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.

Part A - Where risk communications from these countries 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

Part B - Where label changes 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

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

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