Commentaries: Art. 64a

Competent foreign authorities shall, on notifying the Agency, be entitled to inspect Swiss establishments operating in the therapeutic products sector provided that:
1. the inspection has the sole purpose of verifying compliance with regulations on therapeutic products;
2. the results of the inspection are used solely in administrative proceedings in connection with the enforcement of regulations on therapeutic products;
3. the establishment concerned consents to the inspection; and
4. the foreign authority informs the Agency of the results by providing it with the inspection report in an official Swiss language or in English.
The Agency may accompany the foreign authority during its inspection.
It may in consultation with the competent authorities carry out inspections of establishments abroad that operate in the therapeutic products sector, if this is required to guarantee the protection of health. In addition, it may participate in inspections carried out by competent foreign authorities.¹

Second sentence inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961;BBl 2019 1). ↩

Art. 64a