Medicinal Products under REACHMarc Bauer and Sebastian Lach report that new EU legislation on chemicals registration will have a major impact on the pharmaceutical industry.

摘要

Compliance with new European Union legislation regulating chemicals and their safe use has become a major issue for companies operating in sectors affected by the law. This is now even more true as Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals1 - better known as REACH - entered into force on 1 June 2007. The most significant material provisions of this regulation entered into force more recently, on 1 June 2008.REACH replaces about 40 European and national regulations to harmonise and improve the former legislative framework on substances in the EU. It aims mainly to protect human health and the environment from the risks that can be posed by substances. To this end, it places greater responsibility on the industry to manage risks for human health and the environment.The legislation in the first instance may aim to regulate substances manufactured, imported or used by the chemicals industry, but products in almost all industry sectors are affected by the regulation. This article shows to what extent the pharmaceutical industry is affected by REACH and what requirements have to be fulfilled by pharmaceutical companies.