204.—(1) This regulation applies where the licensing authority intends to make a public announcement relating to information on pharmacovigilance concerns.
(2) Subject to paragraph (4), the licensing authority must inform the bodies specified in paragraph (3) not less than 24 hours prior to making the public announcement.
(3) The bodies specified in this paragraph are—
(a)the EMA;
(b)the European Commission; and
(c)the competent authority of each EEA State other than the United Kingdom.
(4) Paragraph (2) does not apply if the information in the announcement needs to be made public urgently for the protection of public health.