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A Guide to Pharmaceuticals in the European Union (EU): The Impact of EU Enlargement
Drug and Market Development Publishing, July 2005, Pages: 85
A Guide to Pharmaceuticals in the European Union (EU) provides detailed explanations of how the EU operates, covering all the main institutions, the way legislation is promulgated, and how the enlargement of the EU has required changes to that process.
The Guide covers the role and functions of the EU, its position in relation to the rest of the world, and the ways in which pharmaceuticals can be marketed in the 25 EU Member States. Detailed explanation of the types of authorization that can be sought in the EU is given and the procedures that must be undergone to obtain them. The Guide provides a detailed analysis of the political and healthcare systems in each of the 10 new Member States and the 2 proposed new Member States, as well as a comprehensive overview of their healthcare systems, how they are funded, their problems, and the way in which pharmaceuticals are managed in each Member State.
About the Author
Dr Robin J Harman is a registered pharmacist who works as a pharmaceutical and regulatory consultant. He has worked within the regulatory affairs sector of both the pharmaceutical and medical device industries for the past 15 years. He has carried out many wide-ranging projects for both companies and regulatory authorities, and regularly meets with senior staff in companies and regulatory authorities to interview them for regulatory publications. In 1990, he was the first Editor of The Regulatory Affairs Journal, establishing the journal as a leading authoritative source of regulatory intelligence worldwide during his 8 years tenure. He was also the first Editor of The Regulatory Affairs Journal (Devices). He has published widely on all aspects of the control and development of medicinal products and medical devices, and has also written and edited four general pharmacy textbooks published by the Pharmaceutical Press, the publishing division of the Royal Pharmaceutical Society of Great Britain.
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