Sanitary surveillance and control
Reglamento de Organización, Funcionamiento y Atribuciones de la Dirección Nacional de Vigilancia y Fiscalización Sanitaria (Regulations on the Organization, Functioning and Responsibilities of the National Directorate for Sanitary Surveillance and Control) (97 pages, in Spanish)
The notified text provides for the supervision, verification, control and surveillance of the compliance by establishments supplying products and services of sanitary interest with legal, technical and administrative regulations. It provides for the implementation of the policies and procedures required to apply the sanitary regulations in force, with a view to remedying any conduct or poor practices that have or may have an impact on human health through technical and legal processes and the imposition of the relevant penalties. It also regulates import and export processes and all other regimes applicable to consumer products for human use and establishes provisions concerning the network of laboratories.
The notified text is of general interest and shall apply to natural and legal persons, public or private, engaged in handling, selling, dispensing, processing, packing, preserving, manufacturing, refurbishing, importing, re-importing, exporting, re-exporting, storing, transporting, distributing, marketing, clinical trial research and advertising activities, in addition to any other activity specified by the ARSA, that involve products of sanitary interest. It shall also apply to any establishment related to the above-mentioned activities, with a view to protecting health.