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Art. 59 Mandatory notification, notification system and the right to notify
1 Any person manufacturing or distributing ready-to-use therapeutic products must put in place a system of notification. He must notify the Agency of any adverse event or reaction which:
2 Any person manufacturing or distributing therapeutic products must furthermore notify the Agency of any quality defects and any further findings and assessments which could influence the basis of evaluation. 3 Any person who professionally dispenses therapeutic products or administers them to humans or animals or who is entitled to do so as medical personnel must notify the Agency of any serious or previously unknown adverse effects and incidents, observations of other serious or previously unknown facts or quality defectsthat are of significance for drug safety.142 3bis Any person who manufactures or places on the market therapeutic products must report to the Agency any suspicion of illegal trading in therapeutic products by third parties that come to its knowledge in connection with its activities, its products or their components.143 4 Consumers, patients and their organisations as well as interested third parties, may notify the Agency for adverse events and reactions with therapeutic products. 5 The notifications referred to in paragraphs 1–3 shall be made in accordance with the recognised rules of good vigilance practice.144 6 The Federal Council shall define the recognised rules of good vigilance practice. It shall take into account internationally recognised guidelines and standards.145 7 Employees of persons and organisations who manufacture, distribute, prescribe or dispense therapeutic products are entitled to notify the competent authorities of observations that indicate a violation of the provisions of this Act.146 142 Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). 143 Inserted by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135). 144 Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). 145 Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). 146 Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). |