How to start Medicines Distribution Business in South Africa?

We have registered a Company in Pretoria and we are planning to distribute the Pharmaceutical products, but we do not have a license and qualification to to that business,How can we ensure that we grow in that field with no overseas based investors and grow our economy.

In every country there is different things required to start a pharmaceutical company but nearly every country require a drug license to start any type of Pharma Business. In South Africa, you will also need a drug license to distribute medicines under your company name. You need to visit your local drug authorities to collect all details about starting drug distribution. They will help you and will provide you all basic knowledge and details of licenses, qualification and registration, you will require to start you drug distribution business in South Africa.

Here we are explaining brief information about starting Pharmaceutical Distribution company in South Africa.

For import, export, distribution and manufacturing any medicine in South Africa, registration of that particular medicine is must. You have to register medicine you want to market and distribute in South Africa at Registrar of Medicines Control Council. After registration of medicine, you have to apply for distribution License to Council.

Steps before Starting Medicine Business:

  • Apply to the Council for a licence to act as wholesaler or distribute medicines, Scheduled substances or medical devices.
  • Appointment of a pharmacist who will control distribution of medicines and related substances
  • Appointment of an authorized person who resides in the Republic and responsible for all activity related to licensing procedure and interaction with council

Procedure for applying for Medicines Distribution License:

  1. Applicant has to submit application to registrar on a prescribed form provided by council
  2. Registrar will issue a written notice to applicant regarding documents to be submitted to council for granting license to distribute medicine and related substances in reasonable time.
  3. Council will inspect the business premises specified in application
  4. If the council is satisfied with all requirements and arrangement, council will issue license to applicant for distribution of medicines and related substances.

Documents Required:

  • Documents related to Business Ownership
  • Registration of the responsible Pharmacist
  • Qualification certificates of staff responsible to distribute and sell medicines and related substances
  • Copy of Local Area Plan of location of the Business
  • Floor plan of building in which business is situated
  • Blue print of Building and Premises
  • Site Master File indicating procedures and practices to be implemented to ensure the safety, efficacy and quality of medicines and related substances
  • List of medicines and related substances to be distributed
  • Application and Inspection Fee Receipt

Growing in any field depend on many circumstances like experience in field, knowledge of field, dedicated, learning skills, approach toward work and many more. Not all time, businesses require overseas investors, you should have capability, you will not need any outsider investor to grow your business..

Hope above information is helpful to you….

Related Article: List of pharmaceutical companies in South Africa

One Comment
  1. My company need to become one of the distributors.

    Thank you.

    Abel Nkuna
    082 600 7880

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