letter to ema

i sent a short letter to EMA awhile ago because i wanted to see if things anything had been referred to them

just put it up here for interests sake, its odd that the EMA says they dont have anything to do with medical devices. so how can VG be referred to them at all in any way? may follow up with another letter
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From: mike68
Sent: 25 October 2012 14:13
To: WF EMEA Requests
Subject: Vitrogro CE mark RFI-2012 No 10-351

To whom it may concern,

I was wondering if there was any public information available about the pending approval/granting of CE mark for Vitrogro formula from Tissue Therapies

Please refer to this website for the product I am referring to

http://www.vitrogro.com/



thank you

mike68
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EMA reply:
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30 October 2012
EMA/697246/2012
Patient Health Protection

Dear mike68

Thank you for your enquiry of 25 October 2012 regarding Vitrogro.

The European Medicines Agency (EMA) is a European scientific body responsible for the evaluation of medicines for authorisation purposes within the European Union and not medical devices. Vitrogro appears to be a medical device and has not been evaluated by the EMA.

In the European Union, medical devices are regulated by the national competent authorities of each Member State. For further information on Vitrogro we would recommend that you contact the relevant agency of the relevant country. A list of contact points within the national competent authorities can be found here:
http://ec.europa.eu/consumers/sectors/medical-devices/files/list-of-contact-points-within-the-national_en.pdf

For further information on medical devices in general please consult the European Commission’s website: http://ec.europa.eu/health/medical-devices/index_en.htm and the legislation on medical devices can be found in the following link: http://ec.europa.eu/health/medical-devices/documents/index_en.htm

We hope you find this information useful.

Kind regards

Paul Blake

Medical Information
European Medicines Agency
7 Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom
[email protected]

http://www.ema.europa.eu
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