Change in eService Marketing Authorisation and lifecycle

messages in brief | 05/12/2023

As part of the implementation of the ISO IDMP requirements in combination with the EU IG, it will be possible to enter marketing information per pack line from 06.12.2023.

For this purpose, the eService Marketing authorisation and lifecycle in the section Overview of medicinal product has been adapted so that the current pack data from Pharos can be supplemented with the marketing status and the corresponding date in the menu item "Report marketing data".

It is still possible to apply for an exemption from the provisions of Article 22 AMG.

Step-by-step instructions can be found in the updated guideline L_Z34.

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