The Human Medicines Regulations 2012

[F1Right to review after paragraph 13F notificationU.K.

This section has no associated Explanatory Memorandum

13G.(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 13F.

(2) The applicant may notify the licensing authority in writing that the applicant wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification before the end of the period of 28 days beginning with the day on which the notification is given to the applicant under paragraph 13F or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the applicant has not made any representations in accordance with paragraph 13C or 13D.]