The Ph.Eur. (European Pharmacopoeia is the scientific and legal benchmark for pharmacopoeial standards contributing to the delivery of high-quality medicine in Europe and beyond. It delivers essential information to thirty-eight European countries and is used worldwide in over one hundred countries. Ph.Eur. is a single reference work that provides a scientific and legal basis for the quality control of medicines in stages of development, production and marketing in the signatory states of the Convention.
The Pharmacopoeia is concerned with the quantitative and qualitative composition of tests carried out on raw materials used to produce medicines and their intermediates of synthesis. All organizations involved in the production of pharmaceutical medicines in the signatory states of the Convention are required to comply with these standards before they are allowed to market their medicinal products.
The purpose of the Ph.Eur. is to provide commonly recognized standards of quality for medicines in order to foster public health. These standards are to be used as an appropriate basis for safety in medicinal use. In addition, the Ph.Eur. facilitates the free movement of pharmaceutical products throughout Europe and beyond.
Texts and monographs are appropriate for use by:
– Regulatory Authorities
– Manufacturers of products for medicinal use, and their components.
– Organisations engaged in Quality Control of medicines and constituents thereof.
Globalisation and expansion in international trade present a growing need for collaboration with Pharmacopoeia users to develop quality standards for medicines worldwide. In this respect, therefore, the Ph.Eur. works closely with all Pharmacopoeia users all over the world and you will found best pharmacopoeial service anywhere in the whole world.
Contracting parties to the Convention undertake to:
– Progressively expound the Pharmacopoeia to become common to all countries concerned and entitled “European Pharmacopoeia”.
– Implement necessary measures to ensure the monographs become official standards in the countries concerned by implementation in national legislation, or indirectly through national translation.