EMA: Regulatory and procedural guideline: Guidance on centrally authorised products requiring a notification of a change for update of annexes

On 23 July 2010 and after a consultation phase, the EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any update of the annexes, except for those when the EMA has specifically indicated that a notification of a change is still required. The following table lists the centrally authorised products that the EMA requires to submit a notification of change before implementation due to safety or quality reasons.