Biotherapeutics evaluation and registration and Similar biotherapeutic Products Procedure
1. MA application. Before submitting an application for MA, you will need to apply for GMP inspection (please refer to the GMP inspection and Compliance procedure). To apply for MA of Biotherapeutics, you will need to meet the minimum requirements as described in the guideline. Proceed to the online portal prims.pharmacyboardkenya.org and fill the application form provided as per the requirements in the Guidelines on submission for documentation for Registration of Biotherapeutic products or Similar biotherapeutic Products Guidelines. There are three pathways for submitting an application i.e. First in first out (FIFO), Fasttrack (full assessment and Reliance) and expedited pathway (emergency use authorization). For eligibility, please refer to Reliance guidelines on regulatory decision making in Kenya, Guidelines for fast track review of applications for Health products and Guidelines on submission of documentation for emergency use and compassionate use authorization of health products. An invoice will be generated upon completion of the form. Make the payments in order to complete the application. Flow chart (marketing Authorisation pathways and timelines).