Division SECTION 3 Template for the reasoned decision addressing a negative reasoned opinion

[Name of the home competent authority responsible for assessing the application for authorisation]

Contact details of the competent authority responsible for assessing the application for authorisation

Name of person(s) responsible for further contacts:

Function:

Telephone number:

Email address:

Reasoned decision addressing the negative opinion(s):

[Choose one option] Proceed/Not Proceed to grant authorisation

[Reasons and justification for determining the reasoned decision…]

Done at …on [insert date] …

On behalf of [Name of the competent authority responsible for assessing the application for authorisation]

[signature]

[attachment: a copy of the decision]