Who approves? RDC 21 stirs the pot
It bluntly violates the World Trade Organization TRIPS Agreement, the Paris Convention, the Brazilian patent law and the country’s 1988 Constitution. Regulation RDC 21 of 2013 amends regulation RDC 48 of 2008, which established ANVISA’s procedures for the prior approval for the grant of pharmaceutical applications claiming pharmaceutical products or processes under the statutory authority of Article 229-C of the Brazilian patent statute.
