Others titles
- EMA API GMP Certificates of EEA Countries
- API Sites Certificates of EEA Countries
Keywords
- EEA Active Substance
- Pharmaceutical Substance
- Active Substance Inspection
- European Medicines Agency Registration
- European Medicines Agency API Certificates
EMA API Registration Certificates of EEA Sites
The European Medicines Agency (EMA) API Registration Certificates of EEA Sites dataset includes API sites registration certificates delivered by EMA or national competent authorities to European Economic Area countries API manufacturers.
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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 they are located.
Active substance manufacturers must comply with 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.
Member states should establish the legal and administrative framework within which inspections relating to Good Manufacturing Practice (GMP) inspections as applied to active substances operate.
Inspectors should be issued with an official means of identification, which includes reference to powers of entry, access to data and the collection of samples and documents for the purpose of inspection.
The primary goal for the inspector should be to determine whether the various elements within the quality assurance system are effective and suitable for achieving compliance with GMP principles and pharmacopeial requirements.
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 | EEA Active Substance, Pharmaceutical Substance, Active Substance Inspection, European Medicines Agency Registration, European Medicines Agency API Certificates |
Other Titles | EMA API GMP Certificates of EEA Countries, API Sites Certificates of EEA Countries |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Registration_Number | API site registration number | string | - |
EudraGMDP_Document_Reference_Number | The EudraGMDP document reference number | integer | level : Nominalrequired : 1 |
Registration_Holder | Registration holder name. | string | required : 1 |
Site_Name | API site name. | string | - |
Address_Line_1 | API site address | string | - |
Address_Line_2 | API site address | string | - |
Address_Line_3 | API site address | string | - |
Address_Line_4 | API site address | string | - |
City | API site city. | string | - |
Postcode | API site Postcode. | string | - |
Country | API site Country. | string | required : 1 |
DUNS_Number | Data Universal Numbering System Number | integer | level : Nominal |
Site_NCA_Reference | Site National Competent Authorities reference. | string | required : 1 |
Last_Updated_Date | Last updated date | datetime | required : 1 |
EudraGMDP_Site_Reference_Number | The EudraGMDP site reference number | integer | level : Nominal |
Data Preview
Registration Number | EudraGMDP Document Reference Number | Registration Holder | Site Name | Address Line 1 | Address Line 2 | Address Line 3 | Address Line 4 | City | Postcode | Country | DUNS Number | Site NCA Reference | Last Updated Date | EudraGMDP Site Reference Number |
SE-H-APIREG-22-103502 | 45978 | Evolan Pharma AB | Evolan Pharma AB | Svardvagen 19 | Danderyd | 182 33 | Sweden | 24:2011/516960 | 187125 | |||||
SE-H-APIREG-22-103502 | 45977 | Evolan Pharma AB | Evolan Pharma AB | Svardvagen 19 | Danderyd | 182 33 | Sweden | 24:2011/516960 | 187125 | |||||
SE-H-APIREG-22-103502 | 45976 | Evolan Pharma AB | Evolan Pharma AB | Svardvagen 19 | Danderyd | 182 33 | Sweden | 24:2011/516960 | 187125 | |||||
SE-H-APIREG-22-103502 | 45975 | Evolan Pharma AB | Evolan Pharma AB | Svardvagen 19 | Danderyd | 182 33 | Sweden | 24:2011/516960 | 187125 | |||||
SE-H-APIREG-22-103502 | 45974 | Evolan Pharma AB | Evolan Pharma AB | Svardvagen 19 | Danderyd | 182 33 | Sweden | 24:2011/516960 | 187125 | |||||
SE-H-APIREG-22-103502 | 45973 | Evolan Pharma AB | Evolan Pharma AB | Svardvagen 19 | Danderyd | 182 33 | Sweden | 24:2011/516960 | 187125 | |||||
SE-H-APIREG-20-044068 | 45972 | Merck Life Science AB | Merck Life Science AB | Frosundaviks Alle 1 | Solna | 169 70 | Sweden | 1666884828989 | 154283 | |||||
SE-H-APIREG-20-047577 | 45971 | Univar Solutions AB | Univar Solutions AB | Kungsgatan 6 | Malmo S:t Johannes | Malmo | 211 49 | Sweden | 1666867451175 | 154259 | ||||
SE-H-APIREG-20-053821 | 45951 | Birka Biostorage AB | Birka Biostorage AB | Odarslovs Gard 332 | Torn | Lund | 225 92 | Sweden | 5.9.4-2019-045328 | 187107 | ||||
SE-H-APIREG-20-063664 | 45931 | Nordmann Nordic AB | Nordmann Nordic AB | Vretenvagen 13 | Solna | 171 54 | Sweden | 1692178883003 | 187082 |