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Marketing authorization
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1	TIGes vet Q&A-update - Sept 2013 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:08 Pharmaceuticals policy Pharmaceutical industry Digital media Research Health Agencies of the European Union Medical research Electronic submission Marketing authorization Heads of Medicines Agencies Electronic common technical document
2	BPGWorksharingEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-07-07 08:05:52 Pharmaceutical industry Agencies of the European Union Pharmaceuticals policy Health European Medicines Agency European Union Marketing authorization Summary of Product Characteristics Business
3	CMDh meeting with representative of Interested Parties 19 May 2015  Type IA variation label implementation guidance. Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-05-29 10:18:53 Economy Pharmaceutical industry Pharmaceuticals policy Business Marketing authorization Packaging and labeling Quality management system
4	Annex VI: Implementation of mandatory VNeeS format for Veterinary regulatory submissions <> "Error"Annex VI: Implementation of mandatory VNeeS format for Veterinary regulatory submissions \ MERGEFORMAT Annex VI: Imple Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:08 Pharmaceutical industry Medical research Clinical data management Clinical research Health care Evaluation Validity Quality Validation Marketing authorization Electronic submission
5	Quasi Drug Rules in Japan December 2011 Quasi-drugs are a unique product classification in Japan. A quasi-drug is defined in Japan as products that have minimal to moderate pharmacologic activity but are restricted in us Add to Reading List Source URL: www.jetro.go.jp Language: English - Date: 2015-03-30 22:38:04 Pharmaceuticals policy Health Pharmaceutical sciences Pharmaceutical industry Drugs Marketing authorization Pharmaceutical industry in China Over-the-counter drug Pharmaceuticals and Medical Devices Agency Cosmetics Pharmaceutical drug Food and Drug Administration
6	BPGAutomatic validationEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-07-27 07:09:22 Pharmaceutical industry Medical research Health care Pharmacology Validity Clinical data management Clinical research Quality Validation Marketing authorization European Medicines Agency
7	Release Notes for Harmonised Technical Guidance for eCTD Submissions in the EU v3.0 This document highlights the changes incorporated in version 3.0, in comparison with version 2.0, of the eCTD guidance document. For cle Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:10 Medical research Clinical research Health Clinical data management Computing Electronic common technical document Pharmaceutical industry Pharmaceuticals policy Marketing authorization Section Diff utility Drug Master File
8	1 AugustElectronic Application Forms are now fully available for use For initial marketing authorisation (human and veterinary), variation and renewal applications Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:40 Pharmaceuticals policy Health Medical research Clinical data management Clinical research Pharmaceutical industry European Union EudraLex European Medicines Agency Electronic common technical document Common Technical Document Marketing authorization
9	VMRFFINAL VETERINARY MUTUAL RECOGNITION FACILITATION GROUP (VMRF) LINE EXTENSIONS Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-06-15 05:38:24 Pharmaceutical industry Pharmaceuticals policy Marketing authorization Health care Health Business REACh authorisation procedure
10	28 September 2015 EMAInformation Technology Electronic Application Form Data Exchange Standard 3.0 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:35 RDM Stage lighting Marketing authorization European Medicines Agency Health Government