Timor-Leste

Pharmacovigilance and medicines regulation in Timor-Leste are administered by the Ministry of Health through the Timor-Leste National Regulatory Authority / National Directorate of Pharmacy and Medicines. The pharmaceutical legal framework is based on the Decree-Law on Pharmaceutical Activities, which regulates authorisation, importation, distribution, quality control and supervision of medicines. The national authority is developing regulatory functions for product safety and quality, and safety concerns should be communicated to the Directorate and Ministry through the applicable national channels. Publicly accessible official materials do not establish a separate industry QPPV role, a Pharmacovigilance System Master File, fixed post-marketing ICSR deadlines, routine PSUR/PBRER schedules, mandatory RMPs or dedicated GVP inspections. Companies should therefore maintain a proportionate global pharmacovigilance system, document local safety responsibilities and confirm any product-specific commitments directly with the authority. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.