Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 is the main piece of pharmaceutical regulation of the European Union.
It relates to medicinal products for human use in mainly countries that are part of the European Union. [1]
The Directive deals with the disparities between certain national provisions, in particular between provisions relating to medicinal products, which directly affect the functioning of the internal market of the European Union, and regulated the activities of the European Medicines Agency.