EMA Good Manufacturing Practice Certificates of Non-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 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

2018-12-08

Version

2018-12-08

Update Frequency

Daily

Temporal Coverage

N/A

Spatial Coverage

N/A

Source

John Snow Labs; European Medicines Agency (EMA), EudraGMP;

Source License URL

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

NameDescriptionTypeConstraints
Certificate_NumberGMP compliance or non-complicance certificate numberstring-
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 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
DE_RP_01_GMP_2020_002994245GMPDABoehringer Ingelheim do Brasil Quimica e Farmaceutica Ltda.Rod. Regis Bittencourt (BR 116), km 286Itapecerica da Serra - Sao Paulo, SP06888-700Brazil132392020-06-222020-06-252020-06-26
GMPEI-CH-100120295565GMPCMIAE-CH-511866-102626158IBSA Institut Biochimique SAVia al Ponte 13Lugano6903Switzerland10003822020-06-182020-07-082020-07-08
GMPE-CH-100120195585GMPCIBSA Institut Biochimique SAVia del PianoPambio-Noranco6915Switzerland10000192020-06-182020-07-082020-07-08
GMPEHV-CH-100120295564GMPCMIAE-CH-511866-102626158IBSA Institut Biochimique SAVia al Ponte 13Lugano6903Switzerland10003822020-06-182020-07-082020-07-08
DE_BY_04_GMP_2020_009596643GMPDASymbiotec Pharmalab Pvt. Ltd.385/2 Pigdamber Off A. B. Road, RauIndore (M. P.)453331India235432020-06-152020-07-162020-07-17
DE_BY_04_GMP_2020_010197643GMPDASymbiotec Pharmalab Pvt. Ltd.385/2 Pigdamber Off A. B. Road, RauIndore (M. P.)453331India235432020-06-152020-07-242020-07-27
VMDGMP/M095/202092102GMPCPrecision Science Inc1517 West Knudsen DrivePHOENIX85027United States9013015917799200002020-06-012020-06-042020-06-10
6.2.1-2020-03989796442GMPDAThermo Fisher Scientific / Brammer Bio, LLC13702 Innovation DriveAlachuaFL 32615United States9380815948852770002020-05-282020-07-152020-07-16
UK GMP 25252 Insp GMP 25252/10303054-000497022GMPCRA CHEM PHARMA LIMITEDPLOT NO A-19/C, ROAD 18IDA, NACHARAMHYDERABADIN-500 076India10303054-RA CHEM PHARMA LIMITED2020-05-202020-07-202020-07-22
GMPEHV-CH-100115594362GMPCMIAE-CH-511356-102608804Dipharma SAPiazza Col C. Bernasconi 5Chiasso6830Switzerland11011632020-05-142020-06-222020-06-26