Many patients with conditions like ALS, Multiple Sclerosis or certain cancers who don't see improvements or a slowing of the condition with the usual treatments may look for medicines that are approved in other countries. The FDA , Health Canada, EMA and all other national agencies can take years to approve a medicine that was developed somewhere else, precious time for some patients.
This is why these agencies allow the import of such medicines that are not yet approved in their respective countries, on some conditions.
For example, a few of the conditions to import unapproved medicine into the US, as stipulated by the FDA:
- The drug is for use for a serious condition for which effective treatment is not available in the US- The drug is considered not to represent an unreasonable risk- The individual importing the drug verifies in writing that it is for his or her own use
Requirements for importing medicine into the US:
- A prescription from the patient’s treating doctor in the US- An import letter written by the patient’s treating doctor in the US- A detailed description of the treatment plan
With the help of a medical advisor and an attorney (from the Netherlands) to legal check, I've written a few short PDFs guide with all the import requirements for the US, Canada, Australia and New Zealand
https://thesocialmedwork.com/custom/files/import-guides/guide-importing-medicine-USA.pdf
https://thesocialmedwork.com/custom/files/import-guides/guide-importing-medicine-Canada.pdf
https://thesocialmedwork.com/custom/files/import-guides/guide-importing-medicine-Australia.pdf
https://thesocialmedwork.com/custom/files/import-guides/guide-importing-medicine-NewZealand.pdf
The PDFs are branded by the Dutch organization I work for (that sources and delivers medicines on a case-by-case basis) because they're the documents we send to our patients so they know what paperwork to arrange in order to receive their medicine.
I got approval to make it available to anyone at all since it's public information, just collected in one place, since we always get questions from people who want a certain medicine but are suspicious: "Is this even legal?? How can my doctor prescribe a medicine if it's not approved in the States?" or they need help with how an import letter should look like.
Hope they're useful to someone.
References:
https://www.fda.gov/industry/import-basics/personal-importation
https://www.fda.gov/about-fda/fda-basics/it-legal-me-personally-import-drugs
https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
https://www.tga.gov.au/personal-importation-scheme
https://www.medsafe.govt.nz/consumers/miet/importmedicines.asp#What
https://ift.tt/eA8V8J Submitted February 16, 2021 at 04:59AM by soverynew https://ift.tt/3u1dGOy