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

2019-03-04

Version

2019-03-04

Update Frequency

Daily

Temporal Coverage

N/A

Spatial Coverage

European Economic Area Countries

Source

Source License URL

John Snow Labs Standard License

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
3476225201LEMANLEMAN, Ventrupvej 6, Greve, 2670DenmarkH2017-09-012017-09-01
2559013407NutriminNutrimin, Bodalen 11, Ans By, 8643DenmarkV2013-08-092013-08-10
1122-IGL8812CFECFE, Molenweg 7, Nederasselt, 6612AENetherlandsV2014-12-042014-12-04
F 14/20218075SCORASCORA, rue de l'Usine, CAFFIERS, 62132FranceH2014-05-022015-10-14
MM 14/17718074SERBSERB, 40 avenue George V, PARIS, 75008FranceH2014-04-182015-10-14
4820049416cewe GmbHcewe GmbH, Audorf 17, Nußbach, 4542AustriaH2008-02-202018-11-30
51796Pharmaplaztest, test, test, test, Co. Roscommon, -IrelandI2007-04-252007-04-25
218 H4769Roche SARoche SA, Rue Dante 75, Bruxelles, 1070BelgiumH2016-03-112016-03-16
V 2862/066325ALFAMEDALFAMED, 13EME RUE LID, CARROS, 06510FranceV2006-10-202014-11-04
1460 H26159Amgen NVAmgen NV, Telecomlaan 5-7, Diegem, 1831BelgiumH2019-02-122019-02-19