12/10/2018
Structured legal guide to cannabinoid drugs, medicinal cannabis and opioid drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? Cannabis use is illegal in most countries and until recently this included South Africa. In terms of the Drugs and Drug Trafficking Act (“the Drugs Act”) it is…
Regulatory reforms in South African Pharma – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? NATIONAL HEALTH INSURANCE BILL AND MEDICAL SCHEMES AMENDMENT BILL On 21 June 2018 the Minister of Health Published the Medical Schemes Amendment Bill and the National Health Insurance…
The ins and outs of patents and trademarks in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patents and Trademarks form part of Intellectual property in terms of South African law, where Intellectual Property is defined as: “a generic term used to refer collectively to…
The key facts about product liability in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? In terms of South African common law legal liability may arise from a breach of contract or from delict. Liability in delict may arise irrespective of the existence of a contract…
Traditional medicines & OTC products in South Africa – a legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In terms of the Medicines Act medication is classified into 4 categories from Category A- Category D depending on the In terms of the…
All legal aspects of marketing, manufacturing, packaging, labeling and advertising of drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? MARKETING OF MEDICINES AND MEDICAL DEVICES OR IVDS: Marketing of medicines are regulated by Section…
All about preclinical & clinical trial requirements in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Clinical Trials do not have to be conducted locally in order for the Regulator to register the product and market approval to…
An insight into regulatory, pricing and reimbursement in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The South African Health Products Regulatory Authority (SAHPRA), previously known as the Medicine and Control Council (MCC). 2. What is the regulatory…
The ins and outs of patents and trademarks in South…
All about preclinical & clinical trial requirements in South Africa.…
Regulatory reforms in South African Pharma – a comprehensive legal…
An insight into regulatory, pricing and reimbursement in South African…
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