BackOn May 31, 2021, a decree was publishedin the Official Gazette of the Federationamending several provisions of the Health Input Regulations(“RIS”).Such modifications are related (i) to the labeling of medicines of the public sector, (ii) the language of the documents that should be submitted before the Federal Commission for the Protection Against Sanitary Risks (“COFEPRIS”), (iii) the Subcommittee for the Evaluation of Biotechnological Products, and (iv) amendments to marketing authorization conditions and extensions of marketing authorizations (the “Decree”).
