Knowledge (XXG)

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

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221:, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to sign agreements with other countries seeking to join PIC. As a consequence the Pharmaceutical Inspection Co-operation Scheme was formed on 2 November 1995. The Pharmaceutical Inspection Co-operation Scheme is an informal agreement between health authorities instead of a formal treaty between countries. PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S. PIC/S became operational in November 1995. 461: 1413: 324: 432: 374: 532: 37: 1506: 1093: 1537: 969: 1313: 271: 1337: 1121: 1237: 995: 787: 724: 298: 1437: 1285: 1261: 1190: 1016: 1482: 1216: 837: 766: 745: 609: 588: 564: 485: 348: 1458: 1145: 1065: 943: 861: 698: 511: 1794: 1044: 672: 816: 1389: 1169: 633: 404: 1361: 919: 882: 652: 224:
Since its conception until 2003, PIC/S did not have a distinct legal identity. Its Secretariat was provided by the European Free Trade Association. Based on PIC/S meeting in June 2003, its committee decided to constitute itself as a Swiss Association in accordance with article 60 of the
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Equivalent principles of inspection methodology, so that it is understood that inspectors in each member country will be following the same best practices when carrying out inspections.
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Mutual recognition of inspection between member countries, so that an inspection carried out by officials of one member country will be recognized as valid by other members.
189:) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of 36: 1323: 384: 1492: 1371: 1468: 929: 230: 1835: 1570: 1423: 471: 847: 1103: 414: 1713: 1547: 1854: 1576: 1521: 1399: 1347: 1271: 542: 334: 1859: 1026: 210: 76: 1582: 255: 1874: 190: 1155: 1828: 1587: 1247: 892: 215:
Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products
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Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices
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Logo of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
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which refer to other internationally active organizations established in Switzerland such as the
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Santé Canada Direction générale des opérations réglementaires et de l'application de la loi
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Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail
233:(ICRC). On 1 January 2004, PIC/S established its own Secretariat in Geneva, Switzerland. 1511: 537: 466: 86: 183:
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
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Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
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Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten
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The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the
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Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM)
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Javna agencija Republike Slovenije za zdravila in medicinske pripomočke
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Directorate General for Animal Health and Veterinary Medicinal Products
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Lines of communication between member country inspectors/inspectorates.
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Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
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PIC/S has a number of provisions intended to establish the following:
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Institute for Standardization and Control of Pharmaceuticals (ISCP)
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Agence nationale de sécurité du médicament et des produits de santé
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European Federation of Pharmaceutical Industries and Associations
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European Federation of Pharmaceutical Industries and Associations
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The following are the state members of PIC/S as of October 2021:
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Direzione generale della sanità animale e dei farmaci veterinari
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Agency for Food, Environmental & Occupational Health Safety
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French National Agency for Medicines and Health Products Safety
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Comisión Federal para la Protección contra Riesgos Sanitarios
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Agency for Medicinal Products and Medical Devices of Croatia
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Federal Commission for the Protection against Sanitary Risk
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National Agency for Medicines and Medical Devices (NAMMD)
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Autoridade Nacional do Medicamento e Produtos de Saúde IP
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Agence Fédérale des Médicaments et des Produits de Santé
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Agencia Española de Medicamentos y Productos Sanitarios
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National Authority of Medicines and Health Products, IP
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Intergovernmental organizations established by treaty
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Pharmaceutical Research and Manufacturers of America
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Pharmaceutical Research and Manufacturers of America
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National Institute of Pharmacy and Nutrition (OGYÉI)
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Medicines and Healthcare products Regulatory Agency
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You can help Knowledge (XXG) by 1648:Brunner, Daniel (September 2004). 1108:Inspectie Gezondheidszorg en Jeugd 1104:Health and Youth Care Inspectorate 1032:Bahagian Regulatori Farmasi Negara 311:Instituto Nacional de Medicamentos 25: 1548:U.S. Food and Drug Administration 1792: 1577:Corrective and preventive action 1535: 1522:Veterinary Medicines Directorate 1504: 1480: 1456: 1435: 1411: 1387: 1359: 1348:Ministry of Food and Drug Safety 1335: 1311: 1283: 1272:State Institute for Drug Control 1259: 1235: 1214: 1188: 1167: 1143: 1119: 1091: 1063: 1042: 1014: 993: 967: 941: 917: 880: 859: 835: 814: 785: 776:Icelandic Medicines Agency (IMA) 764: 743: 722: 696: 670: 631: 607: 586: 562: 543:State Institute for Drug Control 530: 509: 483: 459: 430: 402: 372: 346: 335:Therapeutic Goods Administration 322: 296: 1400:Swedish Medical Products Agency 1054:Malta Medicines Authority (MMA) 598:State Agency of Medicines (SAM) 547:Státní Ústav pro Kontrolu Léčiv 521:Pharmaceutical Services (CyPHS) 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Index

Pharmaceutical Inspection Convention

Intergovernmental organization
Pharmaceutical
Geneva
Switzerland
46°12′18″N 6°09′30″E / 46.2050823°N 6.158363°E / 46.2050823; 6.158363
www.picscheme.org
Good Manufacturing Practices
regulatory authorities
pharmaceutical industry
European Free Trade Association
European law
Swiss Civil Code
International Committee of the Red Cross
Good Manufacturing Practices

Argentina
Australia
Therapeutic Goods Administration
Austria
Belgium
Federal Agency for Medicines and Health Products
Brazil
National Health Surveillance Agency
Canada
Health Canada
Chinese Taipei
Food and Drug Administration
Croatia

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