<Date of submission>

Submission of comments on '<document title>' (EMA/…/…)

Comments from:
Name of organisation or individual	

Please note that these comments and the identity of the sender will be published unless a specific justified objection is received.
When completed, this form should be sent to the European Medicines Agency electronically, in Word format (not PDF).

1. 	General comments
Stakeholder number
(To be completed by the Agency)	General comment (if any)	Outcome (if applicable)
(To be completed by the Agency)	

2. 	Specific comments on text
Line number(s) of the relevant text
(e.g. Lines 20-23)	Stakeholder number
(To be completed by the Agency)	Comment and rationale; proposed changes
(If changes to the wording are suggested, they should be highlighted using 'track changes')	Outcome
(To be completed by the Agency)	
		Comment:

Proposed change (if any):
		
		Comment:

Proposed change (if any):
		
		Comment:

Proposed change (if any):
		
Please add more rows if needed.