On April 8th, the Brazilian health regulatory agency ANVISA published a Normative Instruction (290/2024), establishing the optimized procedure on the analysis and decision of applications for the registration of medical devices. As already mentioned in our earlier...
Life Sciences
Brazilian FDA (ANVISA) adopts a new regulatory framework for the food industry
On February 28th, the Brazilian regulatory agency ANVISA published the Resolution RDC 843/2024 and the Normative Instruction 281/2024, which provide for the regularization of food and packaging under the competence of the National Health Surveillance System (SNVS)...
Brazilian PTO plans change to patent examination process
On 12 December, the Brazilian PTO (BPTO) patent division issued a statement explaining that the patent application examination queue will be based on the date of the request for examination, which is a processing step that needs to be done within 36 months of the...
New Brazilian Resolution Improves Legal Security for Movement of Microorganisms
On November 13, the CGEN Resolution 41 of October 18, 2023, was published in the Brazilian Government’s Official Gazette. The resolution approved a declaration model establishing that the microorganism intended for transfer abroad is not isolated from substrates of...
ANVISA prohibits importation of the Cannabis plant in natura
Through Technical Note No. 35/2023, ANVISA (the Brazilian National Agency for Sanitary Surveillance – the Brazilian FDA) prohibited the importation of the Cannabis plant in natura, whole or in parts (including its flowers), as of July 20, 2023. This decision does not...
Brazilian PTO publishes the final version of the guidelines for examining inventions related to transgenic plants, especially elite events
As previously reported, in June of last year, the Brazilian PTO opened a public consultation on the technical note regarding patentability requirements for inventions related to transgenic plants, especially elite events. After receiving comments and suggestions from...
New cycle of PPH requests starts in January 2023
On January 01, 2023, a new cycle of requests to participate in the Patent Prosecution Highway (PPH) Program began. The PPH program is a bilateral co-operation agreement between the Brazilian PTO and other Patent Offices in the world (such as, USPTO, EPO, JPO, etc.)...