Regulations Governing Pharmacovigilance of Pharmaceutical Products and Medical Devices.

The purpose of these Regulations, composed by three Chapters, is to provide a legal framework for the effective and efficient pharmacovigilance of pharmaceutical products (for administration to human beings or animals) and medical devices. They apply to to the pharmacovigilance activities of pharmaceutical products and medical devices manufactured, imported, exported, advertised, sold, distributed or used in healthcare practice in Rwanda.
The text covers, in Chapter 2, the pharmacovigilance system as a whole, including the quality Management System which is part of it, the good Pharmacovigilance Practices, the Stakeholders, the Processes, Roles and responsibilities. Chapter 2 also establishes a Pharmacovigilance Advisory Committee and regulates the capacity building of the personnel involved in pharmacovigilance activities as well as the inspections for the purpose of ensuring compliance with Good Pharmacovigilance Practices and the provisions of these Regulations. A Risk Management System is also established by Chapter 2, for the collection of data relevant to the safety profile of pharmaceutical products and medical devices as well as for the identification of the risks from continuous evaluation of safety signals and the reporting of adverse drug reactions or unusual failure in efficacy or performance or medication errors. This Chapter also foresees that a Periodic Safety Update Reports, a Periodic Benefit-Risk Evaluation Reports and a Development safety update reports shall be submitted to the Authority according to the timelines specified in the relevant guidelines. Chapter 2 also brings provisions concerning the reporting of unregistered, substandard and/or Falsified Products as well as the reporting channels; provisions on confidentiality and data management; regulatory actions based on carefully analyzed safety information in order to prevent injury to the health or safety of patients; International collaboration for pharmacovigilance activities.
Last Chapter contains miscellaneous provisions, like Appeals to the Authority and Administrative sanctions.