Paragraph 14K F1

The licence holder must record all suspected adverse reactions to the MM medicinal product which are brought to the licence holder’s attention.

The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of the UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the MM medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction.