The Joint Announcement of BfArM and PEI replaces the second Announcement on the notification of variations for purely national licences in accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 which are within the BfArM's responsibility in accordance with Section 77 dated 15 June 2016 and considers the amendments to the Variation Regulation (Regulation (EC) No. 1234/2008) following the entry into force of Commission Delegated Regulation (EU) 2024/1701.

Publication of the Joint Announcement by BfArM and PEI on the Notification of Variations for Purely National Marketing Authorisations in Accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 dated 16 April 2025

Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)

On the occasion of the new Variation Regulation (EC) No 1234/2008 which applies since 1 January 2010 a new web page "Variations" has been created and should be considered.

As of 1^st March 2025 new validation criteria for eCTD submissions are mandatory.

The opinion on the classification of dehydroepiandrosterone is available.

Update on allocation of DCP slots

As of 12.12.2024 online procedures für „Renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG (Medicinal Products Act)“ and „Declarations of the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG (Medicines Products Act)“ are availabe via the portal PharmNet.Bund.