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

2020-08-03

Version

2020-08-03

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
9760-150358Pharma Production ASPharma Production AS, Karihaugveien 22, OSLO, NO-1086NorwayH,V2020-08-052020-08-05
DE_HE_01_MIA_2020_007550377Fidelio Healthcare Limburg GmbHFidelio Healthcare Limburg GmbH, Mundipharmastrasse 2, Limburg, 65549GermanyH,I,V2020-08-052020-08-06
UK MIA 5281148437KINDEVA DRUG DELIVERY LIMITEDKINDEVA DRUG DELIVERY LIMITED, DERBY ROAD, LOUGHBOROUGH, LE11 5SFUnited KingdomH2020-08-052020-08-05
DE_BW_01_MIA_2020_003750380Jaeger GmbHJaeger GmbH, Heinkelstr. 8 + 10, Muggensturm, 76461GermanyH,I,V2020-08-052020-08-06
UK MIA(IMP) 128625251RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITEDRECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED, NOTTINGHAM SITE, THANE ROAD, NOTTINGHAM, NG90 2DBUnited KingdomI2020-08-052020-08-05
109076 F15135Roche Nederland B.V., WOERDENRoche Nederland B.V., Beneluxlaan 2A, WOERDEN, 3446GRNetherlandsH,I2020-08-052020-08-05
DE_BW_01_MIA_2020_006050378Roche Diagnostics GmbHRoche Diagnostics GmbH, Sandhofer Strasse 116, Mannheim, 68305GermanyH,I2020-08-052020-08-06
DE_MV_01_MIA_2020_001650379Seracell Pharma GmbHSeracell Pharma GmbH, Schillingallee 68, Rostock, 18057GermanyH,I2020-08-052020-08-06
9064-150357BASF ASBASF AS, Sandefjord site, Framnesveien 41, SANDEFJORD, NO-3222NorwayH,I2020-08-042020-08-05
UK MIA 142515566MANX HEALTHCARE LIMITEDMANX HEALTHCARE LIMITED, TAYLOR GROUP HOUSE, WEDGNOCK LANE, WARWICK, CV34 5YAUnited KingdomH2020-08-042020-08-04