EMA Allows Labeling Flexibilities for COVID-19 Therapeutics

The European Medicines Agency (EMA), which eased certain labeling requirements for COVID-19 vaccines in December, now says some of the same product labeling flexibilities may apply to COVID-19 therapeutics.

The agency said COVID-19 therapeutics can use English-language-only packaging in member states if the products meet certain criteria, such as being a prescription-only drug that is also a candidate for conditional marketing authorization.

The eased labeling requirements are “reserved for medicines with an important role in tackling the pandemic,” including products under rolling review, EMA said.