Dominican Republic

Medicines regulation and post-marketing safety oversight in the Dominican Republic are carried out by the Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS) under the national medicines framework, including Decree No. 246-06. DIGEMAPS receives suspected adverse-event information and conducts sanitary surveillance and safety actions. However, current publicly accessible national sources do not establish a comprehensive MAH pharmacovigilance framework equivalent to EU GVP with universal requirements for a local QPPV, PSMF, fixed MAH ICSR timelines, routine PSUR/PBRER periodicity or universal RMP submission. Product-specific post-marketing pharmacovigilance obligations should therefore be confirmed directly with DIGEMAPS. Where the cited public sources do not expressly define 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.