Background to the EU Pharma package The reform of the EU pharmaceutical legislation, also known as the ‘EU pharma package’, is the most significant overhaul of the pharmaceutical regulatory framework in more than two decades. It forms part of the implementation of the Commission’s Pharmaceutical Strategy for Europe, adopted on 25 November 2020. The reform is intended to revise and replace the core EU legislation governing medicinal products for human use, including: • Directive 2001/83/EC, the Pharmaceutical Code, as amended, which establishes the regulatory framework for the authorisation, manufacture, classification, labelling, distribution, sale and advertising of medicinal products for human use • Regulation (EC) 726/2004, the EMA Regulation, which establishes the European Medicines Agency (EMA) and lays down the centralised procedure for the authorisation and supervision of medicinal products The package also incorporates and revises the regimes for orphan medicinal product (OMP) and paediatric medicinal products, currently set out in: • Regulation (EC) 141/2000, the Orphan Medicines Regulation, which lays down the criteria for designating certain medicinal products as orphan drugs to prevent,