Competent Bodies

Question 1

Austria

Answer 1

Austrian Agency for Health and Food Safety (AGES)

Question 2

Belgium

Answer 2

Federal Agency for Medicines and Health Products (FAMHP)

Question 3

Bulgaria

Answer 3

Bulgarian Drug Agency (BDA)

Question 4

Croatia

Answer 4

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

Question 5

Cyprus

Answer 5

Pharmaceutical services/Ministry of Health

Question 6

Czechia

Answer 6

State Institute for Drug Control (SUKL)

Question 7

Denmark

Answer 7

Danish Medicines Agency (DMA)

Question 8

Estonia

Answer 8

State Agency of Medicine (SAM)

Question 9

Finland

Answer 9

Finnish Medicines Agency (FIMEA)

Question 10

France

Answer 10

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

Question 11

Germany

Answer 11

Federal Institute for Drugs and Medical Devices (BfArM)

Question 12

Greece

Answer 12

National Organization for Medicines (NOM or EOF)

Question 13

Hungary

Answer 13

National Institute of Pharmacy and Nutrition(OGYEL or NIP)

Question 14

Iceland

Answer 14

Icelandic Medicines Agency (IMA)

Question 15

Ireland

Answer 15

Health products Regulatory Agency (HPRA)

Question 16

Italy

Answer 16

Italian Medicines Agency (AIFA)

Question 17

Latvia

Answer 17

State Agency of Medicines(SAM)

Question 18

Liechtenstein

Answer 18

Office of Health/Department of Pharmaceuticals

Question 19

Lithuania

Answer 19

State Medicines Control Agency (VVKT)

Question 20

Luxembourg

Answer 20

Ministry of Health (MoH)

Question 21

Malta

Answer 21

Malta Medicines Authority (MMA)

Question 22

Netherlands

Answer 22

Medicines Evaluation Board (MEB)

Question 23

Norway

Answer 23

Norwegian Medicines Agency(NMA)

Question 24

Poland

Answer 24

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

Question 25

Portugal

Answer 25

National Authority of Medicines and Health Products (INFARMED)

Question 26

Romania

Answer 26

National Authority of Medicines and MedicalDevices of Romania (ANMDMR)

Question 27

Slovakia

Answer 27

State Institute for Drug Control

Question 28

Slovenia

Answer 28

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

Question 29

Spain

Answer 29

Spanish Agency for Medicines and Health Products (AEMPS)

Question 30

Sweden

Answer 30

Swedish Medical Products Agency (MPA)

Question 31

UK

Answer 31

MHRA (Medicinesand Healthcare Products Regulatory Authority)

Question 32

Switzerland

Answer 32

SwissMedic

Question 33

Australia

Answer 33

Therapeutic GoodsAdministration (TGA)

Question 34

New Zealand

Answer 34

Medsafe

Question 35

Thailand

Answer 35

Thailand Food and Drug Administration (TFDA)

Question 36

Malaysia

Answer 36

Medical Device Authority

Question 37

Indonesia

Answer 37

National Agency of Drug and FoodControl (NADFC)

Question 38

Taiwan

Answer 38

Taiwan Food and Drug Administration (TFDA)

Question 39

Canada

Answer 39

Health Canada

Question 40

Mexico

Answer 40

COFEPRIS - The Federal Commission for Protection Against Health Risks

Question 41

South Africa

Answer 41

South African Health Products Regulatory Authority (SAHPRA)

Question 42

China

Answer 42

National Medical Products Administration - NMPA

Question 43

Japan

Answer 43

Pharmaceuticals &Medical Devices Agency

Question 44

Singapore

Answer 44

Health Sciences Authority

Question 45

Hong Kong

Answer 45

Medical Device Control Office (MDCO)

Question 46

India

Answer 46

Central Drugs Standard Control Organization(CDSCO)

Question 47

Brazil

Answer 47

Brazilian National Health Surveillance Agency (ANVISA)

Question 48

Russia

Answer 48

Ministry of Health of the Russian Federation