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Emeramed's NBMI Availability by Coutry

3/24/2019

Some basic Emeramed information as taken from their website in regard to access of NBMI during FDA trials. If you know the product as OSR or Irminix, it is the same product.

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.

Approval by the regulatory authority not required under certain circumstances:

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 earlyaccess@emeramed.com and we will explain how this is handled.

Approval from regulatory authority required in most countries:

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 earlyaccess@emeramed.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.
Sweden
Denmark
Australia
Canada
Most other countries.