Bahrain

Medicines in Bahrain are regulated by the National Health Regulatory Authority (NHRA), Pharmacy & Pharmaceutical Products Regulation (PPR). The current Medicine Licensing Guideline, Version 4.2 (January 2026) states that the MAH is responsible for the medicine's quality, efficacy and safety throughout its lifecycle and must notify NHRA of new significant safety information. It also defines the local agent as a licensed pharmacy in Bahrain designated by the MAH to communicate with NHRA. The current public NHRA medicines-guideline set does not establish an EU-style local QPPV or PSMF requirement; these are not established as mandatory Bahraini requirements unless supported by a specific NHRA/Gulf requirement applicable to the product. Where the cited public sources do not expressly define ICSR reporting route and timelines, periodic safety reporting, 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.