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Written renouncement

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 (on the right, under "Downloads").

For further information on notification obligations please click on "For more information" on the right.