South Africa - Apply for Registration of Human Medicine

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Procedure

Apply In-Person:

1. To Apply for Registration of Human Medicine, the applicant must go to the South African Health Products Regulatory Authority (SAHPRA) office. Contact Link
2. The application form must be obtained from the authorities at the SAHPRA office, or else it can also be downloaded from the official website linked here. Application Form Link
3. Make sure that you have all the documents that are mentioned in the “Required Documents” section of this page.
4. The application form must be filled with all the necessary details, and along with the required documents, it must be submitted to the Chief Executive Officer in the SAPHRA department.
5. The human medicine application and the details submitted will be verified on various factors.
6. After complete verification if all the details and documents submitted are legitimate then the Human Medicine Registration will be approved by the SAHPRA.
7. The registration certificate for the medicine will be issued to the applicant, and the registered product will be added to the SAHPRA webpage list for the public view.
8. The complete fee details for the registration application are given in the “Fees” section of this page.
9. The complete process to get the human medicine registration certificate will be take anywhere between 30 days to 60 days approximately.

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Required Documents

• Application Form Link
• Owner Consent Form Link
• Letter of application with:
• Purpose of the variation(s)
• Internal SAHPRA Code as per General Information guideline to aid routing
• Description, Classification and Code of the Variation(s) (e.g., Type II – A.0.1)
• SAHPRA name change approval letter
• Proof of payment for the variation application.
• Electronic, certified copy of the letter of cession from the current registered HCR.
• Electronic, certified copy of the letter of acceptance from the proposed HCR.
• The current approved PI and PIL.
• Amendment/variation schedule.
• Medicine register details.
• Variations summary.
• Current approved registration certificate or old medicine letter.
• Valid SAHPRA licence to manufacture, import or export medicines for the proposed HCR.
• Current GMP certificates or manufacturing licences for all approved sites performing a function related to the product’s manufacture, packer, FPRC, FPRR/Applicant.

Office Locations & Contacts

SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
HEAD OFFICE
Physical Address: Building A, Loftus Park,
402 Kirkness Street, Arcadia, Pretoria.
Postal Address: South African Health Products,
Regulatory Authority, Private Bag X828, Pretoria: 0001.
Tel: 012 501 0300
Email: [email protected]

RADIATION CONTROL
2nd Floor Louwville Place Building,
Cnr Kort- and Vrede Streets. Bellville 7535.
Address & Contact Link
Location Link

Eligibility

• Any citizen/resident in South Africa is eligible to apply for the Registration of Human Medicine application at SAHPRA.

Fees

• For complete fee details for the registration application, refer to the official website linked here. are given in the link.
• Fee Link
• Payment Guideline

Validity

• The Human Medicine Registration Certificate is valid forever.

Documents to Use

• Application Form Link
• Owner Consent Form

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The complete process to get the human medicine registration certificate will be take anywhere between 30 days to 60 days approximately.

Related Videos

Videos explaining the procedure or to fill the applications.
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Instructions

Please provide other instructions related to the certificate/documents.
e.g., The state office holds birth records since January 1908.

Required Information

APPLICATION FOR A VARIATION / AMENDMENT TO A REGISTERED PRODUCT

• Registration Number(s)
• Product Proprietary name(s)
• API(s)
• Dosage strength (and Dosage form)
• Type of submission
• Sequence Number
• Description of the submission
• Format of the submission
• Summary of the variations / amendments applied for
• Amendment history
• Name and Surname
• Designation
• Email Address
• Contact Number
• Declaration
• Signature
• Date
• Tabulated Schedule of Amendments
• Modules
• Comparison between Modules – Existing/Amended
• Reason for amendment
• Reviewer’s comment

MEDICINE REGISTER DETAILS

• Product to which this application refers
• Proprietary name of medicine
• Registration/Reference number
• Registered medicine (R) / Old Medicine (OM)
• Details
• Details on Current registration certificate/old medicine letter
• Details on Proposed registration certificate/old medicine letter

AFFIDAVIT BY THE HCR / APPLICANT

• Product Name/Registration Number
• Signature
• Date

Need for the Document

• In order to supply medicinal products in the South African market, the product must be registered with the SAHPRA. Only registered products and medicines will be sold in the market for the welfare of fellow human beings.

Information which might help

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Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
E.g., Birth Certificate can be used as proof of identity.

External Links

• External Link

Others

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