Marketing authorization - PDFSEARCH.IO - Document Search Engine

Marketing authorization
Results: 396

#	Item
41	Annex1 - A guide to the filenaming convention for eSubmission Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:00 Pharmaceutical industry Clinical data management Health informatics Agencies of the European Union Clinical research Electronic common technical document European Medicines Agency Marketing authorization ASMF EMA
42	EMA/CMDvCMDv/BPG/016 BEST PRACTICE GUIDE for Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-06-15 05:38:43 Pharmaceutical industry Marketing authorization Pharmaceuticals policy Variations
43	GUIBlue-box requirementsEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-02-02 09:01:06 Pharmaceuticals policy Pharmaceutical industry Packaging and labeling Retailing Marketing authorization Label
44	B.12 AF user guide consolidated vet version EMA Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-07-03 09:05:53 Pharmaceuticals policy Pharmaceutical industry Council of Europe European Directorate for the Quality of Medicines Marketing authorization Bioequivalence Test data exclusivity European Medicines Agency Supplementary protection certificate
45	CMDv GUI-28 Dossier languagesEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-06-15 05:38:46 Pharmaceutical industry IB Marketing authorization Maa PL-1
46	DOC Document Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-06-15 05:38:47 Pharmaceutical industry Pharmaceuticals policy Marketing authorization
47	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
48	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
49	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
50	CMDh_132_2009_Rev38_2015 12_clean Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-08-02 11:05:45 Pharmaceutical industry Pharmaceuticals policy Summary of Product Characteristics Marketing authorization Test data exclusivity