Management of registrations, renewals, post-registration, and regional mutual recognition of natural medicinal products for human use under Central American Technical Regulation RTCA 11.03.64:19.
The registration of natural medicinal products contemplates different types of procedures depending on the product situation. Saluvexis manages all four types under current regulations.
In addition to initial registration, Saluvexis manages the mutual recognition of sanitary registrations of natural medicinal products for human use under Annex 2 of Resolution Nº 472-2023 (COMIECO-EX).
This allows manufacturers who already have registrations in Central American countries to accelerate their entry to the Costa Rican market.
Procedures are conducted on the official Regístrelo platform of the Costa Rican Ministry of Health (https://v2.registrelo.go.cr).
Analysis of regulatory feasibility
Dossier compilation under RTCA 11.03.64:19
Management via Regístrelo platform
Renewals, post-registration, and modifications
Inquire about mutual recognition to accelerate your entry to Costa Rica.
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