RAJ Reviews Changes to Directive 2001/83/EC

27 Nov 2003

The revision of the European Union's pharmaceutical legislation is progressing quickly. As reported on page 762, the Council of Ministers was expected to take a Common Position on the three texts that make up the legislation on 29 September 2003. These texts are Regulation 2309/93 , governing the operations of the European Medicines Evaluation Agency (EMEA), Directive 2001/83/EC on human medicines and Directive 2001/82/EC on veterinary medicines. The following briefing paper summarises proposed changes to the human directive1.

Risk-benefit balance . Article 1 on definitions contains new language on risk/benefit balance. This is described as an evaluation of...

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