New Regulation by Anvisa
Anvisa has approved a new resolution to streamline the registration and importation process for medicines and vaccines related to Mpox. Under the revised regulation, the Ministry of Health can import these products without prior registration, provided they have been approved by major international regulatory bodies such as the WHO, EMA, FDA, MHRA, PMDA, and Health Canada.
The imported medicines and vaccines must meet the conditions set by these regulatory authorities and be produced in facilities accredited by the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
Anvisa’s technical departments will review requests for registration exemptions, with decisions to be made within seven business days. This regulation aims to expedite the import process, enhancing access to essential medicines and vaccines amid the Public Health Emergency of International Concern (PHEIC) declared by the WHO on August 14th.
Regulatory Impact
- Top Priority: Yes
- Type of Certificate: No
- Spectrum Bands: No
- Import Changes HS Codes: No
- Standard Changes: No
- Product Changes: Yes
- Label Changes: No
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |