Paragraph 9 Surrender of marketing authorisation at same time as a variation application

Subject to sub-paragraphs (2) and (3), where an applicant applies to vary a marketing authorisation in the circumstances set out in paragraph 8(3) of Part 3 of Schedule 4, the fee payable under regulation 19(1) shall be refunded or waived.

Subject to sub-paragraph (3), where an applicant on the same occasion submits more than one such application which relates to medicinal products containing the same active ingredients but no other active ingredient, sub-paragraph (1) shall apply only to one of those applications.

Where in respect of any two or more of the applications mentioned in sub-paragraph (2) provision is made for fees of different amounts by paragraphs 51 and 52 of Part 4 of Schedule 2, sub-paragraph (1) shall apply to the application in respect of which of those paragraphs make provision for the higher or highest fee.