# The Human Medicines Regulations 2012, Regulation 188: Reporting obligations on holders


(1) Subject to paragraphs (1B) and (1C), the holder of a UK marketing authorisation, traditional herbal registration or Article 126a authorisation must in relation to the product (including listed NIMAR products in Northern Ireland)—
(a) submit electronically to the licensing authority a report on all serious suspected adverse reactions that occur in the United Kingdom and countries 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 licensing authority a report on all non-serious suspected adverse reactions that occur in the United 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;
(ca) in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available;
(d) collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the licensing authority by way of an update to the original report within the specified time period; and
(e) collaborate with the licensing authority in the detection of duplicates of suspected adverse reaction reports.
(1A) Subject to paragraphs (1B) and (1C), the holder of a 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 following 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 following the day on which the holder gained knowledge of the reaction;
(ba) in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available;
(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.
(1B) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.
(1C) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.
(2) The holder of a UKMA(NI), a 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 paragraph (1A)(a) or (b), or to provide follow-up information under paragraph (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) Paragraph (4A) applies to medicinal products containing a monitored active substance.
(4) The holder must—
(a) monitor medical literature ... 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).
(4A) The holder of a UKMA(NI), a 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—
...
...
“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.
(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/188 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-188
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.