Pharmaceutical Management Agency

Results: 383



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1BPGAutomatic validationEMA-CMDv

BPGAutomatic validationEMA-CMDv

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Source URL: www.hma.eu

Language: English - Date: 2016-07-27 07:09:22
21 AugustElectronic Application Forms are now fully available for use For initial marketing authorisation (human and veterinary), variation and renewal applications

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
3PSUR Submissions in Single Assessment via EMA Gateway Webclient An agency of the European Union  Presenters of the Day, from EMA

PSUR Submissions in Single Assessment via EMA Gateway Webclient An agency of the European Union Presenters of the Day, from EMA

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:50
4Q & A for EMA eSubmission Gateway

Q & A for EMA eSubmission Gateway

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:47
5Annex1 - A guide to the filenaming convention for eSubmission

Annex1 - A guide to the filenaming convention for eSubmission

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:00
6Clinical 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

Revision version 1.5 for public consultation Comments byJune 2016

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:57
7Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use Doc. Ref: CMDhFebruary 2016

Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use Doc. Ref: CMDhFebruary 2016

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Source URL: www.hma.eu

Language: English - Date: 2016-02-19 11:51:17
8European 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
9Clinical 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
10Clinical 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