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2006•Journal of Commercial BiotechnologyRequires access

Legal and regulatory update

John E. Wilkinson

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Abstract

EC Directive 2001/83/EC (the 'Medicines Directive'), which governs the manufacture, marketing and distribution of medicinal products for human use, is being amended by Directive 2004/27/EC. For ease of reference, a consolidated version of the amended Medicines Directive has been published by the European Commission and is available at the EUDRA website. The deadline for each member state to implement the amendments into national law was 30th October, 2005.

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What this paper is about

EC Directive 2001/83/EC (the 'Medicines Directive'), which governs the manufacture, marketing and distribution of medicinal products for human use, is being amended by Directive 2004/27/EC. For ease of reference, a consolidated version of the amended Medicines Directive has been published by the European Commission and is available at the EUDRA website. The deadline for each member state to implement the amendments into national law was 30th October, 2005.

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Available abstract

EC Directive 2001/83/EC (the 'Medicines Directive'), which governs the manufacture, marketing and distribution of medicinal products for human use, is being amended by Directive 2004/27/EC. For ease of reference, a consolidated version of the amended Medicines Directive has been published by the European Commission and is available at the EUDRA website. The deadline for each member state to implement the amendments into national law was 30th October, 2005.

Key concepts: Directive, Directive on Privacy and Electronic Communications, Member state, European commission, Business, Commission, Investor relations, Member states

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