MINISTRY OF HEALTH RESOLUTIONS
MS-DM-3979-2025. San José at nine o’clock on the twenty-second of July, two thousand twenty-five.
MINISTERIAL RESOLUTION: PROCEDURE FOR THE FACILITATION OF HEALTH REGISTRATIONS AND POST-REGISTRATION CHANGES OF MEDICINES THAT HAVE A HEALTH REGISTRATION ISSUED BY REGULATORY AUTHORITIES LISTED BY THE WORLD HEALTH ORGANIZATION
WHEREAS:
I. The health of the population is a legal asset protected by the State.
II. The Ministry of Health has the mission to guarantee the protection and improvement of the population’s health status through effective governance and institutional leadership, with a focus on health promotion and social participation, under the principles of transparency, equity, solidarity, and universality.
III. By its constitutional and legal powers, and as part of its governance function, the Ministry of Health must safeguard public health and is obliged to take necessary measures to protect the inhabitants, establishing procedures that ensure optimal standards to fulfill its mission.
IV. According to Articles 2 and 112 of the General Health Law, Law No. 5395, the Ministry of Health must plan and execute activities benefiting public health, including the health registration of medicines when regulatory requirements are met.
V. In accordance with Article 269 of the General Public Administration Law, Law No. 6227, this Ministry must organize and execute its actions under the principle of efficiency.
VI. The general regulations governing the registration of medicines are Executive Decree No. 43259-COMEX-S-MEIC of September 27, 2021, “Central American Technical Regulation RTCA 11.03.59:18 Pharmaceutical Products. Medicines for Human Use. Health Registration Requirements,” Executive Decree No. 37006-S of November 15, 2011, “Technical Regulation RTCR 440:2010. Regulation for the Registration and Control of Biological Medicines,” Executive Decree No. 32470 of February 4, 2005, “Regulation for the Health Registration of Medicines Requiring Demonstration of Therapeutic Equivalence,” Executive Decree No. 37988-S of October 22, 2013, “Regulation for the Operation and Use of the ‘Registrelo’ Portal,” and Executive Decree No. 39294 of June 23, 2015, “Regulation RTCR 470:2014 Pharmaceutical Products, Medicines for Human Use. Administrative Provisions for Bioequivalence, Intellectual Property, Homeopathic Medicines, and Health Registration and Importation.”
VII. Without prejudice to the application of current regulations, establishing a differentiated registration procedure for medicines already registered by regulatory authorities listed by the World Health Organization, which have demonstrated recognized global maturity and performance, as well as post-registration changes of these medicines, is necessary and timely to increase process efficiency while ensuring quality, safety, and efficacy.
VIII. In order to make innovative therapies available to patients who require them through efficient evaluation.
The backlog in the evaluation of medicine health registration applications as of June 2025 is 703 and 1,462 (between chemical synthesis products and biological products), of which approximately 25% are registered with authorities on the specified list. These could be more efficiently evaluated through a procedure focused on the most relevant aspects, as authorized by the entities on the WHO-listed authorities. Therefore, this resolution proposes a differentiated registration procedure to obtain results in a shorter time frame.
IX. This efficiency improvement would benefit both the public and the administration, as the list of pending applications affects everyone, including those submitting other types of applications.
CONSIDERING:
I. It is the duty of the Directorate of Regulation of Products of Sanitary Interest to guarantee access to safe and effective medicines, prioritizing public health interests; therefore, it is necessary to issue a special procedure for these applications to facilitate the health registration of medicines registered by authorities listed by the World Health Organization.
II. The relevance of regulatory authorities listed by the WHO lies in the fact that an authority included in the WHO list (WLA) is a regulatory authority or regional regulatory system documented to meet all relevant indicators and requirements specified by the WHO for the requested scope of inclusion, based on a comparative assessment and performance evaluation process, including verification of consistent implementation of good regulatory practices over time.
III. The procedure established in this Resolution for the health registration of medicines and post-registration changes for medicines registered by authorities listed by the WHO offers the public a faster administrative procedure with reduced resolution time.
For the above reasons, it is necessary and timely to issue the “PROCEDURE FOR THE FACILITATION OF HEALTH REGISTRATIONS AND POST-REGISTRATION CHANGES OF MEDICINES THAT HAVE A HEALTH REGISTRATION ISSUED BY REGULATORY AUTHORITIES LISTED BY THE WORLD HEALTH ORGANIZATION” and its respective implementation.
THEREFORE, THE MINISTER OF HEALTH RESOLVES:
First: Establish the procedure for facilitating health registrations and post-registration changes for medicines with health registration issued by authorities listed by the WHO.
Second: Facilitation will apply to the registration of medicines registered by WHO-listed authorities and to subsequent changes meeting equivalent requirements. It does not apply to homeopathic medicines, radiopharmaceuticals, or medicinal natural products.
Third: Definitions of WHO authority, list of authorities, and registration facilitation.
Fourth: Step-by-step procedure for verification, evaluation, and post-registration changes.
Fifth: Resolution deadlines: six months for registrations and 45 days for post-registration changes.
Sixth: Submit a statement of interest to drpis.correspondencia@misalud.go.cr.
Seventh: Repeal Resolution MS-5917-2024.
Eighth: Effective from the date of publication in La Gaceta.
MINISTERIAL OFFICE
Dr. Mary Munive Angermüller, Minister of Health.-1 time.-(IN2025983539).