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Electronic Common Technical Document
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#	Item
41	Annex 2 to the HMA eSubmission Roadmap: Implementation of mandatory eCTD format for regulatory submissions (Status: Final version adopted by the eSubmission CMB. Dated 26 JulyScope This annex is intended for both Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:41 Clinical research Clinical data management Electronic common technical document Pharmaceutical industry Pharmaceuticals policy Marketing authorization Electronic submission
42	BAP_Guidance_v1 0_June 2013 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:06 Digital preservation Information technology management Content management systems Records management Archival science Open Archival Information System Electronic common technical document PDF/A Enterprise content management Document management system Archive Data definition specification
43	23 June 2016 EMAversion 1.1 Periodic Safety Update Report (PSUR) repository mandatory use: questions and answers Information for Marketing Authorisation Holders on how to submit a PSUR 1. What is the PSUR r Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:04 Clinical research Clinical data management Electronic common technical document Agencies of the European Union Pharmaceuticals policy
44	Updated 08 JulyRelease Notes Detailing the updates of the EU eCTD Module 1 Specification The published version 3.0 has been updated to versionto correct pick list values and the updated version was publishe Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:41 Clinical data management Clinical research Identifiers Universal identifiers Pharmaceutical industry Universally unique identifier Electronic common technical document Validation Globally unique identifier
45	E-submission-GL- VerSeptember 15 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:07 Clinical data management Clinical research Electronic common technical document Pharmaceutical industry Digital media Directory structure Common Technical Document Folder Computer file Marketing authorization Directory Electronic submission
46	Implementation guide for EU eCTD M1 specification Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:42 Clinical data management Clinical research Quality Identifiers Universal identifiers Electronic common technical document Validation Universally unique identifier Globally unique identifier Specification
47	Revision version 1.5 for public consultation Comments byJune 2016 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:57 Clinical research Clinical data management Pharmaceutical industry Electronic common technical document Pharmaceuticals policy Common Technical Document Marketing authorization ASMF European Medicines Agency European Directorate for the Quality of Medicines Dossier Electronic submission
48	E-Submission Guideline - Jan 2013 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:06 Digital media Research Clinical data management Clinical research Electronic common technical document Directory structure Folder Computer file Electronic submission Portable Document Format Directory File format
49	22 JulyJuly 2016 EMAv7.0 User Guidance for Marketing Authorisation Holders (MAHs) for PSUR Repository Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:02 Clinical research Clinical data management Pharmaceutical industry Electronic common technical document Pharmaceuticals policy Marketing authorization Common Technical Document Validation Product lifecycle
50	FebruaryError codes If your submission was unsuccessful you will be able to find out the reason for this by viewing the error code inside the acknowledgement message. The error codes below reflect common errors wh Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:56 Computer errors Error message Electronic common technical document Error Open HTTP 404 Error detection and correction Key Code Qualifier

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