New rules regarding medicine leaflets must be observed by the pharmaceutical industry starting in February
On February 6, 2024, the regulation of the National Health Surveillance Agency (“Anvisa”), RDC No 831/2023, which amends RDC No 47/2009, will come into effect. Both RDC 831/2023 and RDC 47/2009 establish the rules for the preparation, harmonization, updating, publication, and availability of medicine leaflets for patients and healthcare professionals. The regulations also define the requirements for content, format, language, and presentation of the leaflets, as well as the deadlines and procedures for their updating and availability.
Report of Personal Data Security Incident in Pix Payment Arrangements
See our Technology and Data Protection Bulletin on BACEN Resolution 342/2023, which addresses the obligation for Pix Participants to report security incidents and imposes penalties in the event of a security breach.
