Category Archives: Sanitary Registration of Products
At BLP, Blog, Costa Rica, Sanitary Registration of Products
Newsflash Costa Rica | Ministry of Health: Extension of validity of sanitary registrations
Apr
Costa Rica: Extension of Validity of Sanitary Registrations for Medicines (Resolution DM-1725-2026) The Ministry of Health of Costa Rica issued Resolution DM-1725-2026, establishing an exceptional one-year extension of the validity of certain sanitary registrations for medicines that are required to demonstrate therapeutic equivalence. This measure aims to ensure the continuity in the supply of essential…
Blog, Costa Rica, News, Sanitary Registration of Products
Newsflash: Regulatory Updates – January 2026
Feb
Recognition of the Term “REF” through a Supplementary Label Resolution Although RTCR 505:2022 does not recognize or authorize the use of the term “REF” to fulfill the requirement of the product identification code, it is permitted to clarify through a supplementary label that the “REF” indicated by the manufacturer corresponds to the product identification code,…
Blog, Costa Rica, News, Sanitary Registration of Products
Newsflash: Regulatory Updates – November 2025
Nov
Executive Decree No. 45224-S establishes the procedure for simplified sanitary registration by notification and third-party import authorization for low-risk processed foods and cosmetics, streamlining their commercialization in the country. It also regulates the recognition of registrations, control, and monitoring through the digital platform REGÍSTRELO. The simplified registration applies only to foods listed in Annex I…
Blog, Guatemala, News, Sanitary Registration of Products
Guatemala updates its regulation on precursors and chemical substances
Sep
The Ministry of Public Health and Social Assistance (MSPAS) of Guatemala has issued two key provisions that significantly amend the regulatory framework governing precursors and chemical substances. Governmental Agreement 102-2025 establishes a broader regulation with expanded obligations, applicable to any individual or entity handling these types of substances, such as acetone, caustic soda, lime, among…
Sep
Resolution on the Facilitation of Marketing Authorizations The Ministry of Health has established an expedited procedure for the marketing authorization and post-approval changes of medicines previously approved by WHO-listed authorities (WLA). Key aspects: Scope of application: Medicines authorized by WLAs and post-approval changes equivalent to RTCA 11.03.59:18. Exclusions: Not applicable to homeopathic medicines, radiopharmaceuticals, or…
Blog, Costa Rica, News, Sanitary Registration of Products
Costa Rica Introduces New Measures for the Management of Health-Related Products
Aug
The Costa Rican Ministry of Health has issued three important provisions for companies and professionals involved in managing health-related products: Reactivation of Rejected Applications: The Directorate of Health-Related Products Regulation will assess, on a case-by-case basis, the reactivation of previously rejected files with duly submitted appeals. The decision will take into account the ease of…
Blog, Costa Rica, News, Sanitary Registration of Products
Regulatory Updates in Health and Food Law Costa Rica – May 2025
May
Costa Rica leads regulatory changes on food additives and synthetic dyes As Pro Tempore President of the Council of Ministers for Economic Integration (COMIECO) during the first half of 2025, Costa Rica convened a meeting of the Central American Commission on Food Additives (CCAA) on March 18 to evaluate the removal of the synthetic dye…