A written renouncement in accordance with Section 31 sub-section 1 number 2 AMG entails expiry of the marketing authorisation as of receipt of the declaration of renouncement, meaning that the marketing authorisation no longer exists. As a rule, this renouncement must only be declared by the marketing authorisation holder or a third party acting on authority of the marketing authorisation holder.

If the marketing authorisation expires due to a written renouncement in accordance with Section 31 sub-section 1 number 2 AMG, Section 31 sub-section 4 AMG specifies that the medicinal product can still be placed on the market for two years starting with either 1 January or 1 July following the announcement of the expiry pursuant to Section 34 AMG. However, this does not apply if the competent federal higher authority ascertains that a prerequisite for withdrawal or revocation pursuant to Section 30 AMG was present in which case Section 30 sub-section 4 AMG is applicable.

As Section 31 sub-section 1 number 2 AMG expressly provides for a renouncement in writing, it cannot be submitted electronically, e.g. via e-mail or CESP.

Regarding the written renouncement in accordance with Section 31 sub-section 1 number 2 AMG, the notification obligations have been extended since 28 October 2013 as laid down in Section 29 sub-section 1g AMG.

The BfArM expressly requests use of the form developed for this purpose:

See also further information on notification obligations:

Notification obligations of the marketing authorisation holder in accordance with Section 29 sub-section 1g AMG as of 28 October 2013