EMA Good Manufacturing Practice Certificates of Non-EEA Countries

$79 / 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 including inspection of Non-EEA countries sites.

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 an inspection if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice, as provided by European Union legislation. If the outcome of the inspection is that the manufacturer does 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.
Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP.

Date Created

2011

Last Modified

2018-04-21

Version

2018-04-21

Update Frequency

Daily

Temporal Coverage

N/A

Spatial Coverage

N/A

Source

John Snow Labs => European Medicines Agency (EMA), EudraGMP

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Non-EEA Good Manufacturing Practice, European GMP, 3rd country Inspection, GMP Inspection, European Medicines Agency Registration, European Medicines Agency API Certificates

Other Titles

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

Name Description Type Constraints
Certificate_NumberGMP compliance or non-complicance certificate numberstring-
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 addressstringrequired : 1
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
HMP/FR/30/201528759GMPCMONACHEM3 rue du GabianMONACO98000MonacoA04346624372012-06-132015-04-142015-04-14
2007-057373GMPCSPIMACO ADDWAEIHBuraydahAl-QassimKingdom ofSaudi Arabia11112007-06-212007-10-232007-10-23
2012/5874/H19507GMPCUnichem99 MIDC AreaDhatav - RohaRaigad402116India1624342012-12-072013-06-182013-06-25
2010-3506817GMPCSPIMACO ADDWAEIHBuraydahAl-QassimKingdom ofSaudi Arabia11112010-05-172010-11-012010-11-02
HPF/PT/01/201633676GMPCSOTHEMABP N° 1BOUSKOURA20180Morocco926812801373072092013-02-142016-02-152016-02-15
2010/UMC/PT/0085988GMPCSOTHEMABP N° 1BOUSKOURA20180Morocco926812801373072092010-02-192010-07-012010-07-26
HMP/PT/227/20095337GMPCMONACHEM3 rue du GabianMONACO98000MonacoA043 4662 4372009-07-162009-11-242010-06-02
HMP/PT/224/20095336GMPCMONACHEM3 rue du GabianMONACO98000MonacoA043 4662 4372009-07-162009-11-242010-06-02
HMP/PT/226/20095335GMPCMONACHEM3 rue du GabianMONACO98000MonacoA043 4662 4372009-07-162009-11-242010-06-02
HMP/PT/225/20095340GMPCMONACHEM3 rue du GabianMONACO98000MonacoA043 4662 4372009-07-162009-11-242010-06-02