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41	STATEMENT 12 September, 2014 www.haieurope.org Public health in danger with move of Add to Reading List Source URL: haieurope.org Language: English - Date: 2014-09-12 03:41:06 Clinical research Research Pharmacy Pharmaceutical industry European Medicines Agency Directorate-General for Health and Consumers EudraLex Pharmaceutical sciences Pharmaceuticals policy Pharmacology
42	EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products – authorisations, European Medicines Agency Brussels, Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2014-09-15 10:02:27 Pharmaceutical sciences Health European Medicines Agency Directive 2001/83/EC Agenda EudraLex Clinical research Pharmaceuticals policy Research
43	Microsoft Word - ACRO Response to EU Commission on the Clinical Trials Directive 8 January 2010 Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:33:26 Science Clinical trial Clinical Trials Directive EudraLex EudraCT Pharmacovigilance Ethics Committee Directive Institutional review board Clinical research Research Pharmaceutical sciences
44	BRIEFING PAPER SUBJECT: EGA POSITION ON THE API CMDh MEETING (18 NOV[removed]DATE: SUPPLY Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-12-02 08:15:28 Health Marketing authorization European Directorate for the Quality of Medicines EudraLex Government Pharmaceuticals policy Pharmaceutical industry Good manufacturing practice
45	RECOMMENDATION FOR IMPLEMENTATION OF COMPLIANCE STATEMENT FOR THE AGREED COMPLETED PAEDIATRIC INVESTIGATION PLAN (PIP) Doc. Ref.: CMDh[removed], Rev.1 September 2009 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-07-09 05:40:34 Pharmacology Summary of Product Characteristics Regulatory compliance EudraLex Health Pharmaceutical industry Clinical research Pharmaceuticals policy Research
46	CMD(h)CMDh BEST PRACTICE GUIDE ON THE COMPILATION OF THE DOSSIER FOR NEW APPLICATIONS SUBMITTED IN MUTUAL RECOGNITION & DECENTRALISED PROCEDURES Doc. Ref.: CMDh[removed]Rev.1 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-10-10 05:13:04 Pharmaceutical sciences Health EudraLex Summary of Product Characteristics European Directive on Traditional Herbal Medicinal Products Medicinal product Directive 2001/83/EC Validation Bioequivalence Pharmaceuticals policy Clinical research Research
47	CMDh BEST PRACTICE GUIDE ON THE COMPILATION OF THE DOSSIER FOR NEW APPLICATIONS SUBMITTED IN MUTUAL RECOGNITION & DECENTRALISED PROCEDURES Doc. Ref.: CMDh[removed]Rev.1 September 2014 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-10-10 05:13:04 Research Pharmacology Summary of Product Characteristics EudraLex Bioequivalence Test data exclusivity European Directorate for the Quality of Medicines Supplementary protection certificate Pharmaceuticals policy Clinical research Pharmaceutical sciences
48	Version 7 SUMMARY OF PRODUCT CHARACTERISTICS [NOTE: the following are those items of information required by Article 11 of Directive[removed]EC, as amended, and current practice in the centralised procedure. This guidan Add to Reading List Source URL: apps.who.int Language: English - Date: 2008-06-23 09:06:06 Pharmaceutical industry Research Pharmaceuticals policy Dosage forms Summary of Product Characteristics European Medicines Agency EudraLex Tablet Pharmaceutical drug Pharmacology Pharmaceutical sciences Clinical research
49	Microsoft Word - CMDv Report for Release June 2006 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2007-01-22 08:09:28 Pharmacology European Union law European Medicines Agency Pharmaceutical industry EudraLex Government Medicinal product Supplementary protection certificate Clinical research Research Pharmaceutical sciences
50	CMDh BEST PRACTICE GUIDE ON THE PROCESSING OF RENEWALS IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES CMDh[removed]Rev.9 April[removed] Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-12-02 06:50:39 Risk Pharmacology Drug safety Clinical research Pharmacy Pharmacovigilance Maintenance fee Risk assessment EudraLex Pharmaceuticals policy Pharmaceutical sciences Statistics