Guatemala

Pharmacovigilance activities in Guatemala are regulated by the Ministry of Public Health and Social Assistance (MSPAS) through the National Pharmacovigilance Programme. Companies responsible for the sanitary registration of a medicine must create, register and maintain a pharmacovigilance system, which is registered as the establishment's Plan de Farmacovigilancia, and must have a permanently available qualified person responsible for pharmacovigilance. The responsible company must report suspected adverse drug reactions and prepare and submit Informes Periódicos de Seguridad (IPS). IPS are submitted immediately upon request by the authority, every six months during the first two years after authorisation, annually during the following two years, at the first renewal, and subsequently every five years together with renewal. the current national guidance does not establish an EU-style QPPV or a specific PSMF requirement. Risk-management and risk-minimisation measures should be implemented where required by the national pharmacovigilance framework. Where the cited public sources do not expressly define ICSR reporting route and timelines, risk-management plan, signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.