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Background:
Considering that mouthwashes can cause side effects, patients and
healthcare professionals should report adverse events to national
authorities. To ensure the safety of these products and facilitate the
reporting of adverse events, it is essential for patients and healthcare
professionals to be aware of the regulatory status of the product
responsible for the undesirable event.
The aim
of this paper was to examine the regulatory status of mouthwashes
available on the market in the Republic of North Macedonia.
Materials and Methods:
A market survey was conducted in the Republic of North Macedonia,
covering both traditional and online markets. Mouthwashes were purchased
directly from vendors. The brand names of the products and the
regulatory information indicated on their packaging were documented.
Results:
A total of 76 mouthwashes were available on the market in the Republic
of North Macedonia at the time of conduction of this research. Most of
these (n=71, 93.43%) were classified as cosmetic products, while 3
(3.94%) were categorized as medicines, and 2 (2.63%) as medical devices.
A statistically significant difference was found between the number of
mouthwashes classified as cosmetic products and those registered as
medicines or medical devices.
Conclusion:
Regardless of their classification, all mouthwashes must comply with
national and international safety standards prior to market placement
and must be subject to post-market vigilance during normal or reasonably
foreseeable use.
Key words:
mouthwashes, regulation, medical devices, cosmetics, safety
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Address of correspondence:
Senior Research Associate Zabokova
Bilbilova Efka
Ss. Cyril and Methodius University in Skopje, Faculty of Dentistry,
Skopje, North Macedonia
E-mail: ezabokova@stomfak.ukim.edu.mk
Copyright © 2024by The Editorial Council of The Acta
Stomatologica Naissi
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