EMA API Registration Certificates of EEA Sites

$79 / year

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.

Complexity

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.

Date Created

2011

Last Modified

2018-04-21

Version

2018-04-21

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

John Snow Labs Standard License

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

Name Description Type Constraints
Registration_NumberAPI site registration numberstringrequired : 1
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerrequired : 1 level : Nominal
Registration_HolderRegistration holder name.stringrequired : 1
Site_NameAPI site name.string-
Address_Line_1API site addressstringrequired : 1
Address_Line_2API site addressstring-
Address_Line_3API site addressstring-
Address_Line_4API site addressstring-
CityAPI site city.stringrequired : 1
PostcodeAPI site Postcode.string-
CountryAPI site Country.stringrequired : 1
DUNS_NumberData Universal Numbering System Numberintegerlevel : Nominal
NCA_RefSite National Competent Authorities reference.stringrequired : 1
Last_Updated_DateLast updated datedatetimerequired : 1
Registration_NumberEudraGMDP_Document_Reference_NumberRegistration_HolderSite_NameAddress_Line_1Address_Line_2Address_Line_3Address_Line_4CityPostcodeCountryDUNS_NumberNCA_RefLast_Updated_Date
149/WTC0425/API/179368airtyhjythhyh45hny5Poland (PL)0002017-06-01T07:41:56
25374343Danipharm A/SDanipharm A/SSkalhuse 3Nibe9240Denmark (DK)713012016-08-03T13:37:08
M007081917INKE S.A.INKEc/Argent, 1Castellbisbal08755Spain (ES)10128-0012018-02-23T09:36:26
25581423ZPD A/SZPD A/SH. E. Bluhmes Vej 63Esbjerg6700Denmark (DK)2658422016-08-03T14:00:11
318635825Alsiano A/SAlsiano A/SBlokken 21Birkerød3460Denmark (DK)2703342016-05-30T09:29:49
007 API3268VENIFAR LTDVENIFAR LTD3 Imvrou StreetLatsia2234Cyprus (CY)1012015-07-20T11:26:52
24628409Silvaco A/SSilvaco A/SKrakasvej 10Hillerød3400Denmark (DK)2655432013-09-27T14:00:35
31799413Viminco A/SViminco A/SLodshusvej 11Skælskør4230Denmark (DK)633002016-04-29T12:18:22
2029 API3238Trasis SATrasis SARue Gilles Magnée 90Ans4430Belgium (BE)2029a2016-07-06T10:59:53
M007611929LAINCO, S.A.LAINCO, S.A.AV. BIZET, 8-12RUBÍ08191Spain (ES)277-0012018-02-23T09:43:14