Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Centralised procedure for OTC products: impact on European market and companies ***

Anja Rathgeb (Abschlußjahr: 2010)

Summary

Language: English

Medicines for self-medication are often called 'non-prescription' or 'over-the-counter' (OTC) medicines and are available without a doctor's prescription through pharmacies. In some countries of the European Union OTC products are also available in supermarkets and other outlets. Medicines that require a prescription are called prescription products or Rx products. Although some insured patients may have higher out of pocket costs in paying for non-prescription medicines, the recent switches from Rx to OTC show that most patients benefit overall from non-prescription availability without the need for a medical consultation beforehand. One of the major advantages of Rx-to-OTC switches is the reduction of health care costs. So the availability of OTC products may save millions by reducing the number of physician visits and also the associated costs of a physician visit in travel and time lost from work. The overall health, social and economic benefits of responsible self-medication with non-prescription products are well known. In recent years, a wider access to OTC medicines has helped educate people to the practice of responsible self-care. There is an increasing demand by patients for reliable information about personal healthcare which is expected to increase in the future.

In the year 2009 the first two non-prescription medicinal products received a marketing authorisation via the centralised procedure, issued by the European Commission. Afterwards direct access to the distribution without medical prescription in all 27 Member States of the European Union was possible. In general the European OTC industry has welcomed the permission of the centralised switch and the European Medicines Agency is looking forward to receive further OTC switch applications. But OTC drug reviews in theory should become more simple and quicker since they involve established medicines and known regimens. Smaller clinical and pre-clinical data packages also should allow shorter review times. This fact states the room for improvement for both the European Medicines Agency and all national competent authorities of each Member State in the future.

The object of this master thesis is to present a general overview about the legal basis for OTC medicines in the European Union and the European OTC market including similarities, differences and challenges for OTC medicines. The increasing importance of OTC medicines in the European Union will be highlighted and evaluated. Moreover the first two OTC products are presented which achieved a central marketing authorisation via the centralised procedure, alli and PANTOZOL® Control. The regulatory strategy of both applicants is analyzed in detail. In the end an outlook is given how the exemplary national implementation in Germany took place and how generic competitive companies can react on such a centralised legal status switch.

Pages: 49