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Regulatory Focus™ > News Articles > Anvisa Proposes Mandatory Notice for Manufacturing Suspension

Anvisa Proposes Mandatory Notice for Manufacturing Suspension

Posted 28 June 2013 | By Ansis Helmanis

The Board of Brazil's National Agency for Sanitary Surveillance (Anvisa) has opened a consultation on a proposal that would require companies to provide at least 180 days of advance notice to Anvisa prior to discontinuing, reducing or temporarily suspending the manufacture or importation of essential drugs. 

In cases where the action is being taken due to technical reasons that could impact drug quality, safety and/or efficacy, notice would have to be provided to Anvisa within 24 hours of the suspension. The reasons for the manufacturer's action will be posted on the agency's website, with information as well as to expected resumption of manufacture or importation.

If there would be a risk of a drug shortage, Anvisa would expedite marketing approval of drug substitutes.


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