According to Section 63a, sub-section 3 of the German Medicines Act (AMG), the graduated plan officer and any change must be notified to the competent higher federal authorities BfArM and PEI.

Marketing authorisation holders are able to notify the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG electronically.

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.

Notifications in accordance with Section 29 sub-sections 1b and 1c AMG and with Section 141 sub-section 7 AMG (marketing and cessation of marketing) and applications for exemption and suspension to the Sunset Clause.

Application for supergrouping or a grouping number

enables pharmaceutical companies to create and submit variations