen50171GermanyDE_NW_04_NCA_01612019-08-292019-08-212019-09-04T07:54:00+00:00
004987/06.08.02.00/201917117Wholesale004423/06.08.00.04/2019GDPWDAOy Woikoski AbPuurtajankatu 22JärvenpääFI-04440Finland004423/06.08.00.04/20192019-09-162019-08-212019-09-16T11:11:00+00:00
UK WDA(H) 51282 Insp GDP 51282/18790878-000117064WholesaleUK WDA(H) 51282GDPWDATHE BEACON HEALTH GROUP52 MALDON ROADDANBURYCHELMSFORDCM3 4QLUnited Kingdom18790878-THE BEACON HEALTH GROUP2019-09-042019-08-202019-09-06T18:40:00+00:00
UK WDA(H) 44493 Insp GDP 44493/18895939-000116987WholesaleUK WDA(H) 44493GDPWDAOXLEAS PRISON SERVICES LIMITEDHEATHFIELD ROADLONDONSW18 3HUUnited Kingdom18895939-OXLEAS PRISON SERVICES LIMITED2019-08-282019-08-152019-08-30T18:40:00+00:00
UK WDA(H) 14076 Insp GDP 14076/18890869-000117098WholesaleUK WDA(H) 14076GDPWDANHS SCOTLAND PHARMACEUTICAL SPECIALS SERVICEJAMES ARROTT DRIVENINEWELLS HOSPITALDUNDEEDD2 1UBUnited Kingdom18890869-NHS SCOTLAND PHARMACEUTICAL SPECIALS SERVICE2019-09-062019-08-152019-09-10T18:40:00+00:00
MT/034HW/201917040WholesaleWL056GDPWDARodel Ltd170, St. Christopher StreetVallettaVLT1467MaltaWL0562019-08-222019-08-122019-09-05T07:40:00+00:00
DE_ST_01_GDP_2019_00517054WholesaleDE_ST_01_WDA_2019_002GDPWDAArzneimittelgroßhandel am OpernhausBreiter Weg 40Magdeburg39104Germany504.41504.1.A.1082019-09-062019-08-092019-09-06T10:14:00+00:00
DE_SN_01/26-5117/288_Nr._117049WholesaleDE_SN_01/26-5117/288GDPWDARIGEWA Pharmagroßhandel und Service GmbHSchlehenweg 28aLeipzig04329GermanyDE_SN_01/26-5117/2882019-08-292019-08-082019-09-05T12:18:00+00:00
MT/033HM/201916914WholesaleWL096GDPWDAFocused Pharma Ltd37 'Wilderness', Geronimo Abos StreetIklinIKL1022MaltaWL 0962019-08-052019-08-052019-08-22T14:09:00+00:00