CHAPTER IXCANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS

Article 48Cancellation or amendment of an authorisation

1

Without prejudice to Article 23, the competent authority F1... shall at any time cancel or amend an authorisation it has granted where it considers that:

a

the conditions referred to in Article 19 or, where relevant, in Article 25 are not satisfied;

b

the authorisation was granted on the basis of false or misleading information; or

c

the authorisation holder has failed to comply with its obligations under the authorisation or this Regulation.

2

Where the competent authority F2... intends to cancel or amend an authorisation, it shall inform the authorisation holder thereof and give it the opportunity to submit comments or additional information within a specified time limit. The F3competent authority shall take due account of those comments when finalising its decision.

3

Where the competent authority F4... cancels or amends an authorisation in accordance with paragraph 1, it shall without delay notify the authorisation holder F5....

F6...

F7...