EMA Manufacturing and Importation Authorizations

$179 / year

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.

Complexity

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.

Date Created

2011

Last Modified

2020-05-05

Version

2020-05-05

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

EEA MIA, Manufacturing Authorisations, Pharmaceutical Importation, European Medicines Agency Registration, European Medicines Agency API Certificates

Other Titles

EMA MIA Certificates of EEA Countries, MIA Certificates of EEA Countries

NameDescriptionTypeConstraints
MIA_NumberManufacturing and Importation Authorisation Numberstringrequired : 1
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerlevel : Nominal required : 1
Authorization_HolderMIA Authorization holder.stringrequired : 1
Site_DetailsSite addressstringrequired : 1
CountrySite Country.stringrequired : 1
Legal_BasisMIA 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.stringrequired : 1
Authorization_DateAuthorization date (0001-01-01 replaced with the empty field)date-
Last_Updated_DateLast updated datedate-
MIA NumberEudraGMDP Document Reference NumberAuthorization HolderSite DetailsCountryLegal BasisAuthorization DateLast Updated Date
DE_NW_03_MIA_2020_001746621UCB Pharma GmbHUCB Pharma GmbH, Alfred-Nobel-Str. 10, Monheim, 40789GermanyH2020-06-022020-05-29
M00235/0000127437GE Healthcare Ireland LimtedGE Healthcare Ireland Limited, IDA Business Park, Carrigtwohill, Cork, -, T45 AV60IrelandH2020-05-292020-05-29
DE_RP_01_MIA_2020_002746620Boehringer Ingelheim Pharma GmbH & Co. KGBoehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, Ingelheim am Rhein, 55216GermanyH,I2020-05-282020-05-29
FIMEA/2020/003271766Oy Medfiles LtdOy Medfiles Ltd, Neulaniementie 2, Kuopio, 70210Oy Medfiles Ltd, Neulaniementie 2, Kuopio, 70210FinlandH,I,V2020-05-282020-05-28
IMP00007/0000128503Gilead Sciences Ireland UCGilead Sciences Ireland UC, IDA Business and Technlogy Park, Carrigtohill, Cork, -, T45 DP77IrelandI2020-05-282020-05-29
DE_RP_01_MIA_2019_002546619Boehringer Ingelheim Pharma GmbH & Co. KGBoehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, Ingelheim am Rhein, 55216GermanyH,I2020-05-282020-05-29
0000000063/20/146577Ε. Ι. ΖΑΡΜΠΗ & ΣΙΑ Ε.Ε / E.I.ZARBIS & Co., LPΕ. Ι. ΖΑΡΜΠΗ & ΣΙΑ Ε.Ε / E.I.ZARBIS & Co., LP, Θηβών 35 / Thivon 35, Μέγαρα Αττικής / Megara Attiki, 19100GreeceH2020-05-282020-05-28
DE_NI_01_MIA_2020_001446622CSL Plasma GmbHCSL Plasma GmbH, Rodeweg 18, Goettingen, 37081CSL Plasma GmbH, Weender Str. 75, Goettingen, 37073GermanyH,I2020-05-282020-05-29
UK MIA 4265717037GLAXOSMITHKLINE TRADING SERVICES LIMITEDGLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, HARMIRE ROAD, BARNARD CASTLE, DL12 8DTGLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, PRIORY STREET, WARE, SG12 0DJYUSEN LOGISTICS (UK) LIMITED, CHEANEY DRIVE, GRANGE PARK SOUTH, NORTHAMPTON, NN4 5FBALLOGA UK LIMITED, AMBER PARK 1, 2, AND 3, BERRISTOW LANE, SOUTH NORMANTON, ALFRETON, DE55 2FHALLOGA UK LIMITED, AMBER PARK 5 AND 6, UNIT C2, FARMWELL LANE, SOUTH NORMANTON, ALFRETON, DE55 2JXUnited KingdomH2020-05-282020-05-28
DE_BY_05_MIA_2020_004146625Retterspitz GmbH Heilmittel und Koerperpflege - PraeparateRetterspitz GmbH, Laufer Strasse 17 - 19, Schwaig, 90571GermanyV2020-05-282020-05-29