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Regulatory Focus™ > News Articles > Brazil to Require Notice One Year Prior to Drug Withdrawal

Brazil to Require Notice One Year Prior to Drug Withdrawal

Posted 31 March 2014 | By Louise Zornoza

Drug manufacturers must now provide a year's notice to Brazil's national regulator, Anvisa, prior to withdrawing a drug from the market if that withdrawal might lead to a shortage of the drug. 

The objective of the new mandate, approved on 25 March 2014, is to reduce the potential impact of any drug shortage on the patient population for which the drug is indicated.

The 12-month notice mandate also covers situations where the intent is merely to reduce the level of production or importation of a drug, rather than total marketing withdrawal. If the withdrawal or production reduction would not pose a risk of a shortage, the mandatory notice can be made six months ahead rather than twelve.  There is a 72-hour notice requirement if sudden previously unforeseen circumstances could lead to a drug shortage.


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