Medicinal products

Impact assessment – EU legislation on medicines for rare diseases and paediatric medicines

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  2. English

Based on the outcome of the evaluation of the medicines for rare diseases and children legislation, the Commission will examine the impacts of future policy options to update the legal framework on medicines for rare diseases and paediatric medicines. The first step is an inception impact assessment (roadmap).

The revision of the two legislations is also one of the actions of the EU Pharmaceutical Strategy.