- EMA MIA Certificates of EEA Countries
- MIA Certificates of EEA Countries
- EEA MIA
- Manufacturing Authorisations
- Pharmaceutical Importation
- European Medicines Agency Registration
- European Medicines Agency API Certificates
EMA Manufacturing and Importation Authorizations
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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John Snow Labs Standard End User License Agreement
This Standard End User License Agreement (“EULA”) applies to customers of John Snow Labs Inc. (as defined below), using any product of John Snow Labs Inc. on John Snow Labs Marketplace as defined below (hereinafter referred to “you”) and John Snow Labs Inc., a Delaware corporation (“John Snow Labs”, “we” or “us”).
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Term and Termination
This EULA will become effective as of the date of your order of Products and shall be in effect until terminated.
John Snow Labs may suspend or terminate your right to use our Products, if you or your end user’s use of the Products:
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Limitation of Liability
WE AND OUR SUPPLIERS AND LICENSORS WILL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES, INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS, GOODWILL, USE, DATA, OR OTHER INTANGIBLE LOSSES (EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF THESE DAMAGES), RESULTING FROM YOUR USE OF OUR PRODUCTS AND CONTENT. UNDER NO CIRCUMSTANCES WILL THE TOTAL LIABILITY OF US AND OUR SUPPLIERS AND LICENSORS OF ALL KINDS ARISING OUT OF OR RELATED TO YOUR USE OF THE PRODUCTS AND CONTENT (INCLUDING BUT NOT LIMITED TO WARRANTY CLAIMS), REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT, TORT, OR OTHERWISE, EXCEED THE AMOUNTS, IF ANY, THAT YOU HAVE PAID FOR YOUR USE OF THE PRODUCTS AND CONTENT. BECAUSE SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU.
To the full extent permitted by applicable law, you shall defend, indemnify and hold harmless John Snow Labs, its affiliates and its licensors, and each of their respective employees, officers, directors, and representatives from and against any claims, damages, losses, liabilities, costs, and expenses (including reasonable attorney’s fees) arising out of or relating to any third party claim concerning: (a) your use of the Products; (b) breach of this EULA or violation of applicable law by you; (c) any content or the combination of such content with other software, content or processes, including any claim involving alleged infringement or misappropriation of third-party rights by such content or combination; or (d) breach of any obligation or duty you owe to a third party.
Enforcement of this EULA will be governed by the laws of the State of Delaware, excluding its conflict and choice of law principles. The exclusive jurisdiction and venue for any claims arising out of or related to this EULA or your use of the Products will lie in the state and federal courts located in Sussex County, within the State of Delaware, and you irrevocably agree to submit to the jurisdiction of such courts. Our failure to enforce any right or provision in this EULA will not constitute a waiver of such right or provision unless acknowledged and agreed by us in writing. In the event that a court of competent jurisdiction finds any provision of this EULA to be illegal, invalid, or unenforceable, the remaining provisions will remain in full force and effect.
We may use your contact information to notify you if we have any legitimate interest or if we need to notify you on any important information related to your use of Products. We will not send you newsletters unless you expressly consented to such notifications.
If you have any questions or concerns about our Products or this EULA, you may contact us by email at support@JohnSnowLabs.com.
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
European Economic Area Countries
John Snow Labs; European Medicines Agency (EMA), EudraGMP;
|Source License URL|
|Source License Requirements||
EEA MIA, Manufacturing Authorisations, Pharmaceutical Importation, European Medicines Agency Registration, European Medicines Agency API Certificates
EMA MIA Certificates of EEA Countries, MIA Certificates of EEA Countries
|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||-|
|MIA Number||EudraGMDP Document Reference Number||Authorization Holder||Site Details||Country||Legal Basis||Authorization Date||Last Updated Date|
|73142||VET PRO KOMERS OOD||VET PRO KOMERS OOD, 65, âIndustrialnaâ Str., Gabrovo, Bulgaria., Gabrovo, 5300JSC Scientific and Production Company Ekoprom, 11/23, 11/33, Garshina str, Tomilino town, Lyuberetski district, Moskow region, Russia, Tomilino, 14070||Bulgaria||ORG-100033785 - LOC-100053146ORG-100040747 - LOC-100067023||V||2022-10-12||2022-01-12|
|7277||ACS DOBFAR S.P.A.||ACS DOBFAR S.P.A., VIA ROSSINI, 7/9/11, TRIBIANO, 20067||Italy||-||H,I||2022-09-16||2022-05-10|
|17289||KLIFO A/S||Klifo A/S, Smedeland 36, Glostrup, 2600||Denmark||ORG-100016474 - LOC-100025262||H,I,V||2022-07-01||2022-07-01|
|77058||ENDC B.V.||ENDC B.V., Pascalstraat 7, Harderwijk, 3846 AL||Netherlands||ORG-100043179 - LOC-100071439||H||2022-07-01||2022-06-27|
|6065||ALK-Abello A/S||Alk-Abello A/S, Boege Alle 6/8, Hoersholm, 2970||Denmark||ORG-100001534 - LOC-100005491||H,I||2022-06-30||2022-06-30|
|25848||NATURELLE CONSUMER PRODUCTS LIMITED||NATURELLE CONSUMER PRODUCTS LIMITED, UNIT 5 BANKMORE WAY EAST INDUSTRIAL PARK, OMAGH, BT79 0NZ||United Kingdom (Northern Ireland)||-||I||2022-06-30||2022-06-30|
|77233||Lichtenheldt GmbH Pharmazeutische Fabrik||Lichtenheldt GmbH Pharmazeutische Fabrik, Industriestrasse 7 - 11, Wahlstedt, 23812Lichtenheldt GmbH Pharmazeutische Fabrik, Justus-Liebig-Weg 1, Wahlstedt, 23812||Germany||ORG-100011704 - LOC-100020595ORG-100011704 - LOC-100020699||H,I,V||2022-06-30||2022-07-01|
|77212||Haupt Pharma Amareg GmbH||Haupt Pharma Amareg GmbH, Donaustaufer Strasse 378, Schwabelweis, Ratisbon, 93055||Germany||ORG-100012020 - LOC-100020534||H,I||2022-06-30||2022-07-01|
|6216||Nomeco A/S||Nomeco A/S, Borgmester Christiansens Gade 40, Copenhagen V, 1790Nomeco A/S, Idunsvej 3, Koege, 4600||Denmark||ORG-100012674 - LOC-100018363ORG-100012674 - LOC-100052833||H,V||2022-06-30||2022-06-30|
|77232||Rafarm S.A.||Rafarm S.A., Thesi Pousi Xatzi Agiou Louka, Paiania, 190 02||Greece||ORG-100002688 - LOC-100002663||H,I,V||2022-06-30||2022-06-30|