PART 11U.K.Pharmacovigilance

Recording, reporting and assessment of pharmacovigilance dataU.K.

Reporting obligations on the licensing authorityU.K.

186.—(1) The licensing authority must—

(a)when it receives a suspected adverse reaction report from a person mentioned in regulation 185(b), follow up the report with that person as appropriate;

(b)ensure that reports of suspected adverse reactions in the United Kingdom may be submitted to it, whether by the UK web-portal or by other means;

(c)collaborate with the EMA and the holders of authorisations or registrations in the detection of duplicates of suspected adverse reaction reports;

[F1(d)submit reports of serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i)a UKMA(NI),

(ii)a UKMA(UK),

(iii)a THR(NI),

(iv)a THR(UK), or

(v)an Article 126a authorisation,

to the EMA before the end of the period of 15 days beginning on the day following the day on which the report was received; and

(e)submit reports of non-serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i)a UKMA(NI),

(ii)a UKMA(UK),

(iii)a THR(NI),

(iv)a THR(UK), or

(v)an Article 126a authorisation,

to the EMA before the end of the period of 90 days beginning on the day following the day on which the report was received.]

(2) Paragraph (3) applies where the licensing authority has received a report of a suspected adverse reaction arising from an error associated with the use of a medicinal product.

(3) The licensing authority must (in addition to meeting the requirements in paragraph (1) in respect of the report) ensure that the report is made available to any statutory body with functions in relation to patient safety within the United Kingdom.

F2(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments