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 implementation) and IAIN (minor variations that must be notified immediately) by 30 November at the latest so that the EMA can recognise their validity before its closure (between 23 December 2022 and 3 January 2023) while respecting the 30-day timeframe required for these types of variations, in accordance with Article 14 of the regulation concerning the examination of variations to the terms of a marketing authorisation, or Regulation (EC) No 1234/2008. This regulation also specifies the classification of variations.
Furthermore, the deadline for the communication of information on Type IB variations - minor variations which are not Type IA (variations for which prior approval is required) or Type II (major variations which may have a significant impact on the quality, safety or efficacy of the products, for which approval by a competent authority is required prior to implementation) or an extension - as well as for the communication of groupings of IB and IA variations is set at 2 December for a start of the procedure in 2022.
The procedure for Type IB variations or groupings of variations communicated on or after 5 December may not start until January 2023.
Links to EMA guidance for submitting variations: https://aeur.eu/f/3xj ; https://aeur.eu/f/3xm (Original version in French by Émilie Vanderhulst)