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The European Pharmacopoeia (Ph. Eur.) of the Council of Europe
Council of Europe

The Council of Europe is the oldest international organisation working towards European integration, having been founded in 1949. It has a particular emphasis on legal standards, human rights, democracy development, the rule of law and cultural co-operation....
 is a pharmacopoeia
Pharmacopoeia

Pharmacopoeia , in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society....
, listing a wide range of active substances and excipients used to prepare pharmaceutical products in Europe
Europe

Europe is, conventionally, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally divided from Asia to its east by the water divide of the Ural Mountains, the Ural , the Caspian Sea, and by the Caucasus Mountains to the southeast....
. The 2005 edition includes 1800 specific and general monograph
Monograph

A monograph is a work of writing upon a single subject, usually also by a single author. It is often a scholarly essay or learned treatise, and may be released in the manner of a book, journal article, editorial or written rant....
s, including various chemical substances, antibiotics, biological substances; Vaccines for human or veterinary use; Immunosera; Radiopharmaceutical preparations; Herbal drugs; Homoeopathic preparations and homoeopathic stocks.






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The European Pharmacopoeia (Ph. Eur.) of the Council of Europe
Council of Europe

The Council of Europe is the oldest international organisation working towards European integration, having been founded in 1949. It has a particular emphasis on legal standards, human rights, democracy development, the rule of law and cultural co-operation....
 is a pharmacopoeia
Pharmacopoeia

Pharmacopoeia , in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society....
, listing a wide range of active substances and excipients used to prepare pharmaceutical products in Europe
Europe

Europe is, conventionally, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally divided from Asia to its east by the water divide of the Ural Mountains, the Ural , the Caspian Sea, and by the Caucasus Mountains to the southeast....
. The 2005 edition includes 1800 specific and general monograph
Monograph

A monograph is a work of writing upon a single subject, usually also by a single author. It is often a scholarly essay or learned treatise, and may be released in the manner of a book, journal article, editorial or written rant....
s, including various chemical substances, antibiotics, biological substances; Vaccines for human or veterinary use; Immunosera; Radiopharmaceutical preparations; Herbal drugs; Homoeopathic preparations and homoeopathic stocks. It also contains Dosage forms, General monographs, Materials and Containers, Sutures; 268 General methods with figures or chromatograms and 2210 reagents are described. The monographs give quality standards for all the main medicines used in Europe. All medicines sold in the 36 Member States of the European Pharmacopoeia must comply with these quality standards so that consumers have a guarantee for products obtained from pharmacies and other legal suppliers.

The European Pharmacopoeia is developed by the European Directorate for the Quality of Medicines
European Directorate for the Quality of Medicines

The European Directorate for the Quality of Medicines of the Council of Europe came into being in its current form in 1996. It consists of the Technical Secretariat of the European Pharmacopoeia Commission long referred to as the European Pharmacopoeia set up in 1964 by the European Pharmacopoeia Convention, and other, more recent serv...
 (EDQM) and is a part of the Council of Europe
Council of Europe

The Council of Europe is the oldest international organisation working towards European integration, having been founded in 1949. It has a particular emphasis on legal standards, human rights, democracy development, the rule of law and cultural co-operation....
, Strasbourg
Strasbourg

Strasbourg is the capital and principal city of the Alsace Regions of France in northeastern France. With 702,412 inhabitants in 2007, its metropolitan area is the Aire urbaine....
, France. It has been created by the Convention on the elaboration of a European Pharmacopoeia from 1964. . Although the Pharmacopoeia is often listed as one of Council of Europe partial agreements, it is not, strictly speaking, a partial agreement. It has a different legal basis from the others, being established as the result of a treaty. The others were established by a "statutory resolution" adopted by the Committee of Ministers. It is published by EDQM in English and French, official national translations are available in German and Spanish (Spanish version only online).

Participating countries


Currently there are 37 members of the European Pharmacopoeia Commission: Austria
Austria

Austria , officially the Republic of Austria , is a landlocked country in Central Europe. It borders both Germany and the Czech Republic to the north, Slovakia and Hungary to the east, Slovenia and Italy to the south, and Switzerland and Liechtenstein to the west....
, Belgium
Belgium

* A small German-speaking Community of Belgium exists in eastern Wallonia. Belgium's linguistic diversity and related political and cultural conflicts are reflected in the history of Belgium and a complex Communities and regions of Belgium....
, Bosnia and Herzegovina
Bosnia and Herzegovina

Bosnia and Herzegovina is a country on the Balkans peninsula of South Eastern Europe with an area of 51,129 square kilometres . Bordered by Croatia to the north, west and south, Serbia to the east, and Montenegro to the south, Bosnia and Herzegovina is Landlocked#Nearly landlocked, except for 26 kilometres of the Adriatic Sea coas...
, Bulgaria
Bulgaria

The state of Bulgaria , Scientific transliteration Balgarija, officially the Republic of Bulgaria has played a significant role in the Balkans in south-eastern Europe for over fourteen centuries....
, Croatia
Croatia

Croatia , officially the Republic of Croatia , is a Central European country at the crossroads of Pannonian Plain, Balkans, and the Mediterranean Sea....
, Cyprus
Cyprus

Cyprus , officially the Republic of Cyprus , is an island country situated in the eastern Mediterranean Sea, east of Greece, west of Lebanon, Syria, and Israel, south of Turkey and north of Egypt....
, Czech Republic
Czech Republic

The Czech Republic , is a landlocked country in Central Europe. The country borders Poland to the northeast, Germany to the west, Austria to the south and Slovakia to the east....
, Denmark
Denmark

Denmark is a Scandinavian country in northern Europe and the senior member of the Kingdom of Denmark. It is the southernmost of the Nordic countries....
, Estonia
Estonia

Estonia , officially the Republic of Estonia is a country in the Baltic region of Northern Europe. It is bordered to the north by Finland across the Gulf of Finland, to the west by Sweden across the Baltic Sea, to the south by Latvia , and to the east by the Russia ....
, Finland
Finland

Finland , officially the Republic of Finland , is a Nordic countries situated in the Fennoscandian region of northern Europe. It borders Sweden on the west, Russia on the east, and Norway on the north, while Estonia lies to its south across the Gulf of Finland....
, France
France

France , officially the French Republic , is a country whose Metropolitan France is located in Western Europe and that also comprises various Overseas departments and territories of France....
, Germany
Germany

Germany , officially the Federal Republic of Germany , is a country in Central Europe. It is bordered to the north by the North Sea, Denmark, and the Baltic Sea; to the east by Poland and the Czech Republic; to the south by Austria and Switzerland; and to the west by France, Luxembourg, Belgium, and the Netherlands....
, Greece
Greece

Greece , officially the Hellenic Republic , is a country in southeastern Europe, situated on the southern end of the Balkans. It has borders with Albania, Bulgaria and the former Yugoslav Republic of Macedonia to the north, and Turkey to the east....
, Hungary
Hungary

Hungary , officially in English the Republic of Hungary , is a landlocked country in the Carpathian Basin of Central Europe, bordered by Austria, Slovakia, Ukraine, Romania, Serbia, Croatia, and Slovenia....
, Iceland
Iceland

Iceland, officially the Republic of Iceland , is an island country located in the North Atlantic Ocean between mainland Europe and Greenland....
, Ireland
Ireland

Ireland is the List of islands by area in Europe, and the twentieth-largest island in the world. It lies to the north-west of continental Europe and is surrounded by hundreds of islands and islet....
, Italy
Italy

Italy , officially the Italian Republic , is a country located on the Italian Peninsula in Southern Europe and on the two largest islands in the Mediterranean Sea, Sicily and Sardinia....
, Latvia
Latvia

Latvia The Latvians are a Baltic peoples culturally related to the Estonians and Lithuanians, with the Latvian language having many similarities with Lithuanian language, but not with the Estonian language....
, Lithuania
Lithuania

Lithuania , officially the Republic of Lithuania is a country in Northern Europe, the southernmost of the three Baltic states. Situated along the southeastern shore of the Baltic Sea, it shares borders with Latvia to the north, Belarus to the southeast, Poland, and the Russian exclave of Kaliningrad Oblast to the southwest....
, Luxembourg
Luxembourg

Luxembourg , officially the Grand Duchy of Luxembourg , is a small landlocked country in western Europe, bordered by Belgium, France, and Germany....
, Malta
Malta

Malta , officially the Republic of Malta , is a densely populated developed country European microstates microstate in the European Union....
, Montenegro
Montenegro

Montenegro , Montenegrin language/Serbian language: ???? ????, Crna Gora , ) is a country located in Balkans. It has a coast on the Adriatic Sea to the south and is bordered by Croatia to the west, Bosnia and Herzegovina to the northwest, Serbia to the north, Kosovo to the east and Albania to the south....
, Netherlands
Netherlands

The Netherlands is a country that is part of the Kingdom of the Netherlands. It is a parliamentary democratic constitutional monarchy. The Netherlands is located in North-West Europe, and bordered by the North Sea to the north and west, Belgium to the south, and Germany to the east....
, Norway
Norway

Norway , officially the Kingdom of Norway, is a constitutional monarchy in Northern Europe that occupies the western portion of the Scandinavian Peninsula....
, Poland
Poland

Poland , officially the Republic of Poland , is a country in Central Europe. Poland is bordered by Germany to the west; the Czech Republic and Slovakia to the south; Ukraine, Belarus and Lithuania to the east; and the Baltic Sea and Kaliningrad Oblast, a Russian Enclave and exclave, to the north....
, Portugal
Portugal

Portugal , officially the Portuguese Republic , is a country on the Iberian Peninsula. Located in southwestern Europe, Portugal is the westernmost country of mainland Europe and is bordered by the Atlantic Ocean to the west and south and by Spain to the north and east....
, Romania
Romania

Romania is a country located in Southeastern Europe Central Europe, North of the Balkan Peninsula, on the Lower Danube, within and outside the Carpathian Mountains, bordering on the Black Sea....
, Serbia
Serbia

Serbia , officially the Republic of Serbia , is a country in Central Europe and Balkans Europe, covering the southern part of the Pannonian Plain and the central part of the Balkans....
, Slovak Republic, Slovenia
Slovenia

Slovenia , officially the Republic of Slovenia , is a country in southern Central Europe bordering Italy to the west, the Adriatic Sea to the southwest, Croatia to the south and east, Hungary to the northeast, and Austria to the north....
, Spain
Spain

Spain or the Kingdom of Spain , is a country located in Southern Europe on the Iberian Peninsula.The Spanish constitution does not establish any official denomination of the country, even though Espa?a , Estado espa?ol and Naci?n espa?ola are used interchangeably....
, Sweden
Sweden

Sweden , officially the Kingdom of Sweden , is a Nordic countries on the Scandinavian Peninsula in Northern Europe. Sweden has land borders with Norway to the west and Finland to the northeast, and it is connected to Denmark by the ?resund Bridge in the south....
, Switzerland
Switzerland

Switzerland is a landlocked Swiss Alps country of roughly 7.7 million people in Western Europe with an area of 41,285 km?. Switzerland is a federal republic consisting of 26 states called Cantons of Switzerland....
, Republic of Macedonia
Republic of Macedonia

The Republic of Macedonia , , often referred to simply as Macedonia, is a landlocked country on the Balkans in southeastern Europe. It is bordered by Serbia to the north, Bulgaria to the east, Greece to the south and Albania to the west....
, Turkey
Turkey

Turkey , known officially as the Republic of Turkey , is a Eurasian country that stretches across the Anatolian peninsula in southwest Asia and Thrace in the Balkans region of Southern Europe....
, United Kingdom
United Kingdom

The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom , the UK or Britain,is a sovereign state located off the northwestern coast of continental Europe....
, and the European Union
European Union

The European Union is an economic and political union of 27 European Union member state, located primarily in Europe. It was established by the Treaty of Maastricht on 1 November 1993 upon the foundations of the pre-existing European Economic Community....
.
In these countries and the European Union the Ph. Eur. is the official pharmacopoeia. Additional local pharmacopoeias may exist (e. g. in United Kingdom and Germany). Not all of these countries are member states of the European Union.

Observers from 20 member and non-member states of the Council of Europe
Council of Europe

The Council of Europe is the oldest international organisation working towards European integration, having been founded in 1949. It has a particular emphasis on legal standards, human rights, democracy development, the rule of law and cultural co-operation....
 and international organisations take part on sessions of the European Pharmacopoeial Commission: Albania
Albania

Albania , officially the Republic of Albania , is a country in Balkans. It is bordered by Greece to the south-east, Montenegro to the north, Kosovo to the northeast, and the Republic of Macedonia to the east....
, Algeria
Algeria

Algeria , officially the People's Democratic Republic of Algeria, is a country located in North Africa. It is the largest country of the Mediterranean sea, second largest in the Arab World, and the second largest on the African continent and the eleventh-largest country in the world in terms of land area....
, Australia
Australia

Australia, officially the Commonwealth of Australia, is a country in the southern hemisphere comprising the Australia of the world's smallest continent, the major island of Tasmania, and numerous list of islands of Australia in the Indian Ocean and Pacific Oceans....
, Belarus
Belarus

Belarus is a landlocked country in Eastern Europe, bordered by Russia to the north and east, Ukraine to the south, Poland to the west, and Lithuania and Latvia to the north....
, Brazil
Brazil

Brazil , officially the Federative Republic of Brazil , is a country in South America. It is the List of countries and outlying territories by total area country by geographical area, occupying nearly half of South America, the List of countries by population country, and the fourth most populous democracy in the world....
, Canada
Canada

Canada is a country occupying most of northern North America, extending from the Atlantic Ocean in the east to the Pacific Ocean in the west and northward into the Arctic Ocean....
, China
China

China is a Culture of China, an ancient civilization, and, depending on perspective, a national or multinational entity extending over a large area in East Asia....
, Georgia
Georgia (country)

Georgia is a transcontinental country in the Caucasus region, located at the dividing line between Europe and Asia. It is bordered by the Russia to the north, Azerbaijan to the east, Armenia to the south, and Turkey to the southwest....
, Israel
Israel

Israel officially the State of Israel , is a country in the Middle East located on the eastern shore of the Mediterranean Sea. It borders Lebanon in the north, Syria in the northeast, Jordan in the east, and Egypt on the southwest, and contains geographically diverse features within its relatively small area....
, Madagascar
Madagascar

Madagascar, or Republic of Madagascar , is an island nation in the Indian Ocean off the southeastern coast of Africa. The main island, also called Madagascar, is the List of islands by area, and is home to 5% of the world's plant and animal species, of which more than 80% are Endemism to Madagascar....
, Malaysia
Malaysia

Malaysia is a federation that consists of States of Malaysia in Southeast Asia with a total landmass of . The capital city is Kuala Lumpur, while Putrajaya is the seat of the federal government....
, Morocco
Morocco

Morocco , officially the Kingdom of Morocco , is a country located in North Africa with a population of nearly 34 million and an area just under 447,000 km2....
, Kazakhstan
Kazakhstan

Kazakhstan, also Kazakstan , officially the Republic of Kazakhstan, is a large Eurasian country in Central Asia and Eastern Europe. Ranked as the List of countries by area as well as the world's largest landlocked country, it has a territory of 2,727,300 km? ....
, Russian Federation, Senegal
Senegal

Senegal , officially the Republic of Senegal, is a country south of the S?n?gal River in West Africa. Senegal is bounded by the Atlantic Ocean to the west, Mauritania to the north, Mali to the east, and Guinea and Guinea-Bissau to the south....
, Syria
Syria

Syria , officially the Syrian Arab Republic , is an Arab-majority country in Southwest Asia, bordering Lebanon and the Mediterranean Sea to the west, Israel to the southwest, Jordan to the south, Iraq to the east, and Turkey to the north....
, Tunisia
Tunisia

Tunisia , officially the Tunisian Republic , is a country located in North Africa. It is bordered by Algeria to the west and Libya to the southeast....
, Ukraine
Ukraine

Ukraine is a country in Eastern Europe. It is bordered by Russia to the east; Belarus to the north; Poland, Slovakia, and Hungary to the west; Romania and Moldova to the southwest; and the Black Sea and Sea of Azov to the south....
, United States of America, and the WHO
Who

*Who is an English language interrogative pronoun....
.

The convention is open for signature by all European countries. Other countries can get observer status.

Editions

Since its 5th edition, the pharmacopoeia is published in 2 volumes. Volume 1 contains general chapters and monographs (e.g. on dosage forms, methods of analysis, reagents), volume 2 contains all substance monographs. During runtime of current edition several supplements are published. Electronic versions are also available (CD-ROM and online version).

  • 1st edition: published 1967
  • 2nd edition: published 1980
  • 3rd edition: published 1997
  • 4th edition: published 2001, valid from 1 January 2002
  • 5th edition: published 15 June 2004, valid from 1 January 2005
  • 6th edition: published 16 July 2007, valid from 1 January 2008


See also

  • Pharmacopoeia
    Pharmacopoeia

    Pharmacopoeia , in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society....
  • The International Pharmacopoeia
    The International Pharmacopoeia

    The aim of The International Pharmacopoeia , which is issued by the World Health Organization as a recommendation, is to achieve a wide global uniformity of quality specifications for selected pharmaceutical products, excipients, and dosage forms....


External links