EMA API Registration Certificates of Non-EEA Sites

$179 / 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

2019-07-02

Version

2019-07-02

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

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

NameDescriptionTypeConstraints
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
AMA - 56/201914555FARMAKA S.R.L.Italy (IT)API CORPORATION, Yoshitomi Plant955, Oaza-Koiwai, Yoshitomi-cho, Chikujo-gunJapan (JP)AUTO_SUBMITTER_IT_AIFAIT_AIFA2019-05-31T12:00:03.947000
AMA - 56/201914555FARMAKA S.R.L.Italy (IT)CENTAUR PHARMACEUTICALS PVT LTDPlot No 75, 76, 76/1, Chikhloli, MIDC, Ambernath (west)India (IN)AUTO_SUBMITTER_IT_AIFAIT_AIFA2019-05-31T12:00:03.947000
AMA - 56/201914555FARMAKA S.R.L.Italy (IT)AMANO ENZYME INC.27, Hanno, KunotsuboJapan (JP)AUTO_SUBMITTER_IT_AIFAIT_AIFA2019-05-31T12:00:03.947000
API - 86/20169348OLON S.P.A.Italy (IT)YUIL PHARM TECH CO. LTD365-1 Sinwol-ri, Jincheon-gunKorea, Republic of (KR)AUTO_SUBMITTER_IT_AIFAIT_AIFA2017-05-31T09:40:04.583000
API - 86/20169348OLON S.P.A.Italy (IT)IPCA LABORATORIES LTDNo. 48, Kandivli Industrial Estate, Kandivli (West)India (IN)AUTO_SUBMITTER_IT_AIFAIT_AIFA2017-05-31T09:40:04.583000
API - 86/20169348OLON S.P.A.Italy (IT)DISHMAN PHARMACEUTICAL AND CHEMICALS LTDBavla, Survey No. 47, Paiki sub plot No. 1, Lodariyal Taluka, AhmedabadIndia (IN)AUTO_SUBMITTER_IT_AIFAIT_AIFA2017-05-31T09:40:04.583000
API - 123/20155827SANOFI S.P.A.Italy (IT)HENAN TOPFOND PHARMACEUTICAL CO. LTDNo. 1199 Jiaotong Road (West), Yicheng DistrictChina (CN)AUTO_SUBMITTER_IT_AIFAIT_AIFA2016-05-31T15:10:04.326000
API - 123/20155827SANOFI S.P.A.Italy (IT)CKD Bio Corporation292, Sinwon-ro, Danwon-guKorea, Republic of (KR)AUTO_SUBMITTER_IT_AIFAIT_AIFA2016-05-31T15:10:04.326000
140/WTC0539/API/165846Cornelius Polska Sp. z.o.o.Poland (PL)Bloomage Freda Biopharm Co. Ltd.High - Tech Development ZoneChina (CN)eratkowskaPL_GIF2016-05-31T09:02:11.050000
ASR11431/00001 (Annual Update 2018: AUR18/026)13065Camida LimitedIreland (IE)Spectrum Chemicals755 Jersey AvenueUnited States (US)pkeatingIE_HPRA2018-07-31T09:24:32.666000