{"id":234407,"date":"2021-07-30T12:27:04","date_gmt":"2021-07-30T11:27:04","guid":{"rendered":"https:\/\/buzzsouthafrica.com\/?p=234407"},"modified":"2021-07-30T12:27:08","modified_gmt":"2021-07-30T11:27:08","slug":"guide-to-sahpra-license-application-and-the-contact-details-for-help","status":"publish","type":"post","link":"https:\/\/buzzsouthafrica.com\/guide-to-sahpra-license-application-and-the-contact-details-for-help\/","title":{"rendered":"Guide To SAHPRA License Application and the Contact Details for Help"},"content":{"rendered":"
When it comes to medical issues, countries try to leave no stone unturned because any form of negligence will result in loss of lives for the wrong reasons, and South Africa<\/a> is not left out in this regard. Before opening a company where you sell drugs, medical devices, perform clinical trials, or do anything health-related, you have to apply for a SAHPRA license and get approved.<\/p>\n Applying for this license requires that you follow some set of procedures and make some payments. Getting a SAHPRA license is very important because it makes your company eligible to deal on medical-related products, and your company name will also be published in their list of licensed establishments.<\/p>\n SAHPRA, which is an acronym for South African Health Product Regulatory Authority, is a subsidiary of the National Department of Health. It was created by the South African government to monitor and investigate all health-related products to ensure their safety, quality, and efficacy.<\/p>\n Part of the duties and responsibilities of the SAHPRA is to issue licenses to establishments to import, manufacture, sell, and distribute any health-related product across the country. Before you are given this license, depending on the type of product and establishment you intend to run, you must meet basic requirements and standards to ensure that your product will not cause health hazards to the people who use it.<\/p>\n <\/a><\/p>\n When you register your establishment with SAHPRA, and it is licensed to sell health-related products, SAHPRA will add its name to the list of licensed establishments<\/a>. The category of establishments you will be published under will depend on the kind of product you manufacture, import, export or, sell within the country.<\/p>\n The kind of SAHPRA license you apply for will depend on the product your establishment deals with. These different types of licenses have general requirements but still have some unique requirements as well. Here is a list of all the license applications you can send to SAHPRA:<\/p>\n You can only submit application forms for the different types of the license above and GMP & CPP certificates<\/a> to SAHPRA. If you submit any other type of application, your entry will be deleted, and your email will be blocked from sending anything to SAHPRA. For each of these license applications, you will be required to prepare and submit a ‘site master file<\/a>.’<\/p>\n <\/a><\/p>\n Although most of the SAHPRA license application forms are long and will take some time to fill, the general application process is not difficult. To avoid moving in circles, you must follow the appropriate procedures, which include the following:<\/p>\n The SAHPRA license application form is to be submitted alongside the following documents:<\/p>\n Please note that your entire application is expected to be in a zip file.<\/p>\n The cost of applying for a SAHPRA license differs, depending on the kind of establishment. Here is a detailed list of the application fee for each establishment:<\/p>\n You can make payments using this bank details:<\/strong><\/p>\n Before making payments for a SAHPRA license application, it is advised that you go through the SAHPRA Fee Categorisation Guideline, Applicants Cover Page, and Gazette Fee Schedule. These documents can be found on the official SAHPRA website. Here are the basic rules to adhere to when making payments:<\/p>\n <\/a><\/p>\n From the day you submit your application, it takes 5 working days for your license to be approved<\/a> and ready.<\/p>\n If you wish to make further inquiries<\/a> about the SAHPRA license application, you can send a mail to enquiries@sahpra.org.za<\/a>, and if you have an emergency, you should send your mail to emergency@sahpra.org.za<\/a>, or you can also reach SAHPRA customer care by calling 012 501 0300<\/strong>.<\/p>\n You can also visit the SAHPRA head office located at Building A Loftus Park 402 Kirkness Street Arcadia Pretoria. This way, you can make your inquiries in person and get personal assistance. Alternatively, you can send your request through the post office to South African Health Products Regulatory Authority, Private Bag X828 Pretoria 0001.<\/p>\n For media inquires, you can send a mail to media@sahpra.org.za<\/a> or call 066 120 2669<\/strong> or 012 501 0422<\/strong> using your cellphone. Alternatively, you can visit the SAHPRA media inquiry page<\/a> to drop your message online.<\/p>\n","protected":false},"excerpt":{"rendered":" When it comes to medical issues, countries try to leave no stone unturned because any form of negligence will result in loss of lives for the wrong reasons, and South Africa is not left out in this regard. Before opening a company where you sell drugs, medical devices, perform clinical trials, or do anything health-related, […]<\/p>\n","protected":false},"author":34,"featured_media":234662,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_oasis_is_in_workflow":0,"_oasis_original":0,"_oasis_task_priority":"2normal","footnotes":""},"categories":[438],"tags":[],"yoast_head":"\nWhat You Should Know About SAHPRA License<\/strong><\/h2>\n
What Type Of License Can I Get From SAHPRA?<\/strong><\/h2>\n
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How Do I Apply For a SAHPRA License?<\/strong><\/h2>\n
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How Much Does The License Application Cost?<\/strong><\/h2>\n
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How Do I Contact SAHPRA?<\/strong><\/h2>\n