Directive 2001 83 EC

Results: 312



#Item
181Clinical research / Pharmaceuticals policy / European Union / Directive 2001/83/EC / Directive on services in the internal market / Council Implementing Regulation (EU) No 282/2011 / Enforcement Directive / European Union law / European Union directives / Law

STATUTORY INSTRUMENTS. S.I. No. 555 of 2010 ————————

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Source URL: www.djei.ie

Language: English - Date: 2010-11-25 09:54:47
182Pharmacology / Research / Drug safety / Pharmacy / Bioequivalence / Summary of Product Characteristics / Test data exclusivity / Pharmacovigilance / Directive 2001/83/EC / Pharmaceuticals policy / Pharmaceutical sciences / Clinical research

CMDh QUESTIONS & ANSWERS GENERIC APPLICATIONS Doc. Ref.: CMDh[removed], Rev0 October 2012 SUBMISSION OF A DESCRIPTION OF PHARMACOVIGILANCE SYSTEM AND EU RISK MANAGEMENT PLANS FOR GENERIC AND HYBRID APPLICATIONS .........

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Source URL: www.hma.eu

Language: English - Date: 2012-11-09 05:52:11
183Research / European Union / Biologic / Medicinal product / Directive 2001/83/EC / Supplementary protection certificate / Pharmacology / Clinical research / Pharmaceuticals policy

CMDh QUESTIONS & ANSWERS BIOLOGICALS Doc. Ref.: CMDh[removed], Rev0 October 2012 What is the definition of a biological medicinal product? .................................................................. 2 How is this

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Source URL: www.hma.eu

Language: English - Date: 2012-11-09 05:52:11
184European Union law / European Court of Justice / Directive 2001/83/EC / General Court / European Union / Public law / Costa v ENEL / Law / Clinical research / Pharmaceuticals policy

Non-exhaustive list of judgements rendered by the European Court of Justice Scope of application (borderlines)  Case C[removed]European Court reports xxx Judgment of the Court (First Chamber) of 15 November[removed]Euro

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Source URL: ec.europa.eu

Language: English - Date: 2014-06-30 04:41:43
185Evaluation / Reference / Standards / Directive 2001/83/EC / Law / Directive 93/41/EEC / Council Implementing Regulation (EU) No 282/2011 / Clinical research / Pharmaceuticals policy / European Union

NEGATIVE LIST Products covered by Communitiy legislation with specific provisions relating to border controls. Products covered by these provisions are not subject to import controls described in Articles 27 to 29 of Reg

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Source URL: ec.europa.eu

Language: English - Date: 2012-03-16 09:31:02
186Pharmacology / Research / Health / Pharmaceutical industry / European Medicines Agency / Good Laboratory Practice / Pharmacovigilance / Summary of Product Characteristics / Directive 2001/83/EC / Clinical research / Pharmaceutical sciences / Pharmaceuticals policy

L[removed]EN Official Journal of the European Union

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 08:59:37
187Pharmaceutical sciences / Health / EudraLex / Directive 2001/83/EC / Pharmacovigilance / Qualified Person Responsible For Pharmacovigilance / Regulation / Directive / Medicinal product / Pharmaceuticals policy / Clinical research / Research

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products – authorisations, EMA PHARM 618

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 08:48:36
188Health / Pharmaceutical sciences / European Medicines Agency / Directive 2001/83/EC / Medical device / Medicinal product / Medical Devices Directive / Supplementary protection certificate / European Directive on Traditional Herbal Medicinal Products / Pharmaceuticals policy / Clinical research / Medicine

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products – authorisations, EMA PHARM 628

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-30 04:33:16
189Pharmacology / Health / Drug safety / Pharmacy / European Medicines Agency / Pharmacovigilance / Directive 2001/83/EC / Qualified Person Responsible For Pharmacovigilance / Supplementary protection certificate / Pharmaceuticals policy / Clinical research / Pharmaceutical sciences

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products – authorisations, European Medicines Agency PHARM 648

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Source URL: ec.europa.eu

Language: English - Date: 2014-05-05 07:48:08
190Research / Pharmaceuticals policy / Pharmaceutical industry / Biologic / European Medicines Agency / Biosimilar / Pharmacovigilance / Directive 2001/83/EC / Medicinal product / Pharmacology / Pharmaceutical sciences / Clinical research

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products – authorisations, European Medicines Agency PHARM 630

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-30 04:33:16
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