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CHAPTER XIVU.K. DATA PROTECTION AND DATA-SHARING

Article 59U.K.Protection of data held by competent authorities or the Agency

1.Without prejudice to Articles 62 and 63, data submitted for the purposes of Directive 98/8/EC or of this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where:

(a)the subsequent applicant submits a letter of access; or

(b)the relevant time limit for data protection has expired.

2.When submitting data to a competent authority or to the Agency for the purposes of this Regulation the applicant shall, where relevant, indicate the name and contact details of the data owner for all data submitted. The applicant shall also specify whether it is the data owner or holds a letter of access.

3.The applicant shall, without delay, inform the competent authority or the Agency about any changes to the ownership of the data.

4.The advisory scientific committees set up under Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment(1) shall also have access to the data referred to in paragraph 1 of this Article.