Pharmaceutical Manufacturers Association of SA: In re Ex parte President of RSA

The President promulgated regulations under the Medicines Act without following proper procedures. The Pharmaceutical Manufacturers Association challenged the regulations, arguing they were unconstitutional and invalid because they exceeded the President's powers and were enacted without proper consultation.

The regulations were declared invalid. The court ordered that new regulations could only be promulgated after proper consultation and within the limits of the enabling legislation.

This landmark case established the principle of legality as a ground of constitutional review separate from the Bill of Rights. It confirmed that all exercises of public power - including by the President - must be authorized by law and must be rational. The case is foundational to administrative law and constitutional litigation in South Africa.