President of Costa Rica signs decree that speeds up the sanitary registration of medicines

On June 22, 2022, the president of Costa Rica, Rodrigo Chaves, signed an executive decree that speeds up the registration processes of sanitary registrations of medicines that have already been approved by the United States Food and Drug Administration (FDA) or by the European Medicines Agency (EMA), which would exempt applicants from submitting certain documentation that is required today.

With this, it is sought to speed up the registration process of said sanitary registries, reducing their registration time, which can last up to one year on average.

Among the sanitary registrations benefited by this decree are the following: medicines, dietary supplements, medical devices, foods and cosmetics.

It is important to take into consideration that this decree will enter into force 6 months after its publication in the Official Gazette, and it is until then that the Ministry of Health will have 6 months to draft and approve the regulation that determines how to proceed in those cases that this decree can be applied to.