Notice to manufacturers on the marketing of nasal sprays claiming virucidal and antimicrobial actions

During the COVID-19 pandemic, EU authorities identified several nasal sprays claiming to be effective against COVID-19 on their national markets. In some cases, the manufacturers did not have the required clinical evidence to substantiate such claims.

In response, the HPRA collaborated with EU authorities to develop a notice for manufacturers of nasal sprays placed on the market as medical devices. This notice reminds manufacturers of their legal obligations with regards to:

• correctly qualifying and classifying their products,
• clinical data, and
• claims

Manufacturers should read this notice and ensure compliance with their applicable regulatory obligations.