European Pharmacopoeia

[1] It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines.

It is used as an official reference to serve public health,[1] and is part of the regulatory requirements for obtaining a Marketing Authorisation (MA) for a medicinal (human or veterinary) product.

All manufacturers of medicines or substances for pharmaceutical use therefore must apply the European Pharmacopoeia quality standards in order to be able to market and use these products in Europe.

This Commission meets in Strasbourg, France, three times a year, to adopt texts proposed by its groups of experts, and to decide on its programme of work and general policies.

Items are added to the work programme in response to requests received by the European Directorate for the Quality of Medicines & HealthCare from the member states and their national authorities, industry or experts from around the world, based on current scientific and health issues.

texts contain detailed analytical methods to identify the substance or product and control its quality and quantitative strength.

texts also address the issue of impurities in medicinal products, which do not offer any therapeutic benefit for the patient and sometimes are potentially toxic.

A new edition of the European Pharmacopoeia is published every three years: in both English and French,[7] by the Council of Europe.

Each of these issues will contain the new and revised texts adopted at one of the three European Pharmacopoeia Commission (EPC) sessions held annually.

What will not change is the implementation schedule, which remains January, April and July, respectively, of the year following publication of a text [1]"