List of Regulatory Authorities for the Purposes of Section C.01A.019 of the Food and Drug Regulations

Australia

Therapeutic Goods Administration (TGA) of Australia

Pharmaceuticals for human use;

Active ingredients; Drugs listed in Schedules C and D to the Act

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Austria

Bundesamt für Sicherheit im Gesundheitswesen "Federal Office for Safety in Health Care, BASG"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Austria

AGES GmbH (Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH)
"Austrian Agency for Health and Food Safety (AGES) / PharmMed Austria"
Note: Delegated Inspectorate

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Belgium

Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
"Federal Agency for Medicines and Health Products (FAMHP)"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Bulgaria

Изпълнителната агенция по лекарствата

"Bulgarian Drug Agency (BDA)"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Bulgaria

Българска агенция по безопасност на храните

"Bulgarian Food Safety Agency (BFSA)"

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Croatia

Agencija za lijekove i medicinske proizvode (HALMED)

"Agency for Medicinal Products and Medical Devices"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Cyprus

Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας
"Pharmaceutical Services, Ministry of Health"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Cyprus

Κτηνιατρικές Υπηρεσίες, Υπουργείο Γεωργίας
"Veterinary Services, Ministry of Agriculture, Rural Development and Environment"

Pharmaceuticals

for veterinary use;

Drugs listed in Schedules C and D to the Act

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Czech Republic

Státní ústav pro kontrolu liéčiv (SÚKL)

"State Institute for Drug Control"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Czech Republic

Ústav pro Státní Kontrolu Veterinárních Biopreparátù a liéčiv (ÚSKVBL)
"Institute for State Control of Veterinary Biologicals and Medicaments"

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Denmark

Laegemiddelstyrelsen

"Danish Health and Medicines Authority"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Estonia

Ravimiamet

"State Agency of Medicines (SAM)"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Finland

Lääkealan turvallisuus- ja kehittämiskeskus

"Finnish Medicines Agency, FIMEA"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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France

Agence nationale de sécurité du médicament et des produits de santé (ANSM)

"The French National Agency for Medicines and Health Products Safety"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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France

Agence nationale du médicament vétérinaire (ANMV)

"National Agency for Veterinary Medicinal Products"

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Baden-Württemberg

Ministerium für Soziales, Gesundheit und Integration Baden-Württemberg

(Stuttgart)

Regierungspräsidium Tübingen

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Bayern Bayerisches Staatsministerium für Gesundheit und Pflege

(München)

Regierung von Oberbayern

Regierung von Oberfranken

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Berlin Senatsverwaltung für Gesundheit Pflege und Gleichstellung (Berlin)

Landesamt für Gesundheit und Soziales Berlin

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Brandenburg

Ministerium für Soziales, Gesundheit, Integration und Verbraucherschutz des Landes Brandenburg, Abteilung 1 (Postdam)

Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit Potsdam

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Germany

Brandenburg Ministerium für Soziales, Gesundheit, Integration und Verbraucherschutz des Landes Brandenburg, Abteilung 3 (Postdam)

Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit Abteilung Verbraucherschutz Cottbus

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Bremen Die Senatorin für Gesundheit, Frauen und Verbraucherschutz

(Bremen)

Die Senatorin für Gesundheit und Verbraucherschutz Bremen

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Hamburg Behörde für Justiz und Verbraucherschutz der Freien und Hansestadt Hamburg

(Hamburg)

Behörde für Justiz und Verbraucherschutz der Freien und Hansestadt Hamburg

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Hessen Hessisches Ministerium für Soziales und Integration

(Wiesbaden)

Hessisches Landesamt für Gesundheit und Pflege
Abteilung V Darmstadt

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Germany

Hessen Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz (Weisbaden)

Regierungspräsidium Darmstadt

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Mecklenburg-Vorpommern

Ministerium für Soziales, Gesundheit und Sport,

(Schwerin)

Landesamt für Gesundheit und Soziales Arzneimittelüberwachungs- und –prüfstelle

Pharmaceuticals for human use;

Drugs listed in Schedules C and D

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Germany

Mecklenburg-Vorpommern

Ministerium für Klimaschutz, Landwirtschaft, ländliche Räume und Umwelt Schwerin

Landesamt für Landwirtschaft, Lebensmittelsicherheit und Fischerei Rostock

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Niedersachsen Niedersächsisches Ministerium für Soziales, Gesundheit und Gleichstellung (Hannover)

Staatliches Gewerbeaufsichtsamt Braunschweig

Staatliches Gewerbeaufsichtsamt Hannover

Staatliches Gewerbeaufsichtsamt Lüneburg

Staatliches Gewerbeaufsichtsamt Oldenburg

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Nordrhein-Westfalen Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen (Düsseldorf)

Bezirksregierung Arnsberg

Bezirksregierung Detmold

Bezirksregierung Düsseldorf

Bezirksregierung Köln

Bezirksregierung Münster

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Germany

Nordrhein-Westfalen

Ministerium für Landwirschaft und Verbraucherschutz des Landes Nordrhein-Westfalen

(Düsseldorf)

Landesamt für Natur, Umwelt und Verbraucherschutz Nordrhein-Westfalen

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Rheinland-Pfalz

Ministerium für Wissenschaft und Gesundheit (Mainz)

Landesamt für Soziales, Jugend und Versorgung

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Saarland Ministerium für Arbeit, Soziales, Gesundheit, und Frauen des Saarlandes (Saarbrücken)

Ministerium für Arbeit, Soziales, Gesundheit, und Frauen des Saarlandes

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Sachsen

Sächsisches Staatsministerium für Soziales und Gesellschaftlichen Zusammenhalt

(Dresden)

Landesdirektion Sachsen Dienststelle Leipzig

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Sachsen-Anhalt

Ministerium für Arbeit, Gesundheit und Gleichstellung

(Magdeburg)

Landesverwaltungsamt Sachsen-Anhalt Sachsen-Anhalt

Ministerium für Wirtschaft, Tourismus, Landwirtschaft und Forsten (Magdeburg)

Landesverwaltungsamt Sachsen-Anhalt

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Schleswig-Holstein

Ministerium für Justiz und Gesundheit des Landes Schleswig-Holstein

(Keil)

Landesamt für soziale Dienste Schleswig-Holstein

Schleswig-Holstein

Ministerium für Landwirtschaft, ländliche Räume, Europa und Verbraucherschutz (Kiel)

Landesamt für soziale Dienste Schleswig-Holstein

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Germany

Thüringen

Thüringer Ministerium für Arbeit, Soziales, Gesundheit, Frauen und Familie (Erfurt)

Thüringer Landesamt für Verbraucherschutz

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Greece

Ethnikos Organismos Farmakon (EOF) - (ΕΘΝIΚΟΣ ΟΡΓΑΝIΣΜΟΣ ΦΑΡΜΑΚΩΝ))
"National Organization for Medicines"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Hungary

Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI)
"National Institute of Pharmacy and Nutrition"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Hungary

Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (NEBIH ÁTI)
"National Food Chain Safety Office, Directorate of Veterinary Medicinal Products (DVMP)"

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Ireland

Health Products Regulatory Authority (HPRA)

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Italy

Agenzia Italia del Farmaco (AIFA), Ministero della Salute
"Italian Medicines Agency, Ministry of Health"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Italy

Ministero della Salute / Direzione Generale della Sanità Animale e dei Farmaci Veterinari
"Ministry of Health / Direction General for Animal Health and Veterinary Medicinal Products"

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Lithuania

Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos
"State Medicines Control Agency" (SMCA)

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Malta

Medicines Regulatory Authority

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Netherlands

Inspectie Gezondheidszorg en Jeugd (IGJ)
"Health and Youth Care Inspectorate"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Netherlands

Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG)
"Veterinary Medicinal Products Unit, Medicines Evaluation Board (MEB)"

Note: Regulatory Authority

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Netherlands

Inspectie voor de Gezondheidszorg, Ministerie van Volksgezondheid, Welzijn en Sport (VWS)
"Health Care Inspectorate, Ministry of Health, Welfare and Sport (VWS)"

Note: Delegated Inspectorate

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Poland

Główny Inspektorat Farmaceutyczny (GIF)
"Chief Pharmaceutical Inspectorate (CPI)"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Portugal

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

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Portugal

Direcção-Geral de Alimentação e Veterinária (DGAV)
"General Directorate of Food and Veterinary"

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Romania

Agentia Nationala a Medicamentului si a Dispozitivelor Medicale (ANMDM)
"National Agency for Medicines and Medical Devices (NAMMD)"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Slovak Republic

Štátny ústav pre kontrolu liečiv (SUKL)
"State Institute for Drug Control (SIDC)"

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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Slovak Republic

Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL), Ministerstvo pôdohospodárstva
"Institute for State Control of Veterinary Biologicals and Medicaments (ISCVBM), Ministry of Agriculture"

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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Slovenia

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
"Agency for Medicinal Products and Medical Devices of the Republic of Slovenia"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Spain

Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
"Spanish Agency of Medicines and Health Products"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Sweden

Läkemedelsverket
"Medical Products Agency"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Iceland

Lyfjastofnun
"Icelandic Medicines Agency"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Lichtenstein

Amt für Gesundheit (AG), Kontrollstelle für Arzneimittel
"Office of Public Health, Medicinal Products Agency 1"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Norway

Statens Legemiddelverk
"Norwegian Medicines Agency"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Switzerland

Schweizerisches Heilmittelinstitutm (Swissmedic) "Swiss Agency for Therapeutic Products"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Switzerland

Regionales Heilmittelin-spektorat der Nordwestschweiz (RHI NW) "Regional Medicines Inspectorate of Northwestern Switzerland"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Switzerland

Regionale Fachstelle der Ost- und Zentralschweiz (RFS-OZ)
"Regional Medicines Inspectorate of Eastern and Central Switzerland"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Switzerland

Ispettorato regionale die medicamenti della Svizzera del Sud (IRM-S)
"Regional Medicines Inspectorate of Southern Switzerland"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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Switzerland

Inspectorat de Suisse occidentale des produits thérapeutiques (ISOPTh)
"Regional Medicines Inspectorate of Western Switzerland"

Pharmaceuticals for human and veterinary use;

Drugs listed in Schedules C and D to the Act

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United Kingdom

Medicines and Healthcare Products Regulatory Agency (MHRA)

Pharmaceuticals for human use;

Drugs listed in Schedules C and D to the Act

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United Kingdom

Veterinary Medicines Directorate (VMD)

Pharmaceuticals for veterinary use;

Drugs listed in Schedules C and D to the Act

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