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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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Data exclusivity for Rx-to-OTC switches in Europe, Carolin Stäbler
- Sprache
- Erscheinungsdatum
- 2014
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- Titel
- Data exclusivity for Rx-to-OTC switches in Europe
- Sprache
- Englisch
- Autor*innen
- Carolin Stäbler
- Verlag
- Govi-Verl.
- Erscheinungsdatum
- 2014
- ISBN10
- 3774112592
- ISBN13
- 9783774112599
- Kategorie
- Skripten & Universitätslehrbücher
- Beschreibung
- 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.