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

2020-06-23

Version

2020-06-23

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
20/03744-1194629GMPC9106-1PhotoCure ASAHoffsveien 4OSLONO-0275Norway9106-12020-06-252020-06-302020-06-30
DE_BW_01_GMP_2020_008594244GMPCDE_BW_01_MIA_2020_0054Rentschler Biopharma SEErwin-Rentschler-Strasse 21Laupheim88471Germany000258812020-06-242020-06-252020-06-26
BE/GMP/2020/02994927GMPC1285 IMPKaneka Eurogentec SARue Bois Saint-Jean 14Seraing4102Belgium12852020-06-182020-07-022020-07-02
DE_TH_01H_GMP_2020_000794905GMPCDE_TH_01H_MIA_2020_0006PharmCann Deutschland AGFriedrich-Eckardt-Strasse 22Bad Salzungen36433Germany000515162020-06-162020-07-012020-07-02
OGYÉI/30539-5/202095002GMPCHU-M-MEDTMeditop Gyógyszeripari Korlátolt Felelősségű Társaság (Meditop Gyógyszeripari Kft.) /Meditop Pharmaceutical Ltd.Ady Endre u. 1.Pilisborosjenő2097HungaryHU-M-MEDI012020-06-102020-07-022020-07-02
UK MIA 17696 Insp GMP 17696/36548-001192686GMPCUK MIA 17696COBRA BIOLOGICS LIMITEDSTEPHENSON BUILDINGTHE SCIENCE PARKKEELEST5 5SPUnited Kingdom36548-COBRA BIOLOGICS LIMITED2020-06-092020-06-102020-06-15
NL/H 20/202083393024GMPC6349 FCristal Delivery B.V.Oxfordlaan 55MAASTRICHT6229EVNetherlandsFUSY/329472020-06-052020-06-172020-06-17
DE_HE_01_GMP_2020_008893367GMPCDE_HE_01_MIA_2018_0092Grieshaber Logistics Group AGEduard-Fresenius-Strasse 4Biebesheim64584Germany000250242020-06-042020-06-182020-06-19
sukls64848/202094522GMPCsukls62434/2019Univerzita Karlova, 2. lékařská fakulta, budova č. 23V Úvalu 84Praha 5 - Motol150 06Czechia00216208_22020-06-032020-06-222020-06-29
UK MIA(IMP) 42195 Insp IMP 42195/8467466-000295124GMPCPUBLIC HEALTH ENGLANDVACCINES & COUNTERMEASURES RESPONSE, 4TH FLOORSOUTH WING, WELLINGTON HOUSE, 153-155 WATERLOO ROADLONDONSE1 8UGUnited Kingdom8467466-PUBLIC HEALTH ENGLAND2020-06-012020-07-032020-07-03