NLGeneTherapy object

Yes

For clinical gene therapy:
• LVFS 2003:6 - The Medical Product Agency's provisions and guidelines on clinical trials of medicinal products for human use (see the unofficial English translation: LVFS 2003:6 English version)
Due to the fact that gene therapy medicinal products are covered by LVFS 2003:6 the legal procedure is generally the same as for medicinal products for human use (see chapter 1 guideline to 1 § of LVFS 2003:6).
Exceptions and peculiarities for gene therapy are provided in Chapter 5 5 § and 6 § of LVFS 2003:6 (EC review) and Chapter 3 guideline to 3 § of LVFS 2003:6 (Data protection).

If GMO are involved, the following regulations/ ordinances have to be additionally considered:

• SFS 2000:271 Genetically Modified Organisms (Contained Use) Ordinance
• SFS 2002:1086 Genetically Modified Organisms (Deliberate Release) Ordinance
• LVFS 2004:10: Medical Product Agency's Regulation on Deliberate Release of Medical Products Containing or Consisting of Genetically Modified Organisms
• SWEA Provisions/ Statute Book: AFS 2011:2 Contained Use of Genetically modified Micro-organisms (available in English).

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.