Several legal texts make the European Pharmacopoeia mandatory in Europe.[1] The Convention on the Elaboration of a European Pharmacopoeia (CETS 50)[3] which was adopted by the Council of Europe in 1964, laid the groundwork for the development of the European Pharmacopoeia. In 1994, a Protocol (ETS No. 134)[1][4] was adopted, amending the Convention to prepare for the accession of the European Union (EU), and defining the respective powers of the European Union and its Member States within the European Pharmacopoeia Commission.