- 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|
|DE_NW_03_MIA_2021_0041||69245||Bayer AG||Bayer AG, Friedrich-Ebert-Strasse 217-333, Wuppertal, 42117||Germany||H,I||2021-09-20||2021-09-16|
|0000010832/17/1||25357||Î¦ÎÎ¡ÎÎÎÎÎ ÎÎÎ©ÎÎ¥ÎÎ Î¦ÎÎ¡ÎÎÎÎÎ¥Î¤ÎÎÎ ÎÎÎ ÎÎ¡ÎÎÎ ÎÎÎÎÎÎ§ÎÎÎÎÎ ÎÎ¤ÎÎÎ¡ÎÎÎ / PHARMAZAC PHARMACEUTICAL COMMERCIAL INDUSTRIAL SOCIETE ANONYME||Î¦ÎÎ¡ÎÎÎÎÎ ÎÎÎ©ÎÎ¥ÎÎ Î¦ÎÎ¡ÎÎÎÎÎ¥Î¤ÎÎÎ ÎÎÎ ÎÎ¡ÎÎÎ ÎÎÎÎÎÎ§ÎÎÎÎÎ ÎÎ¤ÎÎÎ¡ÎÎÎ / PHARMAZAC PHARMACEUTICAL COMMERCIAL INDUSTRIAL SOCIETE ANONYME, ÎÎ±Î¿ÏÏÎ·Ï 31 / Naousis 31, ÎÎ¸Î®Î½Î± ÎÏÏÎ¹ÎºÎ® / Athens Attiki, 10447||Greece||H,I||2021-09-17||2021-09-17|
|HU-M-PSOL||39318||PlazmaszolgÃ¡lat Kft.||PlazmaszolgÃ¡lat Kft., Czuczor u. 2-10., Budapest, 1093PlazmaszolgÃ¡lat KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g, Kisfaludy u. 32-38. IV. emelet, Budapest, 1082PlazmaszolgÃ¡lat KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g, MikszÃ¡th KÃ¡lmÃ¡n u. 20-22., Szeged, 6722PlazmaszolgÃ¡lat KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g, ÃrpÃ¡d Ãºt 39., GyÅr, 9021PlazmaszolgÃ¡lat KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g, KÃgyÃ³ u. 4., Szeged, 6720PlazmaszolgÃ¡lat KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g, JancsÃ¡r kÃ¶z 5., SzÃ©kesfehÃ©rvÃ¡r, 8000PlazmaszolgÃ¡lat KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g, SzÃ©chenyi utca 31., Debrecen, 4025PlazmaszolgÃ¡lat KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g, Ãchim AndrÃ¡s utca 2., KaposvÃ¡r, 7400PlazmaszolgÃ¡lat KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g, Ãrs vezÃ©r tere 25., Budapest, 1106PlazmaszolgÃ¡lat KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g, KÃ¶rmendi Ãºt 11/a, Szombathely, 9700||Hungary||H||2021-09-16||2021-09-16|
|DE_BW_01_MIA_2021_0103||69360||Weleda AG||Weleda AG, Moehlerstr. 3 - 5, Schwaebisch Gmuend, 73525Weleda AG, Am Pflanzengarten 1, Schwaebisch Gmuend, 73527||Germany||H,I,V||2021-09-16||2021-09-17|
|DE_RP_01_MIA_2021_0035||69359||BioNTech Manufacturing GmbH||BioNTech Manufacturing GmbH, Kupferbergterrasse 17 - 19, Mainz, 55116||Germany||H,I||2021-09-16||2021-09-17|
|4081 F||8760||Patheon Biologics B.V., GRONINGEN||Patheon Biologics B.V., Zuiderweg 72/2, GRONINGEN, 9744APPatheon Biologics B.V., Rozenburglaan 17, GRONINGEN, 9727DL||Netherlands||H,I||2021-09-16||2021-09-16|
|HU-M-EAPI||69299||EUROAPI Hungary KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g (EUROAPI Hungary Kft.) / EUROAPI Hungary Limited Liability Company (EUROAPI Hungary Ltd.)||EUROAPI Hungary KorlÃ¡tolt FelelÅssÃ©gÅ± TÃ¡rsasÃ¡g (EUROAPI Hungary Kft.) / EUROAPI Hungary Limited Liability Company (EUROAPI Hungary Ltd.), TÃ³ utca 1-5., Budapest, 1045||Hungary||H,I||2021-09-16||2021-09-16|
|2021_158_1_2||69319||RECIPHARM MONTS||RECIPHARM MONTS, 18 rue de Montbazon, site de Monts sud, MONTS, 37260||France||H,I||2021-09-16||2021-09-16|
|DE_ST_01_MIA_2021_0018||69246||Plasma Service Europe GmbH||Plasma Service Europe GmbH, Gotthardstrasse 35, Merseburg, 06217||Germany||H||2021-09-15||2021-09-16|
|BG/MIA-0265||4109||BALKANPHARMA-RAZGRAD AD||BALKANPHARMA-RAZGRAD, 68 Aprilsko vastanie Blvd, Razgrad, 7200||Bulgaria||H,I||2021-09-15||2021-09-17|