Legislative Assembly publishes harmonized text on homologation of medicines
24 marzo 2022


On March 24, the Legislative Assembly of Costa Rica published the updated text of file 22280 on the homologation of sanitary registrations of medicines from countries that are part of the Organization for Economic Cooperation and Development (OECD). The text includes the 12 modifications approved last March 17 by the International Relations Committee, and will be the new base text for the discussion. The initiative has already been received by the plenary of the Assembly, so it is expected that its discussion will be resumed in the short term.

Among the amendments incorporated is the modification of Article 17, indicating that in the event that a holder of the registry of a non-member country wishes to establish homologation or recognition, the applicant must submit a technical study on the respective country to the Ministry of Health, which must give its approval in order to obtain the endorsement. An amendment to Article 9 on post-registration changes was also incorporated, adding that the Ministry of Health may review approved sanitary registrations when there is a technically justified doubt.

It is worth remembering that the bill mentions among its provisions those documents that must be submitted by the private companies to request the homologation. It also indicates that the validity of the approved sanitary registrations will run from the date on which the approval is approved until the expiration date of the registration granted by the sanitary authority of the country of origin of the product, provided that it does not exceed five years.