INSTRUÇÃO NORMATIVA - IN Nº 294, DE 2 DE MAIO DE 2024 (parte 2 de 2)

ANEXO
AUTORIDADE REGULADORA ESTRANGEIRA EQUIVALENTE PARA FINS DE
INSPEÇÃO SANITÁRIA E DE CERTIFICAÇÃO DE BOAS PRÁTICAS DE FABRICAÇÃO (CBPF)
Jurisdição e Autoridade
1. Alemanha - Federal Ministry of Health (BMG) e Central Authority of the
Laender for Health Protection regarding Medicinal Products and Medical Devices (ZLG);
2. Arábia Saudita - Saudi Food and Drug Authority (SFDA);
3. Austria - Austrian Federal Office for Safety in Healthcare;
4. Bélgica - Federal Agency for Medicines and Health Products;
5. Bulgária - Bulgarian Drug Agency (BDA);
6. Canadá - Heath Canada (HC);
7. Cingapura - Health Sciences Authority (HSA);
8. Chipre - Pharmaceutical Services (CyPHS);
9. Coreia do Sul - Ministry of Food and Drug Safety (MFDS);
10. Croácia - Agency for Medicinal Products and Medical Devices of Croatia (Halmed);
11. Dinamarca - Danish Medicines Agency (DKMA);
12. Eslováquia - State Institute of Drug Control (SIDC);
13. Eslovênia - Agency for Medicinal Products and Medical Devices
(JAZMP);
14. Espanha - Spanish Agency of Medicines and Medical Devices
(AEMPS);
15. Estado Unidos da América - U.S Food and Drug Administratio (US FDA);
16. Estônia - State Agency of Medicines (SAM);
17. Finlândia - Finnish Medicines Agency (FIMEA);
18. França - French National Agency for Medicines and Health Products
Safety (ANSM) e Agency of Food, Environmental & Occupational Health Safety
(ANSES);
19. Grécia - Greek National Organisation for Medicines (EOF);
20. Holanda - Health and Youth Care Inspectorate (IGJ);
21. Hungria - National Center for Public Health and Pharmacy (NCPHP);
22. Irlanda - Health Products Regulatory Authority (HPRA);
23. Islândia - Iceland Medicines Agency (IMA);
24. Itália - Italian Medicines Agency (AIFA);
25. Japão - Ministry of Health, Labour and Welfare (MHLW) e
Pharmaceuticals and Medical Devices Agency (PMDA);
26. Letônia - State Agency of Medicines (ZVA);
27. Liechtenstein - Office of Healthcare (AG);
28. Lituânia - State Medicines Control Agency (SMCA);
29. Malta - Malta Medicines Authority (MMA);
30. México - Federal Commission for the Protection Against Sanitary Risks (COFEPRIS);
31. Noruega - Norwegian Medical Products Agency (NOMA);
32. Polonia - Chief Pharmaceutical Inspectorate (CPI);
33. Portugal - National Authority of Medicines and Health Products, IP (Infarmed, IP);
34. Reino Unido - Medicines & Healthcare Products Regulatory Agency (MHRA);
35. República Checa - State Institute for Drug Control (SÚKL) e Institute for
State Control of Veterinary, Biologicals and Medicines (ISCVBM);
36.Romênia-NationalAgencyforMedicinesandMedicalDevicesofRomania(NAMMDR);
37. Suécia - Swedish Medical Products Agency (MPA);
38. Suíca - Swiss Agency for Therapeutic Products (Swissmedic);
39. Turquia - Turkish Medicines and Medical Devices Agency (TMMDA ou TITCK);
40. Taiwan - Taiwan Food and Drug Administration (TFDA);
41. Ucrânia - State Service of Ukraine on Medicines and Drugs Control (SMDC); e
42. União Européia - European Medicines Agency (EMA).