Brazil: New Drug and Device Import Rules Issued
| Posted: 13 August 2012
By Ansis Helmanis, RegLink
New import rules (RDC 43) released by Brazilian regulatory authority Anvisa on 6 August clarify that products subject to regulation may obtain import approval if the import license application is not examined within five working days from the date of request by the importer.
The new rules cover situations where a labor strike—such as the one recently launched by many Anvisa regulators—or other event slows down the import administrative process or when there is insufficient storage capacity for cargo in shipping ports and airports.
The goods may only be removed and transported from the port or airport to the storage location indicated by the importer, after signing an Anvisa disclaimer. Failure to comply with the requirements set forth in the new rules may result in the assessment of penalties against the importer.
Anvisa – RDC 43
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