Marketing authorization

Results: 396



#Item
1Pharmaceuticals 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

TIGes vet Q&A-update - Sept 2013

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:08
2Pharmaceutical industry / Agencies of the European Union / Pharmaceuticals policy / Health / European Medicines Agency / European Union / Marketing authorization / Summary of Product Characteristics / Business

BPGWorksharingEMA-CMDv

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Source URL: www.hma.eu

Language: English - Date: 2016-07-07 08:05:52
3Economy / Pharmaceutical industry / Pharmaceuticals policy / Business / Marketing authorization / Packaging and labeling / Quality management system

CMDh meeting with representative of Interested Parties 19 May 2015  Type IA variation label implementation guidance.

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Source URL: www.hma.eu

Language: English - Date: 2015-05-29 10:18:53
4Pharmaceutical industry / Medical research / Clinical data management / Clinical research / Health care / Evaluation / Validity / Quality / Validation / Marketing authorization / Electronic submission

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

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:08
5Pharmaceuticals 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

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

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Source URL: www.jetro.go.jp

Language: English - Date: 2015-03-30 22:38:04
6Pharmaceutical industry / Medical research / Health care / Pharmacology / Validity / Clinical data management / Clinical research / Quality / Validation / Marketing authorization / European Medicines Agency

BPGAutomatic validationEMA-CMDv

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Source URL: www.hma.eu

Language: English - Date: 2016-07-27 07:09:22
7Medical research / Clinical research / Health / Clinical data management / Computing / Electronic common technical document / Pharmaceutical industry / Pharmaceuticals policy / Marketing authorization / Section / Diff utility / Drug Master File

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

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:10
8Pharmaceuticals 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

1 AugustElectronic Application Forms are now fully available for use For initial marketing authorisation (human and veterinary), variation and renewal applications

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:40
9Pharmaceutical industry / Pharmaceuticals policy / Marketing authorization / Health care / Health / Business / REACh authorisation procedure

VMRFFINAL VETERINARY MUTUAL RECOGNITION FACILITATION GROUP (VMRF) LINE EXTENSIONS

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Source URL: www.hma.eu

Language: English - Date: 2015-06-15 05:38:24
10RDM / Stage lighting / Marketing authorization / European Medicines Agency / Health / Government

28 September 2015 EMAInformation Technology Electronic Application Form Data Exchange Standard 3.0

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:35
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