Optimizing the Marketing Authorization Process in Benin: Institutionalization and Development of Medicine Registration Standard Operating Procedures

DPMED is responsible for registration of medicines prior to importation by licensed importers and their use by health providers and consumers. However, the department is hindered in execution of its mandate because of several challenges. The extent of illegal and unregistered medicines in circulation is not uncommon. DPMED is constrained by its capacity to effectively regulate the pharmaceutical sector with consequent inefficiencies in key processes, such as medicine registration, leading to delayed access to life-saving medicines. For these reasons, the Benin MOH sought assistance from USAID to help strengthen the medicine registration system for effective performance to hasten access to quality assured medicines. The SIAPS Program conducted a rapid assessment of the medicine registration system in November 2016, and in August 2017, conducted a detailed assessment of the medicine registration system at DPMED. Based on the findings from the two assessments conducted by the SIAPS Program, several recommendations were made. One of the recommendations was to optimize the medicine registration process by establishing a consistent way of handling registration dossiers to promote an efficient process. Standard operating procedures (SOPs) were developed so that the registration department could operate more efficiently. In addition, the SOPs served as a prerequisite for establishing an effective and sustainable electronic medicine registration system.