EMA API Registration Certificates of EEA Sites

$179 / 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

2018-12-16

Version

2018-12-16

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 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

NameDescriptionTypeConstraints
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/179368airtyhjythnannannanhyh45hny5Poland (PL)nan0002017-06-01T07:41:56.644000
338907905LEMANLEMANVentrupvej 6nannannanGreve2670Denmark (DK)nan2759542019-02-27T13:14:07.692000
373335585NEFF A/SNEFF A/SSolvang 42nannannanAllerød3450Denmark (DK)nan373332018-12-21T09:30:35.120000
48200413817cewe GmbHcewe GmbHAudorf 17nannannanNußbach4542Austria (AT)nan4820042018-11-30T16:29:42.998000
25374343Danipharm A/SDanipharm A/SSkalhuse 3nannannanNibe9240Denmark (DK)nan713012016-08-03T13:37:08.250000
M007081917INKE S.A.INKEc/Argent, 1nannannanCastellbisbal08755Spain (ES)nan10128-0012018-02-23T09:36:26.223000
25581423ZPD A/SZPD A/SH. E. Bluhmes Vej 63nannannanEsbjerg6700Denmark (DK)nan2658422016-08-03T14:00:11.227000
318635825Alsiano A/SAlsiano A/SBlokken 21nannannanBirkerød3460Denmark (DK)nan2703342016-05-30T09:29:49.894000
M006921961QUIMIDROGA S.A.QD11C/TUSET 26nannannanBARCELONA08006Spain (ES)nan10918-0022018-05-24T12:01:23.958000
007 API3268VENIFAR LTDVENIFAR LTD3 Imvrou StreetnannannanLatsia2234Cyprus (CY)nan1012015-07-20T11:26:52.253000