Labeling requirements of pharmaceutical products for human use in Central America, the Caribbean and South America

Abstract

Pharmaceutical products are evaluated according to the requirements established in each country for its sanitary registration. Sanitary regulations must have complied with these products to be commercialized. These specifications depend on what the laws consider essential in each case. This situation complicates label design for distribution in different countries. The objective of this research was to facilitate compliance with the regulation of drug labeling by verifying the requirements of Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Peru, Chile, Bolivia, Colombia, Ecuador, Paraguay, Uruguay, Dominican Republic, Cuba, Trinidad and Tobago, Jamaica, Aruba, Curaçao, and Guyana. For this, a regulation compilation and review (regulations, rules, and laws for the registration of pharmaceutical products for human use) of these countries´ regulatory entities was done. The information found was selected and summarized. With this summary, a comparison of the requirements was prepared for each of the regions mentioned above. When conducting a review of labeling regulations of the various countries, it was found that their stipulations in Central America, the Caribbean, and South America regions are not homologated.