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

2019-11-19

Version

2019-11-19

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 numberintegerlevel : Nominal required : 1
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 19/2016430b61580GMPC7007 FIncyte Biosciences Distribution B.V.Paasheuvelweg 25AMSTERDAM1105BPNetherlandsFUSY/429372019-11-132019-11-142019-11-14
NL/H 19/2016430a61579GMPC7007 FIncyte Biosciences Distribution B.V.Paasheuvelweg 25AMSTERDAM1105BPNetherlandsFUSY/429372019-11-132019-11-142019-11-14
NL/H 19/201553262559GMPC6863 FCyclotron Rotterdam B.V.Dr. Molewaterplein 40ROTTERDAM3015GDNetherlandsFUSY/402002019-10-312019-11-202019-11-20
VMDGMP/M081/201959420GMPCManA 18584TELSOL LIMITED23/24 COLOMENDY INDUSTRIAL ESTATERHYL ROADDENBIGHLL16 5TAUnited Kingdom11066-TELSOL LIMITED2019-10-292019-10-312019-10-31
UK MIA(IMP) 25076 Insp IMP 25076/331469-001258599GMPCMEDPHARM LIMITEDUNIT 1 & UNIT 3 CHANCELLOR COURT50 OCCAM ROAD, SURREY RESEARCH PARKGUILDFORDGU2 7ABUnited Kingdom331469-MEDPHARM LIMITED2019-10-252019-10-252019-10-28
UK MIA(IMP) 13101 Insp IMP 13101/21095-000858380GMPCCOVANCE CLINICAL RESEARCH UNIT LIMITEDSPRINGFIELD HOUSEHYDE STREETLEEDSLS2 9LHUnited Kingdom21095-COVANCE CLINICAL RESEARCH UNIT LIMITED2019-10-242019-10-242019-10-25
UK MIA 4351 Insp GMP/IMP 4351/15302-003058361GMPCUK MIA 4351PENN PHARMACEUTICAL SERVICES LIMITEDUNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATETAFARNAUBACHTREDEGARNP22 3AAUnited Kingdom226277259.015302-PENN PHARMACEUTICAL SERVICES LIMITED2019-10-242019-10-242019-10-25
UK GMP 31047 Insp GMP/IMP 31047/343945-0014 [V]59040GMPCITS TESTING SERVICES (UK) LIMITEDINTERTEK PHARMACEUTICAL SERVICES MANCHESTER, ANALYTICAL SERVICES GROUPHEXAGON TOWER, CRUMPSALL VALE, BLACKLEYMANCHESTERM9 8GQUnited Kingdom343945-ITS TESTING SERVICES (UK) LIMITED2019-10-242019-10-242019-10-29
UK ManA 4351 Insp GMP/IMP 4351/15302-003058379GMPCPENN PHARMACEUTICAL SERVICES LIMITEDUNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATETAFARNAUBACHTREDEGARNP22 3AAUnited Kingdom226277259.015302-PENN PHARMACEUTICAL SERVICES LIMITED2019-10-242019-10-242019-10-25
UK MIA(IMP) 4351 Insp GMP/IMP 4351/15302-003058382GMPCPENN PHARMACEUTICAL SERVICES LIMITEDUNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATETAFARNAUBACHTREDEGARNP22 3AAUnited Kingdom226277259.015302-PENN PHARMACEUTICAL SERVICES LIMITED2019-10-242019-10-242019-10-25