New notification obligations of the marketing authorisation holder in accordance with Section 29 sub-section 1g AMG as of 28 October 2013
Section 29 sub-section 1g AMG which came into force on 28 October 2013 in accordance with Article 5 sub-section 2 of the Third Act to Amend Provisions under the Law Concerning Medicinal Products and Other Provisions of 7 August 2013 (BGBl. I page 3108) entails new notification obligations of marketing authorisation holders from that date onward.
As of 28 October 2013, the competent federal higher authority is to be notified immediately of the reasons for
- the temporary or permanent cessation of the marketing of a medicinal product
- the recall of a medicinal product
- the renouncement of a marketing authorisation
- the non-submission of an application for renewal of a medicinal product
This notification is to state especially whether the measure has been taken for one of the following reasons ("risks"):
- Section 25 sub-section 2 number 3 AMG: the medicinal product is not manufactured in accordance with recognised pharmaceutical rules or does not meet appropriate quality standards
- Section 25 sub-section 2 number 4 AMG: the therapeutic efficacy attributed to the medicinal product by the applicant is lacking or is insufficiently substantiated by the applicant in accordance with the confirmed state of scientific knowledge
- Section 25 sub-section 2 number 5 AMG: the benefit/risk profile is unfavourable
- Section 30 sub-section 2 sentence 1 number 1 AMG: withdrawal of the marketing authorisation if incorrect or incomplete information is given in the documents specified in Sections 22, 23 or 24 AMG
- Section 69 sub-section 1 sentence 2 number 4 AMG: there is sufficient reason to suspect that the medicinal product has harmful effects which exceed the bounds considered justifiable according to the prevailing standard of scientific knowledge
- Section 69 sub-section 1 sentence 2 number 5 AMG: the prescribed quality controls have not been carried out.
If one of these reasons is present, the marketing authorisation holder also has to notify the European Medicines Agency (EMA) accordingly.
Likewise, the marketing authorisation holder is to inform federal higher authorities and EMA of cessation of the marketing of the medicinal product, renouncement of marketing authorisation, non-submission of an application for renewal of marketing authorisation or a recall in a third country based on one of the aforementioned reasons.
However, all other reasons for one of the stated measures are also to be notified, e.g. economic reasons, changes to the product portfolio et cetera.
The reasons for the measures stated in Section 29 sub-section 1g AMG are to be communicated to the BfArM in the following manner:
- Temporary or permanent cessation of marketing
The BfArM is to be informed of the reasons for this measure via the electronic „Sunset Clause“ procedure. The form "Notification of cessation (temporary/permanent) of marketing" according to Section 29 sub-section 1c AMG was adapted accordingly. The "Explanatory Notes by BfArM and BVL Concerning Notification Procedures under the "Sunset Clause" Provisions" have also been updated.
- Recall of a medicinal product, renouncement of marketing authorisation and non-submission of an application for renewal of marketing authorisation
The BfArM is to be informed of the reasons for this measure via the following form for download
Please note that the written renouncement of marketing authorisation can also be declared on this form, i.e. renouncement and reasoning can be submitted jointly.
Presence of a "risk" according to Section 29 sub-section 1g sentence 2 AMG in Germany or a third country
a.) Within the scope of the AMG:
If a "risk" in accordance with Section 29 sub-section 1g sentence 2 AMG is the basis for such a measure, the details thereof are to be sent electronically by way of the form provided by the EMA to the BfArM e-mail address PAR291g@bfarm.de along with an Excel list in addition to the form mentioned above.
b.) If such a measure has been taken in a third country for a medicinal product (or a qualitatively or quantitatively comparable medicinal product for which the pharmaceutical company holds a marketing authorisation in Germany) due to a "risk" in accordance with Section 29 sub-section 1g sentence 2 AMG, the reasoning for this is also to be sent electronically by way of the form provided by the EMA to the BfArM e-mail address PAR291g@bfarm.de along with an Excel list in addition to the form mentioned above.