top of page

South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs

Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional Information For Human Medicines (Categories A and D)" and "Guideline For Classification of Medical Devices and IVDs".


As part of its regulatory framework, SAHPRA has established guidelines for the preparation of professional information for human medicines in Categories A and D. This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances.


Professional information (PI) for human medicines refers to the comprehensive documentation that provides healthcare professionals with essential information about a medicine. This includes details about the medicine's composition, indications, dosage, administration, contraindications, warnings, precautions, and adverse reactions.


Categories A and D refer to the classification of medicines in South Africa based on their safety profiles and the level of control required for their distribution and use.

Category A: Medicines in Category A are considered to have a low potential for harm and are typically available without a prescription. These medicines are commonly referred to as over-the-counter (OTC) medicines. Category D: Medicines in Category D are considered to have a higher potential for harm and are subject to stricter controls. These medicines are typically available only with a prescription from a qualified healthcare professional, such as a doctor or pharmacist.


The intention of this guideline is to:

  • Help applicants with the correct way of presenting the PI for evaluation; and

  • Enhance consistency in the content of the PI.


For a PI variation for medicine after registration, the approved PI (for eSubmissions only), the proposed PI with the variation(s), and the evidence/motivation for the variation(s) should be submitted together with the application form. Each PI must be accompanied by a PIL, reflecting the corresponding proposed variation(s).



This guideline is intended to provide recommendations to interested persons wishing to submit applications for the licensing of manufacturers, distributors, and wholesalers, and registration of medical devices and IVDs. Also, this guideline provides the classification rules for the classification of medical devices (Non-IVDs) and IVDs in South Africa.


A medical device (non-IVD), other than an IVD medical device, has the medical device classification applying under the classification rules set out in the Classification Rules for Medical Devices.

An IVD medical device has the medical device classification applied under the classification rules set out in the Classification Rules for IVDs. All the classification rules must be considered to determine the classification of the medical device or IVD.


Click this LINK to know more about the principles for applying the classification rules, classification of non-IVD medical devices, etc.

Comentários


bottom of page