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




EMA Europe

August 19, 2022

EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox

August 19, 2022 EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex 1 used as an intradermal injection (given just below the top layer of the skin). The vaccine is...

Read the Full Article
EMA Europe

June 2, 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 the Full Article
EMA MAH

June 15, 2022

EMA adopts first list of critical medicines for COVID-19

News On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...

Read the Full Article