No approval by the regulatory authority needed for the physician to order the drug:
- New Zealand – MedSafe allows the importation of Irminix® by authorized prescribers under Section 25 of the New Zealand Medicines Act 1981
- Lebanon – Ministry of Public Health has approved the import by physicians for individual patients.
- Switzerland – Article 49 of the 2018 Regulation for the Authorisation of Medicines permit an attending physician holding a cantonal licence to import small quantities of human medicine for Compassionate Use for the treatment of a given patient.
- Austria – The Austrian form must be an urgently needed for the treatment of specific patient to avert a life-threatening or chronically debilitating situation and that successful treatment with licensed or available medicinal products cannot be achieved based on the scientific state of the art.
- Germany – the physician can send us an email at firstname.lastname@example.org and we will explain how this is handled.
- United Kingdom – A system has been set up through a company that handles the application process to the MHRA; the physician can send us an email at email@example.com and we will explain how this is handled.
- US – The FDA has a complicated two step process.
1) The physician will need to fill out all the necessary documents for the Irminix® Early Access program.
2) An Institutional Review Board (IRB) is required to oversee the actual treatment. There will be IRB information contained in the early access documents for the USA.
- Most other countries.