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Any change arising from the primary change has to be noti ed separately Consequential changes form part of the same noti cation whereas parallel changes do not A consequential change to type IA can only be another type IA whereas a consequential change to type IB can be type IA or type IB All other variations should be submitted as Type II variations Guideline on Dossier Requirements for Type IA and Type IB Noti cations provides a complete list of all changes, conditions required to be met for the particular change, and documentation required by the regulatory authority [10] 1333 Regulatory Guidance on SUPAC by Agencia Nacional de Vigilancia Sanitaria Agencia Nacional de Vigilancia Sanitara (ANVISA) issues Brazil s generic drug policy.
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