15 Oct The AEMPS endorses our client Montplet’s hydroalcoholic virucidal gel
Our client Montplet is part of the exclusive list of the 25 authorised manufacturers of hydroalcoholic gel with virucidal activity that has just been updated by the Spanish Agency of Medicines and Health Products (Agencia Española del Medicamento y Productos Sanitarios).
Of all the companies marketing antiseptics for healthy skin, only 25 have been authorised. This means that their efficacy in biocidal activity against target organisms is proven.
Among these companies is Montplet, a company founded in 1889 initially as a warehouse for spirits and a factory for rectifying spirits. After more than 130 years, and now in the fifth generation of the family business, the Montplet Group markets alcohol-related products. It is currently the main distributor of ethanol and blends in Spain and a leading manufacturer of antiseptics, cosmetics, disinfectants and insect repellents.
What is a hydroalcoholic disinfectant gel?
According to the AEMPS, these products fall under the so-called “antiseptics for healthy skin“. These are biocidal products for human hygiene in accordance with Annex V of Regulation 528/2012 concerning the placing on the market and use of biocidal products. They aim to eliminate micro-organisms from the skin to prevent their possible transmission from healthy carriers to other individuals.
Is this solution a medical device?
This health-authorised virucidal hydroalcoholic gel, MONTPLET® Antiseptic Gel (Reg. AEMPS 939-DES), is not classified as a medical device, as defined in Regulation 745/2017. However, its marketing as a biocide in Spain requires prior authorisation from the AEMPS. For this purpose, product documentation must be submitted, highlighting the documentation related to the efficacy in biocidal activity against the target organisms.
Hydrogel solutions must comply with a regulation in order to be authorised by the AEMPS. Montplet’s virucidal gel complies with UNE-EN 13727, UNE-EN 12791, UNE-EN 13624 and UNE-EN 14476: 2014+A1:2015 which regulate, among other things, how virucidal efficacy is demonstrated through a quantitative suspension test for the evaluation of virucidal activity in medicine.
If you have any doubts about the procedure to obtain a manufacturer’s or distributor’s licence for your product, or how to obtain the CE marking necessary to market it, EpisKey Medical Consulting SL can help you.