Reference Manual on Legislation on Sub-standard and Falsified Medical Products: An African Perspective

The objective of the Reference Manual is to provide comprehensive guidance on the necessary legislative framework to ensure an effective national and regional response to the risks associated with Substandard and Falsified Medical Products (SFMP) in Africa. It aims to identify the key rules and roles necessary in national legislation and makes recommendations based on international and regional best practices

The Reference Manual includes a general introduction, followed by two main sections and conclusions:

• The first section deals with the regulatory system, based on the African Union Model Law on Medical Products Regulation of 2016.
• The second section covers the criminal justice response, describing the offences to be established in criminal law to effectively prevent and respond to trafficking in SFMP; the tools for investigation and prosecution, including international cooperation in criminal matters; and measures for the protection of the rights of victims and ensuring the safety of witnesses.
• The Conclusions chapter provides a summary of the key messages of the Reference Manual and a checklist for legislators.

This CBRN resource has been produced within the framework of the EU CBRN CoE Project 66 ‘MEDISAFE – Combating illicit traffic and enhancing the safety of medicines in Eastern and Central Africa’.