Fukuma Advogados & Consultores

It was published on this date, the Resolution of the Collegiate Board – RDC No. 327/2019, which establishes the procedures and requirements for granting Sanitary Authorization for manufacturing, marketing, prescription, dispensing, monitoring and supervision of Cannabis products for medicinal purposes. It defines the category of Cannabis Product: industrialized product, object of Sanitary Authorization by ANVISA, intended for medicinal […]

It was published in the Official Gazette of 26/02/2019 the Collegiate Board Resolution Nº 268, of  February 25th 2019 proposing a change in Collegiate Board Resolution – RDC nº 234, of June 21st 2018 that rules the outsourcing of production steps, quality control analysis, transportation and storage of medicines and biologic products, and other measures. […]

It was published on the Official Gazette, Section 1, from 10/19/2017, RDC 183 from 10/17/2017 that disposes about programs of inspection and administrative procedures to Grant Good Manufacturing Practices Certification for establishments that manufacture medical devices located abroad and in Mercosul.   This Resolution establishes that ANVISA will evaluate the compliance of GMP primarily through […]

It was published on the Official Gazette, on 09/15/2017, Interpretative Orientation 9, from 09/13/2017, clarifying that the analysis of price approval of drug object of ownership transfer will be initiated only when its registration becomes valid. CMED, through this Orientation, suggests that DIP – Price Informative Document referent to drugs subject to ownership transfer shall […]

The Resolution of the Collegiate Board of Directors No. 166, which provides for the validation of analytical methods, was published on July 25, 2017 in the Official Gazette. The resolution is more detailed than the previous one dealing with the subject, but there have been no changes with regard to the work ranges, need to […]

It was published on 2017.06.19, Official Gazette, the Public Consultation No. 355/2017, which full text was made available on 06.22 and aims to establish new procedures for the approval of clinical studies, good manufacturing practices certificate and registration of drugs intended for treatment, diagnosis and prevention of rare diseases. The deadline for contribution is 30 […]