Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Special consideration of OTC switches with respect to application and national implementation from the generic perspective ***

Anna Geist (Abschlußjahr: 2010)

Language: English

In the majority of the European Member States medicines are categorised in two main classifications: prescription medicines (Rx) and over-the-counter medicines (OTC).

Whereas some Member States implemented highly regulated reclassification procedures, in other European countries the marketing authorisation holder has to submit a national variation in order to change the prescription status of his medicinal product. Before reclassification is possible several criteria have to be met. Such criteria are defined in the European Commission "Guideline on changing the classification for the supply of a medicinal product for human use."

There is an increasing number of medicines, previously requiring a prescription from physicians, that can be now obtained over the counter. A noticeable amount of recently performed switches included substance classes that were not regarded as suitable in the past. Precedent was set with the authorisation of the first OTC product and the first "switch" to a non-prescription medicine, by making use of the Centralised Procedure.

Target of this master thesis is to point out the major switch procedures that are in place in the European Union and to demonstrate the discrepancy in timelines and dates when products or substances are reclassified. Furthermore, this thesis will cover some selected case studies of products, recently switched to OTC with special consideration of their impact on the generic industry. Finally, conclusions will be drawn from the evaluation of these switches to improve the regulatory strategy for upcoming Rx-to-OTC switches.

Pages: 33