Medicine Registrations and Distribution Licenses

Theme: People Date Added: 2018-12-11

What is it?

The South African Health Products Regulatory Authority (SAHPRA) regulates the introduction (and withdrawal) of medicines in South Africa, and publishes new medicine registration notifications as well as information on licenses to manufacture and distribute medicine, product recalls and safety alerts.

Key Points

  • Over 12,500 new medicine registrations have been recorded
  • Monthly updates with details on new registrations
  • Includes name, dosage form, active ingredients, shelf-life
  • Published as tables in PDF documents

Why is it Important?

New medicine registration notifications are important for health practitioners and consumers who would like to verify that medicines have been approved for distribution in the country; and for the industry, to ensure there is transparency and competition in the supply of medicine.

How can it be accessed and used?

There are a few different sections and types of reports related to medicine registrations. Highlights include:

  1. New medicine registrations up to (date): These are aggregate lists of all medicine registrations up to a certain date such as this one up to July 2017. The list typically only has three columns with the medicine brand name, registration number and key active ingredients.
  2. New medicine registrations for a specific month: These documents contain more detailed information on medicines registered during that month.
  3. Licences issued to manufacture, import, export, wholesale or distribute medicines.
  4. Safety alerts: Provide warnings about use of specific medicines.
  5. Product recalls: Provide information on medicines that are being withdrawn from the market.

New medicine registrations up to July 2017

Location: South Africa
Format: XLSX CSV
Year: 2017Last Checked:None
Online: Access URL
File Names:
  • Registration number: SAHPRA registration number
  • Proprietary name: Brand name of the medicine
  • Ingredients: Key active ingredients in the medicine

Licences to manufacture, import, export, wholesale or distribute medicines

Location: South Africa
Year: 2017Last Checked:None
Online: Access URL
File Names:
  • COMPANY NAME: Name of the medicine manufacturer, importer or distributor
  • TYPE OF LICENCE AND AUTHORISED SITE ACTIVITY: Activities the company is licenced to perform
  • RESIDENTIAL ADDRESS: Address of the company
  • licensing
  • health

Resource contact name:South African Health Products Regulatory Authority

Creation or start date:2018-12-11

Resource contact updated at:2018-12-18

Spatial coverage  South Africa

Where else has the resource been used?

Year Project Name::
2018 A brief look at a complex matter: Regulation and registration of complementary medicines and health supplements
2017 Conditions frequently self-treated with herbal remedies by patients visiting a tertiary hospital in Gauteng, South Africa - review