There are legal ways to access new medicines if you can't wait for local approvals
Have you been in this situation? You or someone you love suffers from a serious condition and the medical options you have in your country don’t work (anymore). So you’re searching for options abroad and trying to access them although they’re not approved in your country.
Fortunately, in most countries there are legal regulations in place that allow the import of unapproved medicines.
Read more about it here. Being aware of these regulations enabled us to help patients from over = $countriesReached; ?> countries gain access to medicines that are not yet approved in their country - making it possible for them to start a treatment soon.
The next questions inevitably are:
Let's take them one by one:
1 - Does MY country have a legal regulation that allows me to import unapproved medicines?
Scrolling below, you can check a country you are interested in and read these regulations on the government website. (in a hurry? click here to skip to countries)
2 - Will I be denied by Customs because the medicine is not approved?
Customs will not deny you as they are aware of the regulations that make it legal to import unapproved medicines.
3 - Will my doctor prescribe to me a medicine that is not approved in our country?
Your doctor or hospital however might not be aware that it is in fact legal for them to prescribe and administer unapproved medication and could deny you treatment.
This is a common occurrence and can happen because the doctor is not aware of the potential treatments being approved in the world and/or because they might not be aware that it is legal to prescribe a medicine that is not approved or not approved in this dosage and/or for the indication (the latter is called "off-label use"). This is not only permissible under certain conditions, but sometimes even necessary.
The doctor decides upon his own medical discretion. They must take into account the medical standard and closely monitor the treatment. The doctor weighs carefully the pros and cons of the potential treatment and informs the patient about the risks. Together, they will share the responsibility of an unapproved treatment. Often, and especially for treatments of life-threatening diseases, the pros outweigh the cons as there is no other therapy available.
Sometimes we hear from our patients that they had to inform their doctor and hospital about the legality of prescribing locally unapproved medicine or for the off-label use of medicines - you can read such a story here.
4 - What are the next steps?
Step #1: Obtain a prescription
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.
You and your doctor can learn more about it in our physician’s guide to importing a medicine approved abroad [PDF].
Step #2: Prepare additional documents
This step is entirely dependent on the country where the prescription is from. Medicine import rules differ per country, some countries might only require a prescription, while others could ask for import licenses, letters from the doctor, forms to be filled in and more.
Our experts are knowledgeable about the regulations of most countries of the world and as such, we have been able to deliver medicine to over 88 countries.
Read below the regulations from countries allowing patients to import unapproved medicines under the set requirements. *We strive to monitor and renew all amendments shortly after implementation for each country but cannot guarantee its completeness or accuracy at all times. Should you spot any discrepancy we’re grateful if you let us know so we can update our systems.
Step #3: Place your request with TheSocialMedwork
Once you have a prescription and documents for your country, we can help you access medicine from our website. If you can’t find your country and/or the documents required in the list below, simply find the medicine you need and place a Request for details. Our Patient Support Team will gladly assist you and tell you what documents are required and how to obtain them.
Country-specific regulations that allow the import of unapproved medicine
Select a country and you will see the specific country regulations here.
Importing a medicine that is unapproved by the Therapeutic Goods Administration (TGA) is possible under the Personal Importation Scheme.Visit the government website.
Patients can import medicines into Brazil even if they are not approved by Agência Nacional de Vigilância Sanitária Anvisa, provided they are strictly for personal use and do not contain restricted substances.Visit the government website.
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.Visit the government website.
Importing a medicine that is not yet approved by the European Medicines Agency (EMA) and/or French Agence nationale de sécurité du médicament et des produits de santé (ANSM), is possible without an import authorisation when the medicine is for personal use for an individual patient.Visit the government website.
Patients can import medicines not approved in the EU or by The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM) in Germany under certain conditions.Visit the government website.
It is possible for patients to import medicines that are not approved in India, as stipulated by the Central Drugs Standard Control Organization of the Ministry of Health & Family Welfare India for personal use and under specific conditions.Visit the government website.
The New Zealand Medicines and Medical Devices Safety Authority, Medsafe, stipulates that patients can legally import medicines for personal use from overseas.Visit the government website.
The Drug Regulatory Authority of Pakistan (DRAP) specifies that patients can import unapproved medicine in small quantities and only for personal use.Visit the government website [PDF].
Patients in Poland can import medicine that is not approved in Poland for personal use, as stipulated by the Polish Ministry of Health.Visit the government website.
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 “ORDIN nr. 680 din 16 iulie 2003” by the Ministry of Health on the Legislative Portal.Visit the Legislative Portal.
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.Visit the government website.
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.Visit the government website.
The UK Government stipulates on their website that doctors may prescribe an unlicensed medicine if they think it will treat their patient’s condition effectively and the benefits are greater than any risks.Visit the government website.
We can help you access medicine
If you wish to order medicine with us, we’ll inform you exactly what the regulations for your country are and what paperwork is required, 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.
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 be happy to assist you