DRUGS AND DEVICES APPROVAL

Our Drug and Devices approval practice advises on the acquisition of Pharmaceutical licenses for retail outlets and the approval of drugs for human, veterinary and herbal use. In addition, we advise on the authorisation process for the use of medical devices.

In specific terms, we advise on:

• Market authorisation for new and improved drugs;
• Registration and approval of local licensees and manufacturers of imported drugs after an extensive process of inspection and assessment;
• Assessment and registration of medical devices;
• Product recall and liability arising therefrom;
• Enforcement action relating to counterfeit, fake and substandard drugs;
• Adherence to regulations for donated drugs, biologics and devices;