HMA

Results: 2302



#Item
131Pharmaceuticals policy / Pharmaceutical industry / Packaging and labeling / Retailing / Marketing authorization / Label

GUIBlue-box requirementsEMA-CMDv

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Source URL: www.hma.eu

Language: English - Date: 2016-02-02 09:01:06
132Pharmaceuticals 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

B.12 AF user guide consolidated vet version EMA

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Source URL: www.hma.eu

Language: English - Date: 2015-07-03 09:05:53
133Luxembourg / Western Europe / Heads of Medicines Agencies

CMDh Strategy Christer Backman, MPA 81th HMA MEETING Luxembourg Presidency of the Council of the EU 2015 Luxembourg, 7th-9th July 2015

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Source URL: www.hma.eu

Language: English - Date: 2015-11-27 10:35:36
134Pharmaceutical industry / IB / Marketing authorization / Maa / PL-1

CMDv GUI-28 Dossier languagesEMA-CMDv

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Source URL: www.hma.eu

Language: English - Date: 2015-06-15 05:38:46
135Recommendation

CMDv BPG-15-Unforeseen variationsEMA-CMDv

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Source URL: www.hma.eu

Language: English - Date: 2015-06-15 05:38:24
    136Pharmaceutical industry / Pharmaceuticals policy / Marketing authorization

    DOC Document

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    Source URL: www.hma.eu

    Language: English - Date: 2015-06-15 05:38:47
    137

    MINUTES Meeting with representatives of Interested Parties on DCP/MRP improvements Monday 16th November EMA, Room 2D Chairperson: Christer Backman, SE

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    Source URL: www.hma.eu

    Language: English - Date: 2016-02-04 12:03:24
      138Clinical research / Clinical data management / Electronic common technical document / Pharmaceutical industry / Pharmaceuticals policy / Marketing authorization / Electronic submission

      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

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      Source URL: esubmission.ema.europa.eu

      Language: English - Date: 2016-08-19 03:15:41
      139Pharmaceutical industry / Technical communication / Summary of Product Characteristics / Documentation / Drug safety / Chemical safety / European Medicines Agency

      EMEA/CMDvCMDv/GUI/006 GUIDANCE for

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      Source URL: www.hma.eu

      Language: English - Date: 2015-07-03 09:58:44
      140Agencies of the European Union / European Medicines Agency / European Union / European Federation of Pharmaceutical Industries and Associations / Rup

      CMDh meeting with IPs on MRP_DCP Improvements - Minutes -May 2016

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      Source URL: www.hma.eu

      Language: English - Date: 2016-08-02 09:25:15
      UPDATE