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Medicines & Health
Whether it’s the management of bad health, striving for good health or monitoring daily health – the health sector is a fast-growing industry capturing new customers and markets with every scientific development. Health practitioners are governed by industry bodies, medicines are scrutinized before going to market and technology is democratizing our health, by putting the power to remain healthy into customers’ hands, or more likely, into their pockets.
But behind the scenes, the medicines and health industry is a highly regulated and carefully managed world. In-depth laws are in place to ensure the practitioners are licensed and practice ethically, the products are safe and advertised truthfully and the medicines sold are safe and legal. As regulations specialists, at Legalese we’re proud to be advising both startups and established businesses on the regulatory hurdles and requirements of operating a medical or health-related business.
What can we offer you?
Guidance to Health Professionals in any health profession recognised under the Health Professionals Act 56 of 1974 (as amended):
- Regulatory advice regarding specific medical-legal related queries.
- Assistance with engaging regulators of industry bodies.
- Guidance on registrations.
Advice regarding products or substances regulated in terms of the Medicines and Related Substances Act 101 of 1965 (as amended), including:
- Medicines (including complementary medicines like health supplements).
- Complementary medicines.
- Scheduled substances.
- Medical devices or IVD medical devices.
which includes assistance with:
- Licensing suppliers across the supply chain and registering products with SAHPRA.
- Formally engaging with SAHPRA.
- Guidance on product labeling and other compliance requirements.
Crossover between health and technology for health software, devices or programmes:
- Data and privacy advice
- Regulatory assessment of new business proposition.
- Analysis of product, service or product/service combination in regard to the legal framework.
- Guidance on licensing and registration.
Liaising with regulators and industry bodies:
- Engagement with relevant regulators and industry bodies regarding areas of legal uncertainty with a view to obtaining formal position statements.
General advice on medical-legal compliance:
- Regarding crossover between health, food, cosmetics and consumer regulations.
- Guidance on labelling of non-medical products.
- Consumer-related queries.