Marketing-authorisation holders are required to submit information on new marketing authorisations within 15 calendar days from the date of notification of the granting of the marketing authorisation by the national competent authority. This obligation applies to:
Marketing-authorisation holders are also required to submit information concerning all medicinal products for which they hold a marketing authorisation in EEA countries outside the EU (i.e. Iceland, Liechtenstein, and Norway), as the pharmacovigilance legislation is part of the EEA Agreement.
Information on any amendments to the terms of marketing authorisations following variation, transfer, renewal, suspension, revocation, or withdrawal must be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised.
The Agency is currently in a transition phase, during which the focus is on the maintenance of data submitted on authorised medicines. This “transition maintenance phase” continues until the implementation of the ISO IDMP standards. At this stage, the Agency will update the data-submission format in line with these standards, including information on pack sizes.