Erschienen: 12.03.2014 Abbildung von Stäbler | Data exclusivity for Rx-to-OTC switches in Europe | 1. Auflage | 2014 |


Data exclusivity for Rx-to-OTC switches in Europe

lieferbar, ca. 10 Tage

Buch. Softcover


208 S.

In englischer Sprache

Govi Verlag. ISBN 978-3-7741-1259-9

Format (B x L): 17.4 x 24.3 cm

Gewicht: 515 g

Das Werk ist Teil der Reihe: Govi


Prescription-free medicinal products play an important role when it comes to providing people suffering from self-diagnosable and self-treatable diseases with safe and effective treatment options. The change of classification of medicinal products for human use from prescription to non- prescription status (commonly called Rx-to-OTC switch) is the key procedure when it comes to innovating and improving self-medication. The purpose thereof is to provide new and perhaps better options for self-medication, but granting effectiveness as well as safety in the treatment of diseases partly not yet established as a self-treatment option. While the development of new substances to be used as medicinal products is well standardized, the change to non-prescription status is much less defined, making decisions about how to proceed a process with several confounding factors. This thesis discusses the legal background for a change of class of prescription products in Europe and regulatory pathways to be considered when aiming for a successful Rx-to-OTC switch. Focus is laid on data exclusivity as a means to control and improve patient behavior and thus treatment outcome. Options for obtaining data exclusivity are analyzed via post-hoc analysis of some actual cases and proposals are set up how to generate data which reflect patients' needs and knowledge for self-medication more than data derived from prescription use, thus adding new categories of data to be acknowledged as necessary, relevant and new.

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