Chirongenix is committed to ensuring full compliance with the regulatory requirements set by the South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC) for the distribution of complementary medicines in South Africa. This process involves a strategic approach, including active engagement with both regulatory bodies, detailed documentation, and continuous efforts towards achieving and maintaining SAHPRA accreditation.

Chirogenix has partnered with specialist regulatory consultants, PrimeReg Consulting, to navigate the complex regulatory landscape in South Africa. This collaboration aims to ensure that Chirogenix adheres to all regulatory requirements and successfully secures the necessary licenses for distributing complementary medicines in the South African market. PrimeReg Consulting’s expertise in regulatory compliance is instrumental in guiding Chirogenix through the process, ensuring that all regulatory standards are met, and facilitating a smooth and efficient licensing process.

Engaging with SAHPRA
SAHPRA is responsible for regulating health products in South Africa, including complementary medicines. Engaging with SAHPRA is a critical part of the compliance process, requiring a thorough understanding of their guidelines and regulations.

Initial Registration: Distributors must first ensure that all complementary medicines they intend to distribute are registered with SAHPRA. This involves submitting a detailed application for each product, including information on ingredients, which is submitted to SAHPRA via the 3D list of products.  SAHPRA will assess the 3D list to ensure that the products meet safety and efficacy standards and comply with claims for health products marketed and distributed in South Africa.

Pharmacovigilance: Distributors are required to have a pharmacovigilance system in place to monitor and report any adverse effects associated with their products. This system must be documented and submitted to SAHPRA as part of the compliance process.

Ongoing Compliance and Renewals: Achieving SAHPRA accreditation is not a one-time process. Distributors must engage in ongoing compliance activities, including periodic renewals of product registrations, updating product information as required, and ensuring continuous adherence to GMP standards. Regular audits and inspections may be conducted by SAHPRA to verify compliance.

Engaging with SAPC
The South African Pharmacy Council (SAPC) regulates the practice of pharmacy in South Africa, including the licensing of distributors of complementary medicines.

Licensing of Premises: Distributors must ensure that their premises are licensed by the SAPC. This includes meeting specific requirements related to the storage, handling, and distribution of complementary medicines. The premises must be inspected and approved by the SAPC before a license is granted.

Adherence to Pharmacy Practice Standards: The SAPC requires distributors to adhere to specific standards related to the practice of pharmacy. This includes maintaining accurate records of all transactions, ensuring the proper labeling of products, and implementing systems to prevent the sale of counterfeit or substandard products.

Documentation of Ongoing Efforts
To demonstrate a commitment to achieving and maintaining SAHPRA accreditation, distributors must document all efforts related to compliance and regulatory engagement.

Standard Operating Procedures (SOPs): Distributors should develop and maintain SOPs that document all processes related to the distribution of complementary medicines. These SOPs should be regularly reviewed and updated to ensure they align with current regulatory requirements.

By actively engaging in the compliance process with both SAHPRA and SAPC and thoroughly documenting all efforts towards achieving and maintaining SAHPRA accreditation, distributors of complementary medicines, such as Chirogenix, can ensure that they meet the highest standards of safety and efficacy, thereby protecting public health and ensuring the success of their business operations in South Africa.

Yours sincerely,
JOCONNOR

Jane O’Connor
DIRECTOR

081-433-9209
jane@primereg.co.za 
www.primereg.co.za