Electronic common technical document

Results: 446



#Item
51XML delivery file for all submissions via Gateway and Web Client - Statement of Intent

XML delivery file for all submissions via Gateway and Web Client - Statement of Intent

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:48
52CR Acceptable Usage Policy

CR Acceptable Usage Policy

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:46
53EU Module 1 Specification - Annex VersionNovember 2011  Document Control

EU Module 1 Specification - Annex VersionNovember 2011 Document Control

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:45
54CMD(h) meeting with interested parties

CMD(h) meeting with interested parties

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Source URL: www.hma.eu

Language: English - Date: 2015-05-29 10:17:02
55Practical Guidance For the Paper Submission of Regulatory Information in Support of a Marketing Authorisation Application When Using an eCTD or a NeeS as the Source Submission. v2.0

Practical Guidance For the Paper Submission of Regulatory Information in Support of a Marketing Authorisation Application When Using an eCTD or a NeeS as the Source Submission. v2.0

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:51
56European Medicines Agency  Evaluation of Medicines for Human Use  London, August 2009  EMEA  V1.0 

European Medicines Agency  Evaluation of Medicines for Human Use  London, August 2009  EMEA  V1.0 

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:52
57Clinical research / Pharmaceutical industry / Clinical data management / Drug safety / Electronic common technical document / Supplementary protection certificate / European Medicines Agency / Summary of Product Characteristics / Pharmacovigilance / Validation / Drug Master File

DOC Document

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Source URL: www.ema.europa.eu

Language: English - Date: 2016-07-20 07:22:57
5818 March 2015 EMAProcedure Management and Business Support Division Use of XML delivery file for submissions via eSubmission Gateway / Web Client – phased implementation for all

18 March 2015 EMAProcedure Management and Business Support Division Use of XML delivery file for submissions via eSubmission Gateway / Web Client – phased implementation for all

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:00
59Clinical research / Clinical data management / Pharmaceutical industry / Pharmaceuticals policy / Electronic common technical document / Common Technical Document / Marketing authorization / Validation / Pharmacovigilance / HTML element / Summary of Product Characteristics / European Medicines Agency

RTF Document

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:41
60How to send submissions via the Web Client - User Guidance

How to send submissions via the Web Client - User Guidance

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:47