Regulation 204 Obligation on licensing authority in relation to public announcements

(1)

This regulation applies where the licensing authority intends to make a public announcement relating to information on pharmacovigilance concerns F1which relate to products authorised under a UKMA(NI) or F2UKMA(UK)(Category 2).

(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.

Annotations

Textual amendments

F1: Words in reg. 204(1) inserted (31.12.2020) by S.I. 2019/775, reg. 165 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 132); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 204(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 94