812.121 Lescha federala dals 3 d'october 1951 davart ils narcotics e las substanzas psicotropas (Lescha da narcotics, LN)

812.121 Federal Act of 3 October 1951 on Narcotics and Psychotropic Substances (Narcotics Act, NarcA)

Art. 18f En connex cun medicaments da cannabis

1 Il UFSP maina in sistem d’infurmaziun per elavurar las datas tenor l’artitgel 8b.

2 Ils medis che tractan persunas cun medicaments da cannabis ston registrar las datas ch’èn necessarias per la retschertga da datas tenor l’artitgel 8b. Las datas dals pazients ston vegnir registradas en furma pseudonimisada.

3 Il Cussegl federal fixescha:

a.
las datas necessarias per la retschertga tenor l’artitgel 8b, en spezial er davart ils effects secundars;
b.
la frequenza ed il mument da la registraziun da las datas;
c.
ils dretgs d’access dals medis tenor l’alinea 2;
d.
ils aspects tecnics ed organisatorics dal sistem da la retschertga da datas;
e.
ils termins da conservaziun da las datas;
f.
la publicaziun da las evaluaziuns statisticas.

4 El po fixar ch’i na stoppian vegnir registradas naginas datas pli, sche novas datas n’èn betg pli necessarias per l’evaluaziun scientifica tenor l’artitgel 8b alinea 2.

87 Integrà tras la cifra I da la LF dals 19 da mars 2021, en vigur dal 1. d’avust 2022 fin ils 31 da fan. 2029 (AS 2022 385; BBl 2020 6069).

Art. 18f In connection with medicinal cannabis products

1 The FOPH shall operate an information system to process data under Article 8b.

2 Doctors who treat persons with medicinal cannabis products must record the data required for data collection under Article 8b. Data on patients must be recorded in pseudonymised form.

3 The Federal Council shall specify:

a.
the data required for data collection under Article 8b, in particular on side effects;
b.
the frequency and time of data collection;
c.
the doctors’ rights of access in accordance with paragraph 2;
d.
the technical and organisational aspects of the data collection system;
e.
the retention periods for the data;
f.
the publication of the statistical analyses.

4 It may stipulate that data need no longer be recorded if new data is no longer required for the scientific evaluation under Article 8b paragraph 2.

87 Inserted by No I of the FA of 19 March 2021, in force from 1 Aug. 2022 until 31 July 2029 (AS 2022 385; BBl 2020 6069).

 

Il presente documento non è una pubblicazione ufficiale. Fa unicamente fede la pubblicazione della Cancelleria federale. Ordinanza sulle pubblicazioni ufficiali, OPubl.
This document is not an official publication. Only the publication of the Federal Chancellery is legally binding.