Sender
	
Federal Institute for Drugs and Medical Devices
(Bundesinstitut für Arzneimittel und Medizinprodukte) 
SG 13.1
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Germany

Declaration of the reasons for the renouncement of the marketing authorisation, the non-submission of an application for renewal or the recall in accordance with Section 29 sub-section 1g AMG (Medicinal Products Act)
Name of the medicinal product, Pharm. form	MA number	„Eingangs-
nummer“ (processing number)	Date of approval	„Ordnungs-Nr.“ (orga-nisational number)1	

						
(The table may be extended if required)

This is to  

The decision/measure has been taken for the following reasons (Section 29 sub-section 1g AMG):
 	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.

In case the decision/measure was based on one of the above-mentioned reasons, we declare that
a) this also has been notified to the European Medicines Agency (EMA) 
b) the details thereof were 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.

 	Other reasons (please specify):      

The indicated reasons are based on an action which is taken in a third country.

_________________					_________________________________
Place / date	Signature of the marketing authorisation holder

	
	Contact person:
	
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