contents table Lexparency.org
Health Claims
Article 21

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:
    1. the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and
    2. the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and
    3. 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 Commission takes a decision on whether a claim could be or could have been included in the list provided for in Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.