Regulation 188 Reporting obligations on holders

submit electronically to the F4licensing authority a report on all serious suspected adverse reactions that occur in the F5United Kingdom and F6countries 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;

submit electronically to the licensing authority a report on all non-serious suspected adverse reactions that occur in the F7United 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;

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

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;

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

collaborate with the F9licensing authority in the detection of duplicates of suspected adverse reaction reports.

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 F13following the day on which the holder gained knowledge of the reaction;

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 F14following the day on which the holder gained knowledge of the reaction;

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;

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

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

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

the suspected adverse reaction is recorded in a monitored publication.

monitor medical literature F22... for reports of suspected adverse reactions to the product; and

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

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

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