Others titles

  • EMA API GMP Certificates of EEA Countries
  • API Sites Certificates of EEA Countries

Keywords

  • EEA Active Substance
  • Pharmaceutical Substance
  • Active Substance Inspection
  • European Medicines Agency Registration
  • European Medicines Agency API Certificates

EMA API Registration Certificates of EEA Sites

The European Medicines Agency (EMA) API Registration Certificates of EEA Sites dataset includes API sites registration certificates delivered by EMA or national competent authorities to European Economic Area countries API manufacturers.

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Description

Manufacturers of active substances intended for the manufacture of human medicines for the EU market must register with the national competent authority of the Member State where they are located.
Active substance manufacturers must comply with GMP. In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP.

Member states should establish the legal and administrative framework within which inspections relating to Good Manufacturing Practice (GMP) inspections as applied to active substances operate.
Inspectors should be issued with an official means of identification, which includes reference to powers of entry, access to data and the collection of samples and documents for the purpose of inspection.

The primary goal for the inspector should be to determine whether the various elements within the quality assurance system are effective and suitable for achieving compliance with GMP principles and pharmacopeial requirements.

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 Active Substance, Pharmaceutical Substance, Active Substance Inspection, European Medicines Agency Registration, European Medicines Agency API Certificates

Other Titles

EMA API GMP Certificates of EEA Countries, API Sites Certificates of EEA Countries

Data Fields

Name Description Type Constraints
Registration_NumberAPI site registration numberstring-
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerlevel : Nominalrequired : 1
Registration_HolderRegistration holder name.stringrequired : 1
Site_NameAPI site name.string-
Address_Line_1API site addressstring-
Address_Line_2API site addressstring-
Address_Line_3API site addressstring-
Address_Line_4API site addressstring-
CityAPI site city.string-
PostcodeAPI site Postcode.string-
CountryAPI site Country.stringrequired : 1
DUNS_NumberData Universal Numbering System Numberintegerlevel : Nominal
Site_NCA_ReferenceSite National Competent Authorities reference.stringrequired : 1
Last_Updated_DateLast updated datedatetimerequired : 1
EudraGMDP_Site_Reference_NumberThe EudraGMDP site reference numberintegerlevel : Nominal

Data Preview

Registration NumberEudraGMDP Document Reference NumberRegistration HolderSite NameAddress Line 1Address Line 2Address Line 3Address Line 4CityPostcodeCountryDUNS NumberSite NCA ReferenceLast Updated DateEudraGMDP Site Reference Number
ASR11434/00002 (2021 Annual Update: AUR21/034)31805Expeditors Ireland LimitedExpeditors Ireland Limitedc/o Cafferys InternationalUnit 3 CoolforeAshbourneCo. MeathA84 YV79Ireland (IE)ASR11434/000022021-05-31T16:27:19.07000016859
ASR11434/00001 Annual Update 2021 (AUR21/033)31786Expeditors Ireland LimitedExpeditors Ireland LimitedUnit 6 Horizon Logistics ParkHarristownDublin, K67 WE09Ireland (IE)ASR11434/000012021-05-31T16:09:28.75800016843
ASR12130/00001 (AUR21/038 - 2021 Annual Update)31785A.V. Pound & Co. Limited t/a MedexA.V. Pound & Co. Limited t/a MedexGoolds Hill HouseOld Cork RoadMallowCorkP51 FK70Ireland (IE)ASR12130/000012021-05-31T15:43:23.53300045864
6329 API2087Pluripharm B.V., ALKMAARPluripharm B.V.Phoenixstraat 21ALKMAAR1812PPNetherlands (NL)FUSY/328212021-05-31T15:22:04.20000029849
ASR11680/00001 (AUR21/036) Annual Update 202131765TopChem Pharmaceuticals LimitedTopChem Pharmaceuticals LimitedBallymote Business ParkCarrownantyBallymoteF56 RX08Ireland (IE)ASR11680/000012021-05-31T15:15:02.48300034400
5975 API1280Abbott Healthcare Products B.V., WEESPAbbott Healthcare Products B.V.C J van Houtenlaan 36WEESP1381CPNetherlands (NL)FUSY/297592021-05-31T13:32:09.24700025452
AMA - 56/201914555FARMAKA S.R.L.FARMAKA S.R.L.VVIA VILLAPIZZONE, 26MILANO20156Italy (IT)1002752019-05-31T12:00:03.94700054976
API - 86/20169348OLON S.P.A.OLON S.P.A.VIA DELLA VITTORIA, 89MULAZZANO26837Italy (IT)1000682017-05-31T09:40:04.58300037136
API - 123/20155827SANOFI S.R.L.SANOFI S.R.L.VIA ANGELO TITI, 22/26BRINDISI72100Italy (IT)1000432016-05-31T15:10:04.32600034053
API - 66/202129945PATHEON ITALIA S.P.A.PATHEON ITALIA S.P.A.Viale G.B. Stucchi 110MONZA20900Italy (IT)1002722021-03-31T20:48:06.57400054733