On March 17, the International Relations Committee of the Legislative Assembly of Costa Rica approved 12 of the 13 amendments proposed to 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 is expected to be discussed in the plenary of the Assembly in the short term.
Among the approved amendments, the following stand out:
- Modification of Article 17 on homologation of sanitary registrations coming from non-OECD countries. The amendment indicates that in the event that a registration holder from 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.
- Modification of article 1 by removing the provision that indicated that the homologation process will be carried out through the official digital platform Regístrelo, and simply establishing that it will be done through the digital platform designated by the Ministry of Health.
- Modification of Article 9 on post-registration changes, adding that the Ministry of Health may review the approved sanitary registrations when there is a doubt that is technically justified.
- Modification of article 3, paragraph 3.3, clarifying in the definition of the labeling that it must be in Spanish.
On the other hand, the only rejected proposal is the proposal to eliminate Article 17, which allows the Costa Rican State to establish the homologation of sanitary registries with non-OECD countries, giving the Ministry of Health the power to stipulate these new homologation processes.
It is worth remembering that the bill mentions among its provisions the documents to be submitted by private companies to request the homologation. It also indicates that the validity of the homologated sanitary registrations will run from the date on which the homologation 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.