Import unapproved medicine into South Africa

Ukungenisa Imithi Yokusetshenziswa Komuntu Siqu eNingizimu Afrika Ngokomthetho Womuthi Nezinto Ezihlobene Nawo (1965)

Isingeniso

ENingizimu Afrika, ukungenisa imithi engavunyelwe noma engatholakali kuleli, ikakhulukazi uma iyimithi esindisa ukuphila, kubuswa umthetho ohlotshaniswa noMthetho Womuthi Nezinto Ezihlobene Nawo ka-1965. Lo mthetho uhlinzekela izinqubo nemigomo okumele ilandelwe ukuze imithi enjalo ingeniswe ngokomthetho nangendlela ephephile.

Uhlaka Lomthetho

UMthetho Womuthi Nezinto Ezihlobene Nawo ka-1965 uyisisekelo somthetho esilawula ukuthengiswa, ukukhiqizwa, nokusetshenziswa kwemithi eNingizimu Afrika. Ngaphansi kwalesi simo, Isigaba 21 salo Mthetho sihlinzekela amagunya okukhethekile okuvumela ukusetshenziswa kwemithi engavunyelwe ngaphansi kwezimo ezithile.

Izimfuneko Zokungenisa Imithi Engavunyelwe

Kulabo abafuna ukungenisa imithi engavunyelwe yokusetshenziswa komuntu siqu, imithetho elandelayo kufanele ilandelwe:

• Isicelo Esivela Kumsebenzi Wezempilo: Isicelo kufanele senziwe udokotela obhalisiwe noma omunye umsebenzi wezempilo egameni lesiguli.
• Isidingo Esiphuthumayo: Kumele kuboniswe ukuthi imithi iyadingeka kakhulu ukulapha leso siguli futhi ayikho enye indlela etholakalayo eNingizimu Afrika.
• Imvume Ye-South African Health Products Regulatory Authority (SAHPRA): Imvume kufanele itholwe ku-SAHPRA ngaphambi kokungenisa imithi.

Inqubo Yokufaka Isicelo

Inqubo yokufaka isicelo sokungenisa imithi engavunyelwe ihlanganisa lezi zinyathelo ezilandelayo:

1. Ukugcwalisa Ifomu Lesicelo: Udokotela kufanele agcwalise ifomu lesicelo elitholakala ku-webhusayithi ye-SAHPRA.
2. Ukuthumela Izincwadi Ezidingekayo: Lokhu kuhlanganisa izinkcukacha zemithi, izincomo zokwelashwa, nezizathu zokuthi kungani imithi iyadingeka.
3. Ukulinda Ukugunyazwa: SAHPRA izolubheka isicelo bese inikeza impendulo ngokushesha okukhulu ngenxa yobukhulu besidingo.

Imibandela Nemikhawulo

Kubalulekile ukuqaphela ukuthi:

• Imvume inikezwa esigulini esithile futhi ayikwazi ukudluliselwa kwabanye.
• Ukungenisa imithi ngaphandle kwemvume kungaholela ezijezisweni zomthetho.
• Inani lemithi engenisiwe kufanele lihambisane nesidingo sokwelashwa esibekiwe.

Izindlela Zokuthola Ulwazi Oluthe Xaxa

Ngeminye imininingwane, sicela uvakashele i-webhusayithi ye-SAHPRA noma uxhumane nodokotela wakho.

Izikhombo

• UMthetho Womuthi Nezinto Ezihlobene Nawo ka-1965
• ISouth African Health Products Regulatory Authority (SAHPRA)

English version

Importing Medicines for Personal Use into South Africa According to the Medicines and Related Substances Act (1965)

Introduction

In South Africa, importing unapproved or unavailable medicines, especially life-saving ones, is governed by legislation outlined in the Medicines and Related Substances Act of 1965. This Act provides procedures and regulations that must be followed to legally and safely import such medicines.

Legal Framework

The Medicines and Related Substances Act of 1965 forms the legal basis for controlling the sale, manufacture, and use of medicines in South Africa. Under this framework, Section 21 of the Act permits the authorization of unregistered medicines under specific circumstances.

Requirements for Importing Unapproved Medicines

For individuals seeking to import unapproved medicines for personal use, the following regulations must be adhered to:

• Application by a Healthcare Professional: A registered medical practitioner or another authorized healthcare professional must apply on behalf of the patient.
• Demonstrated Urgent Need: It must be shown that the medicine is essential for the patient's treatment and that no alternatives are available in South Africa.
• Approval from the South African Health Products Regulatory Authority (SAHPRA): Authorization must be obtained from SAHPRA before importing the medicine.

Process of Application

The application process to import an unapproved medicine involves the following steps:

1. Completing the Application Form: The medical practitioner must fill out the application form available on the SAHPRA website.
2. Submitting Required Documentation: This includes details of the medicine, treatment protocols, and reasons why the medicine is necessary.
3. Awaiting Authorization: SAHPRA will review the application and provide a response as promptly as possible due to the urgency of the need.

Conditions and Limitations

It is important to note that:

• The authorization is granted for a specific patient and cannot be transferred to others.
• Importing medicines without proper authorization may lead to legal penalties.
• The quantity of medicine imported should align with the prescribed treatment requirement.

How to Obtain More Information

For additional information, please visit the SAHPRA website or consult with your medical practitioner.

References

• Medicines and Related Substances Act of 1965
• South African Health Products Regulatory Authority (SAHPRA)