According to the Treaty establishing the European Communities, the EU Member States have an obligation to implement Directives adopted by the EU Legislature into their national legal systems. In so doing, the Member States have to remain loyal to the spirit of the Treaty. Hence, the mere adoption of legal provisions or creation of administrative procedures is not sufficient. The national policy and legal regime have to conform to the European rules in practice.

The most recent changes made under EU Law that are applicable to homeopathic and anthroposophic medicinal products are laid down in Directive 2004/27/EC, which revises Directive 2001/83/EC. The changes have been published by the European Commission in a consolidated version of Directive 2001/83/EC.

Within a period of 18 months the Member States had to bring their national pharmaceutical legislation in line with the renewed Community legislation. This meant that the Implementation had to be completed by the end of October 2005. However, the process is not yet complete in a number of Member States. To learn more about the national rules in a specific Member State, simply click on the country of your choice. The rules reflect the provisions of Directive 2001/83/EC applicable to homeopathically produced medicinal products. In addition, an ECHAMP overview of how Member States have implemented Article 16 of Directive 2001/83/EC can be found here. A short table overview can be found here.