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Test data exclusivity
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#	Item
31	Impact of EU Trade Agreements on Access to Medicines: Sophie Bloemen December 2009 Add to Reading List Source URL: www.haiweb.org Language: English - Date: 2010-02-27 01:55:28 Pharmaceuticals policy International trade World Trade Organization Monopoly Agreement on Trade-Related Aspects of Intellectual Property Rights Anti-Counterfeiting Trade Agreement Pharmaceutical industry Patent Test data exclusivity Intellectual property law Law Business
32	E-ALERT \| Food & Drug October 27, 2014 EU COURT OF JUSTICE STRENGTHENS RIGHTS OF ORIGINATORS TOWARDS GENERIC APPROVALS In a ruling of 23 October 2014, 1 the EU Court of Justice concluded that the Medicines Directive Add to Reading List Source URL: www.cov.com Language: English - Date: 2014-10-27 09:49:11 Supplementary protection certificate Qualified Person for Pharmacovigilance Pharmaceuticals policy Test data exclusivity Health
33	Test Data Protection: WHO perspective Symposium On The Evolution Of The Regulatory Framework Of Test Data – From The Property Of The Intellect To The Intellect Of Property Geneva, February 8, 2010 Add to Reading List Source URL: www.wipo.int Language: English - Date: 2013-04-22 14:33:33 Health Pharmaceutical industry Clinical research Drug safety Marketing authorization Regulation of therapeutic goods Food and Drug Administration Test data exclusivity Clinical trial Pharmaceutical sciences Pharmacology Pharmaceuticals policy
34	Antitrust AstraZeneca: the first abuse case in the pharmaceutical sector Niklas FAGERLUND and Søren Bo RASMUSSEN, Directorate-General Competition, unit B-2 1. Introduction Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2009-02-06 08:51:47 Medicine Intellectual property law Monopoly Pharmaceutical sciences Sulfoxides Omeprazole Supplementary protection certificate Test data exclusivity Astra AB Proton pump inhibitors AstraZeneca Pharmacology
35	EUROPEAN COMMISSION Bruxelles, [removed]C[removed]final) Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2015-01-09 08:09:51 Health Pharmaceutical sciences European Medicines Agency Ulipristal acetate Directive 2001/83/EC Test data exclusivity Supplementary protection certificate European Directive on Traditional Herbal Medicinal Products Pharmaceuticals policy Clinical research Research
36	BEST PRACTICE GUIDE FOR THE EXCHANGE OF REGULATORY AND ADMINISTRATIVE INFORMATION REGARDING ORPHAN MEDICINAL PRODUCTS BETWEEN THE EMEAEMA AND THE NATIONAL COMPETENT AUTHORITIES October 2003 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2011-11-25 05:34:30 Pharmacology Test data exclusivity Orphan drug Directive 65/65/EEC Directive 75/319/EEC European Medicines Agency Supplementary protection certificate Pharmaceuticals policy Health Pharmaceutical sciences
37	CMDh POSITION PAPER ON PROCESSING OF GENERIC APPLICATIONS WHEN THE GENERIC HAS MORE INDICATIONS OR FEWER INDICATIONS THAN THE REFERENCE PRODUCT IN THE CMS Doc. Ref.: CMDh[removed]Rev2 July 2014 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-08-04 11:35:44 Pharmacology Health Pharmaceutical industry Drug safety Clinical research Pharmaceuticals policy Test data exclusivity Pharmaceutical sciences
38	BEST PRACTICE GUIDE FOR THE EXCHANGE OF REGULATORY AND ADMINISTRATIVE INFORMATION REGARDING ORPHAN MEDICINAL PRODUCTS BETWEEN THE EMA AND THE NATIONAL COMPETENT AUTHORITIES Doc. Ref.: CMDh[removed], Rev2 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2011-11-25 05:34:29 Pharmaceutical sciences Pharmacology Orphan drug Test data exclusivity Directive 65/65/EEC Directive 75/319/EEC European Medicines Agency Supplementary protection certificate Pharmaceuticals policy Clinical research Health
39	CMDh POSITION PAPER ON PROCESSING OF GENERIC APPLICATIONS WHEN THE GENERIC HAS MORE INDICATIONS OR FEWER INDICATIONS THAN THE REFERENCE PRODUCT IN THE CMS Doc. Ref.: CMDh[removed]Rev1Rev2 November 2009 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-08-04 11:35:45 Pharmaceuticals policy Test data exclusivity
40	Mutual recognition and decentralised procedures finalised in[removed]with new active substances Doc.Ref.: CMDh[removed], Rev0 November[removed]In accordance with Directive[removed]EC amending Directive[removed]EC, the pe Add to Reading List Source URL: www.hma.eu Language: English - Date: 2011-11-25 05:32:36 Test data exclusivity Pitavastatin DC Comics Chemistry Pharmaceuticals policy Organic chemistry

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