S.L. 437.47 Art. 69Reports of suspected serious adverse reactions andhumanadverse reactions to be made available to theAgency and the Member States.

(1) Making use of the data-processing network set up by the Agency, in collaboration with the European Commission, the

Veterinary Services shall ensure that reports of suspected serious adverse reactions and human adverse reactions, in accordance with the guidance referred to in regulation 70(1) and that have taken place on the territory are immediately made available to the

Agency and the other Member States, and in any case within fifteen calendar days of their notification, at the latest.

(2) The Veterinary Services shall ensure that reports of suspected serious adverse reactions and human adverse reactions, that have taken place on the territory are immediately made available to the marketing authorisation holder, and in any case within fifteen calendar days of their notification at the latest.