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| home > epc > spring 2003 > data exclusivity under review - striking the balance between originator and generic medicines |
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European Pharmaceutical Contractor
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On 18th July 2001, the European Commission presented details of its proposal for a comprehensive reform of EC pharmaceutical legislation (1). This reform will affect the mutual recognition, or decentralised, procedure as well as the centralised procedure laid down in Regulation (EC) No. 2309/93, and will apply to both medicinal products for human use and veterinary medicinal products (2). The main objectives of the proposal are:
To ensure a high level of public health protection for the European citizen, in particular by allowing rapid access to innovative and safe products and by tight market surveillance, based on reinforced procedures of control and pharmacovigilance
To further complete the internal market in pharmaceuticals and to establish a regulatory framework favourable to the competitiveness of European pharmaceutical industry, while taking into account the stakes of globalisation
To meet the challenges of an enlargement of the European Union
To rationalise and simplify, as far as possible, the current system and to improve its global coherence, its visibility and the transparency of its procedures
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