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The Human Medicines Regulations 2012

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The Human Medicines Regulations 2012, Section 188 is up to date with all changes known to be in force on or before 17 February 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

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Reporting obligations on holdersU.K.

This section has no associated Explanatory Memorandum

188.—(1) [F1The holder of a UK marketing authorisation, traditional herbal registration or Article 126a authorisation] must in relation to the product [F2(including listed NIMAR products in Northern Ireland)]—

(a)submit electronically to the [F3licensing authority] a report on all serious suspected adverse reactions that occur in the [F4United Kingdom] and [F5countries other than the United Kingdom] before the end of the period of 15 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(b)submit electronically to the [F3licensing authority] a report on all non-serious suspected adverse reactions that occur in the [F6United Kingdom] before the end of the period of 90 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(c)establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

(d)collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the [F3licensing authority] by way of an update to the original report within the specified time period; and

(e)collaborate with the [F7licensing authority] in the detection of duplicates of suspected adverse reaction reports.

[F8(1A) The holder of [F9a UKMA(UK)(Category 2)], a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation must, in relation to the product—

(a)submit electronically to the Eudravigilance database a report on all serious suspected adverse reactions that occur in the UK and other countries before the end of the period of 15 days beginning on the day [F10following the day] on which the holder gained knowledge of the reaction;

(b)submit electronically to the Eudraviligance database a report on all non-serious suspected adverse reactions that occur in an EEA State or Northern Ireland before the end of the period of 90 days beginning on the day [F11following the day] on which the holder gained knowledge of the reaction;

(c)collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the Eudravigilance database by way of an update to the original report within the specified time period; and

(d)collaborate with the EMA and the competent authorities of the EEA States in the detection of duplicates of suspected adverse reaction reports.]

(2) The holder [F12of a UKMA(NI), [F13a UKMA(UK)(Category 2)], a THR(NI), a THR(UK) or an Article 126a authorisation] is not required to submit a report of a suspected adverse reaction to the product under [F14paragraph (1A)(a) or (b)], or to provide follow-up information under [F15paragraph (1A)(c)], where—

(a)the suspected adverse reaction relates to a medicinal product which contains a monitored active substance; and

(b)the suspected adverse reaction is recorded in a monitored publication.

(3) [F16Paragraph (4A)] applies to medicinal products containing a monitored active substance.

(4) The holder must—

(a)monitor medical literature F17... for reports of suspected adverse reactions to the product; and

(b)report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1).

[F18(4A) The holder of a UKMA(NI), [F19a UKMA(UK)(Category 2)], a THR(NI), a THR(UK) or an Article 126a authorisation must—

(a)monitor medical literature other than the monitored publications for reports of suspected adverse reactions to the product; and

(b)report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1A).]

(5) In this regulation—

F20...

F20...

“the specified time period” means—

(a)

in the case of serious adverse reactions, the period of 15 days beginning on the day following the day on which the follow up information became known to the holder; and

(b)

in the case of non-serious adverse reactions, the period of 90 days beginning on the day following the day on which the follow up information became known to the holder.

F21(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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