EMA API Registration Certificates of Non-EEA Sites

$79 / year

The European Medicines Agency (EMA) API Registration Certificates of Non-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 API will be imported.
Active substance manufacturers must comply with good manufacturing practices (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.
Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP.
For active substance manufacturing sites located in countries outside the EEA, a Member State which is the supervisory authority for a medicinal product has also the responsibility for supervision and inspection of the active substance manufacturers associated with the medicinal product.

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

Non-EEA Active Substance GMP, EMA Active Substance GMP, Active Substance Inspection, European Medicines Agency Registration, European Medicines Agency API Certificates

Other Titles

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

Name Description Type Constraints
API_Registration_NumberAPI site registration numberstringrequired : 1
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerrequired : 1 level : Nominal
EEA_SiteEuropean economic area site.stringrequired : 1
EEA_Site_CountryEuropean economic area country.stringrequired : 1
Third_Country_SiteNon-EEA sitestringrequired : 1
Third_Country_Site_AddressNon-EEA site addressstringrequired : 1
Third_Country_Site_CountryNon-EEA site countrystringrequired : 1
Last_Updated_ByLast updated submitterstringrequired : 1
Competent_AuthorityCompetent authority namestringrequired : 1
Last_Updated_DateLast updated datedatetimerequired : 1
API_Registration_NumberEudraGMDP_Document_Reference_NumberEEA_SiteEEA_Site_CountryThird_Country_SiteThird_Country_Site_AddressThird_Country_Site_CountryLast_Updated_ByCompetent_AuthorityLast_Updated_Date
R-AV-V-0111624ADIPHARM EADBulgaria (BG)Sun PharmaA-7/A-8India (IN)rhubchevaBG_BDA2017-06-30T14:46:41
001 API5928ANADELCO LTDCyprus (CY)AUROBINDO PHARMA LTDUNIT XIIndia (IN)apaphitouCY_PSMOH2016-06-10T13:04:57
ASR11335/00001222Ranbaxy Ireland LtdIreland (IE)Sun PharmaA-7/A-8India (IN)aallen1IE_HPRA2014-01-17T12:17:32
ASR11335/00001222Ranbaxy Ireland LtdIreland (IE)Hetro DrugsUnit 1India (IN)aallen1IE_HPRA2014-01-17T12:17:32
R-AV-P-V-00810311SOPHARMA ADBulgaria (BG)ALEMBIC LTDAlembic RoadIndia (IN)rhubchevaBG_BDA2017-09-13T09:22:28
R-AV-V-0011609Pharma PLCBulgaria (BG)FDC LimitedPlot No 19 & 20/2India (IN)rhubchevaBG_BDA2014-07-18T08:09:11
ASR11389/00001321Phardiag LimitedIreland (IE)Meiji PharmaHong KongJapan (JP)eobruenIE_HPRA2013-09-11T12:25:23
ASR11335/00001222Ranbaxy Ireland LtdIreland (IE)Unichem99 MIDC AreaIndia (IN)aallen1IE_HPRA2014-01-17T12:17:32
001 API5928ANADELCO LTDCyprus (CY)Aurobindo Pharma LimitedUnit-1India (IN)apaphitouCY_PSMOH2016-06-10T13:04:57
M006281558COVEX, S.A.Spain (ES)AfrimedB.P. 30388Cameroon (CM)AUTO_SUBMITTER_ES_AEMPSES_AEMPS2018-02-23T09:30:38