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

2020-08-03

Version

2020-08-03

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 numberstring-
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerlevel : Nominal required : 1
Registration_HolderRegistration holder name.stringrequired : 1
Site_NameAPI site name.string-
Address_Line_1API site addressstring-
Address_Line_2API site addressstring-
Address_Line_3API site addressstring-
Address_Line_4API site addressstring-
CityAPI site city.string-
PostcodeAPI site Postcode.string-
CountryAPI site Country.stringrequired : 1
DUNS_NumberData Universal Numbering System Numberintegerlevel : Nominal
Site_NCA_ReferenceSite National Competent Authorities reference.stringrequired : 1
Last_Updated_DateLast updated datedatetimerequired : 1
EudraGMDP_Site_Reference_NumberThe EudraGMDP site reference numberintegerlevel : Nominal
Registration NumberEudraGMDP Document Reference NumberRegistration HolderSite NameAddress Line 1Address Line 2Address Line 3Address Line 4CityPostcodeCountryDUNS NumberSite NCA ReferenceLast Updated DateEudraGMDP Site Reference Number
AMA - 56/201914555FARMAKA S.R.L.FARMAKA S.R.L.VVIA VILLAPIZZONE, 26MILANO20156Italy (IT)1002752019-05-31T12:00:03.94700054976
sukls110116/20132916Pharmacie Ostrava spol. s r.o.Pharmacie Ostrava spol. s r.o.Pohořílky 29Fulnek742 45Czechia (CZ)27833488_12017-05-31T09:41:30.66900033526
sukls110116/20132916Pharmacie Ostrava spol. s r.o.Pharmacie Ostrava spol. s r.o.Budovatelska 949Bilovec743 01Czechia (CZ)27833488_22017-05-31T09:41:30.66900035179
API - 86/20169348OLON S.P.A.OLON S.P.A.VIA DELLA VITTORIA, 89MULAZZANO26837Italy (IT)1000682017-05-31T09:40:04.58300037136
API - 123/20155827SANOFI S.P.A.SANOFI S.P.A.VIA ANGELO TITI, 22/26BRINDISI72100Italy (IT)1000432016-05-31T15:10:04.32600034053
UK API 4910514339THERAMEX HQ UK LIMITEDTHERAMEX HQ UK LIMITEDSLOANE SQUARE HOUSE1 HOLBEIN PLACELONDONSW1W 8NSUnited Kingdom (UK)18453797-THERAMEX HQ UK LIMITED2020-03-31T20:35:02.23800056161
16346 API19025D.Q.A. Pharma International B.V., ELLEMEETD.Q.A. Pharma International B.V.Weelweg 4ELLEMEET4323LRNetherlands (NL)FUSY/685862020-03-31T18:41:02.80700083708
ASR12615/00001 (VR20/005)19006McArdle Transport Ltd t/a McArdle SkeathMcArdle Transport Ltd t/a McArdle SkeathNode 4: Chamber 4A, 4B, 4C and 4DCallanbergInniskeenCo.MonaghanA91 XN24Ireland (IE)1261512020-03-31T11:16:07.78500062215
sukls101244/201341Interpharma Praha a.s.Interpharma Praha a.s.Komořanská 955Praha 4 - Modřany14310Czechia (CZ)442654092020-03-31T10:04:11.03200016523
sukls213660/20131804Azelis Czech Republic s.r.o.CEDES Logistik s.r.o.warehouse is in Modletice č.p. 139Říčany251 01Czechia (CZ)264206192020-03-31T10:01:57.13700022859