Notification obligation pursuant to Section 29 sub-section 1b, 1c AMG
D.1. Does the obligation to notify the national competent authority also apply to registered medicinal products?
Yes, in accordance with Section 39 sub-section 2c sentence 2 AMG, Section 31 AMG also applies correspondingly to the expiry of registrations.
D.2. Do notifications also have to be made for medicinal products for which marketing authorisation has been applied for but which are not yet licensed in accordance with Section 105 (so-called fictively licensed medicinal products)?
Yes, in accordance with Section 105 sub-section 1 AMG these medicinal products are considered licensed. Section 105 sub-section 3a AMG defines the exemptions to Section 29 AMG. As these Sections do not include any specifications concerning the sunset clause, sub-sections 1b and 1c of Section 29 AMG also apply to the so-called fictively licensed medicinal products.
D.3. Are notifications for medicinal products licensed centrally with the EMA also to be submitted?
Only licenses within the jurisdiction of the BfArM are subject to the notification procedure. As the EMA is responsible for centralised marketing authorisations, the BfArM does not have to be informed.
D.4. Is a (renewed) notification of marketing required for a medicinal product for which post-marketing authorisation was granted after 6 September 2005 and which was marketed previously?
No new notification is necessary if the granting of the marketing authorisation does not entail changes of the marketing status. This means that such a notification can be dispensed with if the medicinal product was marketed continuously.
D.5. Does a renewed notification of marketing have to be made if there was a marketing alliance and the co-marketer is now acting as the pharmaceutical entrepreneur for this product or if a marketing authorisation is transferred?
No new notification is necessary if there are no changes in the marketing status. This applies to co-marketing as well as to transfer of licenses.
D.6. Are notifications required for medicinal products the marketing authorisation of which was renounced by the marketing authorisation holder in accordance with Section 31 sub-section 1 number 2 AMG in conjunction with Section 31 sub-section 4 AMG and which are now still marketed in accordance with Section 31 sub-section 4 AMG?
There is no longer a notification obligation for expired marketing authorisations. The prerequisite for such an obligation is an existing license. The renunciation of marketing authorisation in accordance with Section 31 sub-section 1 number 2 AMG results in the expiry of the marketing authorisation as of receipt of the written renouncement, i.e. the marketing authorisation which is the logical prerequisite for application of Section 31 sub-section 1 number 1 AMG no longer exists.
D.7. Is a notification of interruption of marketing also required for suspended marketing authorisations?
Yes, notifications in accordance with Section 29 sub-sections 1b and 1c AMG and with Section 141 sub-section 7 AMG are to be separated procedurally from the provisions of Section 31 sub-section 1 number 1 AMG. This means that the notifications have to be made for all medicinal products pursuant to the a.m. regulations. For marketing authorisations which have been suspended the "Date of cessation" as well as "End of shelf life" must not be later than the date from which the suspension was ruled. If the marketing authorisation of a medicinal product has been suspended, it shall neither be placed on the market, nor shall it be introduced into the purview of this Act pursuant to Section 30 sub-section 4 AMG.
D.8. Does the obligation to notify the national competent authority in accordance with Section 29 sub-sections 1b, 1c AMG via PharmNet.Bund application "Notifications for Sunset Clause" also apply to products for which either standard marketing authorisation or standard registration procedures are used?
No, when employing standard marketing authorisation or standard registration procedures no notifications have to be made via PharmNet.Bund application “Notifications for Sunset Clause”. Informations on the use of products for which either standard marketing authorisation or standard registration procedures are used can be found on the BfArM-website Standardzulassung und –registrierung or in the PharmNet.Bund application Standardzulassungen.