There are lawful channels available for acquiring new medications if you find it impractical to wait for local approvals.
Fortunately, many countries have legal regulations in place that permit the import of unapproved medicines.
Read more about it [here]. 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.
The next questions inevitably are:
Let’s take them one by one:
1 - Can people in my country legally bring in medicines that haven't been approved locally?
2 - Might Customs refuse the package because the medicine doesn't have approval?
Customs is unlikely to reject the shipment because they are aware of the regulations that permit the importation of unapproved medicines.
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.
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).
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.
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].
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
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.
Our experts have in-depth knowledge of regulations in most countries globally, enabling us to successfully deliver medicines to over 88 countries.
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.
Step #3: Place your request with cbmeds.in
Country-specific regulations that allow
the import of unapproved medicine
Importing a medicine that is unapproved by the Therapeutic Goods Administration (TGA) is possible under the Personal Importation Scheme.
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.
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.
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.
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.
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.
The New Zealand Medicines and Medical Devices Safety Authority, Medsafe, stipulates that patients can legally import medicines for personal use from overseas.
The Drug Regulatory Authority of Pakistan (DRAP) specifies that patients can import unapproved medicine in small quantities and only for personal use.
Patients in Poland can import medicine that is not approved in Poland for personal use, as stipulated by the Polish Ministry of Health.
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.
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.
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.
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.
Importing a medicine that is not approved by the Food and Drug Administration (FDA) is possible under a policy named Personal Importation Policy (PIP).
We can help you access medicine
cbmeds.in helped us quickly source and receive very hard-to-find medication to help reduce the effects of my mother’s ALS. Their team is incredibly helpful with knowledgeable and prompt responses, willing to communicate by email and/or by telephone.
Frequently Asked Questions | Legal framework | The prescription
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