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

2019-07-02

Version

2019-07-02

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_NI_02_MIA_2019_002432282Plasma Service Europe GmbHPlasma Service Europe GmbH, Schillerstrasse 23, Hannover, 30159GermanyH2019-08-192019-08-16
DE_NI_04_MIA_2019_000332288Blutspendedienst der Landesverbaende des DRK Niedersachsen, Sachsen-Anhalt, Thueringen, Oldenburg und Bremen gGmbHBlutspendedienst der Landesverbaende des DRK Niedersachsen, Sachsen-Anhalt, Thueringen, Oldenburg und Bremen gGmbH, Brandenburger Str. 21, Oldenburg, 26133GermanyH,I2019-08-192019-08-19
UK MIA 453665425SIEMENS HEALTHCARE LIMITEDPETNET SOLUTIONS (SIEMENS HEALTHCARE LIMITED), LESLEY HARRISON BUILDING, MOUNT VERNON HOSPITAL, NORTHWOOD, HA6 2RNPETNET SOLUTIONS (SIEMENS HEALTHCARE LIMITED), NOTTINGHAM CITY HOSPITAL, GATE 1, HUCKNALL ROAD, NOTTINGHAM, NG5 1PBUnited KingdomH2019-08-162019-08-16
DE_NW_06_MIA_2019_000332294Bayer Animal Health GmbH DDAH-PDBayer Animal Health GmbH, Alfred-Nobel-Str. 50, Building 6800, Monheim, 40789GermanyV2019-08-162019-08-19
UK MIA(IMP) 453668003SIEMENS HEALTHCARE LIMITEDPETNET SOLUTIONS (SIEMENS HEALTHCARE LIMITED), LESLEY HARRISON BUILDING, MOUNT VERNON HOSPITAL, NORTHWOOD, HA6 2RNPETNET SOLUTIONS (SIEMENS HEALTHCARE LIMITED), NOTTINGHAM CITY HOSPITAL, GATE 1, HUCKNALL ROAD, NOTTINGHAM, NG5 1PBUnited KingdomI2019-08-162019-08-16
DE_BW_01_MIA_2019_007632287Catalent Germany Eberbach GmbHCatalent Germany Eberbach GmbH, Gammelsbacher Str. 2, Eberbach, 69412GermanyH,I,V2019-08-162019-08-19
109032 F17218Abbott Healthcare Products B.V., WEESPAbbott Healthcare Products B.V., C J van Houtenlaan 36, WEESP, 1381CPNetherlandsH2019-08-152019-08-15
HU-M-CHIN32281CHINOIN Gyógyszer- és Vegyészeti Termékek Gyára Zrt. (CHINOIN Zrt.) / CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd. (CHINOIN Private Co. Ltd.)CHINOIN Gyógyszer- és Vegyészeti Termékek Gyára Zártkörűen Működő Rt. (CHINOIN Zrt.) / CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd. (CHINOIN Private Co. Ltd.), 1. telephely (újpesti telephely) / Site 1 (Újpest site), Tó utca 1-5., Budapest, 1045CHINOIN Zrt. / CHINOIN Private Co. Ltd., Csanyikvölgy, Miskolc, H-3510CHINOIN Gyógyszer- és Vegyészeti Termékek Gyára Zártkörűen Működő Rt. (CHINOIN Zrt.) / CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd. (CHINOIN Private Co. Ltd.), 3. telephely (csanyikvölgyi telephely) / Site 3 (Csanyikvölgy site), Csanyikvölgy, Miskolc, 3510HungaryH,I2019-08-152019-08-15
M00868/0000128605Rottapharm LimitedRottapharm Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, -, D15 XD71IrelandH2019-08-152019-08-15
6751 F23918ADOH B.V., NIJMEGENADOH B.V., Godfried Bomansstraat 31, NIJMEGEN, 6543JANetherlandsH2019-08-152019-08-15