Kiri
| Dokumendiregister | Sotsiaalministeerium |
| Viit | 5.2-7/1126-3 |
| Registreeritud | 06.05.2025 |
| Sünkroonitud | 07.05.2025 |
| Liik | Sissetulev kiri |
| Funktsioon | 5.2 Tervishoiuteenuste kättesaadavuse korraldamine |
| Sari | 5.2-7 Ravimite, meditsiiniseadmete ja verepreparaatidega seotud kirjavahetus (Arhiiviväärtuslik) |
| Toimik | 5.2-7/2025 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Vebasan OÜ |
| Saabumis/saatmisviis | Vebasan OÜ |
| Vastutaja | Johanna Liis Udumets (Sotsiaalministeerium, Kantsleri vastutusvaldkond, Terviseala asekantsleri vastutusvaldkond, Tervishoiukorralduse osakond) |
| Originaal | Ava uues aknas |
Failid
Digiallkirjad
Suur-Ameerika 1 / 10122 Tallinn / ESTONIA / +372 626 9301 / [email protected] / www.sm.ee / Reg. no 70001952
Dr. Martin Weber Vebasan OÜ [email protected]
Our ref. 03.05.2025 No 5.2-7/1126-2
Väljaminev kiri Dear Dr. Martin Weber, Thank you for your message and for your interest in contributing to the Estonian business environment, economy, and security. We understand that the regulatory process you have encountered has caused frustration and uncertainty. The Republic of Estonia places high value on a transparent and lawful regulatory framework that ensures the safety of patients and users. The classification and placing on the market of medical devices is governed by Regulation (EU) 2017/745, which applies uniformly across all EU Member States. The aim of this regulation is to ensure high level of safety and efficacy for all medical devices sold in the European market and at the same time foster innovation. The Estonian Medicines Agency (Ravimiamet), as the competent authority, is responsible for assessing medical devices in accordance with this regulation. It operates independently and is required to follow the legal framework established by the European Union. The Ministry of Social Affairs does not interfere with individual classification decisions. In this particular case, the Estonian Medicines Agency has carefully reviewed the technical documentation, intended purpose, composition and the mode of action of SkinNeutrAll, which is also marketed under the commercial names BodyNeutrAll and PlumBodyNeutrAll, and compared it with the position of the German competent authority, BfArM. BfArM has determined the product in question to be a Class IIa medical device. Upon review, the Estonian Medicines Agency concluded that the product submitted for registration in Estonia as a Class I device is materially the same as that assessed by BfArM and therefore also Class IIa medical device. Therefore, in accordance with the applicable classification rules, the product must undergo a conformity assessment by notified body. Although this process may require more time and financial resources compared to Class I devices, it is necessary to ensure that only safe products are placed on the market. Due to the reasons mentioned above, Estonian Medicines Agency has refused the registration of the product as Class I medical device. Should the company disagree with the decision, we encourage it to submit an appeal to the Estonian Medicines Agency with relevant explanations and evidence, as indicated in the official response from the Estonian Medicines Agency. We would like to emphasize that if the product qualifies as a Class I device and is legally placed on the market in Germany under that classification, it can also be made available on the market in Estonia under the same conditions. Please note that the distribution of a Class I medical device in Estonia does not require notification in the Medical Devices Database (MSA). Alternatively, if the product is marketed in Germany as a Class IIa device with proper documentation and conformity assessment, there should also be no obstacles to its
2 (2)
distribution in Estonia provided that the required notification of distribution is submitted. We appreciate your initiative and welcome your continued interest in supporting public health and the local market in Estonia. Yours sincerely, Anniki Lai Vice Chancellor Copy to: Ravimiamet Riigikantselei Majandus- ja Kommunikatsiooniministeerium Kaitseministeerium E-residency Hub Johanna Liis Udumets +372 [email protected]
Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. |
Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. |
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
|
-------- Originalnachricht --------
| Betreff: | Väljaminev kiri |
|---|---|
| Datum: | 2025-05-05 10:04 |
| Von: | [email protected] |
| An: | Vebasan OÜ <[email protected]>, Ravimiamet <[email protected]>, Riigikantselei <[email protected]>, Majandus- ja Kommunikatsiooniministeerium <[email protected]>, Kaitseministeerium <[email protected]>, E-residency Hub <[email protected]> |
|
Digiallkirjad
Suur-Ameerika 1 / 10122 Tallinn / ESTONIA / +372 626 9301 / [email protected] / www.sm.ee / Reg. no 70001952
Dr. Martin Weber Vebasan OÜ [email protected]
Our ref. 03.05.2025 No 5.2-7/1126-2
Väljaminev kiri Dear Dr. Martin Weber, Thank you for your message and for your interest in contributing to the Estonian business environment, economy, and security. We understand that the regulatory process you have encountered has caused frustration and uncertainty. The Republic of Estonia places high value on a transparent and lawful regulatory framework that ensures the safety of patients and users. The classification and placing on the market of medical devices is governed by Regulation (EU) 2017/745, which applies uniformly across all EU Member States. The aim of this regulation is to ensure high level of safety and efficacy for all medical devices sold in the European market and at the same time foster innovation. The Estonian Medicines Agency (Ravimiamet), as the competent authority, is responsible for assessing medical devices in accordance with this regulation. It operates independently and is required to follow the legal framework established by the European Union. The Ministry of Social Affairs does not interfere with individual classification decisions. In this particular case, the Estonian Medicines Agency has carefully reviewed the technical documentation, intended purpose, composition and the mode of action of SkinNeutrAll, which is also marketed under the commercial names BodyNeutrAll and PlumBodyNeutrAll, and compared it with the position of the German competent authority, BfArM. BfArM has determined the product in question to be a Class IIa medical device. Upon review, the Estonian Medicines Agency concluded that the product submitted for registration in Estonia as a Class I device is materially the same as that assessed by BfArM and therefore also Class IIa medical device. Therefore, in accordance with the applicable classification rules, the product must undergo a conformity assessment by notified body. Although this process may require more time and financial resources compared to Class I devices, it is necessary to ensure that only safe products are placed on the market. Due to the reasons mentioned above, Estonian Medicines Agency has refused the registration of the product as Class I medical device. Should the company disagree with the decision, we encourage it to submit an appeal to the Estonian Medicines Agency with relevant explanations and evidence, as indicated in the official response from the Estonian Medicines Agency. We would like to emphasize that if the product qualifies as a Class I device and is legally placed on the market in Germany under that classification, it can also be made available on the market in Estonia under the same conditions. Please note that the distribution of a Class I medical device in Estonia does not require notification in the Medical Devices Database (MSA). Alternatively, if the product is marketed in Germany as a Class IIa device with proper documentation and conformity assessment, there should also be no obstacles to its
2 (2)
distribution in Estonia provided that the required notification of distribution is submitted. We appreciate your initiative and welcome your continued interest in supporting public health and the local market in Estonia. Yours sincerely, Anniki Lai Vice Chancellor Copy to: Ravimiamet Riigikantselei Majandus- ja Kommunikatsiooniministeerium Kaitseministeerium E-residency Hub Johanna Liis Udumets +372 [email protected]
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Väljaminev kiri | 03.05.2025 | 4 | 5.2-7/1126-2 | Väljaminev kiri | som | Vebasan OÜ, Ravimiamet, Riigikantselei, Majandus- ja Kommunikatsiooniministeerium, Kaitseministeerium, E-residency Hub |