-
Environmental License for the Pharmaceutical Industry in Guatemala: What You Need to Know
Written by: Sara Scheel The purpose of an Environmental License is to ensure that projects are carried out in compliance with environmental prevention, mitigation, and compensation requirements. In this article, we explain which companies must obtain it, how to do it, and the most common mistakes during the process. 1. Who needs to obtain an…
-
Honduras: ARSA Highlights the Need for Pre-Approval on updates to a Marketing Authorization
Keywords: Regulatory Affairs, Honduras, Medicines, ARSA Has your company updated the formula of its product or the analytical methodology?If the answer is yes: Have you already requested the update of the Marketing Authorization from the Health Agency? Summary The Health Regulation Agency (ARSA) of Honduras published notice No. A-ARSA-027-V1 on June 10 of the current…
-
Costa Rica Announces Extension of Health Registrations for Medicines and Medical Devices Expiring between January and March 2025
Keywords: Health Registrations / Costa Rica / Regulatory Affairs On January 8, 2025, the Ministry of Health of Costa Rica announced the “Administrative provisions regarding the renewal procedures for medicines and biomedical equipment and materials on the Regístrelo platform.” This announcement is particularly relevant to the industry, given the time required for health registration approvals…
-
FDA Revokes the Use of Red No. 3 (Erythrosine) in Food and Ingested Drugs
Keywords: FDA / Erythrosine / Regulatory Affairs / Formulation / Export The FDA (Food and Drug Administration, United States) announced on January 15, 2025, that it will revoke authorization for the use of FD&C Red No. 3 in food and ingested drugs, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act…
-
Marketing Authorization Approval (MAA) for a drug product in Guatemala: How to obtain
If you want to market drug products in Guatemala, you must first obtain a Marketing Authorization Approval (MAA). Scheel Consulting offers this service in Guatemala, as well as in Central America and the Dominican Republic. There are two types of processes: a) Normal process: Sample and standard submission is required. b) Process through approval by…
-
What are the categories of Pharmaceutical Products in Guatemala?
Regulatory projects for different countries make evident that each Regulatory Authority in the region has different criteria and product categories. A starting point for a Marketing Approval is to know in which category the product will be classified in the country. The requirements for the process depend on this. In Guatemala, the Department of Regulation…
