Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 458.35 · Pharmacovigilance Regulations (S.L. 458.35)

S.L. 458.35 Art. 21Recording suspected adverse reactions.

In KraftAmtlicher Text

The Authority shall record all suspected adverse reactions that occur in its territory which are brought to its attention from healthcare professionals and patients. The Authority shall involve patients and healthcare professionals, as appropriate, in the follow-up of any reports they receive in order to comply with the provisions of regulation 3(5) and (6).