SAHPRA clarifies process for importation of medicines

SAHPRA has noted the numerous media articles on the statement made by Minister Sisulu, having secured medicine for the late Jessie Duarte. To this effect, SAHPRA is looking into the reports in the media and is engaging with the minister’s office. 

There are numerous oncology medicines that are registered by the South African Health Products and Regulatory Authority (SAHPRA) and which are available in South Africa for a range of cancers. In the event that a treating oncologist needs to secure an unregistered medicine for a specific patient, SAHPRA does have a mechanism in place as guided by section 21 of the Medicines and Related Substances Act (Act 101 of 1965 as amended). This process enables authorised access to specific quantities of the unregistered medicine for a specific patient, post a review of the application as submitted to SAHPRA by the treating oncologist. In an effort to enable access to the specific medicines, which vary depending on the type of cancer, SAHPRA reviews the application and makes a decision within a period of three working days. 

SAHPRA has strict rules and guidelines on the importing and exporting of medicines

Process for importing and exporting medicines 

SAHPRA has strict rules and guidelines on the importing and exporting of medicines. This is stipulated in the Medicines and Related Substances Act (Act 101 of 1965 as amended). South African legislation prescribes that only a South African registered company that is licensed by SAHPRA can import medicines registered by SAHPRA into South Africa. In the event that a medicine not registered in South Africa is to be accessed, the guideline on importing and exporting of medicines states explicitly: 

No person shall order any medicine from abroad for personal use unless SAHPRA has granted the said person an authorisation in terms of section 21 of the Medicines Act.” 

Furthermore, Regulation 8 (1) to Medicines Act stipulates that “any person entering or departing from the Republic of South Africa may be in possession, for personal medicinal use, of a quantity of a Schedule 3, Schedule 4, Schedule 5 or 6 substance which shall not exceed a quantity required for use for a period of one month;

a) the said person must have – a valid prescription for such Scheduled substance or medicine;

b) a certificate to the effect that the Scheduled substance or medicine concerned including its quantity was prescribed for the person including the name and address of such authorised prescriber;

c) his or her particulars of residence in the Republic, in the case of the person entering the Republic, recorded at the port of entry”. 

A closer look at conditions of access

In terms of Section 21 of the Medicines Act, unregistered medicines on a named patient basis can be accessed under strict conditions as stipulated in the SAHPRA guideline wherein it states: 

“In terms of section 21 of the Act, SAHPRA may in writing authorise any person to import and sell during a specified period to any specified person or institution a specified quantity of any particular medicine, which is not registered. This permission is however subjected to confirmation from a medical professional that the product is needed and that no similar product is available in the country. SAHPRA will evaluate the requests and may grant the authorisation which will be issued by the CEO in the prescribed manner and subject to such conditions as SAHPRA deems fit.” 

Thus, all medicines that would be available in South Africa must either be registered by SAHPRA or have the Section 21 authorisation. 

Click here to access the SAHPRA guideline.

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