The South African Health Products Regulatory Authority (SAHPRA) has published the new fees payable to them. SAMED made a submission on the draft fees issued earlier in 2020. Members should note the following fee increases:

New licence application fees – Section 4 (a)

  • Manufacturer R 25 200
  • Distributor R 15 000
  • Wholesale R 15 000

Licence renewal fees – Section 4 (b)

  • Manufacturer R 22 000
  • Distributor R 12 600
  • Wholesale R 12 600

Annual licence retention fee – Section 4 (c)

  • R 4 200 Payable before the last working day of June

Licence collection fee

  • R 3 400

Licence amendment fee

  • R 5 300