X1CHAPTER V GENERAL AND FINAL PROVISIONS

Annotations:

Article 21 Data protection

1

The scientific data and other information in the application required under Article 15(3) may not be used for the benefit of a subsequent applicant for a period of five years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:

a

the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and

b

the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and

c

the health claim could not have been authorised without the submission of the proprietary data by the prior applicant.

2

Until the end of the five-year period specified in paragraph 1, no subsequent applicant shall have the right to refer to data designated as proprietary by a prior applicant unless and until the F1appropriate authority takes a decision on whether a claim could be or could have been F2authorised under Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.