Others titles
- EMA API GMP Certificates of Non-EEA Countries
- API Sites Certificates of Non-EEA Countries
Keywords
- Non-EEA Active Substance GMP
- EMA Active Substance GMP
- Active Substance Inspection
- European Medicines Agency Registration
- European Medicines Agency API Certificates
EMA API Registration Certificates of Non-EEA Sites
The European Medicines Agency (EMA) API Registration Certificates of Non-EEA Sites dataset includes API sites registration certificates delivered by EMA or national competent authorities to European Economic Area countries API manufacturers.
Get The Data
- ResearchNon-Commercial, Share-Alike, Attribution Free Forever
- CommercialCommercial Use, Remix & Adapt, White Label Log in to download
Description
Manufacturers of active substances intended for the manufacture of human medicines for the EU market must register with the national competent authority of the Member State where API will be imported.
Active substance manufacturers must comply with good manufacturing practices (GMP). In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP.
Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP.
For active substance manufacturing sites located in countries outside the EEA, a Member State which is the supervisory authority for a medicinal product has also the responsibility for supervision and inspection of the active substance manufacturers associated with the medicinal product.
About this Dataset
Data Info
Date Created | 2011 |
---|---|
Last Modified | 2023-08-18 |
Version | 2023-08-18 |
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 | Non-EEA Active Substance GMP, EMA Active Substance GMP, Active Substance Inspection, European Medicines Agency Registration, European Medicines Agency API Certificates |
Other Titles | EMA API GMP Certificates of Non-EEA Countries, API Sites Certificates of Non-EEA Countries |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
API_Registration_Number | API site registration number | string | required : 1 |
EudraGMDP_Document_Reference_Number | The EudraGMDP document reference number | integer | level : Nominalrequired : 1 |
EEA_Site | European economic area site. | string | required : 1 |
EEA_Site_Country | European economic area country. | string | required : 1 |
EudraGMDP_Site_Reference_Number | The EudraGMDP site reference number | integer | level : Nominal |
Third_Country_Site | Non-EEA site | string | required : 1 |
Third_Country_Site_Address | Non-EEA site address | string | required : 1 |
Third_Country_Site_Country | Non-EEA site country | string | required : 1 |
Last_Updated_By | Last updated submitter | string | required : 1 |
Competent_Authority | Competent authority name | string | required : 1 |
Data Preview
API Registration Number | EudraGMDP Document Reference Number | EEA Site | EEA Site Country | EudraGMDP Site Reference Number | Third Country Site | Third Country Site Address | Third Country Site Country | Last Updated By | Competent Authority |
109235 API | 45911 | MSD International Manufacturing Nederlandse vestiging | Netherlands | 187037 | Curia New York Inc. | 33 Riverside Avenue, Rensselaer, NY, 12144-2951 | United States | ||
ASR12829/00001 (AUR23-030 Annual Update 2023) | 45871 | The United Laboratories Forzal Limited | Ireland | 186774 | The United Laboratories (Inner Mongolia) Co. Ltd. | Economy And Technology Park, Bayannaoer, 015000 | China | ||
ASR12829/00001 (AUR23-030 Annual Update 2023) | 45871 | The United Laboratories Forzal Limited | Ireland | 186777 | Fujian Fukang Pharmaceutical Co. Ltd. | No 6 Gaogang Avenue, Jiangyin Industrial Estate, Fuqing, Fuzhou, 350309 | China | ||
ASR12829/00001 (AUR23-030 Annual Update 2023) | 45871 | The United Laboratories Forzal Limited | Ireland | 186776 | The United Laboratories (Inner Mongolia) Co. Ltd. | Economy And Technology Park, Bayannaoer, 015000 | China | ||
ASR12829/00001 (AUR23-030 Annual Update 2023) | 45871 | The United Laboratories Forzal Limited | Ireland | 186775 | The United Laboratories (Inner Mongolia) Co. Ltd. | Economy And Technology Park, Bayannaoer, 015000 | China | ||
sukls100169/2013 | 89 | IMCoPharma a.s. | Czechia | 186703 | Shilpa Medicare Limited | Plot No 4a, Industrial Area, Deosugur, Karnataka, 584170 | India | CZ_SUKL | |
sukls100169/2013 | 89 | IMCoPharma a.s. | Czechia | 186711 | Riocare India Private Limited | Ttc Industrial Area, R940 Shri Mokam Bika Mandir Marg, Ghansoli, Navi Mumbai, Maharashtra, 400701 | India | CZ_SUKL | |
sukls100169/2013 | 89 | IMCoPharma a.s. | Czechia | 186710 | Shouguang Fukang Pharmaceutical Co. Ltd. | North East Of Dongwaihuan Road, Dongcheng Industrial Area, Shouguang, 262700 | China | CZ_SUKL | |
sukls100169/2013 | 89 | IMCoPharma a.s. | Czechia | 186709 | Hebei Shengxue Dacheng Pharmaceutical Co. Ltd. | No. 50 Shengxue Road, Luanchengxian, Shijiazhuang, 051430 | China | CZ_SUKL | |
sukls100169/2013 | 89 | IMCoPharma a.s. | Czechia | 186708 | IPCA Laboratories Limited | Sejavta District, Ratlam, 457001 | India | CZ_SUKL |