Our local pharmaceutical environment is highly regulated.The most important legislative provisions are found in the Medicines Act and the Pharmacy Act....more
6/20/2018
/ Consumer Protection Act ,
Drug Pricing ,
Incentives ,
Licensing Rules ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
South Africa ,
Transparency Directive ,
TRIPS Agreement
Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive...more
Although medicines have always been heavily regulated in South Africa, medical devices have not. Recently, however, Medical Device Regulations have been issued to bring medical devices into the regulatory fold. Medical...more
Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa. Prescriptive requirements for medical devices were not in force and advertisers and marketers of medical devices...more