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

2020-11-13

Version

2020-11-13

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
076/2017/RO10620Wholesale18DGDPWDAPOLISANO S.R.L.Şos. Alba Iulia nr.156Sibiucod 550052Romania18D12017-10-032016-07-152017-10-26T07:35:00+00:00
GIF-IW-400/0031_03_03/04/168/166674API75/WTC0031/API/15GDPAPIGEDEON RICHTER POLSKA Sp. z o.o.ul. Graniczna 35Grodzisk Mazowiecki05-825PolandWTN0332016-07-062016-04-292016-07-13T05:39:00+00:00
GIF-IW-400/0031_03_03/04/169/166672API75/WTC0031/API/15GDPAPIGEDEON RICHTER POLSKA Sp. z o.o.ul. Graniczna 35Grodzisk Mazowiecki05-825PolandWTN0332016-07-062016-04-292016-07-13T05:35:00+00:00
GIF-IW-400/0033_04_02/04/114/178987API116/WTC0033/API/15GDPAPIWrocławskie Zakłady Zielarskie "HERBAPOL" S.A.Zakład w Legnicyul. Hetmańska 1Legnica59-220PolandWTN1872017-05-092017-02-162017-05-11T10:43:00+00:00
GIF-IW-400/0033_02_02/04/212/167002API116/WTC0033/API/15GDPAPIWrocławskie Zakłady Zielarskie "HERBAPOL" S.A.ul. Św. Mikołaja 65/68Wrocław50-951PolandWTN0372016-08-252016-06-032016-09-01T11:12:00+00:00
IWSF.405.22.2021.IP.3.1 WTC/0037_01_01/8521500API58/WTC0037/API/15GDPAPIZakłady Farmaceutyczne POLPHARMA S.A., Oddział Medana w Sieradzuul. Wojska Polskiego 73Sieradz98-200PolandWTN0442021-04-282021-04-092021-05-04T09:57:00+00:00
IWSF.405.22.2021.IP.9.1 WTC/0037_03_01/9121499API58/WTC0037/API/15GDPAPIZakłady Farmaceutyczne POLPHARMA S.A., Oddział Medana w Sieradzuul. Polskiej Organizacji Wojskowej 57Sieradz98-200PolandWTN3022021-04-282021-04-092021-05-04T09:49:00+00:00
IWZJ.405.78.2018.ER.212790API18/WTC0038/API/15GDPAPIOCEANIC Spółka AkcyjnaTrąbki Małeul. Gdańska 5Trąbki Wielkie83-034PolandWTN0038_12018-06-072018-03-072018-06-13T09:17:00+00:00
sukls315867/201814786Wholesale14111/1/INS/99GDPWDAAngelini Pharma Česká republika s.r.o.Páteřní 1216/7Brno635 00Czechia18824706_12018-12-182018-10-262019-01-10T09:13:00+00:00
sukls315867/201814785Wholesale14111/1/INS/99GDPWDAAngelini Pharma Česká republika s.r.o.Páteřní 1216/7Brno635 00Czechia18824706_12018-12-182018-10-262019-01-10T09:00:00+00:00