The Human Medicines Regulations 2012

Reporting obligations on holders

188.—(1) Subject to paragraph (2), the holder 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 EEA and third 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 Eudravigilance database a report on all non-serious suspected adverse reactions that occur in the EEA 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 Eudravigilance database by way of an update to the original report within the specified time period; and

(e) 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 is not required to submit a report of a suspected adverse reaction to the product under paragraph (1)(a) or (b), or to provide follow-up information under paragraph (1)(d), 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 (4) applies to medicinal products containing a monitored active substance.

(4) The holder 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 (1).

(5) In this regulation—

“monitored active substance” means an active substance on the list of active substances being monitored by the EMA published under Article 27 of Regulation (EC) No 726/2004;

“monitored publication” means a publication on the list of publications being monitored by the EMA published under Article 27 of Regulation (EC) No 726/2004; and

“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) This regulation is subject to regulation 212 (transitional arrangements).