{"id":1806,"date":"2020-11-26T16:11:33","date_gmt":"2020-11-26T16:11:33","guid":{"rendered":"https:\/\/amigroups.com\/attorneys\/?page_id=1806"},"modified":"2021-10-19T09:51:55","modified_gmt":"2021-10-19T09:51:55","slug":"medicines-health","status":"publish","type":"page","link":"https:\/\/amigroups.com\/attorneys\/?page_id=1806","title":{"rendered":"Medicines & Health"},"content":{"rendered":"\t\t
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Whether it\u2019s the management of bad health, striving for good health or monitoring daily health \u2013 the health sector is a fast-growing industry capturing new customers and markets with every scientific development. Health practitioners are governed by industry bodies, medicines are scrutinized before going to market and technology is democratizing our health, by putting the power to remain healthy into customers\u2019 hands, or more likely, into their pockets.<\/strong><\/p>

But behind the scenes, the medicines and health industry is a highly regulated and carefully managed world. In-depth laws are in place to ensure the practitioners are licensed and practice ethically, the products are safe and advertised truthfully and the medicines sold are safe and legal. As regulations specialists, at AMI Attorneys we\u2019re proud to be advising both startups and established businesses on the regulatory hurdles and requirements of operating a medical or health-related business.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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What can we offer you?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1.<\/span> <\/span><\/h2>\n\t\t\t\t

HEALTH PROFESSIONALS<\/p><\/span>\n\t\t\t\t<\/div>\n\t\n\t\t\n\t\t\n\t\t\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Guidance to Health Professionals in any health profession recognized under relevant law:<\/p>

  • Regulatory advice regarding specific medical-legal related queries.<\/li>
  • Assistance with engaging regulators of industry bodies.<\/li>
  • Guidance on registrations.<\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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    2.<\/span> <\/span><\/h2>\n\t\t\t\t

    MEDICINES<\/p><\/span>\n\t\t\t\t<\/div>\n\t\n\t\t\n\t\t\n\t\t\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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    Advice regarding products or substances regulated in terms of relevant laws, including:<\/p>

    • Medicines (including complementary medicines like health supplements).<\/li>
    • Complementary medicines.<\/li>
    • Scheduled substances.<\/li>
    • Medical devices or IVD medical devices.<\/li><\/ul>

      which includes assistance with:<\/p>

      • Licensing suppliers across the supply chain and registering products with SAHPRA.<\/li>
      • Formally engaging with SAHPRA.<\/li>
      • Guidance on product labeling and other compliance requirements.<\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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        3.<\/span> <\/span><\/h2>\n\t\t\t\t

        HEALTH TECH<\/p><\/span>\n\t\t\t\t<\/div>\n\t\n\t\t\n\t\t\n\t\t\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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        Crossover between health and technology for health software, devices or programmes:<\/p>\n

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        • Data and privacy advice<\/li>\n
        • Regulatory assessment of new business proposition.<\/li>\n
        • Analysis of product, service or product\/service combination in regard to the legal framework.<\/li>\n
        • Guidance on licensing and registration.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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          4.<\/span> <\/span><\/h2>\n\t\t\t\t

          REGULATORS<\/p><\/span>\n\t\t\t\t<\/div>\n\t\n\t\t\n\t\t\n\t\t\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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          Liaising with regulators and industry bodies:<\/p>\n

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          • Engagement with relevant regulators and industry bodies regarding areas of legal uncertainty with a view to obtaining formal position statements.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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            5.<\/span> <\/span><\/h2>\n\t\t\t\t

            GENERAL ADVICE<\/p><\/span>\n\t\t\t\t<\/div>\n\t\n\t\t\n\t\t\n\t\t\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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            General advice on medical-legal compliance:<\/p>\n

            \n
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            • Regarding crossover between health, food, cosmetics and consumer regulations.<\/li>\n
            • Guidance on labelling of non-medical products.<\/li>\n
            • Consumer-related queries.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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              \nPrice list<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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              \n\t\t\t\t\t\t\t\t\t\t\t\t\t\tSERVICE<\/span><\/th>\n\t\t\t \t\t\t\t \n\t\t\t\t\t\t\t\t\t\t\t\t\t\tPRICE*<\/span><\/th>\n\t\t\t \t\t\t\t <\/tr>\n\t\t\t <\/thead>\n\t\t\t \t
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              \n\nContact us for pricing specific to your matter!\n\n<\/div><\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t\t\t\t
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              Whether it\u2019s the management of bad health, striving for good health or monitoring daily health \u2013 the health sector is a fast-growing industry capturing new customers and markets with every scientific development. Health practitioners are governed by industry bodies, medicines are scrutinized before going to market and technology is democratizing our health, by putting the…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":10,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":[],"_links":{"self":[{"href":"https:\/\/amigroups.com\/attorneys\/index.php?rest_route=\/wp\/v2\/pages\/1806"}],"collection":[{"href":"https:\/\/amigroups.com\/attorneys\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amigroups.com\/attorneys\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amigroups.com\/attorneys\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amigroups.com\/attorneys\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1806"}],"version-history":[{"count":0,"href":"https:\/\/amigroups.com\/attorneys\/index.php?rest_route=\/wp\/v2\/pages\/1806\/revisions"}],"wp:attachment":[{"href":"https:\/\/amigroups.com\/attorneys\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1806"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}