EMA: List of centrally authorised products requiring a notification of a change for update of annexes

August 3, 2022

August 2022

EMA Regulatory and Procedural Guideline

Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing authorisation once a year in their annual update application, except in cases related to safety or quality issues. The downloadable table lists the centrally authorised products for which the EMA requires notifications of safety update before implementation.

Download List of Products

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs




FDA MHRA

August 3, 2022

Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement

Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...

Read More
EMA Europe

August 3, 2022

Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)

JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...

Read More
EMA Europe

August 3, 2022

EMA appoints Chief Medical Officer

June 1, 2022 Steffen Thirstrup has been appointed as Chief Medical Officer of EMA. In this role, he will provide scientific leadership across EMA and its scientific committees to reinforce the...

Read More