Switching in Europe
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SWITCHING IN EUROPE HUBERTUSCRANZ Director General, Association of the European Self-Medication Industry (AESGP), Brussels, Belgium
Having a uniform switching policy from prescription to over-the-counter (OTC) drugs across Europe is a diflcult task which is largely due to the previous national evaluations and, to a certain extent, reimbursement policies and cultural differences. The impact of the European Classijkation Directive 92R6/EC has initiated a process of harmonization which, at least for newer products in the OTC area, is helpful in getting nonprescription status all over Europe. The European switching guideline is also expected to provide a general indication of what the consultation process should comprise and make the general process more transparent. It is hoped that the cooperation created among the European Member States will also lead to a more liberal policy with regard to issues such as trade names, distribution, and pricing. Together with the intensified dialogue with health professionals this should contribute to an increase of the OTC market in Europe, which would be in line with recommendations by health politicians. Key Words: Switching; Classification; Medicinal products; OTC; Nonprescription
DIRECTIVE 92126EC
filled is the medicinal product classified as prescription only. According to Article 3 (1) of the directive, a medicinal product should be subject to medical prescription where:
AS PART OF ITS OBJECTIVE to create a free movement of goods, the European Community developed an ambitious working program for the pharmaceutical sector. Most of the scheduled legislative acts were adopted in 1992. Directive 92/26EEC concerning the 1. It is likely to present a danger either directly or indirectly, even when used corClassification of Medicinal Products for hurectly, if utilized without medical superviman use is of major importance (1). This sion, directive sets out detailed criteria for prescription medicines and aims to establish 2. It is frequently and to a very wide extent used incorrectly, and as a result is likely common requirements among Member States. to present a direct or indirect danger to It has certainly affected the regulatory clihuman health, mate in a favorable way. The distinct separation between prescription only and nonpre- 3. It contains substances or preparations whose activity or side effects need further scription medicines has finally made it clear investigation, that the European approach is that the “normal” classification is “nonprescription.” In 4. It is normally prescribed by a doctor to be administered parenterally. other words, only if certain criteria are ful-
It is important to note that the directive does not say anything specific about selfReprint address: Dr. Hubertus Cranz. Director General, medication. Article 4, however, states that all Association of the European Self-Medication Industry, 7, Avenue de Tervuren, B-1040, Brussels, Belgium. other
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