The nasal spray designed by the company Pharma & Beauty – Centrepharma can ultimately not be marketed. However, the firm announced a launch on the market in early March and a 99% effectiveness against Sars-Cov-2. Why can’t it ultimately be sold?
Marketing suspended by the Medicines Agency
It is certainly a blow for the pharmaceutical laboratory Center Pharma and the French group P & B. Indeed, a week before the launch of their ” Nasal Spray COV-Defense “, Also called” nasal spray Biokami », It turns out that the product will ultimately not be able to be sold in pharmacies. In a press release published on February 22, the ANSM (National Agency for the Safety of Medicines), suspended its marketing. It was a rather preventive treatment, in no way curative, allowing “ inactivation of the Sars-CoV-2 virus by more than 99% “, According to the manufacturer. It was considered virucidal, due to its composition based on ionized water and purified water. However, despite this assertion, the ANSM lacks clinical validation data. She did not, so to speak, receive any. However, this is an absolutely necessary prerequisite for a “ medical device can be placed on the market according to European regulations “. It is for this reason that the health police cannot agree to give their consent for the marketing of the anti-Covid nasal spray developed by Pharma & Beauty.
Reminder of lots
This is not all, since the drug monitoring establishment not only suspends the marketing of the product, but also prohibits it ” distribution, advertising and [son] use “. It also obliges society to “ recall the batches of these devices and inform all natural or legal persons likely to hold the products concerned “. This requirement is requested, pending receipt of any additional information constituting security guarantees. In addition, the ANSM recalls that “ medical devices are health products “. Therefore, they need to be tracked and monitored by the organization. The goal is to control the conformity of products, their performance, but also their safety, to guarantee their safety when patients use them.