In order to improve the link between applications for addition to their respective applications of origin, as well as to reduce the timeline and standardize these procedures, ANVISA have informed that, from November, applications for additional data of Drug Products (DP) and Active Pharmaceutical Ingredients (API) Marketing Authorization and/or Variation, as well as application related to Clinical Trials must be submitted by the electronic system, called “Sistema Solicita”.

It is important to mention that, according to Brazilian Legislation RDC 204/2005, additions are tools to be used as a complement to the process related to a specific subject, which is limited to improving knowledge of the object of the process, not resulting in different information than the one requested.

Access the complete new on ANVISA’s website: https://bit.ly/3G6dPpR.

Count on Vita to assist your company in developing drug products registration and post-registration projects in Latin America.