List of Regulatory Authorities for Purposes of Section C.01.050 of the Food and Drug Regulations
Section C.01.050 of the Food and Drug Regulations requires DIN and NOC holders to submit information to Health Canada that they receive or become aware of regarding actions taken in foreign countries. This "List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations" contains three parts and supports the regulation. Part A where risk communications from these countries are reportable; Part B where label changes are reportable; and Part C where recalls, reassessment and suspensions or revocations of market authorization are reportable.
Regulatory Authority |
Country |
|---|---|
The United States Food and Drug Administration |
United States of America |
The European Medicines Agency |
European Commission |
The Australian Therapeutic Goods Administration |
Australia |
Australian Pesticides and Veterinary Medicines Authority |
Australia |
Ministry of Primary Industries |
New Zealand |
Swiss Agency for Therapeutic Products |
Switzerland |
Health Sciences Authority |
Singapore |
Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care, BASG) |
Austria |
Federal Agency for Medicines and Health Products |
Belgium |
Pharmaceutical Services, Ministry of Health |
Cyprus |
Státní Ústav pro Kontrolu Léčiv (SÚKL) - State Institute for Drug Control - Institut national de contrôle des médicaments |
Czech Republic |
Laegemiddelsstyrelsen (Danish Health and Medicines Authority) |
Denmark |
State Agency of Medicines, Estonia (SAM) |
Estonia |
Lääkealan turvallisuus- ja kehittämiskeskus, Finnish Medicines Agency, Fimea |
Finland |
Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
France |
Agence nationale du médicament vétérinaire |
France |
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten |
Germany |
Bundesministerium für Gesundheit |
Germany |
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit |
Germany |
National Organization for Medicines |
Greece |
Gyógyszerészeti és Egészségügyi Minőség - és Szervezetfejlesztési Intézet Országos Gyógyszerészeti Intézet Főigazgatósága (Short name: GYEMSZI-OGYI) National Institute for Quality and Organizational Development in Healthcare and Medicines (Institut national de pharmacie) [INP] |
Hungary |
State Agency of Medicines |
Latvia |
State Medicines Control Agency |
Lithuania |
Inspectie voor de Gezondheidszorg (IGZ) Health Care Inspectorate |
Netherlands |
Health Products Regulatory Authority (HPRA) |
Ireland |
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Poland |
Main Pharmaceutical Inspectorate |
Poland |
Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED) - National Authority of Medicines and Health Products I.P. - Autorité nationale des médicaments et des produits de santé |
Portugal |
Italian Medicines Agency (AIFA) |
Italy |
Medicines Authority |
Malta |
National Medicines Agency |
Romania |
SIDC/State Institute For Drug Control |
Slovak Republic |
Agencija za zdravila in medicinske pripomočke - Agency for Medicinal Products and Medical Devices of the Republic of Slovenia |
Slovenia |
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) - Spanish Agency of Medicines and Health Products - Agence Espagnole des Médicaments et des Produits de Santé |
Spain |
Medical Products Agency |
Sweden |
Medicines and Healthcare products Regulatory Agency (MHRA) |
United Kingdom |
Veterinary Medicines Directorate |
United Kingdom |
Lyfjastofnun/Icelandic Medicines Agency (IMA) |
Iceland |
Amt für Gesundheit (AG) |
Liechtenstein |
Norwegian Medicines Agency (NoMA) |
Norway |
Ministry of Agriculture, Forestry and Fisheries |
Japan |
Regulatory Authority |
Country |
|---|---|
The United States Food and Drug Administration |
United States of America |
The European Medicines Agency |
European Commission |
The Australian Therapeutic Goods Administration |
Australia |
Australian Pesticides and Veterinary Medicines Authority |
Australia |
Ministry of Primary Industries |
New Zealand |
Swiss Agency for Therapeutic Products |
Switzerland |
Health Sciences Authority |
Singapore |
Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care, BASG) |
Austria |
Federal Agency for Medicines and Health Products |
Belgium |
Pharmaceutical Services, Ministry of Health |
Cyprus |
Státní Ústav pro Kontrolu Léčiv (SÚKL) - State Institute for Drug Control - Institut national de contrôle des médicaments |
Czech Republic |
Laegemiddelsstyrelsen (Danish Health and Medicines Authority) |
Denmark |
State Agency of Medicines, Estonia (SAM) |
Estonia |
Lääkealan turvallisuus- ja kehittämiskeskus, Finnish Medicines Agency, Fimea |
Finland |
Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
France |
Agence nationale du médicament vétérinaire |
France |
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten |
Germany |
Bundesministerium für Gesundheit |
Germany |
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit |
Germany |
National Organization for Medicines |
Greece |
Gyógyszerészeti és Egészségügyi Minőség - és Szervezetfejlesztési Intézet Országos Gyógyszerészeti Intézet Főigazgatósága (Short name: GYEMSZI-OGYI) National Institute for Quality and Organizational Development in Healthcare and Medicines (Institut national de pharmacie) [INP] |
Hungary |
State Agency of Medicines |
Latvia |
State Medicines Control Agency |
Lithuania |
Inspectie voor de Gezondheidszorg (IGZ) Health Care Inspectorate |
Netherlands |
Health Products Regulatory Authority (HPRA) |
Ireland |
Office for Registration of Medicinal Products, |
Poland |
Main Pharmaceutical Inspectorate |
Poland |
Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED) - National Authority of Medicines and Health Products I.P. - Autorité nationale des médicaments et des produits de santé |
Portugal |
Italian Medicines Agency (AIFA) |
Italy |
Medicines Authority |
Malta |
National Medicines Agency |
Romania |
SIDC/State Institute For Drug Control |
Slovak Republic |
Agencija za zdravila in medicinske pripomočke - Agency for Medicinal Products and Medical Devices of the Republic of Slovenia |
Slovenia |
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) - Spanish Agency of Medicines and Health Products - Agence Espagnole des Médicaments et des Produits de Santé |
Spain |
Medical Products Agency |
Sweden |
Medicines and Healthcare products Regulatory Agency (MHRA) |
United Kingdom |
Veterinary Medicines Directorate |
United Kingdom |
Lyfjastofnun/Icelandic Medicines Agency (IMA) |
Iceland |
Amt für Gesundheit (AG) |
Liechtenstein |
Norwegian Medicines Agency (NoMA) |
Norway |
Ministry of Agriculture, Forestry and Fisheries |
Japan |
Regulatory Authority |
Country |
|---|---|
The United States Food and Drug Administration |
United States of America |
The European Medicines Agency |
European Commission |
The Australian Therapeutic Goods Administration |
Australia |
Australian Pesticides and Veterinary Medicines Authority |
Australia |
Ministry of Primary Industries |
New Zealand |
Swiss Agency for Therapeutic Products |
Switzerland |
Health Sciences Authority |
Singapore |
Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care, BASG) |
Austria |
Federal Agency for Medicines and Health Products |
Belgium |
Pharmaceutical Services, Ministry of Health |
Cyprus |
Státní Ústav pro Kontrolu Léčiv (SÚKL) - State Institute for Drug Control - Institut national de contrôle des médicaments |
Czech Republic |
Laegemiddelsstyrelsen (Danish Health and |
Denmark |
State Agency of Medicines, Estonia (SAM) |
Estonia |
Lääkealan turvallisuus- ja kehittämiskeskus, Finnish Medicines Agency, Fimea |
Finland |
Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
France |
Agence nationale du médicament vétérinaire |
France |
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten |
Germany |
Bundesministerium für Gesundheit |
Germany |
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit |
Germany |
National Organization for Medicines |
Greece |
Gyógyszerészeti és Egészségügyi Minőség - és Szervezetfejlesztési Intézet Országos Gyógyszerészeti Intézet Főigazgatósága |
Hungary |
State Agency of Medicines |
Latvia |
State Medicines Control Agency |
Lithuania |
Inspectie voor de Gezondheidszorg (IGZ) Health Care Inspectorate |
Netherlands |
Health Products Regulatory Authority (HPRA) |
Ireland |
Office for Registration of Medicinal Products, |
Poland |
Main Pharmaceutical Inspectorate |
Poland |
Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED) - National Authority of Medicines and Health Products I.P. - Autorité nationale des médicaments et des produits de santé |
Portugal |
Italian Medicines Agency (AIFA) |
Italy |
Medicines Authority |
Malta |
National Medicines Agency |
Romania |
SIDC/State Institute For Drug Control |
Slovak Republic |
Agencija za zdravila in medicinske pripomočke - Agency for Medicinal Products and Medical Devices of the Republic of Slovenia |
Slovenia |
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) - Spanish Agency of Medicines and Health Products - Agence Espagnole des Médicaments et des Produits de Santé |
Spain |
Medical Products Agency |
Sweden |
Medicines and Healthcare products Regulatory Agency (MHRA) |
United Kingdom |
Veterinary Medicines Directorate |
United Kingdom |
Lyfjastofnun/Icelandic Medicines Agency (IMA) |
Iceland |
Amt für Gesundheit (AG) |
Liechtenstein |
Norwegian Medicines Agency (NoMA) |
Norway |
Ministry of Agriculture, Forestry and Fisheries |
Japan |
Page details
- Date modified: