Commentaries: Art. 16a

The Agency shall revoke the authorisation for a medicinal product if:
1. it is not actually placed on the market within three years of the granting of the authorisation;
2. it is no longer actually on the market during a period of three successive years after it has been placed on the market.
The Federal Council may provide for exceptions from paragraph 1.
It may provide that, in the case of medicinal products for severe illnesses, injuries or disabilities or of medicinal products with a paediatric indication or for paediatric use, the authorisation is revoked before the period referred to in paragraph 1 has expired. It decides the duration of such periods and lays down the criteria for revocation.¹
If theholder of the marketing authorisation intends to cease marketing a medicinal product authorised for apaediatric indication or for paediatric use for which they have obtained protection under Article 11b paragraphs 3 and 4 of this Act or under Article 140n or 140t of the Patents Act of 25 June 1954², they shall publish that intention in an appropriate form.³
The holder of the marketing authorisation must state in the publication that they will transfer the authorisation documentation to third parties so they can obtain their own authorisation.⁴

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). ↩
SR 232.14 ↩
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). ↩
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). ↩

Art. 16a