Others titles
- EMA MIA Certificates of EEA Countries
- MIA Certificates of EEA Countries
Keywords
- EEA MIA
- Manufacturing Authorisations
- Pharmaceutical Importation
- European Medicines Agency Registration
- European Medicines Agency API Certificates
EMA Manufacturing and Importation Authorizations
![EMA Manufacturing and Importation Authorizations](https://www.johnsnowlabs.com/wp-content/uploads/2018/09/normal/European-Medicine-Agency-Authorizations-and-Certificates.png)
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.
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Description
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.
About this Dataset
Data Info
Date Created | 2011 |
---|---|
Last Modified | 2024-06-16 |
Version | 2024-06-16 |
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 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
MIA_Number | Manufacturing and Importation Authorisation Number | string | required : 1 |
EudraGMDP_Document_Reference_Number | The EudraGMDP document reference number | integer | level : Nominalrequired : 1 |
Authorization_Holder | MIA Authorization holder. | string | required : 1 |
Site_Details | Site address | string | required : 1 |
Country | Site Country. | string | required : 1 |
Legal_Basis | MIA 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. | string | required : 1 |
Authorization_Date | Authorization date (0001-01-01 replaced with the empty field) | date | - |
Last_Updated_Date | Last updated date | date | - |
Data Preview
MIA Number | EudraGMDP Document Reference Number | Authorization Holder | Site Details | Country | Legal Basis | Authorization Date | Last Updated Date |
2024_182_1 | 91003 | Biocodex | Biocodex, 1 Avenue Blaise Pascal, Beauvais, 60000 | France | H,I | 2024-07-26 | 2024-07-26 |
ML062 | 91006 | Rx Farma (Malta) Limited | Rx Farma (Malta) Limited, Kw20a, Zona Industrijali Ta' Kordin, Paola, PLA 3000 | Malta | H | 2024-07-26 | 2024-07-26 |
24/16486-2 | 90997 | Smerud Medical Research International AS | Smerud Medical Research International AS, Thunes Vei 2, Oslo, 0274 | Norway | I | 2024-07-26 | 2024-07-26 |
SE-HI-MIA-24-056660 | 91000 | Apotek Produktion & Laboratorier AB | Apotek Produktion & Laboratorier AB, Celsiusgatan 43, Malmo St Johannes, Malmo, 212 14 | Sweden | I | 2024-07-25 | 2024-07-26 |
SE-H-MIA-24-056583 | 90998 | Apotek Produktion & Laboratorier AB | Apotek Produktion & Laboratorier AB, Celsiusgatan 43, Malmo St Johannes, Malmo, 212 14 | Sweden | H | 2024-07-25 | 2024-07-26 |
SE-VI-MIA-24-056649 | 91001 | Apotek Produktion & Laboratorier AB | Apotek Produktion & Laboratorier AB, Celsiusgatan 43, Malmo St Johannes, Malmo, 212 14 | Sweden | V | 2024-07-25 | 2024-07-26 |
SE-V-MIA-24-056635 | 90999 | Apotek Produktion & Laboratorier AB | Apotek Produktion & Laboratorier AB, Celsiusgatan 43, Malmo St Johannes, Malmo, 212 14 | Sweden | V | 2024-07-25 | 2024-07-26 |
24/14476-2 | 90962 | Fresenius Kabi Norge AS | Fresenius Kabi Norge AS, Svinesundsveien 336, Halden, 1788Fresenius Kabi Norge AS, Svinesundsveien 80, Halden, 1788 | Norway | H,I | 2024-07-24 | 2024-07-24 |
2024_255_1_2_3_7 | 90967 | Benta Lyon | Benta Lyon, 29 Avenue Charles De Gaulle, Saint-Genis-Laval, 69230 | France | H,I | 2024-07-24 | 2024-07-24 |
2004-F | 84701 | Lelypharma B.V. | Lelypharma BV, Zuiveringweg 42, Lelystad, 8243 PZ | Netherlands | V | 2024-07-24 | 2024-07-24 |