Brazilian Regulatory Authorities to Expedite Minor Labeling Changes

Posted 17 December 2012 | By Ansis Helmanis 

Brazil's national regulatory authority, Anvisa, has announced that its Board has approved an amendment that will permit its regulators to immediately approve minor labeling changes upon notice by a pharmaceutical company.

The new rule, approved 12 December 2012, covers changes that pose no risk to the consumer such as safety information and packaging color, size, and layout of patient leaflets and package labeling.

According to the CEO of Anvisa, Dirceu Barbano, the new measure accelerates the regulatory processing of issues that do not require a detailed analysis, allowing the agency to concentrate its resources on more important issues such as the registration of new drugs and generics. 

Under the new notification process, a company will be able put the drug with the labeling changes on the market immediately after submitting a notice to Anvisa of the nature of the changes.  Anvisa has the option to review the notification at any time or at the time of renewal of the registration of the product, and may take appropriate regulatory action if it finds any concerns with the labeling changes.


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