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

2019-07-02

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

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
NL/H 16/1009758V154714GMPC4491 FMedcor Pharmaceuticals B.V.Artemisweg 232LELYSTAD8239DENetherlandsFUSY/178182019-06-202019-06-202019-06-20
DE_SH_01_GMP_2019_002955237GMPC5N Plus Luebeck GmbHKaninchenborn 24-28Luebeck23560Germany000187662019-06-192019-07-092019-07-11
25647/ IMP1251255046GMPCEramol LimitedBlock BThe Cresent BuildingNorthwood, SantryDublin 9-D09 C6X8IrelandIMP12512/00001-A12019-06-172019-07-022019-07-02
DE_NW_02_GMP_2019_001755209GMPCDE_NW_02_MIA_2018_0012C. Hedenkamp GmbH & Co.KGSchierbusch 1Hoevelhof33161Germany000043632019-06-122019-07-012019-07-11
25453/M11938-155292GMPCM11938/00001Allergan Pharmaceuticals International LimitedClonshaugh Business & Technology ParkDublin 17-D17 E400IrelandM11938/00001-A12019-06-112019-07-172019-07-17
25454/QCLab1228755069GMPCComplete Laboratory SolutionsSmall Business Industrial EstateMervueGalwayIreland858912659919497922019-06-112019-07-032019-07-03
25454/QCLab12287_(V)55071GMPCComplete Laboratory SolutionsSmall Business Industrial EstateMervueGalwayIreland857512659918063622019-06-112019-07-032019-07-03
6.2.1-2019-04626555031GMPC6.2.1-2019-046265Q-Med ABSeminariegatan 21 och 33Uppsala75228Sweden1535813636192027002019-06-112019-07-032019-07-03
004108/06.08.02.00/201755180GMPC000985/06.08.00.04/2019Bayer OyArtukaistentie 10TurkuFI-20240FinlandBayer2019-06-072019-07-092019-07-09
004108/06.08.02.00/2017W255198GMPC000985/06.08.00.04/2019Bayer OyArtukaistentie 10TurkuFI-20240FinlandBayer2019-06-072019-07-092019-07-09