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Pharmaceutical Law

Receive Up-To-Date Advice on Pharmaceutical Laws and Regulations

Pharmaceutical law relates to the laws and regulations that govern the development, manufacturing, registration, importation, exportation, sale, distribution, and use of medicine.

Pharmaceutical law covers aspects such as:

  • Intellectual Property:  Intellectual property law is utilised to protect drug discoveries made by companies involved in drug design and development.
  • Good Practices Guidelines: These guidelines are facets of pharmaceutical law associated with SAHPRA licensing regulations which ensure that the proper quality, safety, and efficacy standards are upheld during the manufacturing, wholesale, and distribution of medicines. 
  • Marketing Restrictions: Restrictions on the marketing of medicines are established in law and mentioned in marketing codes. Restrictions may pertain to the scheduling and/or registration status of medicines.  
  • Prescription and Sale: The prescription and sale of medicines are both controlled by law.

FAQs

What is pharmaceutical law?

Pharmaceutical law is an umbrella term which refers to all legislation relevant to medicines. It includes all matters associated with medicines from development to use by the end consumer. Pharmaceutical law encompasses a wide variety of legislation such as the Medicines and Related Substances Act, the Pharmacy Act, the Drugs and Drug Trafficking Act and its regulations. It may, in some cases, be important to refer to legislation such as the Consumer Protection Act, the Interpretation Act or the Constitution of the Republic of South Africa. Various guidelines and codes as well as common law and court cases are also taken into account.

At Pharmalaw we believe that both scientific and practical experience makes a huge difference in dealing with pharmaceutical law. Science, law, and commerce go hand in hand in interpreting and applying pharmaceutical law.

The main function of pharmaceutical laws and regulations worldwide is to ensure that the quality, safety, and efficacy of medicines are controlled in public interest
It is advisable to employ the services of a pharmaceutical law expert when dealing with legislative or regulatory affairs pertaining to medicines. Such an expert can provide you with the needed information and advice to navigate this area of law. It is of utmost importance that persons involved in the medicine commercial chain should ensure legal compliance in order to prevent liability. It is also of importance to involve a pharmaceutical law expert during litigation since pharmaceutical law is a very complex area of the law.