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endfreigebender Importeur

English translation: importer obtaining final customs clearance approval through customs broker

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)

German term or phrase:	endfreigebender Importeur
English translation:	importer obtaining final customs clearance approval through customs broker
Entered by:	Antoinette-M. Sixt Ruth

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15:59 Apr 22, 2011

German to English translations [PRO]
Bus/Financial - Law: Taxation & Customs

German term or phrase: endfreigebender Importeur

This term appears in context with the importation of medical products into the EU. Apparently the "engreigebender Importeur" has to sign off on various documents.
Could this be translated as the "importer giving final approval"?

Antoinette-M. Sixt Ruth KudoZ activity Questions: 279 (6 open) (3 without valid answers) Answers: 524
Local time: 03:45

importer obtaining final customs clearance approval through customs broker

Explanation:
importer obtaining final customs clearance approval through customs broker

sources:

A brief guide to import procedures - HM Revenue & Customs - This notice outlines some of the more important customs import facilities and procedures .... you can obtain customs clearance at an approved inland depot. ...
customs.hmrc.gov.uk/.../channelsPortalWebApp.portal?_... -

[PDF] Public Authority for Industry - PDF/Adobe Acrobat - Quick view
condition for obtaining final customs clearance and allowing the products to be ... Approval' allowing the importer to clear the consignment from Customs, ...
www.intertek.com/.../Kuwait Exporter Importer Guidelines.pd... -

Regulatory Changes in the South Korean Medical Market: Medical ... - Finally, foreign importers must obtain final import approval after the STM and type .... sold freely in the Korean market within the last 3 years (products sold for ... Next, U.S. suppliers must obtain a customs clearance from the Korea ...
www.pacificbridgemedical.com/.../1998_regulatory_changes_in... -

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Note added at 6 hrs (2011-04-22 22:16:47 GMT)
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importer obtaining centralized ("Community") Marketing Authorization from the European Medicines Agency (EMA):

European Medicines Agency - Wikipedia, the free encyclopedia - Centralized marketing authorizations and CHMP/CVMP‎: The centralized procedure is compulsory for all ... for a marketing authorisation to the EMA. ...
en.wikipedia.org/.../European_Medicines_Agency -

European Medicines Agency - European public assessment reports ... - The European Medicines Agency publishes a full scientific assessment report ... every medicine granted a central marketing authorisation by the European Commission. ... 1995-2011 EMA. 7 Westferry Circus . Canary Wharf . London E14 4HB . ...
www.ema.europa.eu/htms/human/epar/a.htm -

Novartis withdraws its marketing authorisation application for ... - 20 Apr 2011 ... Novartis has notified the European Medicines Agency (EMA) of its ... for a centralised marketing authorisation for lumiracoxib (Joicela), ...
www.nelm.nhs.uk/.../Novartis-withdraws-its-marketing-author... application-for-lumiracoxib-Joicela/ -

Marketing authorisations: Types of application : MHRA - 5 Feb 2010 ... Centralised procedure. In the European Union (EU), a company may submit a single ... European Medicines Agency (EMA) for a marketing authorisation (licence) ... This is called the centralised (or community) authorisation ...
www.mhra.gov.uk/.../Medicines/Licensingofmedicines/ Marketingauthorisations/.../index.htm -

BfArM Centralised Procedures - 12 Apr 2010 ... Under the centralised procedure, companies submit a single marketing authorisation application to the European Medicines Agency. At the EMA ...
www.bfarm.de/EN/...Authorisation/.../central-node-en.html -

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Note added at 6 hrs (2011-04-22 22:25:24 GMT)
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this works for non-EU pharmaceutical producers too:

European Medicines Agency - Withdrawn applications - Withdrawal of ... - On 14 January 2011, Abbott Laboratories Ltd officially notified the Committee for Medicinal ... The European Medicines Agency has been formally notified by Abbott ... for a centralised marketing authorisation for the medicine Ozespa ... The application for the marketing authorisation for Ozespa was submitted to the ...
www.ema.europa.eu/ema/index.jsp?.../medicines/.../medicines... /.../medicines/medicines... -

Gilead Sciences Submits European Marketing Application for Once ... - 3 Sep 2010 ... Gilead Sciences Submits European Marketing Application for Once-Daily ... has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for ... Review of the MAA will be conducted by the EMA under the centralized licensing procedure, which, ...
www.gilead.com/pr_1466665 -

European Medicines Agency - Withdrawn applications - Bristol-Myers ... - 18 Mar 2009 ... Bristol-Myers Squibb Pharma EEIG withdraws its marketing authorisation application for Ixempra. The European Medicines Agency has been ...
www.ema.europa.eu/ema/index.jsp?.../medicines/.../medicines... /.../medicines/medicines... -

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Note added at 7 hrs (2011-04-22 23:31:21 GMT)
--------------------------------------------------

glossed over Novartis (cited in one of my above sources) as being a non-EU pharmaceutical producer

Roche also falls into this category:

[PDF] EPAR - Public assessment report - 28. ema.europa.eu - PDF/Adobe Acrobat - Quick view
21 Oct 2010 ... Authorisation to the European Medicines Agency (EMA) for Iasibon, ... The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 27 ... Marketing authorisation holder: Roche Registration Limited ...
www.ema.europa.eu/docs/en_GB/document.../WC500101690.pdf

European Medicines Agency (EMA) RSS Pharmaceuticals - The EMA review will follow a centralized marketing authorization ..... Roche announced today that on behalf of the European Medicines Agency (EMA), ...
www.medworm.com/.../search.php?..."European Medicines Agenc... +EMA...European+Medicines+Agency+(EMA)... -

Selected response from:

andres-larsen
Venezuela
Local time: 04:15

Grading comment

Thank you, Andres. I found your information very interesting and useful. However, my client has since decided to cancel the statement containing the term in question.
Antoinette
4 KudoZ points were awarded for this answer

Summary of answers provided

importer obtaining final customs clearance approval through customs broker

andres-larsen

Discussion entries: 5

andres-larsen

Venezuela

EMA and non-EU pharmaceutical producers

22:28 Apr 22, 2011

this works for non-EU pharmaceutical producers too:

European Medicines Agency - Withdrawn applications - Withdrawal of ... - On 14 January 2011, Abbott Laboratories Ltd officially notified the Committee for Medicinal ... The European Medicines Agency has been formally notified by Abbott ... for a centralised marketing authorisation for the medicine Ozespa ... The application for the marketing authorisation for Ozespa was submitted to the ...
www.ema.europa.eu/ema/index.jsp?.../medicines/.../medicines... /.../medicines/medicines... -

Gilead Sciences Submits European Marketing Application for Once ... - 3 Sep 2010 ... Gilead Sciences Submits European Marketing Application for Once-Daily ... has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for ... Review of the MAA will be conducted by the EMA under the centralized licensing procedure, which, ...
www.gilead.com/pr_1466665 -

andres-larsen

Venezuela

EMA centralized marketing authorization

22:21 Apr 22, 2011

importer obtaining centralized ("Community") Marketing Authorization from the European Medicines Agency (EMA):

European Medicines Agency - Wikipedia, the free encyclopedia - Centralized marketing authorizations and CHMP/CVMP‎: The centralized procedure is compulsory for all ... for a marketing authorisation to the EMA. ...
en.wikipedia.org/.../European_Medicines_Agency -

European Medicines Agency - European public assessment reports ... - The European Medicines Agency publishes a full scientific assessment report ... every medicine granted a central marketing authorisation by the European Commission. ... 1995-2011 EMA. 7 Westferry Circus . Canary Wharf . London E14 4HB . ...
www.ema.europa.eu/htms/human/epar/a.htm -

Novartis withdraws its marketing authorisation application for ... - 20 Apr 2011 ... Novartis has notified the European Medicines Agency (EMA) of its ... for a centralised marketing authorisation for lumiracoxib (Joicela), ...
www.nelm.nhs.uk/.../Novartis-withdraws-its-marketing-author... application-for-lumiracoxib-Joicela/ -

Kim Metzger

Mexico

How can

18:43 Apr 22, 2011

an 'endfreigebender Importeur' be a governmental agency? I'd still like to see some German text.

Antoinette-M. Sixt Ruth

ASKER

18:41 Apr 22, 2011

Thanks for your explanation, Andres. However, in this context the "Freigabe" refers to clearance by the authorities governing the approval of pharmaceutical products.
Antoinette

Kim Metzger

Mexico

How about

18:23 Apr 22, 2011

some relevant source text, Antoinette?

Answers

1 hr confidence:

importer obtaining final customs clearance approval through customs broker

andres-larsen
Venezuela
Local time: 04:15
Native speaker of:

English
PRO pts in category: 6

Grading comment

Thank you, Andres. I found your information very interesting and useful. However, my client has since decided to cancel the statement containing the term in question.
Antoinette

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Changes made by editors

Apr 23, 2011 - Changes made by Steffen Walter:
Field (specific)	Marketing / Market Research => Law: Taxation & Customs

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English translation: importer obtaining final customs clearance approval through customs broker

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endfreigebender Importeur

English translation: importer obtaining final customs clearance approval through customs broker

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