Subject: Restart for project
From: "Dr. Martin Weber" <[email-masked]>
To: "Egle Audova" <[email-masked]>, "Karl.kalev Turk" <[email-masked]>
Cc: "Katrin Kiisk", <[email-masked]>, "Ardo Hansson",Sandra Särav, "Kaitseministeerium" <[email-masked]>, "info.sm"
Date: Tue, 6 May 2025 12:05:10 +0300

Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.
Tundmatu saatja korral palume linke ja faile mitte avada.

Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.
Tundmatu saatja korral palume linke ja faile mitte avada.

Dear Ms. Audova, dear Mr. Turk,

I received the enclosed letter from Anniki Lai  from the Ministry of Social 
Affairs yesterday, and I am pleased that there is still great interest in my 
project.

I would like to restart the project in accordance with the offer and 
register my product in Estonia under a different name and with a modified 
indication and instructions for use. Its use will be restricted to immediate 
use after contact with hazardous substances and, if possible, always with 
water. The indication is limited to organic contaminants, hydrofluoric acid 
and oxidizing agents, and diluted acids and alkalis. These two formulations 
would ensure compliance with Risk Class I, particularly regarding the issue 
that contact with broken skin (possibly caused by a hazardous substance) is 
not part of the intended use.

These warnings would also be stated:

"Do not use in the eyes, on mucous membranes, or on broken skin. In case of 
such contact, rinse with water or a sterile solution."

With this amended indication and instructions for use, the products are also 
marketed in Germany as Class I. However, to restart in Estonia, we need an 
Estonian-accepted registration for an Estonian company that does not rely on 
authorizations from other countries.

If you accept this procedure, I would enter the three affected products (100 
ml, 600 ml, and 5000 ml) in the Estonian database with the new UDI DI and 
the new trade name "NeutralAll" and upload the new labels, the new package 
inserts, and the new declaration of conformity.

I would then be very grateful if this entry in the Estonian database could 
be approved quickly and we could then receive a free sale certificate within 
five days, for which we have already paid the fees.

I would like to clearly confirm once again that the restrictions mentioned 
in the indication are actually only included for legal reasons and do not 
constitute real  contraindications. We have tested the products on wounds, 
mucous membranes, and ocular connective tissue, and no irritation or damage 
was observed. Therefore, there is no risk of any health hazards for a 
patient at any time, even if they use the product outside of its declared 
intended purpose.

Only the rapid Class I registration will enable us to actually bring the 
product from Estonia to the global market in the foreseeable future and make 
the necessary investments there. We are actively working on getting the 
products certified as Class IIa by TÜV Süd in Munich. However, this will 
take at least another year, and we do not want to wait that long.

Please be assured that I have the greatest sympathy for Estonia and would 
very much like to relocate my business activities there, but I am grateful 
for your friendly cooperation.
I am not requesting any funding from Estonia and will finance everything 
myself, but I also don't want tro have any additional hurdles for my 
activities.

I would be very pleased if we could proceed in this way and if I could 
receive a positive response from you soon.

We can also arrange another video conference, or if necessary, I would be 
happy to visit you again in Tartu.

Best regards

Dr. Martin Weber

-- 

Dr. Martin Weber
CEO,
Vebasan OÜ

Email:	 [email-masked] <mailto:[email-masked]>
Website:	 http://vebasan.comMobil: 
+49 175 9144607Address: 
Ahtri 12, Tallinn 15551, EstoniaRegister 
No.	 Business Register Estonia No. 17033216Legal 
form:	 Estonia Private Limited Company (Osaühing/OÜ)Local 
Contact Person:	 E-Residency Hub OÜ, Ahtri 12, Tallinn 15551, Estonia-------- Originalnachricht --------

Betreff:	 Väljaminev kiriDatum: 
2025-05-05 10:04Von: 
[email-masked]: 
Vebasan OÜ <[email-masked]>, Ravimiamet <[email-masked]>, 
Riigikantselei <[email-masked]>, Majandus- ja 
Kommunikatsiooniministeerium <[email-masked]>, Kaitseministeerium 
<[email-masked]>, E-residency Hub <[email-masked]>Tere!

Teile on saadetud Sotsiaalministeeriumi dokumendihaldussüsteemi Delta kaudu 
dokument.

Pealkiri: Väljaminev kiri

Registreerimise kuupäev: 03.05.2025

Registreerimise number: 5.2-7/1126-2

Lugupidamisega

Sotsiaalministeerium

Suur-Ameerika 1, 10122 Tallinn
Tel. (372) 626 9301, faks (372) 626 9209
e-post: [email-masked]
 <http://www.sm.ee> www.sm.ee