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S.L. 437.47 · Veterinary Medicinal Products (S.L. 437.47)

S.L. 437.47 Art. 70Facilitation of exchange of information regarding pharmacovigilance

Title X

In KraftAmtlicher Text

(1) In order to facilitate the exchange of information about pharmacovigilance within the Director and the Member States, the

Veterinary Services, shall take due account of guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of veterinary pharmacovigilance information in accordance with internationally agreed terminology drawn up by the European Commission in consultation with the Agency, Member States and the interested parties.

(2) For the interpretation of the definitions referred to in regulation 2(10) to (16) and principles outlined in this title, the marketing authorisation holder and the Veterinary Services shall refer to the detailed guidance referred to in subregulation (1).