Federal Act
on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA)


Open article in different language:  DE  |  FR  |  IT
Art. 95 Transitional provisions

1 Re­gis­tra­tions of medi­cin­al products car­ried out by the FOPH, the FS­VO and by the In­ter­can­t­on­al Of­fice for the Con­trol of Medi­cin­al Products re­main val­id for up to five years after the com­mence­ment of this Act.

2 Can­ton­al au­thor­isa­tions for medi­cin­al products are val­id un­til 31 Decem­ber 2017; medi­cin­al products may be au­thor­ised by the Agency with­in two years of the ex­piry of the trans­ition­al peri­od.272 The fore­go­ing is without pre­ju­dice to:

a.
the re­voc­a­tion of an au­thor­isa­tion by the can­ton;
b.
the re­place­ment, on re­quest, of a can­ton­al au­thor­isa­tion by a mar­ket­ing au­thor­isa­tion is­sued by the Agency.

3 Re­quests for a mar­ket­ing au­thor­isa­tion for medi­cin­al products for which no au­thor­isa­tion was pre­vi­ously re­quired either un­der can­ton­al or fed­er­al le­gis­la­tion, but which must be au­thor­ised un­der this Act must be sub­mit­ted with­in one year of the com­mence­ment of this Act. Medi­cin­al products may con­tin­ue to be placed on the mar­ket un­til the Agency has reached a de­cision.

4 In vitro dia­gnostics may be placed on the mar­ket in ac­cord­ance with the former Act un­til 7 Decem­ber 2003. Li­cences and re­gis­tra­tions of in vitro dia­gnostics es­tab­lished in ac­cord­ance with the former Act shall be val­id un­til the ex­pir­a­tion of their valid­ity peri­od or for a max­im­um of three years from the com­mence­ment of this Act.

5 Au­thor­isa­tions is­sued by the Con­fed­er­a­tion and by the can­tons in ac­cord­ance with the former Act are val­id un­til the ex­piry of their valid­ity peri­od or for a max­im­um of five years from the com­mence­ment date of this Act.

6 Per­sons who do not sat­is­fy the pro­vi­sions re­lat­ing to the dis­pens­ing of medi­cin­al products (Art­icles 24 and 25) must cease to dis­pense them with­in sev­en years from the com­mence­ment of this Act. The Fed­er­al Coun­cil may, however, is­sue ex­emp­tions for per­sons who can prove that they have suf­fi­cient edu­ca­tion and train­ing.

7 The ad­min­is­trat­ive meas­ures taken by the Agency and re­ferred to in Art­icle 66 are re­served.

272 Amended by No I of the FA of 21 June 2013, in force since 1 Jan. 2014 (AS 2013 4137; BBl 2013 32813289).

BGE

132 II 200 () from 21. Februar 2006
Regeste: Art. 9 Abs. 1 und 2 lit. c, Art. 14 Abs. 1 lit. c HMG; zulassungsfreie Arzneimittel; Hausspezialitäten; eigene Formel. Grundsätzliche Zulassungspflicht für alle verwendungsfertigen Arzneimittel. Herstellung nach eigener Formel als Voraussetzung für die Ausnahme von der Zulassungspflicht gemäss Art. 9 Abs. 2 lit. c HMG (Hausspezialitäten in kleinen Mengen). Zum Merkmal der "eigenen" Formel. Zum Inhalt der Formel (Wirk- und Hilfsstoffe sowie Herstellungsanweisungen; E. 1.7-1.10).

Diese Seite ist durch reCAPTCHA geschützt und die Google Datenschutzrichtlinie und Nutzungsbedingungen gelten.

Feedback
Laden