Omegalabs (Pty) Ltd v Medicines Control Council and Others (32570/2015)
Omegalabs (Pty) Ltd v Medicines Control Council and Others (32570/2015) [2016] ZAGPPHC 1157 (7 December 2016)
The court held that the classification of the Dermalex products as 'medical devices' or 'medicines' is a technical matter requiring expertise and is not within the court's proficiency. This function is statutorily assigned to the Medicines Control Council, which is equipped to make such determinations. The absence of regulations under section 35(1)(xxvii) of the Medicines Act does not preclude the Council from exercising its powers, as the enabling Act itself confers the necessary authority. The applicant cannot unilaterally declare its products as 'medical devices' to avoid registration requ…
Source excerpt
- Judicial Deference
- Statutory Interpretation
- Regulatory Powers
- Classification Of Medical Products
- Declaratory Relief