How to start Pharmaceutical Manufacturing Unit in South Africa?

How to start Pharmaceutical Manufacturing Unit in South Africa?

In this post, we will discuss about how to start Pharmaceutical Manufacturing Unit in South Africa. Topics Cover in this post are

  • Steps before Starting
  • Requirements
  • Sections
  • Procedure
  • Documents Required

Pharmaceutical Manufacturing Unit/Company Licensing and Registration is covered under MEDICINES AND RELATED SUBSTANCES ACT, 1965. Medicines Control Council Handles all process related to registration and licensing in South Africa. Every medicine that are imported, exported, manufactured and distributed in South Africa should be registered at Registrar of council.

Steps before Starting Pharmaceutical Manufacturing Unit in South Africa:

  • Apply to the Council for a licence to manufacture, import or export, act as wholesaler or distribute medicines, Scheduled substances or medical devices
  • Appointment of a technical person such as a pharmacist who will supervise and control the manufacturing or 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
  • Premises as per Good Manufacturing Practice arrangement


Manufacturing Sections

A Medicine manufacturing unit can have one or more section depend at nature and types of product to be manufactured. There is requirement of separate section to manufacture a particular dosage form to prevent contamination and following cGMP requirement. Every dosage form requires different type of machinery and equipment for manufacturing and processing. Few sections that are required in pharmaceutical manufacturing unit are as follow:

Procedure for applying for Pharmaceutical Manufacturing Unit 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 manufacture 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 manufacturing of medicines and related substances

Documents Required:

  • Documents related to Business Ownership
  • Registration of the responsible Pharmacist
  • Qualification certificates of staff responsible to manufacture, store, 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
  • List of Machinery and Equipments and Inventory for it
  • 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 manufactured
  • Application and Inspection Fee Receipt

Hope Above information is helpful to you…

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Related Post: How to start medicine distribution business in South Africa?

List of Pharmaceutical Companies in South Africa.

  1. hi first upon thanks a lot for valuable blog on pharmaceuticals segment
    as i belong to same segment it s very use full to gain knowledge from this blog
    keep continue this ….
    and looking for blog on export from india.
    as we are having own third party marketing co. in india. and want to enter in export market so need knowledge on this from ur blog.

    shailesh runwal
    wellnex biotech p ltd.

  2. Hello,
    I want start a company with third party manufacturing production. I have a registered pharmacist from Kerala, my company is in Tamil Nadu. Is a pharmacist from Kerala Authorized to work in Tamil Nadu?

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