If so requested by the Commission pursuant to Article 36(2) or Article 37(2), the Agency shall issue an opinion within 120 days from the date on which the matter in question was referred to it.

Before issuing its opinion, the Agency shall provide the applicant and, where applicable, the authorisation holder with an opportunity to provide written comments within a specified time limit not exceeding 30 days.

The Agency may suspend the time limit referred to in paragraph 1 to allow the applicant or the authorisation holder to prepare the comments.