Saatja: Evgeni Serebrennikov <
[email protected]>
Saaja: RA MSO
Teema: Konsultatsioon toodete kohta
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.
Tere,
Minu nimi on Evgeni ja ma olen jurist Legix Law Firm OÜ-st
Ma olen juba vestelnud teie kolleegidega Järelevalveosakonnast ja nad kirjutasid mulle, et oleks mõistlik ka teie poole pöörduda arusaamatuste vältimiseks.
Ma sooviksin täpsustada, kas järgmiste toodete vahendamiseks on vaja ravimite vahendamise tegevusluba või piisaks teavituse esitamisest Ravimiametile läbi MSA süsteemi?
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Our planned area of activity focuses on brokering (not physical handling) of the following
categories of products:
A. Dermal Fillers (Hyaluronic Acid-Based and Other Fillers)
Dermal fillers are injectable substances used in aesthetic medicine for volume restoration, wrinkle reduction, and contouring. Some of the fillers we plan to facilitate transactions for include:
Hyaluronic Acid-Based Fillers (HA Fillers):
Juvederm® (Allergan) – Used for lip enhancement, cheek augmentation, and wrinkle
reduction.
Restylane® (Galderma) – A well-known HA filler for facial contouring and skin
hydration.
Teosyal® (Teoxane Laboratories) – Provides deep hydration and volume restoration.
Belotero® (Merz Pharmaceuticals) – A soft filler for fine lines and delicate facial areas.
Non-Hyaluronic Acid-Based Fillers (Longer-lasting fillers used in aesthetic
procedures):
Radiesse® (Merz Aesthetics) – A calcium hydroxylapatite-based filler for deeper
wrinkles and volume loss.
Sculptra® (Galderma) – A poly-L-lactic acid (PLLA) collagen stimulator for skin
rejuvenation.
Ellansé® (Sinclair Pharma) – A biostimulatory filler that promotes collagen production
over time.
Hyaluronic acid-based fillers are typically Class III Medical Devices under the EU MDR
(Medical Device Regulation 2017/745).
B. Hyaluronic Acid-Based Serums (HA Serums and Biorevitalizers)
These products are used for skin hydration, anti-aging, and regenerative treatments. Examples include:
Injectable HA Skin Boosters & Biorevitalizers (Medical Devices)
Profhilo® (IBSA) – A highly concentrated HA injectable for skin tightening and
hydration.
NCTF® 135 HA (Filorga) – A mesotherapy product for skin rejuvenation.
Jalupro® (Professional Derma) – Contains amino acids and HA to stimulate collagen
production.
Topical Hyaluronic Acid Serums (Cosmetic Products)
The Ordinary Hyaluronic Acid 2% + B5 – Hydration booster for skincare.
SkinCeuticals HA Intensifier – Anti-aging serum with HA and Proxylane.
Vichy Minéral 89 – Fortifying daily HA serum.
Injectable HA skin boosters and bio revitalizers are classified as medical devices.
Topical HA serums are classified as skincare cosmetic products under EU Cosmetics
Regulation 1223/2009.
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Ette tänades ja head õhtut!
Lugupidamisega,
<https://ci3.googleusercontent.com/mail-sig/AIorK4wJwBIwOyQwzP7EX5zlnMJmr2G6P3HrF-dRf1ASLWos-Ed95wiuMUuLgZ_D0Kx9YsIP5Ot_Ioj9nEBA>
Evgeni Serebrennikov
Lawyer,
LEGIX LAW FIRM
Email:
[email protected] <mailto:
[email protected]>
Website: legixlaw.eu <http://legixlaw.eu/>
<https://lh7-us.googleusercontent.com/OicTRzleq14aI-8FVfdC75dxQdU8beJD6NS49cT_-6dWHJiq8Pwr8W1BJPcdKE92gRuSIJnLbU6WkLd9dOJws6adReUd7xZGLljIpdkvchMSX9OQ0uGa2bi0PYyoYvFCO6F4inmGgsaXSQZR-wnIIds>