Below you will find all important information about the changes in the radiation protection act applicable since 01.07.2025.

For studies with submission in CTIS and DMIDS, only one radiation protection submission is required - depending on the study focus CTIS or DMIDS.

Aerosol dispensers containing fluorinated greenhouse gases, including medicinal metered dose inhalers, may only be placed on the market, supplied or made available to third parties in the EU from 1 January 2025 if they are labelled in accordance with Article 12(3) of Regulation (EU) 2024/573 on fluorinated greenhouse gases (F-Gas Regulation).

Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.

This article provides information on the correct procedure for reporting a notification procedure in accordance with Section 32 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) as part of CTR submission and for Substantial Modifications in CTIS.

As from 09.02.2019, for medicinal products subject to Directive 2011/62/EC in conjuction with Commission Delegated Regulation (EU) 2016/161 amending Directive 2001/83/EC, a unique identifier (UI) has to be included on the packaging as well as a device allowing verification of whether the packaging has been tampered with (anti-tempering device = ATD).

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.