EMA Good Manufacturing Practice Certificates of EEA Countries

$179 / year

Good manufacturing practice (GMP) describes the minimum standard that a medicine manufacturer must meet in their production processes.
The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonizing GMP activities at European Union (EU) level.

Complexity

The Agency has a coordinating role for GMP inspections of manufacturing sites for medicines whose marketing authorization in the EU is submitted through the centralized procedure or as part of a referral procedure.
A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer by the national competent authority that carried out the inspection if the outcome confirms that the manufacturer complied with the principles of Good Manufacturing Practice, as provided by European Union legislation. If the outcome of the inspection is that the manufacturer did not comply a statement of non-compliance may be entered into EudraGMDP.
GMP requires that medicines are of consistent high quality, appropriate for their intended use and meet the requirements of the marketing authorization or clinical trial authorization.
The Competent Authority should plan the succession of inspections in advance and elaborate a programme. This programme should ensure that the frequency of inspection of individual manufacturers can be adhered to as planned. Sufficient resources must be determined and made available to ensure that the designated programme of inspections can be carried out in an appropriate manner. The planning of inspections should be performed according to the Community Procedure “ A model for risk based planning for inspections of pharmaceutical manufacturers”.

Date Created

2011

Last Modified

2019-09-16

Version

2019-09-16

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

European GMP, GMP Inspection, Pharmaceutical Inspection, European Medicines Agency Registration, European Medicines Agency API Certificates

Other Titles

EMA GMP Certificates of EEA Countries, GMP Certificates of EEA Countries, EMA GMP Good Manufacturing Practice of EEA Countries, Good Manufacturing Practices of EEA Countries

NameDescriptionTypeConstraints
Certificate_NumberGood Manufacturing Practice compliance or non-compliance certificate numberstringrequired : 1
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerrequired : 1 level : Nominal
Document_TypeEMA delivered document typestringenum : Array required : 1
MIA_NumberManufacturing and Importation Authorisation Numberstring-
Site_NameInspected site name.stringrequired : 1
Address_Line_1Inspected site addressstring-
Address_Line_2Inspected site addressstring-
Address_Line_3Inspected site addressstring-
Address_Line_4Inspected site addressstring-
CityInspected site city.string-
PostcodeInspected site Postcode.string-
CountryInspected site Country.stringrequired : 1
DUNS_NumberData Universal Numbering System Numberintegerlevel : Nominal
Site_NCA_ReferenceSite National Competent Authorities reference.stringrequired : 1
Inspection_End_DateInspection end datedaterequired : 1
Issue_DateIssue datedaterequired : 1
Last_Updated_DateLast updated datedaterequired : 1
Certificate NumberEudraGMDP Document Reference NumberDocument TypeMIA NumberSite NameAddress Line 1Address Line 2Address Line 3Address Line 4CityPostcodeCountryDUNS NumberSite NCA ReferenceInspection End DateIssue DateLast Updated Date
IT/161/H/201956134GMPCaG20/2019SICO SOCIETA' ITALIANA CARBURO OSSIGENO S.P.A.VIA SAN GIACOMO, 1MONTECCHIO MAGGIORE36075Italy93312019-09-092019-09-092019-09-09
DE_BY_04_GMP_2019_010556172GMPCDE_BY_04_MIA_2019_0093Denk Pharma GmbH & Co. KGPrinzregentenstr. 79 und Neherstr. 9Muenchen81675Germany000247522019-09-092019-09-102019-09-11
DE_HE_01_GMP_2019_013456168GMPCDE_HE_01_MIA_2019_0061GSK Vaccines GmbHEmil-von-Behring-Str. 200Marburg35041Germany000230672019-09-042019-09-092019-09-11
NL/H 19/2014055A56205GMPC4384 FDr. Fisher Farma B.V.Vijzelweg 32LELYSTAD8243PMNetherlandsFUSY/218452019-09-032019-09-102019-09-12
sukls76131/201956027GMPCSynthesia, a.s.Semtín 103Pardubice53002Czech Republic60108916_12019-09-022019-09-022019-09-03
sukls142195/201955930GMPCsukls22699/2019Alliance Healthcare s.r.o., Alloga - Centrum logistických služebPodle Trati 624/7Praha 10 - Malešice108 00Czech Republic14707420_12019-08-262019-08-262019-08-26
DK API-H 0012261956260GMPCNovo Nordisk A/SHagedornsvej 1Gentofte2820Denmark390062019-08-152019-09-132019-09-13
UK MIA(IMP) 14076 Insp IMP 14076/18890869-000356144GMPCNHS SCOTLAND PHARMACEUTICAL SPECIALS SERVICEJAMES ARROTT DRIVENINEWELLS HOSPITALDUNDEEDD2 1UBUnited Kingdom18890869-NHS SCOTLAND PHARMACEUTICAL SPECIALS SERVICE2019-08-142019-09-062019-09-06
DE_HE_01_GMP_2019_014156171GMPCDE_HE_01_MIA_2019_0061GSK Vaccines GmbHEmil-von-Behring Str. 76Marburg35041Germany000230662019-08-142019-09-092019-09-11
2019/HPF/FR/24656143GMPCM 15/363DELPHARM HUNINGUE SAS26 rue de la ChapelleHUNINGUE68330France528533490000252019-08-082019-09-062019-09-06