Abstract
When considering whether a medicinal product can be granted OTC status i.e. used as a non-prescription drug, a number of criteria need to be addressed and assessed. Conceivably, these criteria should be essentially similar world-wide. However, as judged by considerable national differences in the availability of non-prescription drugs, there are inconsistencies in how regulatory agencies assess the suitability of products for self-medication. The main criteria used by the Swedish Medical Products Agency are i) suitability for self-care indications ii) treatment should not mask serious symptoms or diseases iii) there should be adequate proof of safety at normal use, misuse and overdosing iv) absence of CNS stimulation, tolerance or dependency.
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© 1995 Springer-Verlag Berlin Heidelberg
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Sjöberg, P. (1995). Safety Assessment of OTC Products — A Regulatory View. In: Degen, G.H., Seiler, J.P., Bentley, P. (eds) Toxicology in Transition. Archives of Toxicology, vol 17. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-79451-3_28
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DOI: https://doi.org/10.1007/978-3-642-79451-3_28
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