# The Human Medicines Regulations 2012, Paragraph 12: Human influenza vaccines


(1) By way of exception from paragraph 8, the procedure laid down in sub-paragraphs (2) to (4) applies to the examination of variations concerning changes to the active substance for the purposes of the annual update of a human influenza vaccine.
(2) The holder must submit to the licensing authority an application containing the elements listed in paragraph 9, and if it does so, the licensing authority must acknowledge receipt of a valid application.
(3) The licensing authority must assess the application submitted, and where it deems it necessary, the licensing authority may request additional data from the holder in order to complete its assessment.
(4) The licensing authority must—
(a) adopt a decision within 45 days, beginning with the date on which it receives a valid application; and
(b) take the measures provided for in paragraph 10.
(5) The 45-day period referred to in sub-paragraph (4) is to be suspended from the date on which the additional data referred to in sub-paragraph (3) is requested until the date on which that data is received by the licensing authority.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/10A/paragraph/12 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-10A/paragraph-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.