Working document QAS/11.453/Rev.10January 2018Original: EnglishINDEX OF WORLD PHARMACOPOEIAS and PHARMACOPOEIAL AUTHORITIESThe Index of World Pharmacopoeias and Pharmacopoeial Authorities has been circulated to national and regionalpharmacopoeia secretariats and to pharmacopoeial authorities for their feedback and the data received from themhave been used to update the list. Links to online pharmacopoeias have been provided where available. Where nospecific links to online pharmacopoeias are available, links to organizations of national or regional pharmacopoeiacommissions 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 yourobservations to Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms,World Health Organization, 1211 Geneva 27, Switzerland; email: [email protected] with a copy to [email protected] of pharmacopoeias World Health Organization 2018All rights reserved.

Working document QAS/11.453/Rev.10page 2Table of contentspageI. NATIONAL . 4Argentina . 4Austria* . 5Belarus** . 5Belgium* . 5Bosnia and Herzegovina* .5Brazil . 6Bulgaria* 8Chile .8China . 8Croatia* . 9Cyprus* . .9Czech Republic*. 10Denmark* . 11Egypt . 11Estonia* . 12Finland* . 32France* . 12Germany* . 13Greece* . 14Hungary* . 14Iceland* . 14India . .14Indonesia . 15Iran . 16Ireland* . 16Italy* . 16Japan . 17Kazakhstan** . 19Latvia* . 19Lithuania* . 19Luxembourg* .20

Working document QAS/11.453/Rev.10page 3Malta* . .20Mexico. 21Montenegro . 22Netherlands* .22Norway* . 22Pakistan . 23Philippines. 23Poland* . 24Portugal* . 25Romania* . 25Russian Federation** . 26Serbia* . 26Slovakia* (Slovak Republlic) . 26Slovenia* . 27Spain* . 27Sweden* . 27Switzerland* . 28Thailand . 28Turkey* . 29Ukraine* . 29United Kingdom*. 30United States of America . 30Viet Nam . 31The Former Yugoslav Republic of Macedonia* . .31II. REGIONAL AND SUBREGIONAL . .321Eurasia . .32European Pharmacopoeia Members: 33Africa . 34III. INTERNATIONAL . .35WHO, Geneva . 35

Working document QAS/11.453/Rev.10page 4I. NATIONALCOUNTRYTITLE1. PHARMACOPOEIA COMMISSIONS2. PUBLISHER/DISTRIBUTOR3. ONLINE ACCESS ADDRESS4. FREQUENCY OF PUBLICATIONEDITIONYEARLANGUAGEArgentinaFarmacopea Argentina1. & 2. Farmacopea ArgentinaAdministración Nacional de Medicamentos,Alimentos y Tecnología Médica (ANMAT)Avenida de Mayo 869 (C1084AAD) - CiudadAutónoma de Buenos Aires, ArgentinaWebsite: (Spanish)Email: [email protected] Edition* (vol.1,2,3,4)7th Edition, vol.16th Edition5th Edition4th Edition3rd Edition2nd Edition1st Edition20112002197819661956194319211898Spanish* the content that is onpublic consultation since20113. Farmacopea Argentina7th Edition (Volume1) edicion.htm(Spanish)(only one volume approved and published (vol.1). The online access address of 7th edition are justthe index of the approved vol. 1 and the contentintended to be included in the vol. 2 and vol. 3 thatwere not published.)8th Edition (Volumes 1, 2, 3, ava edicion.asp (Spanish)(the content is on public consultation since 2011)

Working document QAS/11.453/Rev.10page 5Austria*ÖsterreichischesArzneibuch (ÖAB)(AustrianPharmacopoeia)1. Österreichische ArzneibuchkommissionBundesministerium für GesundheitRadetzkystr.2, A -1031 WienWebsite: (English, German)Email: [email protected] Verlag Österreich GmbH,Bäckerstr. 1, A – 1010 html4. yearlyOfficial нойфармакопеиРеспублики Беларусь(State Pharmacopoeia ofthe Republic of Belarus)1. The Pharmacopoeial-and-Pharmaceutical AnalysisLaboratory of the Centre for Expertise and Testing inHealth Care,The Ministry of Health of the Republic ofBelarus2a Tovarishesky Lane, Minsk, 220037, BelarusWebsite: (Russian,English)Email: [email protected] Edition, vol. 1vol. 2vol. 3200620082009Russian2. Ministry of Health of the Republic of Belarus220048, Minsk, Miasnikov street, 39Belgium*1. Belgian Pharmacopoeia CommissionService public federal, Santé publiqueDirection générale Médicamentsplace Victor Horta, 40, BP 10B-1060 BruxellesWebsite: (Dutch, English,French)Email: [email protected] andHerzegovina*The Control Laboratory of the Agency for MedicinalProduct and Medical DevicesTitova 9BA 71000 Sarajevo

Working document QAS/11.453/Rev.10page 6Email: [email protected] Pharmacopoeia(Farmacopéia Brasileira)1. & 2. Pharmacopoeia Coordination, Brazilian HealthSurveillance Agency – ANVISAAgência Nacional de Vigilância Sanitária – ANVISASIA, Trecho 5, Area Especial 57Brasília - DFCity: Brasília – DF, CEP: 71.205-050, Brazil3. Website:, English)Email: [email protected] YearlyBrazilian HomeopathicPharmacopoeia(FarmacopeiaHomeopática Brasileira1,2. see above3. Brazilian Homeopathic Pharmacopoeia(Farmacopeia Homeopática 3832/259147/3a tuguese)5th Edition (5.0)Supplement 5.14th EditionPart 1Part 2, Vol. 1Vol. 2Vol. 3Vol. 4Vol. 5Vol. 63rd Edition2nd Edition1st Edition20102016Portuguese,English,Spanish3rd Edition2nd Edition1st Edition201119971976Portuguese,English,Spanish2nd 33832/259147/Farmacopeia HOMEOPATICA 3a EDICAO INGLES com lish)National 32/259147/Farmacopeia HOMEOPATICA 3a EDICAO ESPANHOL com nish)1,2. see above

Working document QAS/11.453/Rev.10page 7(Formulário Nacional)1st Edition2005English,Spanish1st Edition2011Portuguese,English,Spanish3. National Formulary(Formulário 32/259372/FNFB 2 Revisao 2 COFAR setembro 2012 2/259372/Formulario NACIONAL FARMACOPEIA INGLES com glish)Herbal MedicinesNational Formulary(Formulário documents/33832/259372/Formulario NACIONAL FARMACOPEIA ESPANHOL com nish )1,2. see above3. Herbal Medicines National Formulary(Formulário Nacional s/33832/259456/Formulario de Fitoterapicos da Farmacopeia /33832/259456/Formulario de Fitoterapicos 1a Ed. INGLES com 259456/Formul%C3%A1rio de Fitotet%C3%A1picos 1a Ed. ESPANHOL com alerta.pdf/d869a72c-21b2-42c39c64-90efb29fe064

Working document QAS/11.453/Rev.10page 8Homeopathic MedicinesNational Formulary(Formulário NacionalHomeopático)Herbal MedicinesMemento(Memento Fitoterápico)(Spanish)1,2. see above1st Edition2016Portuguese,English,Spanish1st Edition2016Portuguese3rd Edition2nd EditionReprint of 1st Edition1st h9th Edition8th Edition20102005Chinese, EnglishChinese, English3. Homeopathic Medicines National Formulary(Formulário Nacional Homeopático)1,2. see above3.Herbal Medicines Memento(Memento s/33832/2909630/Memento ortuguese)Bulgarian Pharmacopoeia CommissionBulgarian Drug AgencyDamyan Gruev Str. 8BG-Sofia 1303Email: [email protected]*ChileFarmacopora ChilenaChina1. Chinese Pharmacopoeia CommissionState Food and Drug AdministrationBuilding 11 Fahua Nan li, Chongwen District, 100061Beijing, ChinaWebsite: (Chinese)Email: [email protected] of thePeople's Republic of2. China Medico-Pharmaceutical Science &Technology Publishing House

Working document QAS/11.453/Rev.10page 9Chinahttp://www.cmstp.comA-22, Northern WenHuiYuan Road, Haidian District,Beijing 100082, P. R. China4. once every five yearsCroatia*Cyprus*7th Edition6th Edition5th Edition4th Edition3rd Edition2nd Edition1st Edition2000199519901985197719631953Chinese, EnglishChinese, EnglishChinese, EnglishChinese, EnglishChineseChineseChineseHrvatska FarmakopejaHRF (CroatianPharmacopoeia)1. & 2 (b) Pharmacopoeia CommissionAgency for Medicinal Products and Medical DevicesKsaverska cesta 4, HR-10 000 opeja/Hrvatskafarmakopeja/ (Croatian, English)Email: [email protected] 3.0Supplement 3.1Supplement 3.2Supplement 3.3Supplement 3.4Supplement 3.5Supplement 3.6Supplement 3.7Supplement 3.8Edition roatianCroatianCroatianHrvatska Farmakopeja(CroatianPharmacopoeia)2 (a) Croatian Pharmaceutical Society(Hrvatsko Farmaceutsko Društvo)Masarykova 2, 10 000 Zagreb, CroatiaWebsite: (Croatian, English)Email: [email protected] farmakopeja20072007Croatian3 (a) Hrvatska eni/2007 03 33 1095.html3 (b) Hrvatska ja/Hrvatskafarmakopeja/ (Croatian)4. new edition every three years; three supplementsyearly (from 2014)Hrvatska farmakopeja2007Dr Louis PanayiDepartment of Pharmaceutical Services, Ministry ofHealth, CY 1475 LefkosiaCroatian

Working document QAS/11.453/Rev.10page 10Email: [email protected]*Český lékopis1. Czech Pharmacopoeia CommissionState Institute for Drug ControlCZ-Šrobárova 48,100 41 Praha 10cWebsite: (Czech, English)Email: [email protected] Vydala Grada Publishing a.s. U Pruhonu 466/22,Praha 7-Holešovice, Jako svou 1739. publikaciABOVE ADDRESS AT 2. NOT IMPORTANT,PRINTER ONLYEdition (MMIX)SupplementEdition (MMV)Supplement 1Supplement 2Edition (MMII)Supplement 1Supplement 2Supplement 3Edition (MCMXCVII)Supplement 1Supplement 2Supplement 34th EditionSupplement3rd Edition, Vol. 1,Vol. 2Supplement2nd EditionSupplement1st 3)4th edition is the lastauthentic andteamworkpharmacopoeia forthe Czech Republicand Slovakia

Working document QAS/11.453/Rev.10page 11Denmark*EgyptEuropeanPharmacopoeiaPharmacopoea Nordica,Danish EditionEgyptianPharmacopoeia1. Danish Pharmacopoeia CommissionDanish Medicines AgencyAxel Heides Gade 1DK-2300 København SWebsite: (Danish, English)Email: [email protected] Permanent Commission of the EgyptianPharmacopoeia,The Egyptian Drug Authority21 Abd El-Aziz Al Soud Street, El-Manial, Cairo, EgyptWebsite: (Arabic,English)Email: [email protected] General Organization for Government PrintingOffice, CairoJoin with Ph.Eur.Pharmacopoea Nordica,Danish EditionAddendumPharmacopoea Nordica,Danish EditionJoint Pharmacopoeia ofthe Nordic countriesPharmacopoea Danica9th8th7th6thAdditamenta adPharmacopoeamDanicam 0184018051772LatinLatinLatinLatinLatin4th Edition3rd Edition2nd Edition1st Edition2005198419721953Arabic, English

Working document QAS/11.453/Rev.10page 12Estonia*State Agency of Medicines1 Nooruse StreetEE 50411 [email protected]*1. FIMEA Pharmacopoeia CommitteeFinnish Medicines AgencyPO Box 55, FI-000034 HelsinkiWebsite: (Finnish, Swedish,English)Email: [email protected]*1. Commission nationale de pharmacopéeAgence nationale de sécurité du médicament et desproduits de santé, Direction des Contrôles, PôleStandardisation, Pharmacopée, Normalisation143/147 bld Anatole FranceF- 93285 Saint Denis cedexWebsite: armacopée française2. Wolters Kluwer France1 rue Eugène et Armand Peugeot92856 Rueil-Malmaison cedex11th Edition (free online)2012French tions/Phar updated)macopee-francaise-Plan-Preambule-index10th Edition2010(Some updated textsare in English)4. updated yearly, Since 1998, the FrenchPharmacopoeia consists of three folders regularly

Working document QAS/11.453/Rev.10page 13updatedGermanyDeutsches Arzneibuch(DAB)1. Deutsche Arzneibuch-Kommission,Bundesinstitut für Arzneimittel und Medizinprodukte(Federal Institute for Drugs and Medical Devices)Kurt-Georg-Kiesinger-Allee 3, D-53175 BonnWebsite: (English, German)Email: [email protected] and [email protected] Deutscher Apotheker Verlag, StuttgartMedpharm GmbH Scientific Publishers,Birkenwaldstraβe 44, D-70191 Stuttgart4. updated yearly.In accordance with Section 55 of the PharmaceuticalsAct (Arzneimittelgesetz - AMG), the Pharmacopoeiaand the date of entry into force of the revised version.DeutschesHomoeopathischesArzneibuch(HAB)1. Deutsches Homöopathisches ArzneibuchBundesinstitut für Arzneimittel und MedizinprodukteKurt-Georg-Kiesinger-Allee 3, D-53175 BonnWebsite: (English, German)Email: [email protected] yearly.2. Deutscher Apotheker Verlag, StuttgartGovi-Verlag- Pharmazeutischer Verlag GmbH,EschbornDAB 2015DAB 1999-201410th Edition9th Edition8th Edition7th Edition6th Edition5th Edition4th Edition3rd Edition2nd Edition1st EditionHAB 2000-2014HAB 890188318722000-20142015GermanGerman

Working document QAS/11.453/Rev.10page 14Greece*Greek PharmacopoeiaGreek Pharmacopoeia CommissionPharmacopoeia SectionNational Organisation for MedicinesMesogeion Avenue, 284GR-15562 Holargos AttikisWebsite: (English, Greek)Email: [email protected] Edition, vols 1, 2Supplement 1Supplement 2Supplement 3Supplement 419982000200220062009GreekHungary*Magyar gyógyszerkönyv(PharmacopoeiaHungarica)1. Hungarian Pharmacopoeia Commission (OGYI)National Institute for Quality and OrganizationalDevelopment in Healthcare and MedicinesNational Institute of Pharmacy, Zrínyi utca 3H-1051 Budapest /PO Box 450, H-1372.BudapestWebsite: (Hungarian, English)Email: [email protected] Edition7th Edition6th Edition5th Edition4th Edition3rd Edition2nd Edition1st h Edition7th EditionAddendumAddendum6th EditionAddendum5th lish2. Medicina konyvkiado, . Head of the Licensing UnitThe Icelandic Medicines AgencyVinlandsleiõ 14IS-113 ReykjavíkWebsite: (Icelandic, English)Email: [email protected] Pharmacopoeia1.& 2.Office of the Secretary-cum-Scientific DirectorIndian Pharmacopoeia CommissionMinistry of Health and Family WelfareGovernment of IndiaSector 23, Raj Nagar, Ghaziabad – 201 002, India3. Not online as yet, New Edition every 4 years and 2 addenda in between

Working document QAS/11.453/Rev.10page 15IndonesiaFarmakope Indonesia1. Indonesian Pharmacopoeia CommissionDirectorate of Therapeutic Products and HouseholdHealthcare StandardizationNational Agency of Drug and Food ControlKesehatan R.I., Jl, PercetakanNegara 23, Jakarta 10560, IndonesiaWebsite: (Indonesian)Emails: [email protected];[email protected] Kementerian Kesehatan, Republik Indonesia(Ministry of Health, Republic of Indonesia)DJL. KuninganJakarta4th EditionAddendumVeterinary SupplementAddendumAddendum3rd EditionAddendumAddendum2nd EditionSupplement1st 9661975195519605th Edition1st Supplement201420154th Edition1st Supplement2nd Supplement3rd Supplement1995200920102011Indonesian

Working document QAS/11.453/Rev.10page 16IranIranian PharmacopoeiaIreland*Italy*1. Iranian PharmacopoeiaDrug Administration of Iran, Division ofPharmaceuticals & Narcotic AffairsMinistry of Health and Medical EducationPO Box 310,Teheran 11344, Islamic Republic of IranLocation: 14th floor, MOHME building, Simaye IranStreet, Phase 5, Shahrake Qods, Teheran, Iran(Islamic Republic of)Website: (Farsi)Email: [email protected] Edition2013Iranian12th Edition11th EditionSupplement (2005)20082002Italian1. Health Products Regulatory AuthorityEarlsfort Centre,Earlsfort Terrace,IRL-Dublin 2Website: (English)Email: [email protected] Ufficialedella Repubblica Italiana1. Segreteria Tecnica della Farmacopea UfficialeItaliana,Istituto Superiore di SanitàViale Regina Elena 299I-00161 - RomaWebsite: (English, Italian)Email: [email protected] Ministerio della Salute,Commissionepermanente per la revisione e pubblicazionedella Farmacopea Ufficiale,Istituto Poligrafico e Zecca dello Stato P.V.,I-1213045 Roma

Working document QAS/11.453/Rev.10page 17JapanThe JapanesePharmacopoeia (JP)1. Expert Committee on the Japanese PharmacopoeiaPharmaceuticals and Medical Devices AgencyShin-kasumigaseki Building,3-3-2, Kasumigaseki,Chiyoda-ku,Tokyo 100-0013JapanWebsite: evelopment/jp/0009.html (Japanese,English)Email: [email protected] Committee on the Japanese Pharmacopoeia/Pharmaceutical Affairs Food Sanitation CouncilPharmaceutical Safety and Environmental HealthBureau,Ministry of Health, Labour and Welfare1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo isakunitsuite/bunya/0000066597.html (Japanese, English)Email: [email protected] The Japanese td/standardsdevelopment/jp/0009.html (English)4. Frequency of publicationNew editions are published every 5 years and twosupplements are published between the regularpublication of JP editions.Moreover, partial revisions are made as necessary.JP 17thJP 16th16 Supplement 116 Supplement 2JP 15th15 Supplement 115 Supplement 2JP 14th14 Supplement 114 Supplement 2JP 13th13 Supplement 113 Supplement 2JP 12th12 Supplement 112 Supplement 2JP 11th11 SupplementJP 10thJP 9thJP 8thJP 7thJP 6thJP 5thJP 4thJP 3rdJP 2ndJP 920190618911886Japanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJapanese, EnglishJa

8th Edition* (vol.1,2,3,4) 7th Edition, vol.1 6th Edition 5th Edition 2nd Edition * the content that is on public consultation since 2011 2011 2002 1978 1966 1956 1943 1921 1898 . Email: [email protected] 4th Edition 3rd Edition 2nd Edition 1st Edition 2005 1984 1972 1953 Arabic