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

2020-10-02

Version

2020-10-02

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 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
M 20/17654257OCTAPHARMAOCTAPHARMA, 72 rue du Maréchal Foch, LINGOLSHEIM, 67380Annexe de stockage OCTAPHARMA, rue Théodore Monod, OSTWALD, 67540FranceH,I2020-10-272020-10-27
DE_BY_04_MIA_2020_013354237Syntacoll GmbHSyntacoll GmbH, Donaustrasse 24 und Auf dem Gries 75, Saal/Donau, 93342GermanyH,I2020-10-272020-10-27
MM 20/17454377STRAGEN FRANCESTRAGEN FRANCE, 30 rue Edouard Nieuport, LYON, 69008FranceH2020-10-272020-10-27
4024243258Takeda Pharma A/STakeda Pharma A/S, Apotekerstien 9, Hobro, 9500DenmarkH2020-10-272020-10-27
UK MIA 4110354217COMMUNITY PHARMACY SUPPLIES LIMITEDCOMMUNITY PHARMACY SUPPLIES LIMITED, UNIT 20/21, EASTER PARK, BEAM REACH 8, FERRY LANE, RAINHAM, RM13 9BPUnited KingdomH2020-10-272020-10-27
4094 F14973Pharmachemie B.V., HAARLEMPharmachemie B.V., Swensweg 5, HAARLEM, 2031GANetherlandsH,I2020-10-272020-10-27
UK MIA 435119239PENN PHARMACEUTICAL SERVICES LIMITEDPENN PHARMACEUTICAL SERVICES LIMITED, UNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATE, TAFARNAUBACH, TREDEGAR, NP22 3AAUnited KingdomH2020-10-262020-10-26
UK MIA 14115027WASDELL PACKAGING LIMITEDWASDELL PACKAGING LIMITED, UNITS 1, 2, 3, 5, 6, 7 & 8 EURO WAY INDUSTRIAL ESTATE, BLAGROVE, SWINDON, SN5 8YWUnited KingdomH2020-10-262020-10-26
M 20/14054197ELAIAPHARMELAIAPHARM, 2881 route des Crêtes, ZI Les Bouillides, VALBONNE, 06560FranceH,I2020-10-262020-10-26
UK MIA 200755549ACCORD HEALTHCARE LIMITEDACCORD HEALTHCARE LIMITED, GROUND FLOOR, SAGE HOUSE, 319 PINNER ROAD, HARROW, HA1 4HFACCORD HEALTHCARE LIMITED, EDGEFIELD AVENUE, NEWCASTLE UPON TYNE, NE3 3NBUnited KingdomH2020-10-262020-10-26