The South African Health Products Authority, better known as SAHPRA(SAHPRA License), was launched by the South African government and merged the duties of the Medicines Control Council and Directorate of Radiation Control, which were previously housed in the National Department of Health. However, to ensure healthcare had an independent body representing – and prioritising – the health and wellness of people and animals, SAHPRA came to be.
What is SAHPRA?
SAHPRA’s mission is to regulate all health products for quality, safety, and efficacy. Part of their duties includes registering, inspecting, evaluating, investigating, and monitoring health products and services available in South Africa, including IVDs, complementary medicine, and medical devices that are available on the market.
Therefore, if anyone wants to sell, distribute, or manufacture health products in South Africa – and for a South African market – they will need a license from SAHPRA to operate.
What is a SAHPRA License?
SAHPRA has several licenses that medicine and scheduled substances manufacturers, importers, exporters, and wholesalers can apply for. These licenses are designed to help regulate the products that consumers – and the medical fraternity – have access to.
Type Of License From SAHPRA
Presently, SAHPRA is only receiving online submissions for the following licenses. Each license has its own application form, which we’ve included links to below.
GMP & CPP certificates
To receive a Good Manufacturing Certificate, your application will need to include the following:
- A business cover letter
- A copy of your current SAHPRA license
- A copy of your current inspection resolution
- A copy of your current or expire GMP/CPP certificate
- Proof of Payment
Wholesalers of Medicine & Scheduled Substances(APIs)
Applicants for this license – who should include non-exempt wholesalers and distributors of medicines and scheduled substances – can download the application form here. This form needs to be printed or filled in with a black pen, and any alterations should be initialled and dated.
Cannabis Cultivation Licence
This form – which you can download here – applies to all non-exempt cannabis importers, manufacturers, and cultivators of medical cannabis.
GMP/Pharma Establishment Licence: Manufactures, Importers & Exporters
Pharma establishments can download the following form to apply to manufacture, export, or import medicine and scheduled substances.
How to Apply for a SAHPRA
Irrespective of the license you’re applying for, the process to complete the application is the same.
Step 1: Access and Complete Application Form
Using the above list of application forms, you will need to download and complete the form in black pen or print with black ink. To ensure SAHPRA accepts the application form, the information on the form needs to be complete and accurate and contain no white-out. You can make alterations. However, you will need to initial and date these alterations.
Step 1(b): Prepare Site Master File.
If you’re applying to be a manufacturer or wholesaler, you need to create a master file. Given that preparing a master file is rather complex, SAHPRA has created a guidance document that details how you need to prepare – and what you need to include – in the Master File in addition to how to prepare the Master File. You can download the Master File guidance here.
Step 2: Make Payment
You can make payment before submitting your application. To do this, SAHPRA encourages you to familiarise yourself with the fee guidelines and relevant documentation before making payment.
This includes having a thorough understanding of the Applications Cover Page in addition to a thorough knowledge of Annexure A within the SAHPRA FEE categorisation guideline. You will also need to familiarise yourself with the Gazette Fee Schedule.
If you need more information about making payment, SAHPRA has created a PDF guideline on the payment of fees to SAHPRA.
It’s important to note that you cannot pay via cheque, and you will need to email your proof of payment along with the cover letter to email@example.com to ensure the allocation of your payment.
If you have any queries about making payments to SAHPRA, you can direct those queries via email to firstname.lastname@example.org.
Below you will find SAHPRA’s banking details:
Account name: SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY
Special name: The Medicines Control Council
Account type: Cheque/Current Account
Account number: 40-5939-2080
Bank Branch Code: 632005
Bank physical address: 240 VERMEULEN STREET, PRETORIA, 0001, SOUTH AFRICA
Swift Code: ABSAZAJJ
Step 3: Prepare Supporting Documentation
After completing the above steps and before submitting your application, you will need to prepare these supporting documents. To ensure SAHPRA accepts these documents, they need to be in digital format. The documents include:
- An application cover letter
- CIPC, CIPRO, or DTI certificates and documents that prove ownership of the business
- A copy of a completed NDOH premise license application or an NDOH premise license
- Registration as a responsible farmer or SAPC case number
- SAPC Certificate of recording of a pharmacy and SAPC Certificate of recording of a pharmacy owner
- (If applicable) latest inspection resolution
- Proof of payment for the license annual retention fee for all preceding years (if the license is older than a year)
- Product list that includes proof of payment of the annual retention fee for each product since the product was registered
- Proof of payment for application with the correct reference according to Annexure A of the SAHPRA fee categorisation guideline
Step 4: Email Zipped File to SAHPRA
Once you’ve completed the aforementioned steps, you will need to email a zipped file with the form and supporting documents, as well as proof of payment to email@example.com. If you send correspondence for an application for a license that doesn’t include one of the licenses listed above, SAHPRA will delete your email and block your email address.
License Application Cost
The cost of applying to SAHPRA will depend on the purpose of the license. You can find a full breakdown of the cost of applying for a new SAHPRA license in addition to the cost of renewing an existing SAHPRA license.
It’s important to note that all application fees are non-refundable. So, should your application be denied, your only recourse to overturn your denial is to submit an appeal against the Authority, which will cost R50 000 and is also non-refundable.
Application Cost for New SAHPRA Licenses:
If you are applying for a new license, the costs are as follows.
- Manufacture: R25 000
- Distribute: R15 000
- Wholesale: R15 000
- Import: R15 000
- Export: R15 000
The Cost of Renewing SAHPRA License
If you are renewing an existing license, the costs areas follows.
- Manufacture: R22 000
- Distribute: R12 600
- Wholesale: R12 600
- Import: R9 200
- Export: R9 2000
You can view a complete breakdown of SAHPRA’s fees through a PDF government gazette detailing SAHPRA’s fee structure.
Applying for a SAHPRA license is a costly and intricate process. If you at any stage need assistance or further information, it’s best to contact SAHPRA. You can find a comprehensive list of key contacts here.