Members

LIST OF PIC/S PARTICIPATING AUTHORITIES

By alphabetical order of the country / entity of each Participating Authority

Argentina

National Institute of Drugs
Instituto Nacional de Medicamentos (INAME)

Inspection Department
Avda. Caseros 2161 – 1er Piso
AR - C1264AAB Buenos Aires

 

Accession to PIC Scheme January 2008

Australia
 

Therapeutic Goods Administration (TGA)

Departement of Health

Manufacturing Quality Branch
PO Box 100
AU - Woden Act 2606

 

 

Accession to PIC January 1993 Accession to PIC Scheme November 1995

Austria
 

Austrian Agency for Health and Food Safety (AGES)

Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES)

Traisengasse 5,
AT - 1200 Vienna

 

Accession to PIC May 1971 Accession to PIC Scheme November 1999

Belgium

Federal Agency for Medicines and Health Products

Agence Fédérale des Médicaments et des Produits de Santé (AFMPS)
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)

EUROSTATION Building, block 2

Place Victor Horta, 40/40
BE - 1060 Bruxelles

 

 

Accession to PIC September 1991 Accession to PIC Scheme February 1997

Canada

Health CanadaSanté Canada

Regulatory Operations and Regions Branch (RORB)
Direction générale des opérations réglementaires et des régions (DGORR)

13th floor, Jeanne Mance Building
200 Eglantine Drive
CA - Ottawa, Ontario, K1Y 1G9

 

Accession to PIC Scheme January 1999

Chinese Taipei

Taiwan Food and Drug Administration (TFDA)

Ministry of Health and Welfare
No. 161-2, Kunyang St.
Nangang District
TW - 115-61 Taipei City

 

Accession to PIC Scheme January 2013

Croatia

Agency for Medicinal Products and Medical Devices of Croatia
Agencija za lijekove i medicinske proizvode (HALMED)

Ksaverska cesta 4
HR - 10 000 Zagreb

 

Accession to PIC Scheme January 2016

Cyprus

Pharmaceutical Services (CyPHS)

Ministry of Health
1475 Lefkosia (Nicosia)

 

Accession to PIC Scheme July 2008

Czech Republic

State Institute for Drug Control
Státní Ústav pro Kontrolu Léčiv (SÚKL)

Srobárova 48
CZ - 100 41 Prague 10

 

Accession to PIC Scheme January 1997

Czech Republic

Institute for State Control of Veterinary Biologicals
and Medicines
(ISCVBM)

Hudcova 56A
CZ - 621 00  Brno

 

Accession to PIC Scheme July 2005

Denmark

Danish Medicines Agency (DKMA)

1 Axel Heides Gade
DK - 2300 Copenhagen S

 

Accession to PIC May 1971 Accession to PIC Scheme November 1995

Estonia

State Agency of Medicines (SAM)

1 Nooruse Str.
EE - 50411 Tartu

 

Accession to PIC Scheme January 2007

Finland

Finnish Medicines Agency (FIMEA)

Mannerheimintie 103b
P.O. Box 55
FI - 00034 FIMEA Helsinki

 

 

Accession to PIC May 1971 Accession to PIC Scheme January 1996

France

French National Agency for Medicines and Health Products Safety
Agence nationale de sécurité du médicament et des produits de santé (ANSM)

143/147 Boulevard Anatole France
FR - 93285 Saint Denis

 

Accession to PIC December 1992 Accession to PIC Scheme February 1997

France

Agency for Food, Environmental & Occupational Health Safety
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)


14, rue Pierre et Marie Curie
FR - 94701 Maisons-Alfort cedex

 

Accession to PIC Scheme January 2009

Germany

Federal Ministry of Health *
Bundesministerium für Gesundheit (BMG)

Rochusstr. 1
DE – 53123 Bonn
Germany

Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices *
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)

Heinrich-Boll-Ring 10
DE - 53119 Bonn
Germany

* the German Ministry of Health (BMG) and the German Central Authority of the Laender (ZLG) count as one PIC/S Participating Authority. All German Medicinal Authorities, which are listed on the ZLG web site, are considered as PIC/S Participating Authorities and are represented in PIC/S by ZLG.

 

Accession to PIC September 1983 Accession to PIC Scheme December 2000

Greece

Greek National Organisation for Medicines
Εθνικός Οργανισμός Φαρμάκων (EOF)

Messoghion Ave 284
GR - Holargos 155 62 (ELLAS)

 

Accession to PIC Scheme January 2002

Hong Kong SAR

Pharmacy and Poisons Board of Hong Kong (PPBHK)

1/F Shun Feng International Centre
182 Queen's Road East
HK - Wan Chai, Hong Kong 

 

Accession to PIC Scheme January 2016

Hungary

National Institute of Pharmacy and Nutrition (NIPN)

Zrínyi u. 3. 1372 P.O. Box 450
HU - 1051 Budapest

 

Accession to PIC August 1976 Accession to PIC Scheme December 1995

Iceland

Icelandic Medicines Agency (IMA)

Vínlandsleið 14
IS - 113 Reykjavik

 

Accession to PIC May 1971 Accession to PIC Scheme November 1995

Indonesia

National Agency for Drug and Food Control (NADFC)
(Badan Pengawas Obat dan Makanan Republik Indonesia)

Jl. Percetakan Negara No.23
ID - Jakarta 10560

 

Accession to PIC Scheme July 2012

Ireland

Health Products Regulatory Authority (HPRA)

Kevin O'Mally House
Earlsfort Centre
Earlsfort Terrace
IE - Dublin 2

 

Accession to PIC December 1977 Accession to PIC Scheme February 1996

Israel

Institute for Standardization and Control
of Pharmaceuticals
(ISCP)

Eliav St. 9,
P.O. Box 34410
IL - Jerusalem 91342

 

Accession to PIC Scheme January 2009

Italy

Italian Medicines Agency 
Agenzia Italiana del Farmaco (AIFA)

Via del Tritone, 181
IT - 00187 Rome

 

Accession to PIC August 1990 Accession to PIC Scheme February 2000

Japan

Ministry of Health, Labour and Welfare (MHLW) *

1-2-2 Kasumigaseki Chiyoda-ku
JP - 100-8916 Tokyo

Pharmaceuticals and Medical Devices Agency (PMDA) *

Shin-Kasumigaseki Building
3-3-2 Kasumigaseki Chiyoda-ku
JP - 100-0013 Tokyo

* Japan's Ministry of Health, Labour and Welfare (MHLW) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) count as one PIC/S Participating Authority. The Japanese Prefectures are represented by MHLW.
 
Accession to PIC Scheme July 2014

Korea (Republic of)

Ministry of Food and Drug Safety (MFDS)

Osong Health Technology Administration Complex
187, Osongsaengmyeong2-ro
Osong-eup, Heungdeok-gu
Cheongju-si, Chungcheongbuk-do
KR - 28159

 

Accession to PIC Scheme July 2014

Latvia

State Agency of Medicines
Zāļu valsts aģentūra (ZVA)

15, Jersikas St.
LV - 1003 Riga

 

Accession to PIC Scheme January 2004

Liechtenstein

Office of Healthcare
Amt für Gesundheit (AG)

Äulestrasse 51
Postfach 684
FL - 9490 Vaduz

 

Accession to PIC May 1971 Accession to PIC Scheme November 1995

Lithuania

State Medicines Control Agency (SMCA)

Žirmūnų str. 139A
LT – 09120 Vilnius

Accession to PIC Scheme July 2009

Malaysia

National Pharmaceutical Regulatory Agency (NPRA)

Ministry of Health Malaysia
Jalan Universiti
PO Box 319
46730 Petaling Jaya
MY – SELANGOR

 

Accession to PIC Scheme January 2002

Malta

Medicines Authority Malta (MAM)

198, Rue D'Argens
MT – GZIRA GZR 1368 

 

Accession to PIC Scheme January 2008

Netherlands

Dutch Health Care Inspectorate*  
Inspectie voor de Gezondheidszorg (IGZ)

P.O. Box 2680
NL - 3500 GR Utrecht
Netherlands

 
* The competence for GMP/GDP inspections in the Netherlands is allocated to the central authority, Dutch Healthcare Inspectorate (IGZ). IGZ is the PIC/S Participating Authority representing GMP/GDP for human as well as veterinary medicinal products. IGZ performs national and international GMP/GDP inspections representing the Health Care Inspectorate - Pharmaceutical Affairs and Medical Technology as well as the Medicines Evaluation Board - Veterinary Medicinal Products Unit, which is mandated to issue GMP certificates on behalf of the Ministry of Economic Affairs.


Accession to PIC Scheme November 1995


New Zealand

Medicines and Medical Devices Safety Authority (Medsafe)
P.O. Box 5013
NZ - 6011 Wellington

 

Accession to PIC Scheme January 2013

Norway

Norwegian Medicines Agency (NOMA)

Postboks 63, Kalbakken

NO - 0901 Oslo

 

Accession to PIC May 1971 Accession to PIC Scheme November 1995

Poland

Chief Pharmaceutical Inspectorate (CPI)

12 Senatorska Street
PL - 00-082 Warsaw

 

Accession to PIC Scheme January 2006

Portugal

National Authority of Medicines and Health Products, IP
Autoridade Nacional do Medicamento e Produtos de Saúde IP (INFARMED IP )

Avenida do Brasil, no 53
Pavilhão 21-A
PT - 1700 Lisbon

 

Accession to PIC May 1971 Accession to PIC Scheme January 1999

Romania

 

National Agency for Medicines and Medical Devices

(NAMMD)

Strada Maior Aviator Sanatescu 48
Sectorul I
RO - 011478 Bucharest

 

Accession to PIC May 1982 Accession to PIC Scheme November 1995

Singapore

Health Sciences Authority (HSA)

11 Biopolis Way
#11-01 Helios
SG - 138667

Accession to PIC Scheme January 2000

Slovak Republic

State Institute for Drug Control (SIDC)

Kvetná 11
SK - 825 08 Bratislava 26
Slovak Republic

 

Accession to PIC Scheme January 1997

Slovenia

Agency for Medicinal Products and Medical Devices
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)

Slovenčeva ulica 22
SI-1000 Ljubljana

 

Accession to PIC Scheme January 2012

South Africa

Medicines Control Council (MCC)

Private Bag X 828
ZA – 0001 Pretoria

 

Accession to PIC Scheme July 2007

Spain

Spanish Agency of Medicines and Medical Devices *
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

Departamento de Inspección y Control de Medicamentos
C/ Campezo, 1
ES - 28022 Madrid

*  The competence for GMP/GDP inspections in Spain is shared between the central authority, Spanish Agency for Medicines and Medical Devices (AEMPS), and the Spanish regional authorities, which count as one PIC/S Participating Authority. All Spanish Medicinal Authorities, which are listed on the AEMPS web site, are considered as PIC/S Participating Authorities and are represented in PIC/S by the AEMPS.

 

Accession to PIC Scheme January 1998

Sweden

Medical Products Agency (MPA)

Box 26
SE - 751 03 Uppsala
Sweden

 

Accession to PIC May 1971 Accession to PIC Scheme February 1996

Switzerland

Swiss Agency for Therapeutic Products (Swissmedic)

Hallerstrasse 7
Postfach
CH - 3000 Bern 9

 

Accession to PIC May 1971 Accession to PIC Scheme February 1996

Thailand

Food and Drug Administration  (Thai FDA)

Ministry of Public Health
88/24 Tiwanon Road
Nonthaburi 11000
Thailand

 

Accession to PIC Scheme August 2016

Ukraine

 

State Service of Ukraine on Medicines and Drugs Control (SMDC)

120, Peremogy av.

UA - 03115 Kyiv

Ukraine

Accession to PIC Scheme January 2011

United Kingdom

Medicines & Healthcare Products Regulatory Agency (MHRA)

151 Buckingham Palace Road
Victoria
GB - London SW1W 9SZ

 

Accession to PIC May 1971 Accession to PIC Scheme June 1999

United Kingdom

Veterinary Medicines Directorate (VMD)

Woodham Lane, New Haw
Addlestone
GB - Surrey KT15 3LS


Accession to PIC Scheme January 2014


U.S.A

U.S. Food and Drug Administration (US FDA)


10903 New Hampshire Avenue
Building 31, Room 3502
Silver Spring, Maryland  20993

 

Accession to PIC Scheme January 2011