PICS 认证的成员.doc

A. PARTICIPATING AUTHORITIES : Argentinian National Institute of DrugsInstituto Nacional de Medicamentos (INAME) Inspection Department Avda. Caseros 2161 1er Piso AR - C1264AAB Buenos AiresArgentina Australian Therapeutic Goods Administration (TGA) Departement of HealthOffice of Manufacturing Quality PO Box 100AU - Woden Act 2606Australia Austrian Medicines and Medical Devices Agencysterreichische Agentur fr Gesundheit und Ernhrungs-sicherheit (AGES)Traisengasse 5, AT - 1200 ViennaAustria Belgian Federal Agency for Medicines and Health ProductsAgence Fdrale des Mdicaments et des Produits de Sant (AFMPS)Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) EUROSTATION Building, block 2Place Victor Horta, 40/40BE - 1060 BruxellesBelgium Canadian Health Products and Food Branch Inspectorate (HPFBI)Health CanadaGraham Spry Building, 7th Floor, Room 710 250 Lanark Avenue, AL 2007BCA - Ottawa, Ontario, K1A 0K9Canada Taiwan Food and Drug Administration (TFDA)Department of HealthNo. 161-2, Kunyang St.Nangang DistrictTW - 115-61 Taipei CityChinese Taipei As from 1 January 2016Agency for Medicinal Products and Medical Devices of Croatia Agencija za lijekove i medicinske proizvode (HALMED)Ksaverska cesta 4HR - 10 000 ZagrebCroatia Cypriot Pharmaceutical Services (CyPHS)Ministry of Health 1475 Lefkosia (Nicosia)Cyprus Czech State Institute for Drug ControlSttn stav pro Kontrolu Liv (SKL) Srobrova 48CZ - 100 41 Prague 10Czech Republic Czech Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM)Hudcova 56ACZ - 621 00 BrnoCzech Republic Danish Health and Medicines Authority (DHMA)1 Axel Heides GadeDK - 2300 Copenhagen SDenmark Estonian State Agency of Medicines (SAM)1 Nooruse Str.EE - 50411 TartuEstonia Finnish Medicines Agency (FIMEA)Mannerheimintie 103bP.O. Box 55FI - 00034 FIMEA HelsinkiFinland French National Agency for Medicines and Health Products SafetyAgence nationale de scurit du mdicament et des produits de sant (ANSM)143-145 Boulevard Anatole FranceFR - 93285 Saint DenisFrance French Agency for Food, Environmental & Occupational Health SafetyAgence nationale de scurit sanitaire de lalimentation, de lenvironnement et du travail (ANSES)14, rue Pierre et Marie Curie FR - 94701 Maisons-Alfort cedex France German Federal Ministry of Health * Bundesministerium fr Gesundheit (BMG) Rochusstr. 1DE 53123 BonnGermany Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices * Zentralstelle der Lnder fr Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) Heinrich-Boll-Ring 10DE - 53119 BonnGermany * 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. Greek National Organisation for Medicines (EOF) Messoghion Ave 284GR - Holargos 155 62 (ELLAS)Greece 香港藥劑業及毒藥管理局 Pharmacy and Poisons Board of Hong Kong As from 1 January 2016Pharmacy and Poisons Board of Hong Kong (PPBHK)1/F Shun Feng International Centre182 Queens Road EastWan ChaiHong Kong Hungarian National Institute of Pharmacy and Nutrition (NIPN)Zrnyi u. 3. 1372 P.O. Box 450 HU - 1051 BudapestHungary Icelandic Medicines Agency (IMA)Vnlandslei 14 IS - 113 Reykjavik Iceland Indonesian National Agency for Drug and Food Control(NADFC)(Badan Pengawas Obat dan Makanan Republik Indonesia)Jl. Percetakan Negara No.23ID - Jakarta 10560 Indonesia Health Products Regulatory Authority (HPRA)Kevin OMally HouseEarlsfort Centre Earlsfort TerraceIE - Dublin 2Ireland Israeli Institute for Standardization and Control of Pharmaceuticals (ISCP) Eliav St. 9, P.O. Box 34410IL - Jerusalem 91342Israel Italian Medicines Agency Agenzia Italiana del Farmaco (AIFA)Via del Tritone, 181 IT - 00187 RomeItaly Japanese Ministry of Health, Labour and Welfare (MHLW) *1-2-2 Kasumigaseki Chiyoda-kuJP - 100-8916 TokyoJapan Japanese Pharmaceuticals and Medical Devices Agency (PMDA) *Shin-Kasumigaseki Building3-3-2 Kasumigaseki Chiyoda-kuJP - 100-0013 TokyoJapan * Japans Ministry of Health, Labour and Welfare (MHLW) and Japans Pharmeuticals and Medical Devices Agency (PMDA) count as one PIC/S Participating Authority. The Japanese Prefectures are represented by MHLW. Korea (Republic of) Ministry of Food and Drug Safety (MFDS)Osong Health Technology Administration Complex187 Osongsaengmyeong2(i)-roOsong-eup, Cheongwon-gun, ChungbukKR 363-700Korea Latvian State Agency of MedicinesZu valsts aentra (ZVA) 15, Jersikas St.LV - 1003 RigaLatvia Liechtensteins Office of Healthcare Amt fr Gesundheit (AG)ulestrasse 51Postfach 684FL - 9490 VaduzLiechtenstein Lithuanian State Medicines Control Agency (SMCA)irmnstr. 139A LT 09120 VilniusLithuania Malaysian National Pharmaceutical Control Bureau (NPCB)Ministry of Health MalaysiaJalan Universiti PO Box 31946730 Petaling JayaMY SELANGORMalaysia Maltese Medicines Authority (MAM) 198, Rue DArgensMT GZIRA GZR 1368 Malta 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. New Zealands Medicines and Medical Devices Safety Authority (Medsafe) P.O. Box 5013 NZ - 6011 WellingtonNew Zealand Norwegian Medicines Agency (NOMA)Postboks 63, KalbakkenNO - 0901 OsloNorway Polish Main Pharmaceutical Inspectorate (MPI) 12 Senatorska Street PL - 00-082 WarsawPoland Portuguese National Authority of Medicines and Health Products, IP Autoridade Nacional do Medicamento e Produtos de Sade IP (INFARMED IP ) Avenida do Brasil, no 53Pavilho 21-APT - 1700 LisbonPortugal Romanian National Agency for Medicines and Medical Devices(NAMMD)Strada Maior Aviator Sanatescu 48Sectorul IRO - Bucharest ZIPCODE 011478Romani Singapores Health Sciences Authority (HSA) 150 Cantonment Road, Cantonment Centre,Blk A # 01-02SG Singapore 089762 Slovak State Institute for Drug Control (SIDC) Kvetn 11SK - 825 08 Bratislava 26Slovak Republic Slovenian Agency for Medicinal Products and Medical DevicesJavna agencija Republike Slovenije za zdravila in medicinske pripomoke (JAZMP)Ptujska ulica 21SI-1000 LjubljanaSlovenija South African Medicines Control Council (MCC)Private Bag X 828ZA 0001 PretoriaSouth Africa Spanish Agency of Medicines and Medical Devices *Agencia Espaola de Medicamentos y Productos Sanitarios (AEMPS) Departamento de Inspeccin y Control de Medicamentos C/ Campezo, 1ES - 28022 MadridSpain * 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. Swedish Medical Products Agency (MPA)Box 26SE - 751 03 UppsalaSweden Swiss Agency for Therapeutic Products (Swissmedic)Hallerstrasse 7PostfachCH - 3000 Bern 9Switzerland Ukrainian State Administration on Medicinal Products(SAUMP)