Background:
In July 2001, the Commission adopted a proposal for a comprehensive reform of the EU pharmaceutical legislation. The Commission proposal for reform particularly concerns Regulation 2309/93 that provides the legislative framework regulating medicinal products, Directive 2001/83 (on human medicines), and Directive 2001/82 (on veterinary medicines).
On 2 October 2002, the Parliament's Environment Committee amended the Commission proposal on two main issues: information to patients and authorisation of generics (see also
EurActiv, 4 October)
The primary objective of the Pharma review is to achieve a high level of health protection in Europe while at the same time boost the competitiveness and innovative capability of the European pharmaceutical industry.