Beskrivning
| Land | Danmark |
|---|---|
| Sektor | Hälsovård |
| Industri | Läkemedel & Handel |
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CS MEDICA A/S ("CS MEDICA" or the "Company") hereby announces that the Company has obtained Free Sales Certificate (FSC) from the Danish Medicines Agency and The Danish Chamber of Commerce for medical devices and cosmetics products respectively. The FSC is valid until November 2023 and allows CS MEDICA to sell and distribute products to countries outside of the EU.
CS MEDICA is working under the Medical Devices Directive (MDD) legislation and is in process of updating according to the new MDR regulation monitored by the Danish Medicines Agency. The area covered by this authority includes the EU, Norway, and Switzerland. The Danish Medicines Agency finalized their last inspection in March 2021 with only findings of minors and remarks. The next inspection from the Danish Medicines Agency is not expected before 3 - 5 years, meaning CS MEDICA is free to operate in Europe, Norway, and Switzerland.
To expand the market territory for their CANNASEN product line, CS MEDICA has applied and been granted free sales certificates (FSC) from the Danish Medicines Agency and the Danish Chamber of Commerce for medical devices and cosmetics products respectively. The newly granted FSC means that in addition to CS MEDICA's approval for Sale in the EU, Norway, and Switzerland through the Danish Medicines Agency, CS MEDICA is now, with their FSC granted, approved to legally and freely sell, or distribute CANNASEN products on the open market (i.e., outside European economic cooperation and to countries without a mutual recognition agreement with the EU). The FSC granted is valid until November 2023 and includes CS MEDICA's products listed below:
Medical devices:- CANNASEN® CBD Arthritis gel
- CANNASEN® CBD Psoriasis gel
- CANNASEN® CBD Wound gel
- CANNASEN® CBD Nasal Spray Night
- CANNASEN® CBD Protective Nasal Gel
- CANNASEN® CBD Pain Patch
- CANNASEN® CBD Anti-Hair loss serum
Medical Device and cosmetics in the pipeline will be applied for and included in the above FSC's as they are launched.
CS MEDICA is currently in the process of reviewing requirements in different countries under FSC and is in the process of listing those countries where CS MEDICA without any restriction can initiate sales legally and freely. The countries approved within CS MEDICA's FSC, and evaluated so far, is listed below:
Countries Free Sales Certificates
Asia
UAE / Dubai yes
China yes
Bangladesh yes
Bahrain yes
Indonesia yes
India yes
Jordan yes
Kuwait yes
Lebanon yes
Thailand yes
Taiwan yes
Vietnam yes
Israel yes
Yemen yes
Syria yes
Saudi Arabia yes
Japan yes
Hong Kong yes
Malaysia yes
Africa
Morocco yes
Egypt yes
EU candidate
Serbia yes
Potential EU candidates
Bosnia yes
Kosovo yes
Other Eu countries
Belarus yes
Georgia yes
CS MEDICA is working hard to extend product availability in several of the countries mentioned above. Currently, CS MEDICA is in the process of registering their medical device products in China and the United Arab Emirates with our FSC.
Current Product availability
CANNASEN® CBD product line is currently available in 522 stores. Currently, CS MEDICA has signed distribution agreements in Denmark, Sweden, Netherland, Belgium. Furthermore, a private label agreement is established in Germany (Alsitan GmbH) and a reseller agreement with DirectSalud in Spain. We are still in the listing process in Netherland and Belgium. Already established sales channels are listed below:
Denmark
Matas - in all 186 Medicare shops and their webshop:
www.matas.dk
Online pharmacies and web shops:
www.med24.dk
www.webapoteket.dk
www.apopro.dk
www.dinapoteker.dk
www.jala-helsekost.dk
www.helsebiksen.dk
www.cosmage.dk (https://cosmage.dk/produkt-kategori/brands/cannasen-brand)(own webshop)
Sweden
Kronans apotek - In all 326 shops and in their webshop:
www.kronansapotek.se
Med24.se - In their web shop:
www.med24.se