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

2019-10-04

Version

2019-10-04

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 numberintegerrequired : 1 level : Nominal
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_BW_01_MIA_2019_010632762Blisterzentrum Baden-Wuerttemberg GmbHBlisterzentrum Baden-Wuerttemberg, Blumenstr. 33/1, Magstadt, 71106GermanyH2019-10-172019-10-18
DE_HB_01_MIA_2019_000432760Henry Lamotte Oils GmbHHenry Lamotte Oils GmbH, Merkurstr. 47, Bremen, 28197GermanyH2019-10-172019-10-18
DE_BW_01_MIA_2019_008832761Universitaetsklinikum Tuebingen Anstalt des oeffentlichen RechtsUniversitaetsklinikum Tuebingen, Department fuer Radiologie, Abteilung fuer Praeklinische Bildgebung und Radiopharmazie, Roentgenweg 15 und 17, Tuebingen, 72076GermanyH,I2019-10-172019-10-18
6985 F27569Shire International Licensing B.V., AMSTERDAMShire International Licensing B.V., Strawinskylaan 481, AMSTERDAM, 1077XXNetherlandsH2019-10-172019-10-17
DE_BW_01_MIA_2019_010332759HWI development GmbHHWI development GmbH, Strassburger Str. 77, Appenweier, 77767GermanyH,I,V2019-10-172019-10-18
DE_BW_01_MIA_2019_010432758CureVac Real Estate GmbHCureVac, Paul-Ehrlich-Str. 15, 17, Tuebingen, 72076GermanyI2019-10-172019-10-18
DE_ST_01_MIA_2019_002132757Linde AG Geschaeftsbereich Linde GasLinde AG Geschaeftsbereich Linde Gas, Spergauer Strasse 1a, Leuna, 06237GermanyH2019-10-172019-10-18
M00868/0000128605Rottapharm LimitedRottapharm Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, -, D15 XD71IrelandH2019-10-162019-10-16
M 19/19932678PIERRE FABRE MEDICAMENT PRODUCTIONPIERRE FABRE MEDICAMENT PRODUCTION, Aquitaine Pharm International 1, Avenue du Béarn, IDRON, 64320FranceH,I2019-10-162019-10-16
DE_BW_01_MIA_2019_010032719Boehringer Ingelheim Pharma GmbH & Co. KGBoehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, Biberach a.d.R., 88397GermanyH,I,V2019-10-162019-10-17