Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Sunset Clause- Implementation within the EU and its influence on regulatory strategies ***

Ines Becker-Schnoor (Abschlußjahr: 2008)

Language: English

The sunset clause provision was introduced into the European medicines legislation in Directive 2001/83/EC, as amended in November 2004.
Under Article 24 (4-6) of the Directive, any marketing authorisation which, within three years of being granted, is not followed by the placing on the market of the medicinal product will cease to be valid. If a product is placed on the market after initial granting of its marketing authorisation, but subsequently ceases to be on the market for a period of three consecutive years, it will also cease to be valid. Similar provisions in Regulation 726/2004 of the European Parliament and the Commission, apply to medicinal products authorised under the Centralised Procedure.
The three year period of the sunset clause starts to run from the granting of the marketing authorisation or from the day the product is taken off the market.

This thesis illustrates the implementation status of the sunset clause in the European Member States, and provides an outline of national provisions and interpretations of the law within said Member States.
On a general basis, the Member States of the European Union are in agreement on the main lines of the sunset clause provision. Nevertheless, there are some different approaches in defining the marketing status of a product and in specifying reasons that may lead to exemptions from the provision.
Almost every member state has a different implementation date for the revised legislation. Thus, the start of the three year period of the sunset clause is not consistent among the countries.
The new provision will have a high impact on regulatory strategies for new submissions and for already authorised medicinal products. Although a great amount of marketing authorisations will become invalid due to the sunset clause in the future there are several strategic alternatives to avoid the cessation of validity and to circumvent the provision.

Pages: 48