Marketing authorisation holders are able to submit renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG electronically by using this online procedure.

A written renouncement in accordance with Section 31 sub-section 1 sentence 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.

If the marketing authorisation expires due to a written renouncement in accordance with Section 31 sub-section 1 sentence 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. This does not apply if the competent higher federal authority ascertains that a condition for the withdrawal or the revocation of the marketing authorisation as defined in section 30 existed; Section 30 sub-section 4 AMG applies.

Section 31 sub-section 1 sentence 1 number 2 AMG expressly provides for a renouncement in writing. In order to maintain the written form, a cover letter containing a qualified electronic signature must be uploaded to the form.

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 reasons for the renouncement of the marketing authorisation must also be declared on the electronic form

Further information is available on the BfArM website: Written renouncement