{"id":2519,"date":"2023-11-08T04:04:27","date_gmt":"2023-11-08T04:04:27","guid":{"rendered":"https:\/\/cbmeds.in\/?page_id=2519"},"modified":"2023-12-18T07:11:33","modified_gmt":"2023-12-18T07:11:33","slug":"country-regulations","status":"publish","type":"page","link":"https:\/\/cbmeds.in\/?page_id=2519","title":{"rendered":"country regulations"},"content":{"rendered":"\t\t
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There are lawful channels available for acquiring new medications if you find it impractical to wait for local approvals.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Have you ever faced this situation? Whether it’s you or someone close to you dealing with a serious condition, and the medical solutions available in your country are not effective. Consequently, you’re exploring options internationally, trying to access treatments even if they haven’t been approved in your country.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\tFortunately, many countries have legal regulations in place that permit the import of unapproved medicines.\n\t\t\t<\/p>\n\t\t\t\t\t<\/blockquote>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Read more about it [here<\/a>]. Being aware of these regulations has empowered us to assist patients from over 50 countries in accessing medicines that have not yet received approval in their respective countries, allowing them to initiate treatment promptly.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The next questions inevitably are:\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1.<\/h3>

Does my country have a legal regulation that allows me to import unapproved medicines?<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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2.<\/h3>

Will Customs refuse my shipment if the medicine is not approved?<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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3.<\/h3>

Will my doctor prescribe me a medicine that is not approved in our country?<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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4.<\/h3>

What are the next steps?\n\n\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Let’s take them one by one:<\/p><\/div><\/div><\/div>

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1 - Can people in my country legally bring in medicines that haven't been approved locally?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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If you’re curious, you can scroll down to find and read the regulations for a specific country on their government website. (Need to rush? Click here to skip to countries<\/a>)<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>

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2 - Might Customs refuse the package because the medicine doesn't have approval?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Customs is unlikely to reject the shipment because they are aware of the regulations that permit the importation of unapproved medicines.<\/p><\/div>

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Yes, your doctor can prescribe a medicine that is not approved in your country if it is necessary for your treatment and there are no alternatives available.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Your doctor or hospital may not be aware that it is legal for them to prescribe and administer unapproved medication, leading to a potential denial of treatment. This often occurs when healthcare professionals are not informed about the availability of treatments approved in other parts of the world or are unaware of the legality of prescribing unapproved medications or using them off-label (for an indication not officially approved).<\/p>

However, prescribing unapproved medicines or using them off-label is permitted under certain conditions and can be necessary in some cases. The doctor uses their medical discretion to make decisions, considering the medical standard and closely monitoring the treatment. They assess the potential risks and benefits, informing the patient about the associated risks. In cases of life-threatening diseases where no other therapy is available, the benefits often outweigh the risks.<\/p>

Patients sometimes find themselves in a situation where they have to educate their doctors and hospitals about the legality of prescribing locally unapproved medicines or using medicines off-label. You can read about such experiences in stories like this one [link to the mentioned story].<\/strong><\/p><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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4 - What are the next steps?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Step #1: Obtain a prescription\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The first and most important step to accessing a newly approved medicine is having a prescription from the treating doctor who must also supervise the treatment.<\/p>

You and your doctor can learn more about it in our\u00a0physician\u2019s guide to importing a medicine approved abroad [PDF]<\/a>.<\/p><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Step #2: Prepare additional documents\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The process depends on the regulations in the country where the prescription originates. Import rules for medicines vary between countries; some may only require a prescription, while others may demand additional documentation such as import licenses, letters from the doctor, and various forms.<\/p>

Our experts have in-depth knowledge of regulations in most countries globally, enabling us to successfully deliver medicines to over 88 countries.<\/p>

You can read about the regulations from 14 countries that allow patients to import unapproved medicines, provided certain requirements are met. *While we make efforts to regularly monitor and update all amendments shortly after implementation for each country, we cannot guarantee absolute completeness or accuracy at all times. If you notice any discrepancies, we appreciate your input so that we can promptly update our systems.<\/p><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Step #3: Place your request with cbmeds.in\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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If you wish to order medicine through our platform, we will inform you about the specific regulations in your country and the necessary paperwork. In some cases, we can even provide you with templates ready to be filled in. Please note that you can only order a medicine if you have a prescription from your treating doctor.<\/p>

Simply search for your medicine in the Search bar or in the menu under Medicines and place a Request for details. Our Patient Support Team will guide you through the process and provide assistance.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Country-specific regulations that allow
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Importing a medicine that is unapproved by the Therapeutic Goods Administration (TGA) is possible under the Personal Importation Scheme.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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Patients can import medicines into Brazil even if they are not approved by Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria Anvisa, provided they are strictly for personal use and do not contain restricted substances.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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Through Health Canada’s special access programs (SAP), health care professionals may access non-marketed drugs and medical devices not yet approved for sale in Canada.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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Importing a medicine that is not yet approved by the European Medicines Agency (EMA) and\/or French Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM), is possible without an import authorisation when the medicine is for personal use for an individual patient.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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Patients can import medicines not approved in the EU or by The Federal Institute for Drugs and Medical Devices (Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte or BfArM) in Germany under certain conditions.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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It is possible for patients to import medicines that are not approved in India, as stipulated by the \u200b\u200bCentral Drugs Standard Control Organization of the Ministry of Health & Family Welfare India for personal use and under specific conditions.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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The New Zealand Medicines and Medical Devices Safety Authority, Medsafe, stipulates that patients can legally import medicines for personal use from overseas.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\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<\/div>\n\t\t<\/div>\n\t\t\t\t

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The Drug Regulatory Authority of Pakistan (DRAP) specifies that patients can import unapproved medicine in small quantities and only for personal use.<\/p>

Visit the government website [PDF].<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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Patients in Poland can import medicine that is not approved in Poland for personal use, as stipulated by the Polish Ministry of Health.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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Patients in Romania can import medicine that is not approved in Romania only for personal use, with a few exceptions that can be consulted in the \u201cORDIN nr. 680 din 16 iulie 2003\u201d by the Ministry of Health on the Legislative Portal.<\/p>

Visit the Legislative Portal.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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Importing a medicine for personal use that is unapproved by the European Medicines Agency (EMA) and\/or The Spanish Agency of Medicines and Medical Devices (AEMPS), is possible under a special access program via an online application.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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According to the Ministry of Health, Turkish Medicines and Medical Devices Agency, it is legal to import unapproved medicines into Turkey for personal use, but there are many conditions.<\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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The UK Government stipulates on their website that doctors may prescribe an unlicensed medicine if they think it will treat their patient\u2019s condition effectively and the benefits are greater than any risks.<\/p>

Visit the government website.<\/a><\/p>

Visit the government website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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Importing a medicine that is not approved by the Food and Drug Administration (FDA) is possible under a policy named\u00a0Personal Importation Policy (PIP)<\/a>.<\/p>

Visit the FDA website.<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\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<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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We can help you access medicine\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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cbmeds.in helped us quickly source and receive very hard-to-find medication to help reduce the effects of my mother\u2019s ALS. Their team is incredibly helpful with knowledgeable and prompt responses, willing to communicate by email and\/or by telephone.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Frequently Asked Questions<\/strong>\u00a0|\u00a0Legal framework<\/a>\u00a0|\u00a0The prescription<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Our Patient Support Team will be happy to assist you<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

There are lawful channels available for acquiring new medications if you find it impractical to wait for local approvals. Have you ever faced this situation? Whether it’s you or someone close to you dealing with a serious condition, and the medical solutions available in your country are not effective. Consequently, you’re exploring options internationally, trying […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-2519","page","type-page","status-publish","hentry"],"yoast_head":"\ncountry regulations - Curiance Biotech<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cbmeds.in\/?page_id=2519\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"country regulations - Curiance Biotech\" \/>\n<meta property=\"og:description\" content=\"There are lawful channels available for acquiring new medications if you find it impractical to wait for local approvals. 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