Medicine Registration In South Africa

What is Medicine?

Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. 

Medicine Registration In South Africa

2.2.1 Eligibility to apply for registration of a medicine is governed by Regulation 22 of the Act. An
application may be made by any of the following:
a) a person, body corporate/juristic person, or company, residing and doing business in South Africa;
b) a close corporation incorporated in South Africa; or
c) a company in South Africa with at least

a responsible delegated person residing in South Africa and

an authorized person residing in South Africa who must be a person with appropriate
knowledge of all aspects of the medicine and who shall be responsible for communication
with Council.
The application submitted should be signed by the pharmacist authorized to communicate with
Council. This pharmacist should be in the full-time employ of the company and may be:
the Responsible Pharmacist in terms of the Pharmacy Act, 1974 (Act 53 of 1974) as amended, or
another registered pharmacist responsible for regulatory affairs and with appropriate knowledge
of all aspects of medicine.
This should be an original signature (scanned signature is not acceptable).
The following should be included:
proof of current registration (copy of certificate) of the pharmacist who signed the dossier, and
proof of current registration of the Responsible Pharmacist in terms of Act 53;
an individualized, person-specific letter of authorization for the signatory, issued by the person
responsible for the overall management and control of the business (CEO). (Note that such a
letter is not required for the Responsible Pharmacist if the Responsible Pharmacist signs the
2.2.3 An Applicant/PHCR should submit a Site Master File (SMF) by the SMF guideline.
For subsequent applications reference to the allocated SMF number will suffice.
The confidentiality of information submitted to the MCC is governed by Section 34 of the Act. The
MCC, committee members, or staff of the Medicines Regulatory Affairs (MRA), may NOT
disclose to any person, any information acquired in the exercise of powers or performance of
functions under the Act and relating to the business affairs of any person, except
to exercise his/her powers, or for the performance of his/her functions under
the Act, or
when required to do so by any competent court or under any law, or
with the written authority of the Director-General, or
use such information for self-gain or the benefit of his employer.
The MCC may insist on written confirmation of the identity and affiliation of an individual inquiring
telephonically, or in person, about a medicine. No information shall be disclosed telephonically unless
the Medicines Control Officer knows the enquirer is entitled to receive the information.
In terms of Regulation 22(4) of the Act, all applications and supporting data submitted to the MCC
should be presented in English (British). Original documents not in English should be accompanied by
an English translation.

The following non-refundable fees are relevant:
A non-refundable screening fee is payable with the screening submission.
An application fee is payable with the full submission of the application for registration.
A registration fee, payable when the application complies with all the requirements for registration, and
which is payable before a registration certificate is issued.
An annual retention fee to maintain registration.
A fee to cover any amendments to the dossier or certificate.
A fee to cover any inspection of any manufacturing site.
A fee to cover authorization of the use of an unregistered medicine.
The fees are published in the Government Gazette and are also available on the website.
Methods of payment: By cheque or electronic payment / direct transfer.
Also, refer to the Bank Detail guideline for electronic payment / direct transfer.