The European Medicines Agency (EMA) offered guidance on labeling requirements for COVID-19 therapeutics as a follow up on their guidance from last year that offered labeling requirement flexibilities on COVID-19 vaccinations. According to the EMA, the product’s intended use must be for prescription use and specifically indicated to treat COVID-19 or it’s affiliated complications. The EMA stated, “These flexibilities are exceptional and may not be appropriate or necessary for all other products with a COVID-19 claim. To avoid any misuse, the full application of these flexibilities will not be automatic.”
Read more here.
More on: News Regulatory