- EMA MIA Certificates of EEA Countries
- MIA Certificates of EEA Countries
- EEA MIA
- Manufacturing Authorisations
- Pharmaceutical Importation
- European Medicines Agency Registration
- European Medicines Agency API Certificates
EMA Manufacturing and Importation Authorizations
The European Medicines Agency (EMA) Manufacturing and Importation Authorizations dataset includes manufacturing and importation authorizations delivered by EMA or national competent authorities to European Economic Area countries manufacturers and importers of pharmaceutical products.
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The Agency has a coordinating role for 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.
Manufacturers and importers located in the European Economic Area (EEA) must hold an authorization issued by the national competent authority of the Member State where they carry European Good Manufacturing Practice (EU GMP) to obtain a manufacturing or import authorization. They can ensure that they meet all their legal obligations by following the EU GMP guidelines.
Importers are responsible to ensure that the third country manufacturer they are importing from complies with GMP.
Companies undertaking secondary packaging for parallel-distributed medicinal products are required to hold this type of authorization.
About this Dataset
European Economic Area Countries
John Snow Labs; European Medicines Agency (EMA), EudraGMP;
|Source License URL|
|Source License Requirements||
EEA MIA, Manufacturing Authorisations, Pharmaceutical Importation, European Medicines Agency Registration, European Medicines Agency API Certificates
EMA MIA Certificates of EEA Countries, MIA Certificates of EEA Countries
|MIA_Number||Manufacturing and Importation Authorisation Number||string||required : 1|
|EudraGMDP_Document_Reference_Number||The EudraGMDP document reference number||integer||level : Nominalrequired : 1|
|Authorization_Holder||MIA Authorization holder.||string||required : 1|
|Site_Details||Site address||string||required : 1|
|Country||Site Country.||string||required : 1|
|Legal_Basis||MIA certificate legal basis code, H: Art. 40 of Directive 2001/83/EC Applicable to human medicines, V: Art. 44 of Directive 2001/82/EC Applicable to veterinary medicines, I: Art. 13 of Directive 2001/20/EC Basic requirements for medicinal products.||string||required : 1|
|Authorization_Date||Authorization date (0001-01-01 replaced with the empty field)||date||-|
|Last_Updated_Date||Last updated date||date||-|
|MIA Number||EudraGMDP Document Reference Number||Authorization Holder||Site Details||Country||Legal Basis||Authorization Date||Last Updated Date|
|82273||Rejuvenate GmbH||Rejuvenate GmbH, Warthestrasse 21, Teltow, 14513||Germany||ORG-100045533 - LOC-100075269||H||2023-01-19||2023-01-18|
|82172||Rejuvenate GmbH||Rejuvenate GmbH, Deutscher Platz 5e, Zentrum-Suedost, Leipzig, 04103Bio City Leipzig, Zentrum-Suedost, 3. Etage Suite 1, Deutscher Platz 5 E, Zentrum-SÃ¼dost, Leipzig, 04103||Germany||ORG-100045533 - LOC-100075828ORG-100023565 - LOC-100032708||H||2023-01-19||2023-01-13|
|82294||Axios Pharma GmbH||Axios Pharma GmbH, Hauptstrasse 198, Brackwede, Bielefeld, 33647||Germany||ORG-100033205 - LOC-100055312||H,I||2023-01-18||2023-01-19|
|82292||Laboratoire Chauvin||Laboratoire Chauvin, 18 Avenue Pierre Et Marie Curie, Aubenas, 07200Additional Details: Annexe de stockage LABORATOIRE CHAUVIN - AUBENAS - 18 Avenue Pierre et Marie CurieLaboratoire Chauvin, Zone Industrielle De Ripotier, 50 Avenue Jean Monnet, Aubenas, 07200Laboratoire Chauvin, 7 Rue Ampere, Aubenas, 07200Additional Details: Annexe de stockage LABORATOIRE CHAUVIN - AUBENAS - 18 Avenue Pierre et Marie CurieAdditional Details: Annexe de stockage LABORATOIRE CHAUVIN - AUBENAS - 7 Rue AmpÃ¨re||France||ORG-100001673 - LOC-100053226ORG-100001673 - LOC-100054195ORG-100001673 - LOC-100073931||H||2023-01-18||2023-01-18|
|82279||Demo S.A. Pharmaceutical IndustryAlternative Name:Demo ÎÎ¹Î¿Î¼Î·ÏÎ±Î½Î¹Î± Î¦Î±ÏÎ¼Î±ÎºÏÎ½ Î.Î.Î.Î.Additional Details: DEMO ÎÎÎÎ ÎÎÎÎÎÎ§ÎÎÎÎ Î¦ÎÎ¡ÎÎÎÎ©Î / DEMO SA PHARMACEUTICAL INDUSTRY, 21Î¿ ÏÎ»Î¼. ÎÎ¸Î½Î¹ÎºÎ®Ï ÎÎ´Î¿Ï ÎÎ¸Î·Î½ÏÎ½-ÎÎ±Î¼Î¯Î±Ï / 21st km National Road Athens -Lamia, ÎÏÏ Î¿Î½ÎÏÎ¹ ÎÏÏÎ¹ÎºÎ®Ï / Krioneri Attiki, 14568||Demo S.A. Pharmaceutical Industry, 21st Km National Road Athens Lamia, Kryoneri, 145 68||Greece||ORG-100000541 - LOC-100001491||H,V||2023-01-18||2023-01-18|
|82293||Abbvie||Abbvie, Route De Saint Andre, La Madeleine De Nonancourt, 27320||France||ORG-100004142 - LOC-100005873||H||2023-01-18||2023-01-18|
|82278||Bieffe Medital S.p.A.||BIEFFE MEDITAL S.P.A., VIA DELL'OSMANNORO 253, SESTO FIORENTINO, 50019||Italy||ORG-100001423 - LOC-100008854||H,V||2023-01-18||2023-01-18|
|82276||B2B Medical GmbH||B2B Medical GmbH, Im SteingerÃ¼st 32, Rastatt, 76437||Germany||ORG-100013680 - LOC-100021462||H||2023-01-17||2023-01-18|
|82217||Elpen Pharmaceutical Co. Inc. S.A.Alternative Name:ELPEN Î¦ÎÎ¡ÎÎÎÎÎ¥Î¤ÎÎÎ ÎÎÎÎÎÎ§ÎÎÎÎ A.E.Additional Details: Î. ÎÎ±ÏÎ±Î¸ÏÎ½Î¿Ï 95, Î Î¹ÎºÎÏÎ¼Î¹ ÎÏÏÎ¹ÎºÎ®Ï, 19009||Elpen Pharmaceutical Co. Inc., Zapani, Block 1048, Keratea, 190 01Additional Details: ELPEN Î.Î. Î¦ÎÎ¡ÎÎÎÎÎ¥Î¤ÎÎÎ ÎÎÎÎÎÎ§ÎÎÎÎ ÎÎ¡ÎÎÎ£Î¤ÎÎ£ÎÎ ÎÎÎ¡ÎÎ¤ÎÎÎ£, ÎÎÎ ÎÎÎ, Î.Î¤. 1048, ÎÎÎ¡ÎÎ¤ÎÎ, ÎÎ¤Î¤ÎÎÎ, 190 01||Greece||ORG-100001232 - LOC-100075085||H,I,V||2023-01-17||2023-01-17|
|82272||Mobilat Produktions GmbH||Mobilat Produktions GmbH, Luitpoldstrasse 1, Pfaffenhofen A.d.ilm, 85276||Germany||ORG-100017243 - LOC-100026038||H||2023-01-17||2023-01-18|