The National Medicines Regulatory Authority (NMRA) as the central regulator responsible for the regulation and control of all aspects of medicines, medical devices and borderline products, gives serious consideration to affordability when granting market authorization to the said medicinal products, in the best interest of the public. Unilateral increase in prices of medicinal products without prior approval of the NMRA is a violation of conditions of market authorization.

Market authorization holders who unilaterally increase price of medicinal products without prior approval of the NMRA commit an offence under the NMRA Act No 5 of 2015 and regulations made thereunder. Failure to fully comply with this directive will compel the NMRA to take appropriate action in terms of section 65 of the Act without any further notice.

Chairman,

National Medicines Regulatory Authority

(Date: 11 August 2020)