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International Regulatory Affairs > Competent Bodies > Flashcards

Competent Bodies Flashcards

1
Q

Austria

A

Austrian Agency for Health and Food Safety (AGES)

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2
Q

Belgium

A

Federal Agency for Medicines and Health Products (FAMHP)

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3
Q

Bulgaria

A

Bulgarian Drug Agency (BDA)

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4
Q

Croatia

A

Agency for medicinal products and medical devices of Croatia (HALMED)

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5
Q

Cyprus

A

Pharmaceutical services/Ministry of Health

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6
Q

Czechia

A

State Institute for Drug Control (SUKL)

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7
Q

Denmark

A

Danish Medicines Agency (DMA)

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8
Q

Estonia

A

State Agency of Medicine (SAM)

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9
Q

Finland

A

Finnish Medicines Agency (FIMEA)

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10
Q

France

A

National Agency for the Safety of Medicine and Health Products (ANSM)

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11
Q

Germany

A

Federal Institute for Drugs and Medical Devices (BfArM)

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12
Q

Greece

A

National Organization for Medicines (NOM or EOF)

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13
Q

Hungary

A

National Institute of Pharmacy and Nutrition(OGYEL or NIP)

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14
Q

Iceland

A

Icelandic Medicines Agency (IMA)

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15
Q

Ireland

A

Health products Regulatory Agency (HPRA)

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16
Q

Italy

A

Italian Medicines Agency (AIFA)

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17
Q

Latvia

A

State Agency of Medicines(SAM)

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18
Q

Liechtenstein

A

Office of Health/Department of Pharmaceuticals

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19
Q

Lithuania

A

State Medicines Control Agency (VVKT)

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20
Q

Luxembourg

A

Ministry of Health (MoH)

21
Q

Malta

A

Malta Medicines Authority (MMA)

22
Q

Netherlands

A

Medicines Evaluation Board (MEB)

23
Q

Norway

A

Norwegian Medicines Agency(NMA)

24
Q

Poland

A

Office for Registration of Medicinal Products, MedicalDevices, and Biocidal Products (URPL)

25
Q

Portugal

A

National Authority of Medicines and Health Products (INFARMED)

26
Q

Romania

A

National Authority of Medicines and MedicalDevices of Romania (ANMDMR)

27
Q

Slovakia

A

State Institute for Drug Control

28
Q

Slovenia

A

Agency for Medicinal Products and MedicalDevices of the Republic of Slovenia (JAZMP)

29
Q

Spain

A

Spanish Agency for Medicines and Health Products (AEMPS)

30
Q

Sweden

A

Swedish Medical Products Agency (MPA)

31
Q

UK

A

MHRA (Medicinesand Healthcare Products Regulatory Authority)

32
Q

Switzerland

A

SwissMedic

33
Q

Australia

A

Therapeutic GoodsAdministration (TGA)

34
Q

New Zealand

35
Q

Thailand

A

Thailand Food and Drug Administration (TFDA)

36
Q

Malaysia

A

Medical Device Authority

37
Q

Indonesia

A

National Agency of Drug and FoodControl (NADFC)

38
Q

Taiwan

A

Taiwan Food and Drug Administration (TFDA)

39
Q

Canada

A

Health Canada

40
Q

Mexico

A

COFEPRIS - The Federal Commission for Protection Against Health Risks

41
Q

South Africa

A

South African Health Products Regulatory Authority (SAHPRA)

42
Q

China

A

National Medical Products Administration - NMPA

43
Q

Japan

A

Pharmaceuticals &Medical Devices Agency

44
Q

Singapore

A

Health Sciences Authority

45
Q

Hong Kong

A

Medical Device Control Office (MDCO)

46
Q

India

A

Central Drugs Standard Control Organization(CDSCO)

47
Q

Brazil

A

Brazilian National Health Surveillance Agency (ANVISA)

48
Q

Russia

A

Ministry of Health of the Russian Federation

International Regulatory Affairs (1 decks)

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