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

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

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
DE_NW_01_Reg_2015_00013752Euro OTC Pharma Sales & Services GmbHEuro OTC Pharma Sales & Services GmbHEdisonstraße 6Bönen59199Germany (DE)24.05.01.11-6232-0022016-10-31T12:17:35.995000
AMA - 56/201914555FARMAKA S.R.L.FARMAKA S.R.L.VVIA VILLAPIZZONE, 26MILANO20156Italy (IT)1002752019-05-31T12:00:03.947000
DE_SH_01_Reg_2018_000812549Fagron GmbH & Co. KGFagron GmbH & Co. KGVon-Bronsart-Strasse 12Barsbuettel22885Germany (DE)000045552018-05-31T08:46:23.485000
DE_SH_01_Reg_2018_000812549Fagron GmbH & Co. KGFagron GmbH & Co. KGGroßer Kamp 7Barsbüttel22885Germany (DE)DE_SH_01142018-05-31T08:46:23.485000
sukls110116/20132916Pharmacie Ostrava spol. s r.o.Pharmacie Ostrava spol. s r.o.Pohořílky 29Fulnek742 45Czech Republic (CZ)27833488_12017-05-31T09:41:30.669000
sukls110116/20132916Pharmacie Ostrava spol. s r.o.Pharmacie Ostrava spol. s r.o.Budovatelska 949Bilovec743 01Czech Republic (CZ)27833488_22017-05-31T09:41:30.669000
API - 86/20169348OLON S.P.A.OLON S.P.A.VIA DELLA VITTORIA, 89MULAZZANO26837Italy (IT)1000682017-05-31T09:40:04.583000
345327405Merck Life Science A/SMerck Life Science A/SVandtårnsvej 62A, 5Søborg2860Denmark (DK)2726742017-05-31T09:23:20.658000
API - 123/20155827SANOFI S.P.A.SANOFI S.P.A.VIA ANGELO TITI, 22/26BRINDISI72100Italy (IT)1000432016-05-31T15:10:04.326000
140/WTC0539/API/165846Cornelius Polska Sp. z o.o.Cornelius Polska Sp. z.o.o.ul. Rzymowskiego 31Warszawa02-697Poland (PL)WTN_0539_012016-05-31T09:02:11.050000