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Art. 58 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Official market surveillance
Legislator summary
AI generatedThe Agency and the other authorities entrusted with the enforcement of this Act shall monitor, within the limits of their powers, whether the manufacture, distribution, dispensing and maintenance of, and claims relating to therapeutic products are lawful. For this purpose, they may carry out announced and unannounced inspections. The Agency shall verify the therapeutic products placed on the market. It shall verify that the medicinal products conform to the marketing authorisation and that the medical devices satisfy the legal requirements. The Agency shall be responsible for monitoring the safety of therapeutic products. To this effect, it shall in particular collect the notifications referred to in Article 59, evaluate them, and take the necessary administrative measures. The Agency and the other authorities entrusted with the implementation of this Act may take samples, request essential information and documents, and ask for any help necessary for this purpose. Neither the samples nor any other kind of help will be compensated for. {note: 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).} In the course of their monitoring services, the cantons shall notify the Agency or the Federal Office of Public Health (FOPH) in accordance with their respective responsibilities of any events, findings or complaints. The Agency or the FOPH shall take the necessary administrative measures. The cantons may also take the necessary administrative measures in the case of a serious direct threat to health. {note: 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).}
Art. 58 TPA · Official market surveillance
The Agency and the other authorities entrusted with the enforcement of this Act shall monitor, within the limits of their powers, whether the manufacture, distribution, dispensing and maintenance of, and claims relating to therapeutic products are lawful. For this purpose, they may carry out announced and unannounced inspections.
The Agency shall verify the therapeutic products placed on the market. It shall verify that the medicinal products conform to the marketing authorisation and that the medical devices satisfy the legal requirements.
The Agency shall be responsible for monitoring the safety of therapeutic products. To this effect, it shall in particular collect the notifications referred to in Article 59, evaluate them, and take the necessary administrative measures.
The Agency and the other authorities entrusted with the implementation of this Act may take samples, request essential information and documents, and ask for any help necessary for this purpose. Neither the samples nor any other kind of help will be compensated for.
In the course of their monitoring services, the cantons shall notify the Agency or the Federal Office of Public Health (FOPH) in accordance with their respective responsibilities of any events, findings or complaints. The Agency or the FOPH shall take the necessary administrative measures. The cantons may also take the necessary administrative measures in the case of a serious direct threat to health.