NLGeneTherapy object

Yes

(1) Heilmittelgesetz (HMG)/Therapeutic Products Act (TPA) (see also the non-official English translation - status 2014: HMG - Therapeutic Products Act (TPA), English version) and
(2) Humanforschungsgesetz (HFG)/Human Research Act (HRA) (see also the non-official English translation - status 2014: HFG - Human Research Act (HRA)
(3) Verordnung über klinische Versuche (KlinV)/Clinical Trials Ordinance (ClinO) (see also the non- official Englisch translation status 2014: KlinV - Clinical Trials Ordinance (ClinO)
(4) Arzneimittelbewilligungsverordnung (ABMV)

Due to the fact that gene therapy medicinal products are covered by the Heilmittelgesetz and the Clinical Trials Ordinance (ClinO) the legal procedure is generally the same as for medicinal products for human use. Exceptions and peculiarities for gene therapy to be found in Art 35 and Annexes 3 & 4 KlinV/ClinO.

(5) As a matter of principle Good Manufacturing Practice (GMP) is required for the manufacture of medicinal products for human use. The EC-GMP-Guideline covers this issue.

Further information is available on the Swissmedic website in section "swissmedic - Clinical trials/Clinical trials on transplant products/ gene therapy/ genetically modified organisms " (e.g. checklist for gene therapy and application form).