frigivelse fra 3. lande
English translation: importation from third countries and release [for sale in the domestic market]
| GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
|---|---|---|---|---|---|---|
|
| 21:38 Dec 2, 2017 |
| Danish to English translations [PRO] Medical - Medical (general) | |||||||
|---|---|---|---|---|---|---|---|
|
| ||||||
|  Selected response from: andres-larsen Venezuela Local time: 14:10 | ||||||
Grading comment
| |||||||
| Summary of answers provided | ||||
|---|---|---|---|---|
| 1 | importation from third countries and release [for sale in the domestic market] |
|
| Summary of reference entries provided | |||
|---|---|---|---|
| importation and release from third countries in the absence of a Mutual Recognition Agreement |
|
Answers
2 hrs confidence: 
importation from third countries and release [for sale in the domestic market] Explanation: The company has procedures for release and keeps a release register, which was submitted. Importation and release from third countries [i.e., importation from third countries and release for sale in the domestic market] sources: he Certified Pharmaceutical GMP Professional Handbook, Second Edition: https://books.google.com/books?isbn=0873899334 - Mark Allen Durivage - 2016 - Business & Economics Importation of finished products should be conducted by an importer. Each batch of imported finished product should be certified by a QP of the importer before release for sale in the EC/EEA. Unless an MRA is in effect between the EC and the third country, samples from each batch should be tested in the EC/EEA before ... Release for the EU - Synerlab www.synerlab.com › Home › CDMO › Specific services The imported pharmaceutical specialities may originate from different countries. Third countries that have not signed an Agreement on Mutual Recognition with the European Union; in this case, the products must be re-analysed in the European Union before being released in the EU. Third countries that have signed an ... in Danish: Engrosforhandlere må ikke modtage eller indkøbe lægemidler fra ... https://laegemiddelstyrelsen.dk/.../engrosforhandlere-maa-ik... 3 nov. 2017 - Engrosforhandlere må ikke modtage eller indkøbe lægemidler fra lande uden for EU/EØS (tredjeland) eller håndtere mellemprodukter ... hvornår der er tale om indførsel fra tredjelande, men det sker, at vi får spørgsmål, hvor der er tvivl, om lægemidler er frigivet til det europæiske marked, eller om der stadig ... Bekendtgørelse om fremstilling og indførsel af lægemidler og ... https://www.retsinformation.dk/Forms/R0710.aspx?id=144720 18 dic. 2012 - 11) Indførsel: Import af lægemidler eller mellemprodukter fra et land uden for EU/EØS (tredjeland). 12) Kvalitetskontrol: Procedurer og dokumentation for prøveudtagning, inspektion og kvalitativ samt kvantitativ testning af råvarer, pakkemateriale, mellemprodukter og færdigvarer samt frigivelse, som sikrer, ... -------------------------------------------------- Note added at 13 hrs (2017-12-03 11:26:00 GMT) -------------------------------------------------- in the Danish context, the domestic market would be not only in Denmark but also in the intra-European EU and EC/EEA markets |
| |
Grading comment
| ||
| Login to enter a peer comment (or grade) | ||
Reference comments
1 hr |
| Reference: importation and release from third countries in the absence of a Mutual Recognition Agreement Reference information: The Certified Pharmaceutical GMP Professional Handbook, Second Edition: https://books.google.com/books?isbn=0873899334 - Mark Allen Durivage - 2016 - Business & Economics Importation of finished products should be conducted by an importer. Each batch of imported finished product should be certified by a QP of the importer before release for sale in the EC/EEA. Unless an MRA is in effect between the EC and the third country, samples from each batch should be tested in the EC/EEA before ... Release for the EU - Synerlab www.synerlab.com › Home › CDMO › Specific services The imported pharmaceutical specialities may originate from different countries. Third countries that have not signed an Agreement on Mutual Recognition with the European Union; in this case, the products must be re-analysed in the European Union before being released in the EU. Third countries that have signed an ... -------------------------------------------------- Note added at 1 hr (2017-12-02 23:21:21 GMT) -------------------------------------------------- Engrosforhandlere må ikke modtage eller indkøbe lægemidler fra ... https://laegemiddelstyrelsen.dk/.../engrosforhandlere-maa-ik... 3 nov. 2017 - Engrosforhandlere må ikke modtage eller indkøbe lægemidler fra lande uden for EU/EØS (tredjeland) eller håndtere mellemprodukter ... hvornår der er tale om indførsel fra tredjelande, men det sker, at vi får spørgsmål, hvor der er tvivl, om lægemidler er frigivet til det europæiske marked, eller om der stadig ... Bekendtgørelse om fremstilling og indførsel af lægemidler og ... https://www.retsinformation.dk/Forms/R0710.aspx?id=144720 18 dic. 2012 - 11) Indførsel: Import af lægemidler eller mellemprodukter fra et land uden for EU/EØS (tredjeland). 12) Kvalitetskontrol: Procedurer og dokumentation for prøveudtagning, inspektion og kvalitativ samt kvantitativ testning af råvarer, pakkemateriale, mellemprodukter og færdigvarer samt frigivelse, som sikrer, ... |
| |
| Login to enter a peer comment (or grade) | ||
Login or register (free and only takes a few minutes) to participate in this question.
You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.
KudoZ™ translation help
The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.
See also:
Search millions of term translations