Others 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

Keywords

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

EMA Good Manufacturing Practice Certificates of EEA Countries

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.

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Description

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”.

About this Dataset

Data Info

Date Created

2011

Last Modified

2020-11-13

Version

2020-11-13

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

Data Fields

Name Description Type Constraints
Certificate_NumberGood Manufacturing Practice compliance or non-compliance certificate numberstringrequired : 1
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerlevel : Nominalrequired : 1
Document_TypeEMA delivered document typestringenum : Array ( [0] => GMPC [1] => GMPNC [2] => GMPDA ) 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

Data Preview

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 21/2029397124864GMPC6534 FProQR Therapeutics I B.V.Zernikedreef 9LEIDEN2333CKNetherlandsFUSY/355722021-04-012021-04-072021-04-07
NL/H 21/2029294124342GMPC6844 FMedcor Specials B.V.Artemisweg 105 FLELYSTAD8239DDNetherlandsFUSY/400182021-03-302021-03-312021-03-31
30477/QC12289(IMP)125103GMPDAEurofins Biopharma Product Testing Ireland LimitedClogheraneDungarvanCo. WaterfordIreland917812754945232082021-03-262021-04-092021-04-09
30477/QC12289(H)125102GMPDAEurofins Biopharma Product Testing Ireland LimitedClogheraneDungarvanCo. WaterfordIreland917812754945232082021-03-262021-04-092021-04-09
30477/QC12289(V)125122GMPDAEurofins Biopharma Product Testing Ireland LimitedClogheraneDungarvanCo. WaterfordIreland917812754945232082021-03-262021-04-092021-04-09
DE_HE_01_GMP_2021_0023123767GMPCDE_HE_01_MIA_2020_0108Hormosan Pharma GmbHHanauer Landstrasse 139 - 143Frankfurt am Main60314Germany000100442021-03-192021-03-242021-03-25
sukls70907/2021123282GMPCsukls70907/2021Linde Gas a.s.Areál zpracovatelské části SU a.s.Vřesová357 43Czechia00011754_82021-03-162021-03-192021-03-19
sukls64453/2021123283GMPCLinde Gas a.s.Areál zpracovatelské části SU a.s.Vřesová357 43Czechia00011754_82021-03-162021-03-182021-03-19
DE_BW_01_GMP_2021_0053123510GMPCDE_BW_01_MIA_2021_0027GBA Pharma GmbHErnst-Abbe-Str. 40Ulm89079Germany000262382021-03-152021-03-232021-03-24
DE_BW_01_GMP_2021_0055123502GMPCDE_BW_01_MIA_2021_0027GBA Pharma GmbHErnst-Abbe-Str. 40Ulm89079Germany000262382021-03-152021-03-232021-03-24