Brazil Tightens Outsourcing Restrictions Just Months After Easing Them
ANVISA's new resolution requires that companies importing finished drug products have their own quality control laboratory and warehouse.
You may also be interested in...
A recap of the latest Rx regulatory developments this summer (or winter) from Latin America regulators.
Brazilian drug regulator Anvisa has made some changes over the years, but still restricts companies with approved Rx products from licensing them to another company.
Anvisa is in the process of trying to reduce some of its red tape, but the excessive bureaucracy at COFEPRIS is likely to remain in place for the foreseeable future.