Brazilian Regulator Proposes Fast Track for Some Postmarket Changes

Brazil’s Anvisa is proposing a simplified process to expedite manufacturers’ postmarket changes to drugs.

Companies seeking to make simple changes, such as changing the corporate name of the manufacturing facility, could do so without petitioning the agency as long as they note the change on the Product Change History form, under draft Technical Resolution No. 18.

Companies could also make immediate changes if they register them on the PCH form as soon as they submit a change petition, says Rodrigo Augusto Oliveira Rocci, a lawyer at Dannemann Siemsen Advogados in São Paulo.

Drugmakers seeking more serious changes, such as relocating the manufacturing process, would need to get Anvisa’s approval before making the change.

The proposal applies to changes manufacturers make to packaging, active pharmaceutical ingredients and manufacturing sites, among others. It would replace Resolution No. 48 and Normative Instruction No. 11, both of which were issued in 2009.

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