Working document QAS/11.453/Rev.12 February 2020 Original: English
INDEX OF WORLD PHARMACOPOEIAS and PHARMACOPOEIAL AUTHORITIES
The Index of World Pharmacopoeias and Pharmacopoeial Authorities has been circulated to national and regional pharmacopoeia secretariats and to pharmacopoeial authorities for their feedback and the data received from them have been used to update the list. Links to online pharmacopoeias have been provided where available. Where no specific links to online pharmacopoeias are available, links to organizations of national or regional pharmacopoeia commissions are listed.
The list is provided for reference purposes only and does not pretend to be complete.
In order to bring this list up–to-date, we would appreciate any additional data you may have. Please address your observations to Dr Sabine Kopp, Team Lead, Norms and Standards for Pharmaceuticals, Technology Standards and Specifications, World Health Organization, CH-1211 Geneva 27, Switzerland, email: [email protected], with a copy to [email protected]
______Index of pharmacopoeias © World Health Organization 2020 All rights reserved. Working document QAS/11.453/Rev.12 page 2
Table of contents
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I. NATIONAL Argentina …………………………………………………………………………………………………………………… 4 Austria* …………………………………………………………………………………………………………………… 5 Belarus** …………………………………………………………………………………………………………………… 6 Belgium* …………………………………………………………………………………………………………………… 6 Bosnia and Herzegovina* …………………………………………………………………………………………………………………… 7 Brazil …………………………………………………………………………………………………………………… 7 Bulgaria* …………………………………………………………………………………………………………………… 9 Chile …………………………………………………………………………………………………………………… 9 China …………………………………………………………………………………………………………………… 10 Croatia* …………………………………………………………………………………………………………………… 11 Cyrus* …………………………………………………………………………………………………………………… 12 Czechia* …………………………………………………………………………………………………………………… 13 Denmark* …………………………………………………………………………………………………………………… 14 Egypt …………………………………………………………………………………………………………………… 15 Estonia* …………………………………………………………………………………………………………………… 16 Finland* …………………………………………………………………………………………………………………… 16 France* …………………………………………………………………………………………………………………… 16 Germany* …………………………………………………………………………………………………………………… 17 Greece* …………………………………………………………………………………………………………………… 19 Hungary* …………………………………………………………………………………………………………………… 20 Iceland* …………………………………………………………………………………………………………………… 20 India …………………………………………………………………………………………………………………… 20 Indonesia …………………………………………………………………………………………………………………… 21 Iran (Islamic Republic of) …………………………………………………………………………………………………………………… 22 Ireland* …………………………………………………………………………………………………………………… 23 Italy* …………………………………………………………………………………………………………………… 23 Japan …………………………………………………………………………………………………………………… 24 Kazakhstan** …………………………………………………………………………………………………………………… 25 Korea (Republic of) …………………………………………………………………………………………………………………… 25 Lativa* …………………………………………………………………………………………………………………… 27 Lithuania* …………………………………………………………………………………………………………………… 27 Working document QAS/11.453/Rev.12 page 3
Luxembourg* …………………………………………………………………………………………………………………… 28 Malta* …………………………………………………………………………………………………………………… 28 Mexico …………………………………………………………………………………………………………………… 28 Montenegro* …………………………………………………………………………………………………………………… 30 Netherlands* …………………………………………………………………………………………………………………… 30 Norway* …………………………………………………………………………………………………………………… 31 Pakistan …………………………………………………………………………………………………………………… 31 Philippines …………………………………………………………………………………………………………………… 32 Poland* …………………………………………………………………………………………………………………… 32 Portugal* …………………………………………………………………………………………………………………… 34 Romania* …………………………………………………………………………………………………………………… 34 Russian Federation** …………………………………………………………………………………………………………………… 35 Serbia* …………………………………………………………………………………………………………………… 36 Slovakia* …………………………………………………………………………………………………………………… 37 Slovenia …………………………………………………………………………………………………………………… 37 Spain* …………………………………………………………………………………………………………………… 39 Sweden* …………………………………………………………………………………………………………………… 39 Switzerland* …………………………………………………………………………………………………………………… 40 Thailand …………………………………………………………………………………………………………………… 40 The Former Yugoslav Republic of Macedonia* .……………………………………………………………………………………………………… 41 Turkey* …………………………………………………………………………………………………………………… 41 Ukraine* …………………………………………………………………………………………………………………… 42 United Kingdom of Great Britain and Northern Ireland* ...…………………………………………………………………………………………… 43 United States of America …………………………………………………………………………………………………………………… 44 Viet Nam …………………………………………………………………………………………………………………… 45
II. REGIONAL AND SUBREGIONAL Eurasia …………………………………………………………………………………………………………………… 47 European Pharmacopoeia …………………………………………………………………………………………………………………… 48 Africa …………………………………………………………………………………………………………………… 49
III. INTERNATIONAL WHO, Geneva, Switzerland …………………………………………………………………………………………………………………… 50
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I. NATIONAL
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Farmacopea Argentina 1. & 2. Farmacopea Argentina 8th Edition* (vol.1,2,3,4) 2011 Spanish Administración Nacional de Medicamentos 7th Edition, vol.1 2002 Alimentos y Tecnología Médica (ANMAT) 6th Edition 1978 Avenida de Mayo 869 (C1084AAD) 5th Edition 1966 Ciudad Autónoma de Buenos Aires 4th Edition 1956 3rd Edition 1943 Emails: 2nd Edition 1921 [email protected] 1st Edition 1898? [email protected] [email protected] * the content that is on [email protected] public consultation since 2011
3. Website: http://www.anmat.gov.ar ARGENTINA (Spanish)
3. Farmacopea Argentina
7th Edition (Volume 1)
Website: http://www.anmat.gov.ar/fna/septima_edicion.htm (Spanish)
(Only one volume is approved and published (vol. 1). The online access address of the 7th edition is just the index of the approved vol. 1 and the content intended to be included in vol. 2 and vol. 3 that were not published.)
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8th Edition (Volumes 1, 2, 3, 4)
Website: http://www.anmat.gov.ar/webanmat/fna/ octava_edicion.asp (Spanish)
(The content has been available for public consultation since 2011.)
Österreichisches 1. Österreichische Arzneibuchkommission Official Edition 2011 Russian Arzneibuch (ÖAB) Bundesministerium für Gesundheit Radetzkystr.2 (Austrian Pharmacopoeia) A -1031 Wien
Email: [email protected]
3. Website: https://www.basg.gv.at/en/lab/austrian- pharmacopoeia/ (English, German) AUSTRIA*
2. Verlag Österreich GmbH Bäckerstr. 1 A – 1010 Wien
3. Wesbite: http://www.verlagoesterreich.at/cdrom--- 22406.html
4. Yearly
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1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Государственной 1. Laboratory of Pharmacopoeial and Pharmaceutical 1st Edition, vol. 1 2006 Russian фармакопеи Республики Analysis vol. 2 2008 Беларусь Centre for Examinations and Tests in Health Service vol. 3 2009 Ministry of Health of the Republic of Belarus (State Pharmacopoeia of 4/1 Dunina-Martsinkevicha Str. the Republic of Belarus) Minsk 220092
Email: [email protected] BELARUS**
3. Website: https://www.rceth.by/en/Departments/Lffa (Russian, English)
2. Ministry of Health of the Republic of Belarus 4/1 Dunina-Martsinkevicha Str. Minsk 220092
1. Belgian Pharmacopoeia Commission Federal Agency for Medicines and Health Products – FAMHP Eurostation II Place Victor Horta, 40/40 B-1060 Bruxelles
BELGIUM* Emails: [email protected] [email protected]
3. Website: http://www.fagg-afmps.be (Dutch, English, French)
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The Control Laboratory of the Agency for Medicinal Products and Medical Devices Marsala Tita 9 BOSNIA AND 71 000 Sarajevo HERZEGOVINA* Email: [email protected]
3. Website: http://www.almbih.gov.ba (Bosnian/Croatian, Serbian, English)
Farmacopeia Brasileira - 1. & 2. Brazilian Pharmacopoeia Coordination 6th Edition 2019 Portuguese FB Brazilian Health Surveillance Agency – ANVISA 5th Edition (5.0) 2010 English (Brazilian Agência Nacional de Vigilância Sanitária – ANVISA Supplement 5.1 2016 Spanish Pharmacopoeia) SIA, Trecho 5, Area Especial 57 Supplement 5.2 2017 Brasília - DF 4th Edition 1988 CEP: 71.205-050 Part 1 1996 Part 2, Vol. 1 2000 Emails: Vol. 2 2002 BRAZIL [email protected] Vol. 3 2003 [email protected] Vol. 4 2004 Vol. 5 2005 Vol. 6 1976 3rd Edition 1957 2nd Edition 1929 1st Edition
3. Website: http://portal.anvisa.gov.br/farmacopeia- brasileira (Portuguese, English) Farmacopeia 1,2. see above 3rd Edition 2011 Portuguese Homeopática Brasileira 2nd Edition 1997 English Working document QAS/11.453/Rev.12 page 8
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(Brazilian Homeopathic 1st Edition 1976 Spanish Pharmacopoeia) 3. Websites: http://portal.anvisa.gov.br/farmacopeia- homeopatica (Portuguese, English, Spanish) Formulário Nacional da 1,2. see above. 2nd Edition 2012 Portuguese Farmacopeia Brasileira 1st Edition 2005 English (Brazilian National Spanish Formulary) 3. Websites: http://portal.anvisa.gov.br/formulario-nacional (Portuguese, English, Spanish ) Formulário de 1,2. see above 1st Edition 2011 Portuguese Fitoterápicos da 1st Supplement 2018 Spanish Farmacopeia Brasileira (Herbal Medicines National Formulary) 3. Websites: http://portal.anvisa.gov.br/formulario- fitoterapico (Portuguese, Spanish) Formulário Homeopático 1,2. see above. 2nd Edition 2019 Portuguese da Farmacopeia Brasileira 1st Edition 2016 (Homeopathic National Formulary ) 3. Website: http://portal.anvisa.gov.br/ farmacopeia/formulario-homeopatico
Memento Fitoterápico da 1,2. see above. 1st Edition 2016 Portuguese Farmacopeia Brasileira (Herbal Medicines Memento) 3. Memento Fitoterápico da Farmacopeia Brasileira (Herbal Medicines Memento) Working document QAS/11.453/Rev.12 page 9
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Website: http://portal.anvisa.gov.br/documents/33832/2909630/Mem ento+Fitoterapico/a80ec477-bb36-4ae0-b1d2- e2461217e06b (Portuguese)
1. Bulgarian Drug Agency 8 Damyan Gruev Str. BG-Sofia 1303
Emails: [email protected] [email protected]
BULGARIA* 3. Websites: https://www.bda.bg/en/information-for-companies/123- pharmacopoeia (English) https://www.bda.bg/bg/информация-за-фирмите/75- pharmacopoeia-bg (Bulgarian)
Farmacopoea Chilena 1. Farmacopoea Chilena – Universidad de Valparaíso 3rd Edition 1941 Spanish De, Sta Marta 183 2nd Edition 1905 Spanish Valparaíso Reprint of 1st Edition 1886 Spanish 1st Edition 1882 Spanish CHILE Email: [email protected]
3. Website: http://farmacopea.cl/ (Spanish)
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1. Chinese Pharmacopoeia Commission National Medical Products Administration (NMPA) Building 11, Fahua Nan Li Dongcheng District 100061 Beijing
Emails: [email protected] [email protected] [email protected] [email protected] [email protected]
3. Websites:
http://www.chp.org.cn CHINA (Chinese)
http://wp.chp.org.cn/front/chpint/en/ (English)
https://www.emergobyul.com/resources/china/china-food- drug-administration (English)
Pharmacopoeia of the 2. China Medico-Pharmaceutical Science & Technology 10th Edition 2015 Chinese, English People's Republic of Publishing House 9th Edition 2010 Chinese, English China A-22 Northern WenHuiYuan Road 8th Edition 2005 Chinese, English Haidian District 7th Edition 2000 Chinese, English Beijing 100082 6th Edition 1995 Chinese, English 5th Edition 1990 Chinese, English 4th Edition 1985 Chinese, English 3rd Edition 1977 Chinese Working document QAS/11.453/Rev.12 page 11
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2nd Edition 1963 Chinese 1st Edition 1953 Chinese 3. Website: http://www.cmstp.com
4. Once every five years.
Hrvatska Farmakopeja 1. & 2 (b) Halmed Edition 2.0 2013 Croatian Pharm. HRF Agency for Medicinal Products and Medical Devices of Edition 3.0 2014 Croatia Supplement 3.1 2014 (Croatian Pharmacopoeia Ksaverska cesta 4 Supplement 3.2 2014 Commission) 10 000 Zagreb Supplement 3.3 2014 Supplement 3.4 2015 Emails: Supplement 3.5 2015 [email protected] Supplement 3.6 2015 [email protected] Supplement 3.7 2015 [email protected] Supplement 3.8 2016 Edition 4.0 2017
Supplement 4.1 2017 Supplement 4.2 2017 CROATIA* Supplement 4.3 2017 Supplement 4.4 2017 Supplement 4.5 2018 Supplement 4.6 2018 Supplement 4.7 2019 Supplement 4.8 2019 Edition 5.0 2019 Supplement 2020
Website: http://www.halmed.hr/Lijekovi/Farmakopeja/ Hrvatska-farmakopeja/ (Croatian, English) Working document QAS/11.453/Rev.12 page 12
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2 (a) Croatian Pharmaceutical Society Hrvatska farmakopeja 2007 Croatian (Hrvatsko Farmaceutsko Društvo) 2007 Masarykova 2 10 000 Zagreb
Email: [email protected]
3. Website: http://www.farmaceut.org (Croatian, English)
3 (a) Hrvatska Farmakopeja Hrvatska farmakopeja Croatian 2007 Website: http://narodne-novine.nn.hr/clanci/sluzbeni/ 2007_03_33_1095.html
3 (b) Hrvatska Farmakopeja
Website: http://www.halmed.hr/Lijekovi/Farmakopeja/ Hrvatska-farmakopeja/ (Croatian)
4. New edition every three years; three supplements yearly (from 2014).
1. Dr Loizos Panayi Pharmaceutical Services Ministry of Health CYPRUS* 1475 Nicosia
Email: [email protected]
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3. Website: http://ww.moh.gov.cy/phs/
Český lékopis 1. Czech Pharmacopoeia Commission Edition MMXVII 2017 Czech State Institute for Drug Control (Vol. 1,2,3,4) (Pharmacopoea Šrobárova 48 + Supplement MMXVIII 2018 bohemica) 100 41 Praha 10 + Supplement MMXIX 2019
Edition MMIX (Vol. 2009 Email: 1,2,3) 2010 [email protected] + Supplement MMX 2011
+ Supplement MMXI 2012
+ Supplement MMXII 2013
+ Supplement MMXIII 2014 2a. Grada Publishing, Prague + Supplement MMXIV 2015 + Supplement MMXV 2016 + Supplement MMXVI 2005
Edition MMV (Vol. CZECHIA* 2006 1,2,3)
+ Supplement MMVI 2007 (Vol. 1,2) + Supplement MMVII 2002 (Vol. 1,2)
Edition MMII (Vol. 2003 1,2,3,5) 2004 + Supplement MMIII + Supplement MMIV 1997 (Vol. 1,2)
Edition MCMXCVII
(Vol. 1,2,3) 1999 + Supplement XCIX
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(Vol. 1,2) 2000 + Supplement MM 2001 + Supplement MMI
Československý lékopis 2b. Avicenum, Prague Czech and Slovak 4th Edition 1987
1989 4th edition is the (Pharmacopoea + Reprint of 4th Edition 1991 last authentic and bohemoslovaca) + Supplement 1991 teamwork 1970 3rd Edition (Vol. 1, 2) pharmacopoeia for 1976 + Supplement the Czech Republic 1954 2nd Edition and Slovakia 1959 + Supplement 1947 1st Edition 1952 + Supplement
3. Website: http://www.sukl.eu (Czech, English)
4. Yearly
European Pharmacopoeia 1. The Danish Pharmacopoeia Commission Join with Ph.Eur. 1978 Danish Medicines Agency Pharmacopoea Nordica, 1965 Danish Pharmacopoea Nordica, Axel Heides Gade 1 Danish Edition DK-2300 København S Addendum Danish Edition DENMARK* Emails: Pharmacopoea Nordica, 1963 Danish [email protected] Danish Edition [email protected] Joint Pharmacopoeia of the Nordic countries Pharmacopoea Danica Working document QAS/11.453/Rev.12 page 15
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9th 1948 Danish 8th 1933 Danish 7th 1907 Danish 6th 1893 Danish Additamenta ad 1886 Danish Pharmacopoeam Danicam 1868 5th 1868 Latin 4th 1850 Latin 3rd 1840 Latin 2nd 1805 Latin 1st 1772 Latin 3. Website: http://laegemiddelstyrelsen.dk/en/ (Danish, English)
Egyptian Pharmacopoeia 1. Permanent Commission of the Egyptian Pharmacopoeia 4th Edition 2005 Arabic, English Egyptian Drug Authority 3rd Edition 1984 Ministry of Health 2nd Edition 1972 21 Abd El-Aziz Al Soud Street 1st Edition 1953 El-Manial Cairo
EGYPT Email: [email protected]
3. Website: http://www.eda.mohp.gov.eg (Arabic, English)
2. General Organization for Government Printing Office Cairo
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1. State Agency of Medicines Nooruse 1 50411 Tartu
ESTONIA* Email: [email protected]
3. Website: https://www.ravimiamet.ee/en
1. FIMEA Pharmacopoeia Committee Finnish Medicines Agency PO Box 55 FI-00034 Helsinki
FINLAND* Emails: [email protected] [email protected]
3. Website: http://www.fimea.fi (Finnish, Swedish, English)
1. French NPA ANSM/Agence Nationale de Sécurité du Médicament et des Produits de Santé Direction des Politiques d’Autorisation et d’Innovation (DPAI), Pôle Pilotage Sécurisation des Métiers, des FRANCE* processus et Pharmacopée (SM3P)
F-
Email: [email protected] Working document QAS/11.453/Rev.12 page 17
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3. Website: http://www.ansm.sante.fr (French)
Pharmacopée française 2. Pharmacopée Française 11 e édition, free online 11th Edition (free online) 2012 French (regularly http://ansm.sante.fr/Mediatheque/Publications/Ph updated) armacopee-francaise-Plan-Preambule -index 2010 (Some updated texts are in English) 3. (ANSM website)
http://ansm.sante.fr/Mediatheque/Publications/Pharmacopee- francaise-Plan-Preambule-index; http://ansm.sante.fr/Activites/ Pharmacopee/Qu-est-ce-que-la-Pharmacopee/(offset)/0
4. Updated yearly. Since 1998, the French Pharmacopoeia consists of three folders, regularly updated.
1. Deutsche Arzneibuch-Kommission, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (Federal Institute for Drugs and Medical Devices) Kurt-Georg-Kiesinger Allee 3 GERMANY* D-53175 Bonn
Emails: [email protected] [email protected]
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3. Website: http://www.bfarm.de (English, German)
Deutsches Arzneibuch 2. Deutscher Apotheker Verlag, Stuttgart DAB 2015 2015 German (DAB) Medpharm GmbH Scientific Publishers DAB 1999-2014 1999-2014 Birkenwaldstraβe 44 10th Edition 1991 D-70191 Stuttgart 9th Edition 1986 8th Edition 1978 7th Edition 1964 1968 6th Edition 1926 5th Edition 1910 4th Edition 1900 3rd Edition 1890 2nd Edition 1883 1st Edition 1872 4. Updated yearly.
In accordance with Section 55 of the Pharmaceuticals Act (Arzneimittelgesetz - AMG), the Pharmacopoeia and the date of entry into force of the revised version.
Deutsches 4. Deutsches Homöopathisches Arzneibuch HAB 2000-2014 2000-2014 German Homoeopathisches Bundesinstitut für Arzneimittel und Medizinprodukte HAB 2015 2015 Arzneibuch Kurt-Georg-Kiesinger-Allee 3 (HAB) D-53175 Bonn
Email: [email protected]
3. Website:http://www.bfarm.de (English, German)
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4. Updated yearly.
2. Deutscher Apotheker Verlag, Stuttgart Govi-Verlag- Pharmazeutischer Verlag GmbH Eschborn
Greek Pharmacopoeia Greek Pharmacopoeia Commission 5th Edition, vols 1, 2 1998 Greek Pharmacopoeia Section Supplement 1 2000 National Organisation for Medicines Supplement 2 2002 Mesogeion Avenue 284 Supplement 3 2006 GR-15562 Holargos Attikis Supplement 4 2009
GREECE* Emails: [email protected] [email protected]
3. Website: http://www.eof.gr (English, Greek)
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Magyar gyógyszerkönyv 1. Hungarian Pharmacopoeia Commission 8th Edition 2006 Hungarian National Institute of Pharmacy and Nutrition (OGYEI) 7th Edition 1987 (Pharmacopoea Zrínyi utca 3 6th Edition 1967 Hungarica) PO Box 450, H-1372.Budapest 5th Edition 1958 H-1051 Budapest 4th Edition 1933 3rd Edition 1909 Email: [email protected] 2nd Edition 1888 HUNGARY* 1st Edition 1871 3. Website: http://www.ogyei.gov.hu/ (Hungarian, English)
2. Medicina konyvkiado, Budapest
3. Website: http://www.medicina-kiado.hu
Head of the Licensing Unit Icelandic Medicines Agency (IMA) Vinlandsleiõ 14 113 Reykjavík
ICELAND* Email: [email protected]
3. Website: www.lyfjastofnun.is (Icelandic, English)
Indian Pharmacopoeia 1.& 2. Office of the Secretary-cum-Scientific Director 8th Edition 2018 English Indian Pharmacopoeia Commission Addendum 2019 INDIA Ministry of Health and Family Welfare 7th Edition 2014 Government of India Addendum 2015 Working document QAS/11.453/Rev.12 page 21
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Sector-23, Raj Nagar Addendum 2016 Ghaziabad 201 002 6th Edition 2010 Addendum 2012 Emails: 5th Edition 2007 [email protected] Addendum 2008 [email protected] 4th Edition 1996 [email protected] (cc.) Addendum 2000 Veterinary Supplement 2000 Addendum 2002 Addendum 2005 3rd Edition 1985 Addendum 1989 Addendum 1991 2nd Edition 1966 Supplement 1975 1st Edition 1955 Supplement 1960
3. Website: www.ipc.gov.in
4. New edition every four years and two addenda in between.
Farmakope Indonesia 1. Indonesian Pharmacopoeia Commission 5th Edition 2014 Indonesian Director of Drug, Narcotic, Psychotropic, Precursor, 1st Supplement 2015 Addictive Substance Standardization 2nd Supplement 2017 National Agency of Drug and Food Control (Badan POM) 3rd Supplement 2018 INDONESIA Republic of Indonesia Jl, Percetakan Negara 23 4th Edition 1995 Jakarta Pusat 10560 1st Supplement 2009 2nd Supplement 2010 Working document QAS/11.453/Rev.12 page 22
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Emails: 3rd Supplement 2011 [email protected] [email protected] 3rd Edition 1979
2nd Edition 1974 Extra for 2nd Edition 1972
1st Edition 1962
2. Kementerian Kesehatan, Republik Indonesia (Ministry of Health, Republic of Indonesia) Jl H.R.Rasuna Said Blok X.5 Kav. 4-9 Jakarta Selatan 12950
3. Website: http://www.pom.go.id (Indonesian)
4. New editions are published every five years and two supplements are published between the regular publications.
Iranian Pharmacopoeia Iranian Pharmacopoeia 1st Edition 2013 Iranian Drug Administration of Iran, Division of Pharmaceuticals & Narcotic Affairs Ministry of Health and Medical Education IRAN (ISLAMIC PO Box 310 REPUBLIC OF) 14th floor, MOHME building Simaye Iran Street Phase 5, Shahrake Qods Teheran 11344
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Email: [email protected] 3. Website: http://www.mohme.gov.ir (Farsi)
Health Products Regulatory Authority (HPRA) Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 IRELAND* Email: [email protected]
3. Website: http://www.hpra.ie (English)
Farmacopea Ufficiale 1. Segreteria Tecnica della Farmacopea Ufficiale Italiana 12th Edition 2008 Italian della Repubblica Italiana Istituto Superiore di Sanità 11th Edition 2002 Viale Regina Elena 299 Supplement (2005) I-00161 - Roma
Email: [email protected]
3. Website: http://www.iss.it ITALY* (English, Italian)
2. Ministerio della Salute,Commissione permanente per la revisione e pubblicazione della Farmacopea Ufficiale Istituto Poligrafico e Zecca dello Stato P.V. I-1213045 Roma
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The Japanese 1.&2. Committee on the Japanese JP 17th 2016 Japanese, English Pharmacopoeia (JP) Pharmacopoeia/Pharmaceutical Affairs Food Sanitation 17 Supplement 1 2017 Japanese, English Council 17 Supplement 2 2019 Japanese, English Pharmaceutical Safety and Environmental Health Bureau JP 16th 2011 Japanese, English Ministry of Health, Labour and Welfare 16 Supplement 1 2012 Japanese, English 1-2-2 Kasumigaseki 16 Supplement 2 2014 Japanese, English Chiyoda-ku JP 15th 2006 Japanese, English Tokyo 100-8916 15 Supplement 1 2007 Japanese, English 15 Supplement 2 2009 Japanese, English JP 14th 2001 Japanese, English 14 Supplement 1 2002 Japanese, English 1. Expert Committee on the Japanese Pharmacopoeia 14 Supplement 2 2004 Japanese, English Pharmaceuticals and Medical Devices Agency JP 13th 1996 Japanese, English Shin-kasumigaseki Building 13 Supplement 1 1997 Japanese, English 3-3-2 Kasumigaseki 13 Supplement 2 1999 Japanese, English Chiyoda-ku JP 12th 1991 Japanese, English JAPAN Tokyo 100-0013 12 Supplement 1 1993 Japanese, English 12 Supplement 2 1994 Japanese, English Emails: JP 11th 1986 Japanese, English [email protected] 11 Supplement 1988 Japanese, English [email protected] JP 10th 1981 Japanese, English [email protected] JP 9th 1976 Japanese, English JP 8th 1971 Japanese, English JP 7th 1961 Japanese, English JP 6th 1951 Japanese JP 5th 1932 Japanese, English JP 4th 1920 Japanese, English JP 3rd 1906 Japanese JP 2nd 1891 Japanese, Latin JP 1st 1886
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1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
3. Websites: http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/000006659 7.html (English) http://www.pmda.go.jp/english/rs-sb-std/standards- development/jp/0009.html (English)
4. New editions are published every five years and two supplements are published between the regular publication of JP editions. Moreover, partial revisions are made as necessary.
The State Pharmacopoeia 1. & 2. Republican State Enterprise on the Right of 2nd Edition 2015 Kazakh of the Republic of Economic Management Vol. 1 Russian Kazakhstan (SPRK) “National Center for Expertise of Medicines and Medical 1st Edition 2014 Kazakh Devices” of the Committee for Quality Control and Vol. 3 Russian Safety of Goods and Services of the Ministry of Health of 1st Edition 2008 Kazakh the Republic of Kazakhstan Vols. 1, 2 Russian KAZAKHSTAN** Emails: [email protected] [email protected]
3. Website: http://www.dari.kz (Russian, English)
4. Once every 5 years. Online access in near future.
KOREA 1. Ministry of Food and Drug Safety 12th Edition 2019 Korean (REPUBLIC OF) Osong Health Technology Administration Complex 11th Edition 2012 Korean, English Working document QAS/11.453/Rev.12 page 26
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
187 Osongseangmyeong 2-ro 10th Edition 2007 Korean, English Osong-eup 9th Edition 2009 Heungdeok-gu Supplement 1 2010 Cheonju-si Supplement 2 2010 28159 Chuncheongbuk-do Supplement 3 2010 Supplement 4 2010 Emails: Supplement 5 2011 [email protected] Supplement 6 2011 [email protected] Supplement 7 2012 Supplement 8 2002 8th Edition 2006 Supplement 1 1997 7th Edition 2000 Supplement 1 1992 6th Edition 1993 Supplement 1 1987 5th Edition 1988 Supplement 1 1982 4th Edition 1982 Supplement 1 1976 3rd Edition 1978 Supplement 1 1979 Supplement 2 1967 2nd Edition 1968 Part I 1968 Part II 1969 Supplement 1 1958 Supplement 2 1st Edition 3. Website: http://www.mfds.go.kr (Korean, English)
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1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
The Korean 2. Central Pharmaceutical Affairs Council Pharmacopoeia 5-mosaemi-gil Yangchun-gu Seoul
3. Korea Food and Drug Administration The Korean Pharmacopoeia
Website: http://eng.mfds.go.kr (English)
4. Currently revised every five year term.
Riga Stradins University Dzirciema iela 16 Kurzemes rajons LATVIA* LV 1007 Riga
Email: [email protected]
Lithuanian 1. Lithuania has published only one National 1st Edition 1938 Lithuanian Pharmacopoeia Pharmacopoeia “Lietuvos Farmakopėja” in 1938. Now we use directly the European Pharmacopoeia. (Lietuvos Farmakopėja) Pharmacopoeia Commission LITHUANIA* 2. State Medicines Control Agency Ministry of Health of the Republic of Lithuania Zirmunu str. 139A LT-09120 Vilnius Working document QAS/11.453/Rev.12 page 28
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Emails: [email protected] [email protected]
3. Website: https://www.vvkt.lt (Lithuanian, English)
Ministère de la Santé Division de la Pharmacie et des Médicaments Allée Marconi Villa Louvigny L 2120 LUXEMBOURG*
Emails: [email protected] [email protected]
Malta Medicines Authority Sir Temi Zammit Buildings MALTA* Malta Life Sciences Park San Gwann SGN 3000
Email: [email protected]
Farmacopea de los Estados 1. Comisión Permanente de la Farmacopea de 12th Edition 2018 Spanish Unidos Mexicanos los Estados Unidos Mexicanos Supplement 2019 Rio Rhin 57 11th Edition 2014 Col Cuauhtémoc Supplement 2015 Working document QAS/11.453/Rev.12 page 29
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Alcaldía Cuauhtémoc Supplement 2016 06500, Ciudad de México 10th Edition 2011 México Supplement 2012 MEXICO Supplement 2013 Emails: 9th Edition 2008 [email protected] Supplement 1 2009 [email protected] Supplement 2 2010 8th Edition 2004 2. Secretaría de Salud, Supplement 1 2006 Lieja 7 Col. Juárez 7th Edition 2000 C.P. 06696 Supplement 1 2001 Ciudad de México Supplement 2 2002 6th Edition 1994 Supplement 1 1995 Supplement 2 1998 5th Edition 1988 Supplement 1 1990 Supplement 2 1992 4th Edition 1974 3rd Edition 1962 2nd Edition 1952 1st Edition 1930 (began new edition)
5th Edition 1925 4th Edition 1904 3rd Edition 1896 2nd Edition 1884 1st Edition 1846
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1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
3. Website: http://www.farmacopea.org.mx (Spanish, English)
Mexican Herbal 2nd Edition 2013 Spanish Pharmacopoeia 1st Edition 2001
Mexican Homeopathic 3rd Edition 2015 Spanish Pharmacopoeia 2nd Edition 2007 1st Edition 1998
Medical devices 1st Edition 2005 Spanish Supplement 2nd Edition 2011 3rd Edition 2015 Pharmacies Supplement 4th Edition 2017
1st Edition 1996 2nd Edition 2000 3rd Edition 2005 4th Edition 2010 5th Edition 2015 6th Edition 2019
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1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
The Republic of Montenegro Ministry of Health Rimski trg 46, PC Vektra 81000 Podgorica
Emails: MONTENEGRO* [email protected] [email protected]
Website: http://www.mzdravlja.gov.me (Croatian, English, Serbian)
Secretariat of the Dutch Pharmacopoeia Authority Laboratory for Quality Control of Medicines National Institute for Public Health and the Environment (RIVM) NETHERLANDS* P.O. Box 1 NL 3720 BA Bilthoven
Email: [email protected]
1. Norwegian Pharmacopoeia Authority Statens legemiddelverk/Norwegian Medicines Agency P.O. Box 240 Skøyen NO – 0213 Oslo NORWAY* Norway* (Visiting address is Grensesvingen 26, NO – 0663 Oslo)
Email: [email protected] Working document QAS/11.453/Rev.12 page 32
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
3. Website: http://www.legemiddelverket.no (Norwegian, English)
Pakistan Pharmacopoeia Pakistan Pharmacopoeia Commission 1974 English Ministry of Health (Note: The Ministry of Health was devolved to the provinces under the 18th Amendment by the Federal Government on June 30th 2011)
Drug Regulatory Authorization of Pakistan TF Complax G9/4 Islamabad
PAKISTAN Emails: [email protected] [email protected] 3. Website: http://www.dra.gov.pk/ (English)
Government of Pakistan
3. Web site: http://www.pakistan.gov.pk (English)
Philippine Pharmacopeia Products Services Division 1st Edition 2004 English Bureau of Food and Drugs Department of Health PHILIPPINES Republic of the Philippines San Lazaro Compound Sta. Cruz Working document QAS/11.453/Rev.12 page 33
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
1003 Manila
Email: call [email protected]
3. Website: https://www.doh.gov.ph/ (English)
Farmakopea Polska 1. Pharmacopoeia Commission 11th Edition (and 2017-2019 Polish Pharmacopoeia Department supplements) (current) The Office for Registration of Medicinal Products 10th Edition (and Medical Devices and Biocidal Products supplements) Al. Jerozolimskie 181C 9th Edition (and PL-02-222 Warsaw supplements 8th Edition (and 2014-2016 Email: [email protected] supplements) 7th Edition (and 2013- supplements) 2011 6th Edition 2012- 5th Edition 2008-2011 POLAND* Supplement 2006 4th Edition Volume 1 2002 Volume 2 1990 3rd Edition 1995 Supplement 1 Supplement 2 1965 Supplement 3 1970 2nd Edition 1954 1st Edition 1956 1959 1962 Working document QAS/11.453/Rev.12 page 34
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
1946 1817 3. Website: http://www.urpl.gov.pl (Polish, English)
2. The Office for Registration of Medicinal Products Medical Devices and Biocidal Products Al. Jerozolimskie 181C PL-02-222 Warsaw
3. Website: http://www.urpl.gov.pl (Polish, English)
4. Updated yearly
Farmacopeia Portuguesa Secrétariat de la Pharmacopée Portugaise 9th Edition, 2008 Portuguese Faculdade de Farmácia da Universidade (FFUP) Vol. 1,Vol. 2,Vol. 3 2008 R. Jorge de Viterbo Ferreira 228 Supplement 9.1 2008 4050-313 Porto Supplement 9.2 2009 Supplement 9.3 2009 Email: [email protected] Supplement 9.4 2009 Supplement 9.5 2010 Supplement 9.6 2010 PORTUGAL* Supplement 9.7 2010 Supplement 9.8 2005 8th Edition, Vol. 1,Vol. 2 2002 7th Edition, Vol. 1,Vol. 2 1997 6th Edition 2000 Supplement
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1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
3. Website: http://www.infarmed.pt (Portuguese, English)
Pharmacopea Română 1. Romanian Pharmacopoeia Commission a X-a 1993 Romanian Ministry of Health 9th Edition, 1st Supplement 1981 Romanian National Agency for Medicines and Medical Devices 9th Edition 1976 Romanian Str. Aviator Sanatescu48 8th Edition, 3rd 1972 Romanian Sector 1 Supplement 8th Edition, 1970 Romanian RO-011478 Bucharest 2nd Supplement 1968 Romanian ROMANIA* 8th Edition, 1st Supplement 1965 Romanian Email: [email protected] 8th Edition 1956 Romanian 7th Edition 1948 Romanian 6th Edition 1943 Romanian 5th Edition 1926 Romanian 4th Edition 1915 Romanian Special Edition 1893 Romanian 3rd Edition 1874 Romanian 2nd Edition 1862 Romanian/Latin 1st Edition 3. Website: http://www.anm.ro (Romanian, English)
2. Editura Medicala Bucuresti
Государственная 1. State Pharmacopoeia Council of the Ministry of Health of 14th edition 2018 Russian Фармакопея Российской the Russian Federation 13th edition 2015 RUSSIAN Федерации 3 Rakhmanovsky pereulok 12th edition, part 1 2007 FEDERATION** 127944 Moscow 11th edition, vol. 2 1989 11th edition, vol. 1 1987 Working document QAS/11.453/Rev.12 page 36
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
(State Pharmacopoeia of Emails: 10th Edition 1968 the Russian Federation, [email protected] 9th Edition 1961 former title: State [email protected] 8th Edition 1946 Pharmacopoeia of the 7th Edition 1925 Union of Soviet Socialist 6th Edition 1910 Republics) 5th Edition 4th Edition 1902 3rd edition 1891 2nd edition 1880 1st edition 1871 1866 Translation of the previous
editions into Russian
2nd edition 1st edition 1802 Military Pharmacopoeia 1798 Latin 1778
1765 2. Ministry of Health of the Russian Federation 3 Rakhmanovsky pereulok 127944 Moscow
3. Website: http://femb.ru/femb/pharmacopea.php
4. Updated at least once in 5 years.
Working document QAS/11.453/Rev.12 page 37
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
1. Medicines and Medical Devices Agency of Serbia 458 Vojvode Stepe Str. 11221 Belgrade
SERBIA* Email: [email protected]
3. Website: http://www.alims.gov.rs/ (Serbian, English)
Codex Pharmaceuticus 1. Slovak Pharmacopoeia CommissionŠtátny ústav pre 1st Edition 2007 Slovak Slovacus MMVII/ kontrolu liečiv Ist Edition 1997 Slovenský liekopisná Slovenská liekopisná komisia komisia State Institute for Drug Control Kvetná 11 SK-825 08 Bratislava
Emails: [email protected] [email protected] SLOVAKIA* 3. Website: http://www.sukl.sk (Slovak, English)
Slovenský farmaceutický 2. Ministry of Health of the Slovak Republic kódex V OBZOR s r.o. Bratislava 3. Codex Pharmaceuticus Slovacus MMVII
Website: http://sukl.sk/buxus/docs//Posudzovanie_kvality_ liekov/kodex2007.pdf
Working document QAS/11.453/Rev.12 page 38
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
1. National Pharmacopoeia Authority Agency for Medicnal Products and Medical Devices of the Republic of Slovenia Slovenčeva ulica 22 SI-1000 Ljubljana Slovenija
Website: https://www.jazmp.si/
Emails: [email protected] [email protected]
2. Agency for Medicnal Products and Medical Devices of the Republic of Slovenia Slovenčeva ulica 22
SLOVENIA* SI-1000 Ljubljana Slovenija
Formularium 3. Website: https://www.formularium.si/ 1st Edition 1998 Slovene Slovenicum Suppl. 1.1 1999 Suppl. 1.2 2000 Suppl. 1.3 2001 Suppl. 1.4 2002 Suppl. 1.5 2003 Suppl. 1.6 2004 2nd Edition 2005 Suppl. 2.1 2006 Suppl. 2.2 2007 Suppl. 2.3 2008 Suppl. 2.4 2009 Suppl. 2.5 2010 3rd Edition 2011 Working document QAS/11.453/Rev.12 page 39
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Suppl. 3.1 2012 Suppl. 3.2 2013 Suppl. 3.3 2014 Suppl. 3.3.1 2017 4th Edition 2018 Suppl. 4.1 2019 5th Edition 2020 4. Annual publication
Real Farmacopea 1. Real Farmacopea Española Real Farmacopea Española Española Agencia Española de Medicamentos y Productos Sanitarios 5th Edition (online only) 2015 Spanish (AEMPS) 4th Edition 2011 Spanish División de Química y Tecnología Farmaceútica 3rd Edition 2005 Calle Campezo 1 2nd Edition 2002 Eificio 8 Supplement 2.1 2002 E-28022 Madrid Supplement 2.2 2003 1st Edition 1996 Email: [email protected] Supplement 1.1 1997 Supplement 1.2 1978 Supplement 1.3 2000 SPAIN* Supplement 1.4 2001 3. Website: http://www.aemps.gob.es (Spanish, English) 2. Publicación:
Agencia Estatal Boletín Oficial del Estado Avda. Manoteras 54 E – 28050 Madrid
Email: [email protected]
3. Website: http://www.boe.es/ Working document QAS/11.453/Rev.12 page 40
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3. Real Farmacopea Española
Website: http://extranet.boe.es/index.php?referer=/ farmacopea/index.php
Swedish Pharmacopoeia Commission Swedish Medical Products Agency Box 26 SE-751 03 Uppsala
SWEDEN* Email: [email protected] OR firstname.surname
3. Website: http://www.lakemedelsverket.se (Swedish, English)
Pharmacopoea Helvetica 1. Swiss Pharmacopoeia Commission 11th Edition 2012 French Swissmedic Supplement 11.1 2013 German Swiss Agency for Therapeutic Products Supplement 11.2 2015 Italian Pharmacopoeia Division Supplement 11.3 2019 Hallerstrasse 7 CH-3012 Bern
SWITZERLAND* Email: [email protected]
2. Federal Office for Buildings and Logistics Fellerstrasse 21, CH-3003 Bern Website: www.bundespublikationen.admin.ch
3. Online access: http://phhelv.ch/ Working document QAS/11.453/Rev.12 page 41
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
(French, German, Italian)
4. Updated as necessary.
Thai Pharmacopoeia 1. & 2. Thai Pharmacopoeia Committee 1st Edition Bureau of Drug and Narcotic Department of Medical Vol. I Part 1 1987 English Sciences Vol. I Part 2 1993 Ministry of Public Health Vol. II Part 1 1997 Nonthaburi 11000 Vol. II Part 2 2000 Vol. II Part 3 2003 Email: [email protected] Supplement 2005 Supplement 2010
3. Website: http://www.dmsc.moph.go.th/webroot/ drug/eng/ responsiblility.stm (English, Thai) THAILAND 2. Thai Pharmacopoeia and Reference Substance Section Bureau of Drugs and Narcotics Department of Medical Sciences Ministry of Public Health Tiwanond Road Nonthaburi 11000
Thai 1. & 2. as above. Vol. 1 1995 English Herbal Pharmacopoeia Vol. 2 2000 Supplement 2004 Vol. 3 2009
Working document QAS/11.453/Rev.12 page 42
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Macedonian Agency for Medicines and Medical Devices THE FORMER 54 Cyril and Methodius Street, First floor YUGOSLAV MK-1000 Skopje REPUBLIC OF MACEDONIA* Email: [email protected]
1. Pharmacopoeia Division T.C. Ministry of Health Turkish Medicines and Medical Devices Agency Department of Analysis and Control Laboratories of Vice Presidency of Economic Assessments and Laboratory Services Sağlık Mahallesi A. Adnan Saygun 2 Cad No: 55 TR-06100 Sıhhıye Çankaya TURKEY* Ankara
Emails: [email protected] [email protected]
3. Website: http://www.titck.gov.tr/ (Turkish, English)
The State Pharmacopoeia 1. The Ukrainian Scientific Pharmacopoeial Center for Supplement 3 (2.3) 2018 Ukrainian of Ukraine Quality of Medicines Supplement 2 (2.2) 2018 Ukrainian 33 Astronomicheskaya Str. Supplement 1 (2.1) 2016 Ukrainian UKRAINE* (ДЕРЖАВНА Kharkov 61085 2nd Edition (2.0) Vols 1,2,3 2015 Ukrainian ФАРМАКОПЕЯ Supplement 4 (1.4) 2011 Ukrainian, Russian УКРАЇНИ) State Service of Ukraine on Medicines and Drugs Control Supplement 3 (1.3) 2009 Ukrainian, Russian Ministry of Health of Ukraine Supplement 2 (1.2) 2008 Ukrainian, Russian Working document QAS/11.453/Rev.12 page 43
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Supplement 1 (1.1) 2004 Ukrainian, Russian Emails: 1st Edition (1.0) 2001 Ukrainian, Russian [email protected] [email protected] [email protected]
2. The Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines
3. Website: http://www.sphu.org Online version is not available. 1. The Ukrainian Scientific Pharmacopoeial Center for Supplement 3 (2.3) 2018 Ukrainian Quality of Medicines Supplement 2 (2.2) 2018 Ukrainian 33 Astronomicheskaya Str. Supplement 1 (2.1) 2016 Ukrainian Kharkov 61085 2nd Edition (2.0) Vols 1,2,3 2015 Ukrainian Supplement 4 (1.4) 2011 Ukrainian, Russian State Service of Ukraine on Medicines and Drugs Control Supplement 3 (1.3) 2009 Ukrainian, Russian Ministry of Health of Ukraine Supplement 2 (1.2) 2008 Ukrainian, Russian Supplement 1 (1.1) 2004 Ukrainian, Russian Emails: 1st Edition (1.0) 2001 Ukrainian, Russian [email protected] [email protected] [email protected]
British Pharmacopoeia 1. British Pharmacopoeia Commission BP 2019 English UNITED Medicines and Healthcare Products Regulatory Agency BP 2018 KINGDOM OF (MHRA) BP 2017 GREAT BRITAIN 10 South Colonnade BP 2016 AND NORTHERN Canary Wharf BP 2015 IRELAND* London E14 4PU BP 2014 BP 2013 Working document QAS/11.453/Rev.12 page 44
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Emails: BP 2012 [email protected] BP 2011 [email protected] BP 1914 [email protected] 1st Edition (through the 1864 [email protected] merger of the London, [email protected] Edinburgh and Dublin Pharmacopoeias)
3. Websites: http://www.pharmacopoeia.com; http://www.gov.uk/mhra (English)
2. The Stationery Office
3. British Pharmacopoeia
Website: http://www.pharmacopoeia.com
4. Yearly
The United States 1. & 2. The United States Pharmacopeia USP 42, NF 37 2018 English, Spanish Pharmacopeia and 12601 Twinbrook Parkway Supplement 1 2019 National Formulary Rockville Supplement 2 2019 MD 20852 -1790 USP 41, NF 36 2017 English, Spanish UNITED STATES (USP-NF) Supplement 1 2018 OF AMERICA Email: [email protected] Supplement 2 2018 USP 40, NF 35 2016 English, Spanish Supplement 1 2017 Supplement 2 2017 Working document QAS/11.453/Rev.12 page 45
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
USP 39, NF 34 2015 English, Spanish Supplement 1 2016 Supplement 2 2016 USP 38, NF 33 2014 English, Spanish Supplement 1 2015 Supplement 2 2015 USP 37, NF 32 2013 English, Spanish Supplement 1 2014 Supplement 2 2014 USP 36, NF 31 2012 English, Spanish Supplement 1 2013 Supplement 2 2013 USP 35, NF 30 2011 English, Spanish Supplement 1 2012 Supplement 2 2012 USP 34, NF 29 2010 Supplement 1 2011 Supplement 2 2011 3. Website: http://www.usp.org (English, Spanish)
3. USP-NF Five-year Revisions: 1942-2020
Website: https://online.uspnf.com/ USP 1st Revision 1830 USP 0 1820
4. Yearly.
Since 2002,USP-NF published annually Working document QAS/11.453/Rev.12 page 46
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
1980, USP XX and the NF XV published under same cover; National Formulary purchased from the American Pharmacists Association; became repository for excipients (not a therapeutic formulary) 1942-2000, published every 5 years 1830-1942, revisions at 10-year intervals
Vietnamese 1. & 2. Vietnamese Pharmacopoeia Commission 5th Edition 2017 Vietnamese/English Pharmacopoeia Vietnamese Pharmacopoeia and Formulary Center 4th Edition 2009 Vietnamese Ministry of Health Supplement 2015 English (Pharmacopoeia 48 Hai Ba Trung Street 2010 Vietnamese Vietnamica) Hoan Kiem District 3rd Edition 2002 English Ha Noi 2005 Supplement 2006 Vietnamese Email: [email protected] 2nd Edition Vol. 1 1990 Vol. 2 1991 VIET NAM Vol. 3 1994 1st Edition Vol. 1 1970 Supplement 1977 Vol. 2 1983
3. Website: http://www.moh.gov.vn (English, Vietnamese)
Working document QAS/11.453/Rev.12 page 47
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
4. New edition every 5 to 7 years, supplements in between. Monographs are periodically revised.
______
* National Pharmacopoeia Authorities party to the European Pharmacopoeia Convention. ** Participating countries in the Pharmacopoeia of the Eurasian Economic Union (EAEU) are: Armenia, Belarus, Kazakhstan, Kyrgyzstan and the Russian Federation. Working document QAS/11.453/Rev.12 page 48
II. REGIONAL AND SUBREGIONAL
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Pharmacopoeia of the 1. Pharmacopoeial Committee of the Eurasian Economic 1st Edition 2019 Russian (official) Eurasian Economic Union Union (EAEU) (EAEU) Eurasian Economic Commission Smolensky Boulevard 3/5, Bld 1 Moscow 119121
Email: [email protected]
2. Eurasian Economic Commission
EURASIA** 3. Websites:
http://www.eurasiancommission.org/ru/act/texnreg/deptexre g/LS1/Pages/pharmacopoeia.aspx
http://dosc.eaeunion.org/ru
4. Every three years.
Participating countries in the Pharmacopoeia of the EAEU are: Armenia, Belarus, Kazakhstan, Kyrgyzstan and the Russian Federation.
The draft Pharmacopoeia of the EAEU is prepared by the Pharmacopoeial Committee of the EAEU.
The Pharmacopoeial Committee of the EAEU consists of representatives of Armenia, Belarus, Kazakhstan, Kyrgyzstan and the Russian Federation (7 persons per each member state of EAEU).
Working document QAS/11.453/Rev.12 page 49
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION European Pharmacopoeia 1. & 2. European Directorate for the Quality of 10th Edition (10.0) 2019 English, French Medicines & HealthCare 9th Edition (9.0) 2016 English, French Council of Europe 8th Edition 2014 English, French, 7 allée Kastner 7th Edition 2011 Spanish CS 30026 6th Edition 2008 F-67081 Strasbourg 5th Edition 2005 Emails: 4th Edition 2002 [email protected] 3rd Edition 1997 2nd Edition 1980 EUROPEAN 1st Edition 1967 PHARMACOPIEA MEMBERS 3. Website: http://www.edqm.eu (English, French)
3. European Pharmacopoeia Website: http://online.edqm.eu/entry.htm
4. New Edition every three years. Supplements three times yearly (March, June, November).
Pharmeuropa Online: http://pharmeuropa.edqm.eu\home
39 Member States and the European Union are signatory to the Convention on the Elaboration of a European Pharmacopoeia. European Pharmacopoeia Members: Albania, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Republic of Moldova, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, the former Yugoslav Republic of Macedonia, Turkey, Ukraine, United Kingdom of Great Britain and Northern Ireland, and the European Union.
Working document QAS/11.453/Rev.12 page 50
European Pharmacopoeia Observers: Algeria, Argentina, Armenia, Australia, Azerbaijan, Belarus, Brazil, Canada, China, Georgia, Guinea, India, Israel, Japan, Kazakhstan, Republic of Korea, Madagascar, Malaysia, Morocco, Russian Federation, Senegal, Singapore, South Africa, Syrian Arab Republic, Tunisia, United States of America, Uzbekistan, Taiwan Food and Drug Administration (TFDA) and World Health Organization (WHO).
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
African Pharmacopoeia 1 & 2. African Union Vol. 1 1985 English Scientific Technical Research Commission (STRC) Vol. 2 1986 English Plot 114 Yakubu Gowan Crescent Asokoro PMB 5368 Wuse Zone 2 Abuja Nigeria
Email: [email protected]
3. Website: http://www.austrc.org AFRICA (English)
African Herbal 1 & 2. Association for African Medicinal Plants Standards 1st Edition 2010 English Pharmacopoeia (AfrHP) C/O Executive Services Ltd. 2nd Les Jamalacs Building Vieux Conseil Street Port Louis Mauritius
Email: [email protected]
3. Website: http://www.aamps.org (English, French)
Working document QAS/11.453/Rev.12 page 51
III. INTERNATIONAL
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
The International 1. WHO Expert Committee on Specifications for 9th Edition 2019 English Pharmacopoeia Pharmaceutical Preparations 8th Edition 2018 English 7th Edition 2017 English Emails: 6th Edition 2016 English [email protected] 5th Edition 2015 English
2. WHO Press 4th Edition, Vols 1, 2 2006 World Health Organization 1st Supplement 2008 CH-1211 Geneva 27 2nd Supplement 2011 3rd Supplement 2013 Fax: (41-22) 791 48 57 4th Supplement 2014
Email: [email protected] WHO GENEVA, 3rd Edition, Vol. 1 1979 English SWITZERLAND 1980 French 1980 Spanish 1981 Russian Arabic
Vol. 2 1981 English 1981 French 1983 Spanish 1983 Russian Arabic
Vol. 3 1988 English 1988 French 1989 Spanish 1990 Russian Working document QAS/11.453/Rev.12 page 52
1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION
Arabic Vol. 4 1994 English 1994 French 1996 Spanish 1995 Russian Arabic Vol. 5 2003 English Arabic
2nd Edition 1963 English Reagents 1966 French 1967 English quality control (QC) 1967 French 1971 English supplement for QC 1971 French
1st Edition 1951 English 1955 French 1959 Spanish German Japanese 3. Website: https://www.who.int/medicines/publications/ pharmacopoeia/en/ (English)
3. The International Pharmacopoeia
Website: http://apps.who.int/phint/en/p/about/
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