Current note/update from 2019.02.18 For clinical trials in which there is no sponsor or representative of the sponsor who is domiciled in a Member State of the EU or in the EEA at the time when a so-called hard Brexit becomes effective, revocation or suspension of the con-duct of the trial is mandatory by law. Such clinical trials may then not be continued. If a so-called hard Brexit occurs, the BfArM will accordingly order the suspension of the approval of such clinical trials, • whose sponsors or their representatives are then still resident in the United Kingdom, and • who have not yet notified a change in the sponsor, its representative or their place of business, or • have not yet notified the termination of the clinical trial. From the end of February, the BfArM will begin to hear the sponsors or their representatives still affected in accordance with Section 42a (3) of the German Medicines Act (AMG) prior to the suspension order and give them the opportunity to comment. All affected sponsors or their representatives are urged, in the interest of the care of the participants in such clinical trials, to prepare themselves for the case of the so-called hard Brexit and to notify the BfArM immediately of any change of sponsor, representative or registered office.

BfArM's recommendations regarding clinical trials with medicinal products where sponsor or legal representative are established in the United Kingdom

In order to conduct clinical trials with medicinal products in Germany, the sponsor or his legal representative must be located in a Member State of the European Union (EU) or in another State party to the Agreement on the European Economic Area (EEA). The legal basis for this is laid down in Section 40 sub-section 1 sentence 3 number 1 of the German Medicinal Products Act (Arzneimittelgesetz, AMG).

In cases where the sponsor or legal representative of a clinical trial are currently still located in the United Kingdom, it will become necessary to ensure that these establish a registered office in the EU or EEA.
According to a recent database research from January 2019, there are within the BfArM's responsibility approximately 1,300 clinical trials, the sponsor or legal representative of which is currently still located in the United Kingdom.

In order to maintain the prerequisites for conducting such clinical trials, it is necessary to specify a sponsor or legal representative established in the EU/EEA (and notify the BfArM thereof) in the case of a so-called hard Brexit, i.e. without adoption of an agreement on the withdrawal of the United Kingdom from the EU.

These are substantial amendments and have to be notified and authorised pursuant to Section 10 of the GCP Ordinance, taking into consideration the processing deadlines of 20 or 35 days for notifications of amendment.

To ensure fast processing of these notifications of amendment please do not submit these changes in sponsor or legal representative combined with any other amendments.

In cases where only a change in sponsor or inclusion or alteration of a legal representative is notified, it is possible to submit this amendment for several clinical trials of one single sponsor by way of a collective amendment.

For such simplified collective amendments, a cover letter is to be submitted which includes a table of all the clinical trials affected by the change listing both the BfArM submission number and the EudraCT number of the clinical trial concerned. This cover letter must further confirm that no other amendments have been made aside from changing sponsor and/or legal representative. The "Substantial Amendment Notification Form" does not have to be submitted in such cases.
The reference line of the cover letter should be worded as follows: "Brexit-related change in sponsor/legal representative“.

The EudraCT files (xml and pdf versions of the notification form) can be submitted on one single data medium. In such cases, one folder bearing the BfArM submission number and including the xml and pdf versions of the EudraCT notification form is to be created for each clinical trial.

Changes in the manufacturer responsible for final batch release or importer cannot be notified by way of such a simplified collective amendment, as the manufacturing chain must be reviewed study-relatedly in these cases. Such changes require submission of individual notifications of amendment.