Regulation 205 Obligations on holders in relation to public announcements

(1)

This regulation applies where the holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product.

(2)

The holder must inform the bodies listed in paragraph (3) F1where the product is subject to a UKMA(NI), F2UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation, or the licensing authority where the product is subject to a UKMA(GB) F3, UKMA(UK)(Category 1) or THR(GB), of its intention to make the public announcement—

(a)

as soon as is practicable once it forms that intention; and

(b)

in any event no later than at the same time as, or before, the public announcement is made.

(3)

The bodies listed in this paragraph are—

(a)

the licensing authority;

(b)

the EMA; and

(c)

the European Commission.

(4)

The holder must ensure that the information in the public announcement—

(a)

is presented objectively; and

(b)

is not misleading.

Annotations

Textual amendments

F1: Words in reg. 205(2) inserted (31.12.2020) by S.I. 2019/775, reg. 166(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 133(a)); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 205(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 95(a)
F3: Words in reg. 205(2) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 95(b)