The European Medicines Agency (EMA) reminded marketing authorisation holders on 3 November of the deadlines for submitting variations of their medicines. A variation is a change in the terms of the marketing authorisation.
The EMA urges marketing authorisation holders to submit Type IA (minor variations with little impact on the quality, safety and efficacy of the product; they do not require prior approval, but must be notified to the competent authorities within 12 months of...