Tweet
this is a copy of an email I just received from the Yahoo EPFX group.
Does anyone know what it is all about?
Date: 11 February 2009
To: All interested parties
From: Richard Lloyd
Re: suspension of Health Canada license for the EPFX
This is to inform you that as of 9 February 2009, the EPFX license issued to Eclosion Kft. by Health Canada has been suspended.
This means that the EPFX may not and will not be sold in Canada. It does not affect current owners and users of a current device that has been purchased prior to 9 February 2009.
The suspension of the license has come from Health Canada’s Therapeutic Products Directorate and is the result of numerous communications and an in-person “Opportunity to be Heard” meeting between Health Canada and myself, representing Eclosion Kft. and Gage Tarrant as a Compliance Officer of Education. This Opportunity to be Heard was also attended by our Canadian legal counsel. There were four members of Health Canada who were on the Board during the Opportunity to be Heard.
The regulations state that it is possible to apply for a new license within six months of the suspension of this first license. Maitreya Ltd. is currently reviewing this option with both legal and regulatory counsel.
Please feel free to contact me on richard@qxsubspace.com if you have further questions.
Thank you,
Richard Lloyd
Quality Manager
If anyone knows anymore I would be interested in knowing.
Don
Does anyone know what it is all about?
Date: 11 February 2009
To: All interested parties
From: Richard Lloyd
Re: suspension of Health Canada license for the EPFX
This is to inform you that as of 9 February 2009, the EPFX license issued to Eclosion Kft. by Health Canada has been suspended.
This means that the EPFX may not and will not be sold in Canada. It does not affect current owners and users of a current device that has been purchased prior to 9 February 2009.
The suspension of the license has come from Health Canada’s Therapeutic Products Directorate and is the result of numerous communications and an in-person “Opportunity to be Heard” meeting between Health Canada and myself, representing Eclosion Kft. and Gage Tarrant as a Compliance Officer of Education. This Opportunity to be Heard was also attended by our Canadian legal counsel. There were four members of Health Canada who were on the Board during the Opportunity to be Heard.
The regulations state that it is possible to apply for a new license within six months of the suspension of this first license. Maitreya Ltd. is currently reviewing this option with both legal and regulatory counsel.
Please feel free to contact me on richard@qxsubspace.com if you have further questions.
Thank you,
Richard Lloyd
Quality Manager
If anyone knows anymore I would be interested in knowing.
Don