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the aim to increase the safety and involvement of European citizens, as well as the competitiveness of pharmaceutical industry in accordance with the principle of transparency. Measures related to falsified medicine legal framework (2) pharmacovigilance system (3), as well as clinical data publication

In: European Journal of Health Law
Author: An Baeyens

evaluating applications for MA under the centralised procedure any more than Art. 1(4)bis of Decree-Law No 536/96. As regards the pharmacovigilance system for medicinal products placed on the EU market, that system also covers any use of a medicinal product outside the terms of its. As regards medicinal

In: European Journal of Health Law

Hidden Defects’, Villanova Law Review 51(4) (2006) 803. Stressing the enhancement of pharmacovigilance systems through the massive collection of data, Pasquale, supra note 44, 697. 46 D.K. Citron and D.C. Gray, ‘Addressing the harm of total surveillance: a reply to Professor Neil Richards’, Harv

In: European Journal of Health Law

point for safe medication practices should be designated in each country in a collaborative and complementary way with pharmacovigilance systems for reporting medication errors, analysing causes and disseminating information on risk reduction and prevention. 6. European health authorities should

In: European Journal of Health Law
Author: Katharina Kern

scheme of post-market sur- veillance of human medicines, which must be opened up to include the detec- tion of, and the collection of information on, adverse environmental eff ects. 45 Given the methodical diffi culties in recording environmental eff ects, the exist- ing pharmacovigilance system should be

In: Journal for European Environmental & Planning Law

who who Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems 2004 Geneva World Health Organization Yamashita T. Ram Manohar P. R. ‘Memoirs of Vaidyas: The Lives and Practices of Traditional Medical Doctors in Kerala, India (1

In: Asian Medicine