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<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).

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The

An agency of the European Union Address for visits and deliveries

Refer to www.ema.europa.eu/how-to-find-us

Send us a question

Go to www.ema.europa.eu/contact

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+31 (0)88 781 6000

© European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged.

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1. General comments

Stakeholder number (To be completed by the Agency)

General comment (if any) Outcome (if applicable)

(To be completed by the Agency)

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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.

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