Council of the European Union and European Parliament 6 November 2001, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use

Also known as

Directive 2001/83/EC establishes a comprehensive Community code for medicinal products for human use to safeguard public health while facilitating the internal market through the approximation of national laws. The Directive mandates a marketing authorization for placing products on the market and prescribes uniform standards for manufacture, labeling, wholesale distribution, and pharmacovigilance. It further provides for mutual recognition procedures between Member States and establishes a Committee for Proprietary Medicinal Products to ensure consistent scientific evaluation across the Community.AI