HMA

Results: 2302



#Item
81Economy / 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
82Pharmaceutical 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
83

Pilot on Merging/Splitting IP meeting onMRP/DCP improvementsSusanne Winterscheid Originator | Title | 27 March 2015 | Page 1

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Source URL: www.hma.eu

Language: English - Date: 2016-06-27 10:58:45
    84Geography of Europe / Europe / Croatia / Republics

    CMDh meeting with representative Interested Parties 19 May 2015  Further use of sRUP (Simplified Repeat Use Procedure) in Croatia

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    Source URL: www.hma.eu

    Language: English - Date: 2015-05-29 10:18:54
    85Pharmaceutical 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
    86

    B.01.a Procedural changes to worksharing - practical advice to MAHsEXT

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    Source URL: www.hma.eu

    Language: English - Date: 2015-06-15 05:38:47
      87Law / Patent law / Intellectual property law / South African law / Access control / Chemical safety / REACh authorisation procedure / EU copyright case-law

      Microsoft Word - Parallel Applications - MS-SOP¯EMEA-VMRFGRev 1-Fin…

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      Source URL: www.hma.eu

      Language: English - Date: 2015-06-15 05:38:24
      88Pharmaceuticals policy / Health care / Health / Pharmaceutical industry / Medical research / Healthcare quality / European Medicines Agency / European Union / Qualified Person Responsible For Pharmacovigilance / Marketing authorization / Summary of Product Characteristics / Pharmacovigilance

      B.08 GUIMA Transfer national requirements AT BE CZ DE(BVL, PEI) EE ES FI FR IE IS IT LT LV NL PL RO SE SK SI UKEMA-CMDv

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      Source URL: www.hma.eu

      Language: English - Date: 2016-02-02 09:57:36
      89Pharmaceutical industry / Pharmaceutical sciences / Pharmacology / Pharmaceuticals policy / Health / Directive 2001/83/EC / Biopharmaceutical / Denatured alcohol / Marketing authorization / Pharmaceutical drug

      CMDh_269_2012_Rev0_2012 10 (republished)

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      Source URL: www.hma.eu

      Language: English - Date: 2016-07-27 08:07:45
      90Clinical data management / Clinical research / Evaluation / Pharmaceutical industry / Quality / Validation / Validity / ISO 10303 / Electronic submission / Knowledge

      eAF communication - 1 pager

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      Source URL: www.hma.eu

      Language: English - Date: 2015-06-15 05:38:43
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