Radiological Protection Ordinance
(RPO)

¹ For the pla­cing of products on the mar­ket and ad­min­is­tra­tion of ra­dio­phar­ma­ceut­ic­als in hu­mans, the pro­vi­sions of the TPA²⁴ ap­ply.

2 Ap­prov­al is re­quired from the FOPH for:

a.

the mar­ket­ing au­thor­isa­tion of ra­dio­phar­ma­ceut­ic­als in ac­cord­ance with Art­icle 9 para­graph 1 of the TPA;

b.

the sim­pli­fied au­thor­isa­tion of ra­dio­phar­ma­ceut­ic­als in ac­cord­ance with Art­icle 14 of the TPA;

c.

the au­thor­isa­tion of ra­dio­phar­ma­ceut­ic­als for a lim­ited peri­od in ac­cord­ance with Art­icle 9 para­graph 4 of the TPA.

³ The FOPH shall grant ap­prov­al based on the doc­u­ments re­ceived as part of the ap­plic­a­tion for au­thor­isa­tion, and on the as­sess­ment and reas­on­ing of the Ex­pert Com­mis­sion for Ra­dio­phar­ma­ceut­ic­als.

⁴ Ra­dio­phar­ma­ceut­ic­als must be la­belled as such. Their pack­age la­belling must in­clude at least the fol­low­ing ra­di­olo­gic­al pro­tec­tion-re­lated in­form­a­tion:

a.

the pre­par­a­tion name;

b.

the haz­ard warn­ing sym­bol in ac­cord­ance with An­nex 8;

c.

the ra­di­o­nuc­lides and their activ­ity at the time of cal­ib­ra­tion;

d.

the cal­ib­ra­tion time and the ex­piry time.

⁵For the la­belling, the pro­vi­sions of the medi­cin­al products le­gis­la­tion also ap­ply.

6 Long-lived ra­di­o­nuc­lide im­pur­it­ies rel­ev­ant to dis­pos­al must be in­dic­ated in the ac­com­pa­ny­ing doc­u­ments.