Please enclose this formatted submission cover letter in each PSUR submission to BfArM (DE) according to Section 63d AMG in the folder 'working documents' (eCTD) or as an attachment (non-eCTD).
Parts of the text and layout are taken from the Formatted Table Template (EMA).
Please note: this cover letter for PSUR submission to BfArM does not replace the Formatted Table Template (EMA) which is required when submitting PSURs to EMA.
Mandatory fields are in bold type. Checkboxes are activated by double-clicking. Format dd.mm.yyyy for date fields.

1*	Applicant	     	
2	Customer Account Number	     	
3	Customer Reference / Purchase Order Number	     	
4	INN / Active substance(s)	     	
5	Product Name	Product list see next page	
6*	EU Assessment Procedure Number (PSUSA or WSP number)	     
Product number(s) see next page	
6.1	Is this: 	A submission of a new PSUR		A response to an existing PSUR		
6.2*	Nationally Authorised Product(s) 	see below under Authorisation Procedure(s)	
7*	Application Type	PSUR	
8*	Description of Submission	PSUR No.       from       to      	
9	RMP included in this submission:	 Yes 	 No 	RMP version N.	     	
10*	eCTD sequence	see next page (sequence number for each product)	
11*	Contact Persons’ details
(include email address)	A) Regarding the content of the submission:
Name:      
Phone:      
Email:      
B) Regarding eCTD technical questions:
Name:      
Phone:      
Email:      
C) Regarding financial queries:
Name:      
Phone:      
Email:      	
To be completed as applicable for submission to BfArM (DE):	
12	Assessment procedure		Single Assessment		PSUR Work Sharing	
			Mutual Recognition / Decentralised		Purely national procedure	
			DE is Rapporteur / P-RMS / RMS in the Assessment Procedure	
13	Authorisation procedure(s)	 CAP	 MRP / DCP	 Purely national	
14	Marketing authorisation holder: (only one MAH possible)	     	
15	ATC Code	     	
16	Date of cover letter	     	
17	Other information	     	

Products authorised (not expired) in Germany. 7-digit AMIS "Eingangsnummer" (ENR), absolutely necessary. One line per product, listed by ascending ENR.

No.	BfArM ENR	Product name (Invented name)	MRP / EM(E)A number	BfArM Marketing Authorisation number	eCTD sequence number	Innovator product (X)	Not placed on the market (X)	

1								
2								
3								
4								
5								
6								
7								
8								
9								
10								
11								
12								
13								
14								
15								
16								
17								
18								
19								
20								

Mandatory fields are in bold type. Checkboxes are activated by double-clicking. Date format dd.mm.yyyy.
1	Applicant	An applicant might differ from the MAH (Marketing Authorisation Holder)	
2	Customer Account Number	Not mandatory.	
3	Customer Reference / Purchase Order Number	This is a reference number provided by the applicant (e.g. PO – purchase order number). Not mandatory.	
4	INN / Active substance(s)	Same substance / substance combination for all medicinal products.	
5	Product Name	Product names should be stated on the following page (product list).	
6	EU Assessment Procedure Number (PSUSA or WSP number)	Please only enter the PSUSA number (as published in the EURD list) or the WSP number (PSUR Work Sharing list). Product numbers (including EM(E)A or MRP numbers) should be stated on the following page (product list).	
6.1	Is this: (new/existing PSUR)	Not mandatory.	
6.2	Nationally Authorised Product(s) 	Product names should be stated on the following page (product list).	
7	Application Type	“PSUR” is already marked.	
8	Description of Submission	Please enter the PSUR number (if applicable) and the reporting period (dd.mm.yyyy).	
9	RMP included in this submission:	Activate the box by double-clicking if a Risk Management Plan (RMP) is also being submitted (applicable if the RMP is a direct result of data presented in the PSUR).	
10	eCTD sequence	The eCTD sequence number (electronic common technical document) should be entered on the following page (product list).	
11	Contact Persons’ details
(include email address)	Contact person mandatory for matters regarding regulatory/safety issues; not mandatory for technical (eCTD) and financial questions.	
To be completed as applicable for submission to BfArM (DE):	
12	Assessment procedure	Please choose the correct assessment procedure. Activate the box by double-clicking. 	
		If Germany is Rapporteur / P-RMS / RMS in the assessment procedure, activate the box by double-clicking.	
13	Authorisation procedure(s)	Please choose the appropriate authorisation procedure(s) for the medicinal products (several can be selected). Activate the box by double-clicking.	
14	Marketing authorisation holder: 	Only one MAH (Marketing Authorisation Holder) is possible for one PSUR. 	
15	ATC Code(s)	Anatomical Therapeutic Chemical (ATC) Code.	
16	Date of cover letter	Date of this cover letter (format dd.mm.yyyy)	
17	Other information	Any further remarks concerning the PSUR submission.	
Product list	
	No.	Serial number	
	BfArM-ENR	BfArM "Eingangsnummer" (ENR) (AMIS identification number for each medicinal product).	
	Product name	Name of the medicinal product.	
	MRP / EM(E)A number	EU procedure number for centralised (EM(E)A/...) or mutual recognition procedures (MRP/DCP). Do not fill in assessment procedure numbers (PSUSA, WSP).	
	BfArM Marketing Authorisation number	“BfArM-Zulassungsnummer” (ZNR) (identification number for each medicinal product)	
	eCTD sequence number	eCTD sequence number (electronic common technical document) for the medicinal product.	
	Innovator product (X)	Mark with an 'X' if the medicinal product is the innovator product.	
	Not placed on the market (X)	Mark with an 'X' if the medicinal product is not placed on the market.