Holy See

Within Vatican City State, health and medicines matters fall under the Direzione di Sanità e Igiene, while the Farmacia Vaticana manages the procurement and distribution of pharmaceutical products. Official information on the Pharmacy's programmazione per il 2026 also refers to internal protocols and safe product management. The reviewed Vatican sources do not publish a standalone industry-facing pharmacovigilance code imposing a universal local QPPV, PSMF, fixed ICSR or PSUR/PBRER timetable, or blanket RMP requirement on every marketing authorisation holder. A supplier should therefore confirm product-specific arrangements with the competent Vatican bodies, maintain a documented global safety system and reachable contact, and promptly communicate significant adverse reactions, quality defects, recalls, emerging signals and safety-related changes. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.