THE MEDICINES FEE STRUCTURE PROVIDED FOR BY THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965), AS AMENDED – APRIL 2019
The Medicines and Related Substance Act, 1965 (Act 101 of 1995) makes provision for the Authority to collect fees for the various medicine regulatory functions as provided for by Section 35(1) (xxxi) and (xxxii) of the Act read together with Section 35(4). Sections 35 of the Act (xxxi) prescribing the fees to be paid to the Authority in respect of an application for the registration, and in respect of the registration of a medicine, medical device or IVD, the fee to be paid annually to the Authority in respect of the retention of the certification or the registration of a medicine, medical device or IVD and the date on which such annual fee shall be paid;
(xxxii) prescribing the fee payable in respect of the authorisation of the use of unregistered medicines, medical devices or IVDs, the issuing of permits and certificates under this Act, the issuing or renewal of any licence under this Act, the performance of inspections to assess the safety, quality and efficacy of medicines, Scheduled substances, medical devices or IVDs for the purpose of registration, the evaluation of technical amendments and changes to the particulars contained in registers and the testing for batch release of biological medicines; (4) A regulation under subsection (1) (xxxi) or (xxxii) shall be made only in consultation with the Minister of Finance.
In terms of the said legislative provisions, the South African Health Products Regulatory Authority may collect fees for inter alia:
- An application to register a medicine
- An application to conduct a clinical trial
- An application to License a medicine manufacturing site or Wholesaling site dealing in medicines and medical devices
- An annual retention fee for maintaining the registration of a medicine
- An annual retention fee for maintain the licensing status of a Manufacture or Wholesaler of medicines and medical devices
- Use of an unregistered medicine on the compassionate basis
- Issue of certifies and permits as prescribed by the Act in terms of Section 22A
- The performance of inspections to assess the quality, safety and efficacy of medicines and / or scheduled substances
- Any amendment to any inscription of the medicine register
- The batch release of vaccines
- An application to evaluate technical amendment.
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