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book (6)


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Book
EC pharmaceutical law
Author:
ISBN: 0471936480 Year: 1992 Publisher: London Chancery Law Publ.


Book
Geneesmiddelenwetgeving
Author:
ISBN: 9027115621 Year: 1979 Publisher: Zwolle Tjeenk Willink


Book
Chapters on pharmaceutical law
Authors: --- ---
ISBN: 9050950868 9789050950862 Year: 2000 Publisher: Antwerpen Intersentia

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Abstract

1. Definition of medicinal products - 2. Research and development of medicinal products : clinical trials - 3. Marketing authorisation of a medicinal product - 4. Distribution of medicinal products - 5. General intellectual property aspects and medicinal products - 6. Parallel import of medicinal products - 7. Patient information leaflets and labelling requirements - 8. Legal issues relating to ecommerce in the european health-care sector - 9. Pricing and reimbursement issues of medicinal products - 10. The processing of personal data in the pharmaceutical industry - 11. Legal issues of the exercise of pharmacists


Book
Pharmacy law and ethics
Authors: ---
ISBN: 0853691681 9780853691686 Year: 1983 Publisher: London Pharmaceutical Press


Book
Pharmacie et société
Authors: ---
ISBN: 2870772939 2870772599 9782870772935 9782870772591 Year: 1984 Publisher: Louvain-la-Neuve Cabay

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Abstract

1: Aperçu historique de la réglementation pharmaceutique belge - 2: Objet et sources de la réglementation pharmaceutique - 3: Le médicament - 4: La profession pharmaceutique : fonctions et conditions d'accès - 5: L'officine - 6: La fabrication industrielle et le commerce de gros des médicaments - 7: Les autorités - 8: Aspects économiques de la législation sur les médicaments - 9: Les médicaments dans le cadre de la sécurité sociale et de l'assurance maladie-invalidité


Book
Intellectual Property Rights in Pharmaceutical Test Data : Origins, Globalisation and Impact
Author:
ISBN: 9783031294365 Year: 2023 Publisher: Cham : Springer International Publishing : Imprint: Springer,

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Abstract

This book considers the intellectual property protection of clinical test data that has been submitted to governments, in particular through test data exclusivity rights. It focuses on how these intellectual property rights first emerged in the early 1980s, how they have globalised over the past four decades, and what impact they have had upon access to medicine. This book makes a number of significant and original contributions to the literature around the protection of submitted test data. First, the book draws upon the theory of regulatory globalisation to provide an explanation of how intellectual property rights in submitted pharmaceutical test data have become nearly ubiquitous in the legal systems of most major economies. Second, through a comprehensive analysis and synthesis of provisions on the protection of submitted test data in free trade agreements, as well as a comparison of a range of national approaches to the protection of submitted test data, it reveals the broader global regulatory pattern that has given rise to these intellectual property rights. Third, by analysing data on drug approvals in the US, it provides an empirical insight into the impact of test data exclusivity in national pharmaceutical markets. Fourth, the book covers a number of developments regarding test data exclusivity that have occurred as a result of responses to the COVID-19 pandemic, both at the national level as well as at the World Trade Organisation (WTO). This book will appeal to academics researching the intersection of intellectual property and the life sciences, civil society activists working to promote access to medicines, and students (particularly those at the post-graduate level) studying the relationship between intellectual property and medicine.

Keywords

Drugs --- Intellectual property (International law) --- Intellectual Property. --- Legislation, Pharmacy. --- International Law. --- Legislation as Topic. --- Medical laws and legislation. --- Testing --- Data processing --- Law and legislation --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Chemotherapy --- Materia medica --- Pharmacology --- Pharmacy --- Law, Medical --- Medical personnel --- Medical registration and examination --- Medicine --- Physicians --- Surgeons --- Medical policy --- Medical jurisprudence --- Constitutional Amendments --- Health Legislation as Topic --- Laws and Statutes --- Legislation, Health --- Model Legislation --- Population Law --- Statutes and Laws --- Health Legislation --- Amendment, Constitutional --- Amendments, Constitutional --- Constitutional Amendment --- Law, Population --- Laws, Population --- Legislation, Model --- Population Laws --- Law of Nations --- Public International Law --- International Law, Public --- International Laws --- Law, International --- Laws, International --- Pharmacy Law --- Pharmacy Legislation --- Law, Pharmacy --- Laws, Pharmacy --- Pharmacy Laws --- Intellectual Properties --- Properties, Intellectual --- Property, Intellectual --- Ownership --- Inventions --- International law --- Legal status, laws, etc. --- legislation & jurisprudence --- Clinical pharmacology. --- Drug development. --- Industrial property (International law) --- Law and legislation. --- Clinical medicine --- Development of drugs --- New drug development --- Development --- Information technology --- Mass media --- Biology --- IT Law, Media Law, Intellectual Property. --- Medical Law. --- Biomedical Research. --- Research. --- Biological research --- Biomedical research --- Health Workforce --- Technology and law

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