OF WORLD PHARMACOPOEIAS and PHARMACOPOEIAL AUTHORITIES

Working document QAS/11.453/Rev.11 May 2019 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, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, World Health Organization, CH-1211 Geneva 27, Switzerland, email: [email protected], with a copy to [email protected]

Table of contents

page

I. NATIONAL Argentina …………………………………………………………………………………………………………………… 4 Austria* …………………………………………………………………………………………………………………… 5 Belarus** …………………………………………………………………………………………………………………… 6 Belgium* …………………………………………………………………………………………………………………… 6 Bosnia and Herzegovina* …………………………………………………………………………………………………………………… 7 Brazil …………………………………………………………………………………………………………………… 7 Bulgaria* …………………………………………………………………………………………………………………… 10 Chile …………………………………………………………………………………………………………………… 11 China …………………………………………………………………………………………………………………… 11 Croatia* …………………………………………………………………………………………………………………… 12 Cyrus* …………………………………………………………………………………………………………………… 14 Czechia* …………………………………………………………………………………………………………………… 14 Denmark* …………………………………………………………………………………………………………………… 16 Egypt …………………………………………………………………………………………………………………… 17 Estonia* …………………………………………………………………………………………………………………… 17 Finland* …………………………………………………………………………………………………………………… 17 France* …………………………………………………………………………………………………………………… 18 Germany* …………………………………………………………………………………………………………………… 19 Greece* …………………………………………………………………………………………………………………… 21 Hungary* …………………………………………………………………………………………………………………… 21 Iceland* …………………………………………………………………………………………………………………… 22 India …………………………………………………………………………………………………………………… 22 Indonesia …………………………………………………………………………………………………………………… 23 Iran (Islamic Republic of) …………………………………………………………………………………………………………………… 24 Ireland* …………………………………………………………………………………………………………………… 24 Italy* …………………………………………………………………………………………………………………… 25 Japan …………………………………………………………………………………………………………………… 25 Kazakhstan** …………………………………………………………………………………………………………………… 27 Korea (Republic of) …………………………………………………………………………………………………………………… 27 Lativa* …………………………………………………………………………………………………………………… 29 Lithuania* …………………………………………………………………………………………………………………… 29 Working document QAS/11.453/Rev.11 page 3

Luxembourg* …………………………………………………………………………………………………………………… 29 Malta* …………………………………………………………………………………………………………………… 30 Mexico …………………………………………………………………………………………………………………… 30 Montenegro* …………………………………………………………………………………………………………………… 32 Netherlands* …………………………………………………………………………………………………………………… 32 Norway* …………………………………………………………………………………………………………………… 33 Pakistan …………………………………………………………………………………………………………………… 33 Philippines …………………………………………………………………………………………………………………… 34 Poland* …………………………………………………………………………………………………………………… 34 Portugal* …………………………………………………………………………………………………………………… 35 Romania* …………………………………………………………………………………………………………………… 36 Russian Federation** …………………………………………………………………………………………………………………… 37 Serbia* …………………………………………………………………………………………………………………… 38 Slovakia* …………………………………………………………………………………………………………………… 38 Slovenia …………………………………………………………………………………………………………………… 39 Spain* …………………………………………………………………………………………………………………… 39 Sweden* …………………………………………………………………………………………………………………… 40 Switzerland* …………………………………………………………………………………………………………………… 40 Thailand …………………………………………………………………………………………………………………… 41 The Former Yugoslav Republic of Macedonia* .……………………………………………………………………………………………………… 42 Turkey* …………………………………………………………………………………………………………………… 42 Ukraine* …………………………………………………………………………………………………………………… 43 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

ARGENTINA 3. Website: http://www.anmat.gov.ar (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.) Working document QAS/11.453/Rev.11 page 5

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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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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. Pharmacopoeia Coordination 5th Edition (5.0) 2010 Portuguese Brazilian Health Surveillance Agency – ANVISA Supplement 5.1 2016 English (Brazilian Agência Nacional de Vigilância Sanitária – ANVISA Supplement 5.2 2017 Spanish Pharmacopoeia) SIA, Trecho 5, Area Especial 57 1988 Brasília - DF CEP: 71.205-050 4th Edition 1996 Part 1 2000 Emails: Part 2, Vol. 1 2002 [email protected] Vol. 2 2003 [email protected] Vol. 3 2004 Vol. 4 2005 BRAZIL Vol. 5 1976 Vol. 6 1957 3rd Edition 1929 2nd Edition 1st Edition 3. Website: http://portal.anvisa.gov.br/ (Portuguese, English)

(Farmacopeia 1,2. see above 3rd Edition 2011 Portuguese Homeopática Brasileira) 2nd Edition 1997 English 1st Edition 1976 Spanish Working document QAS/11.453/Rev.11 page 8

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Brazilian Homeopathic Pharmacopoeia

3. Brazilian Homeopathic Pharmacopoeia (Farmacopeia Homeopática Brasileira)

Websites: http://portal.anvisa.gov.br/documents/33832/259147/3a_edi cao.pdf/cb9d5888-6b7c-447b-be3c-af51aaae7ea8 (Portuguese)

http://portal.anvisa.gov.br/documents/33832/259147/Farma copeia+HOMEOPATICA+3a+EDICAO+INGLES+com+al erta.pdf/49a48a50-0d3e-4ab9-bc41-eb361c8afbb1 (English)

http://portal.anvisa.gov.br/documents/33832/259147/Farma copeia+HOMEOPATICA+3a+EDICAO+ESPANHOL+co m+alerta.pdf/7e1f40c1-53fa-4fba-ba66-e5e376e02051 (Spanish)

National Formulary 1,2. see above. 2nd Edition 2012 Portuguese 1st Edition 2005 English (Formulário Nacional) Spanish 3. National Formulary (Formulário Nacional)

Websites:

http://portal.anvisa.gov.br/documents/33832/259372/FNFB +2_Revisao_2_COFAR_setembro_2012_atual.pdf/20eb296 9-57a9-46e2-8c3b-6d79dccf0741 Working document QAS/11.453/Rev.11 page 9

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(Portuguese)

http://portal.anvisa.gov.br/documents/33832/259372/Formu lario+NACIONAL+FARMACOPEIA+INGLES+com+alert a.pdf/056212ea-c30e-4f80-bf0e-63a7fdf6c149 (English)

http://portal.anvisa.gov.br/documents/33832/259372/Formu lario+NACIONAL+FARMACOPEIA+ESPANHOL+com+ alerta.pdf/8cf5a930-fc74-4e2c-b257-a59270e56526 (Spanish )

Herbal Medicines 1,2. see above 1st Edition 2011 Portuguese National Formulary 1st Supplement 2018 Spanish

(Formulário Nacional Fitoterápico)

3. Herbal Medicines National Formulary (Formulário Nacional Fitoterápico)

http://portal.anvisa.gov.br/documents/33832/259456/Formu lario_de_Fitoterapicos_da_Farmacopeia_Brasileira.pdf/c76 283eb-29f6-4b15-8755-2073e5b4c5bf (Portuguese)

http://portal.anvisa.gov.br/documents/33832/259456/Formu l%C3%A1rio+de+Fitotet%C3%A1picos+1a+Ed.+ESPAN HOL+com+alerta.pdf/d869a72c-21b2-42c3-9c64- 90efb29fe064 (Spanish)

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Homeopathic Medicines 1,2. see above. 1st Edition 2016 Portuguese National Formulary English Spanish (Formulário Nacional Homeopático)

3. Homeopathic Medicines National Formulary (Formulário Nacional Homeopático)

Herbal Medicines 1,2. see above. 1st Edition 2016 Portuguese Memento

(Memento Fitoterápico) 3. Herbal Medicines Memento (Memento Fitoterápico)

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: BULGARIA* [email protected] [email protected]

3. Websites: https://www.bda.bg/en/information-for-companies/123- Working document QAS/11.453/Rev.11 page 11

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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)

1. Chinese Pharmacopoeia Commission National Medical Products Administration (NMPA) Building 11, Fahua Nan Li Dongcheng District 100061 Beijing

Emails: CHINA [email protected] [email protected] [email protected] [email protected] [email protected]

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3. Websites:

http://www.chp.org.cn (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 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 Croatian Pharm. Croatia Supplement 3.1 2014 Croatian Pharm. CROATIA* Ksaverska cesta 4 Supplement 3.2 2014 Croatian Pharm. (Croatian Pharmacopoeia 10 000 Zagreb Supplement 3.3 2014 Croatian Pharm. Supplement 3.4 2015 Croatian Pharm. Working document QAS/11.453/Rev.11 page 13

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Commission) Emails: Supplement 3.5 2015 Croatian Pharm. [email protected] Supplement 3.6 2015 Croatian Pharm. [email protected] Supplement 3.7 2015 Croatian Pharm. [email protected] Supplement 3.8 2016 Croatian Pharm. Edition 4.0 2017 Croatian Pharm.

Supplement 4.1 2017 Croatian Pharm. Supplement 4.2 2017 Croatian Pharm. Supplement 4.3 2017 Croatian Pharm. Supplement 4.4 2017 Croatian Pharm. Supplement 4.5 2018 Croatian Pharm. Supplement 4.6 2018 Croatian Pharm. Supplement 4.7 2019 Croatian Pharm. Supplement 4.8 2019 Croatian Pharm.

Website: http://www.halmed.hr/Lijekovi/Farmakopeja/ Hrvatska-farmakopeja/ (Croatian, English) 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

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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 1475 Nicosia CYPRUS* Email: [email protected]

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 CZECHIA* [email protected] + Supplement MMX 2011

+ Supplement MMXI 2012

+ Supplement MMXII 2013

+ Supplement MMXIII 2014 2a. Grada Publishing, Prague + Supplement MMXIV 2015 + Supplement MMXV 2016 Working document QAS/11.453/Rev.11 page 15

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+ Supplement MMXVI 2005 Edition MMV (Vol. 2006 1,2,3) + Supplement MMVI 2007 (Vol. 1,2) + Supplement MMVII 2002 (Vol. 1,2) 2003 Edition MMII (Vol. 2004 1,2,3,5) + Supplement MMIII 1997 + Supplement MMIV

(Vol. 1,2) 1999 Edition MCMXCVII (Vol. 1,2,3) 2000 + Supplement XCIX 2001 (Vol. 1,2) + Supplement MM + 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 Working document QAS/11.453/Rev.11 page 16

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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 Emails: Pharmacopoea Nordica, 1963 Danish [email protected] Danish Edition [email protected] Joint Pharmacopoeia of [email protected] the Nordic countries Pharmacopoea Danica 9th 1948 Danish 8th 1933 Danish DENMARK* 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://www.sst.dk (Danish, English)

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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

Email: [email protected] EGYPT

3. Website: http://www.eda.mohp.gov.eg (Arabic, English)

2. General Organization for Government Printing Office Cairo

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 FINLAND* PO Box 55 FI-00034 Helsinki

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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 processus et Pharmacopée (SM3P)

F-

Email: [email protected]

3. Website: http://www.ansm.sante.fr FRANCE* (French)

Pharmacopée française 2. Pharmacopée Française 11 e édition, free online 11th Edition (free online) 2012 French (regularly http://ansm.sante.fr/Mediatheque/Publicat ions/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/ Working document QAS/11.453/Rev.11 page 19

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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 D-53175 Bonn

Emails: [email protected] [email protected]

3. Website: http://www.bfarm.de (English, German) GERMANY*

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 Working document QAS/11.453/Rev.11 page 20

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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)

4. Updated yearly.

2. Deutscher Apotheker Verlag, Stuttgart Govi-Verlag- Pharmazeutischer Verlag GmbH Eschborn

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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)

Magyar gyógyszerkönyv 1. Hungarian Pharmacopoeia Commission (OGYI) 8th Edition 2006 Hungarian National Institute for Quality and Organizational 7th Edition 1987 (Pharmacopoea Development in Healthcare and Medicines 6th Edition 1967 Hungarica) National Institute of Pharmacy and Nutrition (OGYEI) 5th Edition 1958 Zrínyi utca 3 4th Edition 1933 PO Box 450, H-1372.Budapest 3rd Edition 1909 H-1051 Budapest 2nd Edition 1888 1st Edition 1871 HUNGARY* Email: [email protected]

3. Website: http://www.ogyi.hu/ (Hungarian, English)

2. Medicina konyvkiado, Budapest

3. Website: http://www.medicina-kiado.hu

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ICELAND* Head of the Licensing Unit Icelandic Medicines Agency (IMA) Vinlandsleiõ 14 113 Reykjavík

Emails: [email protected] [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 7th Edition 2014 Ministry of Health and Family Welfare Addendum 2015 Government of India Addendum 2016 Sector-23, Raj Nagar 6th Edition 2010 Ghaziabad 201 002 Addendum 2012 5th Edition 2007 Emails: Addendum 2008 [email protected] 4th Edition 1996 INDIA [email protected] (cc.) Addendum 2000 Veterinary Supplement 2000 Addendum 2002 Addendum 2005 3rd Edition 1985 Addendum 1989 Addendum 1991 2nd Edition 1966 Supplement 1975 Working document QAS/11.453/Rev.11 page 23

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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 2018 National Agency of Drug and Food Control (Badan POM) Republic of Indonesia 4th Edition 1995 Jl, Percetakan Negara 23 1st Supplement 2009 Jakarta Pusat 10560 2nd Supplement 2010 3rd Supplement 2011 Emails: [email protected] 3rd Edition 1979 INDONESIA [email protected] 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

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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 PO Box 310 14th floor, MOHME building Simaye Iran Street IRAN (ISLAMIC Phase 5, Shahrake Qods REPUBLIC OF) Teheran 11344

Email: [email protected]

3. Website: http://www.mohme.gov.ir (Farsi)

IRELAND* Health Products Regulatory Authority (HPRA) Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2

Email: [email protected]

Working document QAS/11.453/Rev.11 page 25

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

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

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 JP 16th 2011 Japanese, English Pharmaceutical Safety and Environmental Health Bureau 16 Supplement 1 2012 Japanese, English Ministry of Health 16 Supplement 2 2014 Japanese, English JAPAN Labour and Welfare JP 15th 2006 Japanese, English 1-2-2 Kasumigaseki 15 Supplement 1 2007 Japanese, English Chiyoda-ku 15 Supplement 2 2009 Japanese, English Tokyo 100-8916 JP 14th 2001 Japanese, English 14 Supplement 1 2002 Japanese, English 1. Expert Committee on the Japanese Pharmacopoeia 14 Supplement 2 2004 Japanese, English Working document QAS/11.453/Rev.11 page 26

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

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 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 [email protected] JP 8th 1971 Japanese, English [email protected] JP 7th 1961 Japanese, English [email protected] JP 6th 1951 Japanese, English [email protected] JP 5th 1932 Japanese JP 4th 1920 Japanese, English JP 3rd 1906 Japanese, English JP 2nd 1891 Japanese JP 1st 1886 Japanese, Latin

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. Working document QAS/11.453/Rev.11 page 27

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

The State Pharmacopoeia 1. & 2. RSE “The National Center for Expertise of 2nd Edition of the Republic of Medicines, Medical Devices and Equipment” Vol. 1 2015 Kazakh Kazakhstan (SPRK) Ministry of Health of the Republic of Kazakhstan 1st Edition Russian Vol. 3 2014 Kazakh Emails: 1st Edition Russian [email protected] Vols. 1, 2 2008 Kazakh KAZAKHSTAN** [email protected] Russian

3. Website: http://www.dari.kz (Russian)

4. Once every 5 years. Online access in near future.

1. Ministry of Food and Drug Safety 11th Edition 2014 Korean Osong Health Technology Administration Complex 10th Edition 2012 Korean, English 187 Osongseangmyeong 2-ro 9th Edition 2007 Korean, English Osong-eup Supplement 1 2009 Heungdeok-gu Supplement 2 2010 Cheonju-si Supplement 3 2010 363-700 Chuncheongbuk-do Supplement 4 2010 Supplement 5 2010 KOREA Emails: Supplement 6 2011 (REPUBLIC OF) [email protected] Supplement 7 2011 [email protected] Supplement 8 2012 [email protected] 8th Edition 2002 Supplement 1 2006 7th Edition 1997 Supplement 1 2000 6th Edition 1992 Supplement 1 1993 Working document QAS/11.453/Rev.11 page 28

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

5th Edition 1987 Supplement 1 1988 4th Edition 1982 Supplement 1 1982 3rd Edition 1976 Supplement 1 1978 Supplement 2 1979 2nd Edition 1967 Part I 1968 Part II 1968 Supplement 1 1969 Supplement 2 1958 1st Edition 3. Website: http://www.mfds.go.kr (Korean, English)

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.

Working document QAS/11.453/Rev.11 page 29

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

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

2. State Medicines Control Agency Ministry of Health of the Republic of Lithuania Zirmunu str. 139A LITHUANIA* LT-09120 Vilnius

Emails: [email protected] [email protected]

3. Website: https://www.vvkt.lt (Lithuanian, English)

Ministère de la Santé LUXEMBOURG* Division de la Pharmacie et des Médicaments Allée Marconi Working document QAS/11.453/Rev.11 page 30

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

Villa Louvigny L 2120

Emails: [email protected] [email protected]

MALTA* Malta Medicines Authority Sir Temi Zammit Buildings Malta Life Sciences Park San Gwann SGN 3000

Email: [email protected]

MEXICO Farmacopea de los Estados 1. Comisión Permanente de la Farmacopea de 12th Edition 2018 Spanish Unidos Mexicanos los Estados Unidos Mexicanos 11th Edition 2014 Rio Rhin 57 Supplement 2015 Col Cuauhtémoc Supplement 2016 Alcaldía Cuauhtémoc 10th Edition 2011 06500, Ciudad de México Supplement 2012 México Supplement 2013 9th Edition 2008 Emails: Supplement 1 2009 [email protected] Supplement 2 2010 [email protected] 8th Edition 2004 Supplement 1 2006 2. Secretaría de Salud, 7th Edition 2000 Lieja 7 Col. Juárez Supplement 1 2001 C.P. 06696 Supplement 2 2002 Ciudad de México 6th Edition 1994 Working document QAS/11.453/Rev.11 page 31

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

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

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

Working document QAS/11.453/Rev.11 page 32

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

1st Edition 1996 2nd Edition 2000 3rd Edition 2005 4th Edition 2010 5th Edition 2015 6th Edition 2019

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) P.O. Box 1 NETHERLANDS* NL 3720 BA Bilthoven

Email: [email protected]

Working document QAS/11.453/Rev.11 page 33

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

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]

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)

Working document QAS/11.453/Rev.11 page 34

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

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 Republic of the Philippines San Lazaro Compound Sta. Cruz PHILIPPINES 1003 Manila

Email: call [email protected]

3. Website: https://www.doh.gov.ph/ (English)

Farmakopea Polska 1. Pharmacopoeia Commission 10th Edition (and 2014-2016 Polish Pharmacopoeia Department supplements) (current) Office for Registration of Medicinal Products 9th Edition (and 2013- Medical Devices and Biocidal Products supplements 2011 Al. Jerozolimskie 181C 8th Edition (and 2012- PL-02-222 Warsaw supplements) 2008-2011 POLAND* 7th Edition (and 2006 Email: [email protected] supplements) 6th Edition 2002 5th Edition 1990 Supplement 1995 4th Edition Working document QAS/11.453/Rev.11 page 35

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

Volume 1 1965 Volume 2 1970 3rd Edition 1954 Supplement 1 1956 Supplement 2 1959 Supplement 3 1962 2nd Edition 1946 1st Edition 1817 3. Website: http://www.urpl.gov.pl (Polish, English)

2. Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Al. Jerozolimskie 181C 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 PORTUGAL* Email: [email protected] Supplement 9.4 2009 Supplement 9.5 2010 Supplement 9.6 2010 Supplement 9.7 2010 Supplement 9.8 2005 Working document QAS/11.453/Rev.11 page 36

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

8th Edition, Vol. 1,Vol. 2 2002 7th Edition, Vol. 1,Vol. 2 1997 6th Edition 2000 Supplement

3. Website: http://www.infarmed.pt (Portuguese, English)

ROMANIA* 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 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

Working document QAS/11.453/Rev.11 page 37

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

ГосударственнаЯ 1. Ministry of Health of the Russian Federation 12th Edition, Vol. 1 2008 Russian ФармакопеЯ Российской 3 Rakhmanovsky pereulok 11th Edition Федерации 127944 Moscow Vol. 1 1987 Vol. 1990 (State Pharmacopoeia of Emails: 10th Edition 1968 the Russian Federation) [email protected] 9th Edition 1961 [email protected] 8th Edition 1946 [email protected] 7th Edition 1925 [email protected] 6th Edition 1910 [email protected] 5th Edition 1902 [email protected] 4th Edition 1891 [email protected] 3rd Edition 1880 2nd Edition 1871 1st Edition 1778 3. Website: www.grls.rosminzdrav.ru RUSSIAN

FEDERATION** Center of Pharmacopoeia and International Collaboration of the Federal State Budget Institution Scientific Center of Expert Evaluation of Medicinal Products

Email: [email protected]

3. Website: www.regmed.ru

2. Medicina Petroverigskiy Pereulok 6/8 101000 Moscow

3. Updated once in 5 years.

Working document QAS/11.453/Rev.11 page 38

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.11 page 39

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

Pharmacopoeia Commission Agency For Medicinal Products and Medical Devices of the Republic of Slovenia (Javna Agencija Rebublike Slovenije Za Zdravila In Medicinske Pripomočke) Slovenceva ulica 22 SI-1000 Ljubljana SLOVENIA*

Email: [email protected]

3. Website: http://www.jazmp.si (English, Slovenian)

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 SPAIN* Supplement 1.2 1978 Supplement 1.3 2000 Supplement 1.4 2001 3. Website: http://www.aemps.gob.es (Spanish, English)

2. Publicación:

Agencia Estatal Boletín Oficial del Estado Working document QAS/11.453/Rev.11 page 40

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

Avda. Manoteras 54 E – 28050 Madrid

Email: [email protected]

3. Website: http://www.boe.es/

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. Commission Suisse de Pharmacopée 11th Edition 2012 French Swissmedic Supplement 11.1 2013 German Swiss Agency for Therapeutic Products Supplement 11.2 2015 Italian SWITZERLAND* Pharmacopoeia Division PO Box Hallerstrasse 7 10th Edition 2006 CH-3000 Bern 9 Supplement 10.1 2007 Supplement 10.2 2009 Working document QAS/11.453/Rev.11 page 41

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

Email: [email protected] Supplement 10.3 2010

3. Website: http://www.swissmedic.ch (English, French, German, Italian)

2. Office fédéral des constructions et de la logistique Fellerstrasse 21 CH-3003 Bern

3. Website: www.bundespublikationen.admin.ch

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

THAILAND 3. Website: http://www.dmsc.moph.go.th/webroot/ drug/eng/ responsiblility.stm (English, Thai)

2. Thai Pharmacopoeia and Reference Substance Section Bureau of Drug and Narcotic Department of Medical Sciences Ministry of Public Health Tiwanond Road Working document QAS/11.453/Rev.11 page 42

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

Nonthaburi 11000

Thai 1. & 2. as above. Vol. 1 1995 English Herbal Pharmacopoeia Vol. 2 2000 Supplement 2004 Vol. 3 2009

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)

Working document QAS/11.453/Rev.11 page 43

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

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 (ДЕРЖАВНА Kharkov 61085 2nd Edition (2.0) Vols 1,2,3 2015 Ukrainian ФАРМАКОПЕЯ Supplement 4 (1.4) 2011 Ukrainian УКРАЇНИ) State Administration of Ukraine on Medicinal Products Supplement 3 2009 Ukrainian Ministry of Health of Ukraine (1.3) 2008 Ukrainian, Supplement 2 2004 Ukrainian, Russian Emails: (1.2) 2001 Ukrainian, Russian [email protected] Supplement 1 UKRAINE* [email protected] (1.1) [email protected] 1st Edition (1.0)

3. Website: http://www.sphu.org

2. The Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines

3. Online version is not available.

British Pharmacopoeia 1. British Pharmacopoeia Commission Medicines and Healthcare products Regulatory Agency BP 2019 English (MHRA) BP 2018 UNITED 10 South Colonnade BP 2017 KINGDOM OF Canary Wharf BP 2016 GREAT BRITAIN London E14 4PU BP 2015 AND NORTHERN BP 2014 IRELAND* Emails: BP 2013 [email protected] BP 2012 [email protected] BP 2011 [email protected] Working document QAS/11.453/Rev.11 page 44

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

[email protected] 1914 [email protected] BP 1864 1st Edition (through the merger of the London, 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 36, NF 31 2012 English, Spanish Pharmacopeia and 12601 Twinbrook Parkway Supplement 1 2013 National Formulary Rockville Supplement 2 2013 MD 20852 -1790 USP 35, NF 30 2011 English, Spanish (USP-NF) Supplement 1 2012 UNITED STATES Email: [email protected] Supplement 2 2012 OF AMERICA USP 34, NF 29 2010 Supplement 1 2011 Supplement 2 2011 3. Website: http://www.usp.org (English, Spanish, Chinese, Portuguese) Working document QAS/11.453/Rev.11 page 45

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

3. USP-NF Five-year Revisions: 1942-2000

Website: http://www.uspnf.com/uspnf/login USP 1st Revision 1830 USP 0 1820

4. Yearly.

 Since 2002,USP-NF published annually  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 5the Edition 2017 Vietnamese/English Pharmacopoeia Vietnamese Pharmacopoeia and Formulary Center 4th Edition 2009 Vietnamese Ministry of Health 2010 English (Pharmacopoeia 48- Hai Ba Trung Street 3rd Edition 2002 Vietnamese Vietnamica) Hoan Kiem District 2005 English Hanoi Supplement 2006 2nd Edition Vietnamese VIET NAM Email: [email protected] Vol. 1 1990 Vol. 2 1991 Vol. 3 1994 1st Edition Vol. 1 1970 Supplement 1977 Vol. 2 1983

Working document QAS/11.453/Rev.11 page 46

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

3. Website: http://www.moh.gov.vn (English, Vietnamese)

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.11 page 47

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.11 page 48

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 1st Edition 1967 EUROPEAN PHARMACOPIEA 3. Website: http://www.edqm.eu MEMBERS (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 1. & 2. above. Vol. 28 1-4 2016 English, French Vol. 27 1-4 2015 Vol. 26 1-4 2014 Vol. 24 1-4 2012 Vol. 23 1-4 2011 2010 Vol. 22 1-4 3. Pharmeurope online.

38 Member States and the European Union are signatory to the Convention on the Elaboration of a European Pharmacopoeia. European Pharmacopoeia Members: 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.11 page 49

European Pharmacopoeia Observers: Albania, 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.11 page 50

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 5th Edition 2018 English Pharmacopoeia Pharmaceutical Preparations 2017 English 4th Edition, Vols 1, 2 2016 English Emails: 1st Supplement 2015 English [email protected] 2nd Supplement [email protected] 3rd Supplement 2006 4th Supplement 2008 2. WHO Press World Health Organization 2011 CH-1211 Geneva 27 3rd Edition, Vol. 1 2013 Fax: (41-22) 791 48 57 2014 WHO GENEVA, Email: [email protected] SWITZERLAND Vol. 2 1979 English 1980 French 1980 Spanish 1981 Russian Arabic Vol. 3 1981 English 1981 French 1983 Spanish 1983 Russian Arabic Vol. 4 1988 English 1988 French Working document QAS/11.453/Rev.11 page 51

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

1989 Spanish 1990 Russian Arabic

Vol. 5 1994 English 1994 French 1996 Spanish 1995 Russian Arabic 2nd Edition 2003 English Reagents Arabic

quality control (QC) 1963 English supplement for QC 1966 French 1967 English 1967 French 1st Edition 1971 English 1971 French

1951 English 1955 French 1959 Spanish German Japanese Working document QAS/11.453/Rev.11 page 52

1. PHARMACOPOEIA COMMISSIONS 2. PUBLISHER/DISTRIBUTOR COUNTRY TITLE 3. ONLINE ACCESS ADDRESS EDITION YEAR LANGUAGE 4. FREQUENCY OF PUBLICATION

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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