Regulatory - Natural Products - Strategic Advice
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Regulatory

Product Registration

Natural product registration doesn’t happen overnight. It can take several years to successfully register a dossier with the South African Health Products Regulatory Authority (SAHPRA).

 

With an in-depth understanding of the inner-workings of the Complementary and Alternative Medicines (CAMs) within South Africa and Africa, PharmaReg utilises their own staff to act on behalf of the client, sharing the costs and time of registration, and significantly reducing overall expenses and delays.

 

The process

 

  • The new product is initially registered in PharmaReg’s name, though the product still remains the sole property of the client.
  • All regulatory work becomes the sole property of PharmaReg.
  • Once the product is successfully registered, all sole rights to the dossier are transferred to the client’s name.
  • Clients then have the option of utilising PharmaReg on a contract basis to maintain their product qualification with regards to legislation updates.

 

Together, PharmaReg and NP-SA ensure each product is successfully registered and marketed according to present legislation of Complementary and Alternative Medicines (CAMs) within South Africa.

Overview of Services

1. Applicant / MA Holder

 

PharmaReg acts on behalf of the client as a contract applicant or Marketing Authorisation (MA) Holder, working in liaison with the South African Health Products Regulatory Authority (SAHPRA).

 

2. Orthodox / Allopathic and Complementary Medicines

 

  • Products are screened to ensure compliance with registration requirements
  • Data assessment, CTD and eCTD compilation
  • Dossier updates, life cycle management
  • Writing of reports and pharmaceutical development reposts of CTD applications
  • Compilation of professional information contained within product leaflets
  • Labeling requirements
  • Regulatory authoring for data not available in CTD format

 

3. Inspections and GMP compliance

 

  • Compilation and review of:
    • Site master files
    • Standard operating procedures
  • Conducting and assisting with:
    • Self-inspections
    • Inspections at 3rd party suppliers and vendors
    • Local and foreign manufacturer, warehouse and distribution facility audits

 

PharmaReg also offers its expertise and applications for product registration within the following African nations: Angola, Botswana, Cameroon, Congo, DRC, Ethiopia, Ghana, Ivory Coast, Kenya, Malawi, Mauritius, Mozambique, Namibia, Nigeria, Sudan, Tanzania, Uganda, Zambia and Zimbabwe.

 

If you’re interested in registering a product within the South African or African market, please complete the Product Specification form here.